Letter – B - Drugonomy™

Bystolic

Sama Mohamed — Tue, 10 Feb 2026 23:07:17 +0000

What is Bystolic?

Bystolic belongs to a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Bystolic is used to treat hypertension (high blood pressure). Lowering blood pressure may lower your risk of a stroke or heart attack.

Bystolic may also be used for other purposes not listed in this medication guide.

Warnings

Do not skip doses or stop taking Bystolic without first talking to your doctor. Stopping suddenly may make your condition worse or cause other serious heart problems such as severe chest pain or heart attack. You may need to use less and less before you stop the medication completely. If you need surgery, tell the surgeon ahead of time that you are using Bystolic.

Bystolic may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Bystolic is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Keep using Bystolic as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Before taking this medicine

To make sure you can safely take Bystolic, tell your doctor if you have any of these other conditions:

severe liver disease; or
a heart problem such as heart block, sick sinus syndrome, slow heart rate, or heart failure.

If you have any of these other conditions, you may need a Bystolic dose adjustment or special tests:

asthma, bronchitis, emphysema;
liver or kidney disease;
diabetes;
a thyroid disorder;
a history of allergies;
problems with circulation (such as Raynaud’s syndrome);
pheochromocytoma (tumor of the adrenal gland); or
if you have recently had a heart attack.

FDA pregnancy category C. It is not known whether Bystolic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Bystolic. It is not known whether nebivolol passes into breast milk or if it could harm a nursing baby. Do not use Bystolic without telling your doctor if you are breast-feeding a baby.

How should I take Bystolic?

Take Bystolic exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take Bystolic at the same time every day. You may take the medication with or without food.

Your blood pressure will need to be checked often. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using Bystolic.

Bystolic is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Keep using Bystolic as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store Bystolic at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include slow heart rate, dizziness, vomiting, trouble breathing, or feeling like you might pass out.

What should I avoid?

Bystolic may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Bystolic side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Bystolic: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

feeling short of breath, even with mild exertion;
swelling of your ankles or feet;
slow or uneven heartbeats; or
numbness or cold feeling in your hands and feet.

Less serious Bystolic side effects may include:

headache;
tired feeling;
nausea, stomach pain;
diarrhea; or
sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Bystolic?

Tell your doctor about all other medicines you use, especially:

cimetidine (Tagamet);
clonidine (Catapres);
digitalis (digoxin, Lanoxin);
isoniazid (for treating tuberculosis);
methimazole (Tapazole);
reserpine;
ropinirole (Requip);
ticlopidine (Ticlid);
another beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;
an antibiotic such as terbinafine (Lamisil);
an antidepressant such as clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), fluoxetine (Prozac, Rapiflux, Sarafem, Selfemra, Symbyax), imipramine (Tofranil), paroxetine (Paxil, Pexeva), sertraline (Zoloft), or tranylcypromine (Parnate);
anti-malaria medication such as chloroquine (Aralen) or pyrimethamine (Daraprim), or quinine (Qualaquin);
heart or blood pressure medicine such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), clonidine (Catapres, Clorpres, Kapvay, Nexiclon), diltiazem (Cardizem, Cartia, Dilacor, Diltia, Diltzac, Taztia, Tiazac), nicardipine (Cardene), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan, Tarka), and others;
heart rhythm medicine such as amiodarone (Cordarone, Pacerone), quinidine (Quin-G), procainamide (Pronestyl), disopyramide (Norpace), flecaininde (Tambocor), mexiletine (Mexitil), propafenone, (Rythmol), and others;
HIV or AIDS medicine such as delavirdine (Rescriptor) or ritonavir (Norvir, Kaletra); or
medicine to treat psychiatric disorders, such as aripiprazole (Abilify), chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril).

Buspirone

Sama Mohamed — Tue, 10 Feb 2026 23:00:29 +0000

What is buspirone?

Buspirone is an anti-anxiety medicine that affects chemicals in the brain that may be unbalanced in people with anxiety.

Buspirone is used to treat symptoms of anxiety, such as fear, tension, irritability, dizziness, pounding heartbeat, and other physical symptoms.

Buspirone is not an anti-psychotic medication and should not be used in place of medication prescribed by your doctor for psychotic disorders.

Warnings

Do not use buspirone if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

Before taking this medicine

You should not use buspirone if you are allergic to it.

To make sure this medicine is safe for you, tell your doctor if you have any of these conditions:

kidney disease; or
liver disease.

Buspirone is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether buspirone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Buspirone is not FDA-approved for use by anyone younger than 18 years old, but this medicine has been used in children and adolescents under close medical supervision and at the appropriate dosage.

How should I take buspirone?

Take buspirone exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take buspirone with or without food but take it the same way each time.

Some buspirone tablets are scored so you can break the tablet into 2 or 3 pieces in order to take a smaller amount of the medicine at each dose. Do not use a tablet if it has not been broken correctly and the piece is too big or too small. Follow your doctor’s instructions about how much of the tablet to take.

If you have switched to buspirone from another anxiety medication, you may need to slowly decrease your dose of the other medication rather than stopping suddenly. Some anxiety medications can cause withdrawal symptoms when you stop taking them suddenly after long-term use.

This medication can cause false positive results with certain medical tests. You may need to stop using the medicine for at least 48 hours before your test. Tell any doctor who treats you that you are using buspirone.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol may increase certain side effects of buspirone.

Grapefruit and grapefruit juice may interact with buspirone and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Buspirone side effects

Get emergency medical help if you have any signs of an allergic reaction to buspirone: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

chest pain;
shortness of breath; or
a light-headed feeling, like you might pass out.

Common buspirone side effects may include:

headache;
dizziness, drowsiness;
sleep problems (insomnia);
nausea, upset stomach; or
feeling nervous or excited.

BuSpar

Sama Mohamed — Tue, 10 Feb 2026 22:55:47 +0000

What is BuSpar?

BuSpar is an anti-anxiety medicine that affects chemicals in the brain that may be unbalanced in people with anxiety.

BuSpar is used to treat anxiety disorders or the symptoms of anxiety, such as fear, tension, irritability, dizziness, pounding heartbeat, and other physical symptoms.

BuSpar is not an anti-psychotic medication and should not be used in place of medication prescribed by your doctor for mental illness.

BuSpar may also be used for purposes not listed in this medication guide.

Warnings

Do not use BuSpar if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

Before taking this medicine

You should not use BuSpar if you are allergic to buspirone.

To make sure BuSpar is safe for you, tell your doctor if you have any of these conditions:

kidney disease; or
liver disease.

BuSpar is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether buspirone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Buspirone is not FDA-approved for use by anyone younger than 18 years old, but has been used in children in adolescents under close medical supervision. Do not give buspirone to anyone younger than 18 years of age without consulting with a doctor.

How should I take BuSpar?

Take BuSpar exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take BuSpar with or without food but take it the same way each time.

Some BuSpar tablets are scored so you can break the tablet into 2 or 3 pieces in order to take a smaller amount of the medicine at each dose. Do not use a tablet if it has not been broken correctly and the piece is too big or too small. Follow your doctor’s instructions about how much of the tablet to take.

If you have switched to BuSpar from another anxiety medication, you may need to slowly decrease your dose of the other medication rather than stopping suddenly. Some anxiety medications can cause withdrawal symptoms when you stop taking them suddenly after long-term use.

Buspirone can cause false positive results with certain medical tests. You may need to stop using the medicine for at least 48 hours before your test. Tell any doctor who treats you that you are using BuSpar.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Although no deaths have been reported following BuSpar overdose, symptoms may include nausea, vomiting, dizziness, drowsiness or sleepiness, and stomach upset.

What should I avoid?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol may increase certain side effects of BuSpar.

Grapefruit and grapefruit juice may interact with buspirone and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

BuSpar side effects

Get emergency medical help if you have any signs of an allergic reaction to BuSpar: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

chest pain;
shortness of breath; or
a light-headed feeling, like you might pass out.

Common BuSpar side effects may include:

headache;
dizziness, drowsiness;
sleep problems (insomnia);
nausea, upset stomach; or
feeling nervous or excited.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect BuSpar?

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. The following medications can interact with BuSpar;

MAO Inihibitors (including isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine as well as methylene blue injection);
Amitriptyline;
Diazepam;
Haloperidol;
Nefazodone;
Trazodone;
Triazolam or flurazepam;
Diltiazem or verapamil;
Antibiotics, including erythromycin and rifampin;
Antifungals, including itraconazole; or
Cimetidine.

Bupropion

Sama Mohamed — Tue, 10 Feb 2026 22:50:09 +0000

What is bupropion?

Bupropion is an antidepressant medication used to treat depression and seasonal affective disorder, it also supports smoking cessation and weight management. Bupropion is the active ingredient in Wellbutrin and Zyban, Auvelity contains bupropion and dextromethorphan, and Contrave contains bupropion and naltrexone. Bupropion improves mood regulation and nicotine cravings and, when combined with naltrexone, helps reduce food intake.

Bupropion is thought to work by changing levels of certain chemicals in the brain, including noradrenaline and dopamine.

Bupropion first became an FDA-approved medicine on 30 December 1985.

What is bupropion used to treat?

The brands of bupropion are FDA-approved for specific conditions.

Wellbutrin SR is used to treat major depressive disorder.
Wellbutrin XL is used to treat MDD and seasonal affective disorder (SAD).
Zyban (discontinued) was used to help stop smoking.
Auvelity (bupropion with dextromethorphan) is used to treat MDD in adults.
Contrave (bupropion and naltrexone) is used for weight management for specific patients.

The information on this page is only about bupropion, and not bupropion with dextromethorphan (Auvelity) or bupropion with naltrexone (Contrave).

Bupropion side effects

Common bupropion side effects

The most common side effects may include:

dry mouth, sore throat, stuffy nose;
ringing in the ears;
blurred vision;
nausea, vomiting, stomach pain, loss of appetite, constipation;
sleep problems (insomnia);
tremors, sweating, feeling anxious or nervous;
fast heartbeats;
confusion, agitation, hostility;
rash;
weight loss;
increased urination;
headache, dizziness; or muscle or joint pain.

Serious bupropion side effects

Get emergency medical help if you have any of these signs of an allergic reaction to bupropion: (hives, itching, fever, swollen glands, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, depression, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

a seizure (convulsions);
confusion, unusual changes in mood or behavior;
blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
fast or irregular heartbeats; or
a manic episode – racing thoughts, increased energy, reckless behavior, feeling extremely happy or irritable, talking more than usual, severe problems with sleep.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not take bupropion if you have seizures, an eating disorder, or suddenly stopped using alcohol, seizure medication, or sedatives. You should not take two medicines together that contain bupropion for example, if you take Wellbutrin for depression, you should not also take Contrave for weight control.

Do not use bupropion within 14 days before or 14 days after you have used a MAO inhibitors , such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some young people (up to 24 years of age) have thoughts about suicide when first taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

You should know that your mental health may change in unexpected ways when you take bupropion or other antidepressants even if you are an adult over age 24 or if you do not have a mental illness and you are taking bupropion to treat a different type of condition. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

This medicine may cause seizures, especially in people with certain medical conditions or when using certain drugs. Tell your doctor about all of your medical conditions and the drugs you use.

Bupropion can cause mild pupillary dilation, which can lead to an episode of angle-closure glaucoma in susceptible individuals. Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.

Before taking this medicine

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not take this medicine if you are allergic to it or if you have ever had:

a seizure disorder;
an eating disorder such as anorexia or bulimia; or
if you have suddenly stopped using alcohol, seizure medication, or a sedative (such as Xanax, Valium, Fiorinal, Klonopin, and others).

Do not take this medicine to treat more than one condition at a time. If you take bupropion for depression, do not also take this medicine to quit smoking or for weight management.

Tell your doctor about all of your medical conditions and the drugs you use.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

a head injury, seizures, or brain or spinal cord tumor;
narrow-angle glaucoma;
heart disease, high blood pressure, or a heart attack;
diabetes;
kidney or liver disease (especially cirrhosis);
depression, bipolar disorder or other mental illness; or
if you drink alcohol.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using this medicine. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Pregnancy

Talk to your healthcare provider if you are pregnant or plan to become pregnant about the risk to your unborn baby. It is not known whether this medicine will harm an unborn baby. Tell your doctor right away if you become pregnant. Do not start or stop taking bupropion without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of this medicine on the baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed while taking this medicine. This medicine passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with this medicine.

How should I take bupropion?

Take bupropion exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Too much of this medicine can increase your risk of a seizure.

Do not crush, chew, or break tablets. Swallow the tablet whole.

Take bupropion with food if the medication upsets your stomach.

If you have trouble falling asleep or staying asleep, do not take tablets too close to bedtime.

Your doctor will probably start you on a low dose of this medicine and gradually increase your dose.

It may take 4 weeks or longer before you feel the full benefit of this medicine. Continue to take your tablets even if you feel well. Do not stop taking this medicine without talking to your doctor. Your doctor may decrease your dose gradually.

You should not change your dose or stop using bupropion suddenly unless you have a seizure while taking this medicine. Stopping suddenly can cause unpleasant withdrawal symptoms.

Ask your doctor how to stop using bupropion safely.

Some people taking bupropion have severe high blood pressure, especially when using a nicotine replacement product (patch or gum). Your blood pressure may need to be checked before and during treatment with this medicine.

This medicine can cause you to have a false positive drug screening test ( amphetamines). If you provide a urine sample for drug screening, tell the laboratory staff you are taking this medicine.

For smoking cessation.

If you take bupropion to help you stop smoking, you may continue to smoke for about 1 week after you start the medicine. Set a date to quit smoking during the second week of treatment. Talk to your doctor if you are having trouble quitting after you have used bupropion for at least 7 to 12 weeks.

Your doctor may prescribe a nicotine replacement product (such as patches or gum) to help you stop smoking. Start using the nicotine replacement product on the same day you stop (quit) smoking or using tobacco products.

You may have nicotine withdrawal symptoms when you stop smoking, including increased appetite, weight gain, trouble sleeping, trouble concentrating, slower heart rate, having the urge to smoke, and feeling anxious, restless, depressed, angry, frustrated, or irritated. These symptoms may occur with or without using medication such as bupropion.

Smoking cessation may also cause new or worsening mental health problems, such as depression.

Bupropion hydrochloride dosing information

Usual Adult Bupropion Dose for Depression:

Immediate-release tablets:

Initial dose: 100 mg orally twice a day, increase if necessary after 3 days to 100 mg orally three times a day.
Maintenance dose: 100 mg orally three times a day
Maximum dose: 450 mg/day in up to 4 divided doses; single doses should not exceed 150 mg
Immediate-release tablets should be given at least 6 hours apart.
Dose increases of the immediate-release tablet should not exceed 100 mg per day in a 3-day period.

Sustained-release tablets:

Initial dose: 150 mg orally once a day in the morning, increase if necessary after 3 days to 150 mg orally twice a day.
Maintenance dose: 150 mg orally twice a day
Maximum dose: 400 mg/day; maximum single dose should not exceed 200 mg
Sustained-release oral tablets should be given at least 8 hours apart

Extended-release tablets:

Initial dose: 150 mg orally once a day in the morning, increase if necessary after 4 days to 300 mg orally once a day.
Maintenance dose: 300 mg orally once a day
Maximum dose: 450 mg/day
Extended-release oral tablets should be given at least 24 hours apart

Comments:

So as not to exceed the maximum single dose of 150 mg for immediate-release tablets, a dose of 100 mg orally four times a day (using the 100 mg tablet) may be administered.
Patients who are taking 300 mg/day for at least 2 weeks (OR are currently taking 450 mg/day) of any formulation may be switched to the extended-release 450 mg dose.
Bupropion hydrobromide 174 mg oral tablet is equivalent to bupropion hydrochloride 150 mg.
Patients should be periodically reviewed to determine the need for maintenance treatment and the appropriate dose for such treatment.

Usual Adult Bupropion Dose for Seasonal Affective Disorder:

Extended-release tablets:

Initial dose: 150 mg orally once a day in the morning, increased if necessary after 7 days to 300 mg orally once a day
Maintenance dose: 150 to 300 mg orally once a day
Maximum dose: 300 mg/day

Comments:

Treatment should be initiated in the autumn prior to the onset of depressive symptoms, continued through the winter season, and discontinued in early spring.
If bupropion hydrochloride 300 mg orally per day is not tolerated, it should be reduced to 150 mg once a day before discontinuing treatment.
Patients taking bupropion hydrochloride 300 mg orally per day during the autumn-winter season should have their dose tapered to 150 mg once a day for 2 weeks prior to discontinuation.
The timing of initiation and treatment duration for seasonal affective disorder should be individualized according to the patient’s historical pattern of seasonal major depressive episodes.

Usual Adult Dose for Smoking Cessation:

Sustained-release tablets:

Initial dose: 150 mg orally once a day for 3 days, increased to 150 mg orally twice a day
Maintenance dose: 150 mg orally twice a day
Maximum dose: 300 mg/day; maximum single dose should not exceed 150 mg
Duration of therapy: 7 to 12 weeks

Comments:
Begin dosing one week before quit day; the target stop date should be set within the first 2 weeks of treatment, preferably in the second week.
There should be an interval of at least 8 hours between doses.
May be used with a nicotine transdermal system.
If there is no effect after 12 weeks, treatment should be discontinued; longer treatment should be guided by the relative benefits and risks for the individual patient.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of bupropion can be fatal. Overdose symptoms may include muscle stiffness, hallucinations, fast or uneven heartbeat, shallow breathing, or fainting.

What to avoid

Drinking alcohol with bupropion may increase your risk of seizures. If you drink alcohol regularly, talk with your doctor before changing the amount you drink. This medicine can also cause seizures in people who drink a lot of alcohol and then suddenly quit drinking when they start using the medication.

Bupropion may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What other drugs will affect bupropion?

You may have a higher risk of seizures if you use certain other medicines while taking bupropion.

Many drugs can interact with bupropion. Tell your doctor about all medicines you use, and those you start or stop using during your treatment. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Some examples of drugs that interact with bupropion are:

Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels
MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with this medication.
Drugs that lower seizure threshold: Dose bupropion with caution.
Medicines that are CYP2B6 inducers: Dose increase may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) based on clinical response, but should not exceed the maximum recommended dose.
Medicines metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can increase concentrations of antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, flecainide). A dose reduction of these medicines may be considered when used with bupropion.
Dopaminergic drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with this medicine.

Buprenorphine/naloxone (Oromucosal, Sublingual)

Sama Mohamed — Tue, 10 Feb 2026 22:44:14 +0000

Uses for buprenorphine/naloxone

Buprenorphine and naloxone sublingual tablet is used to treat opioid (narcotic) dependence or addiction. Buprenorphine and naloxone buccal film, sublingual film, or sublingual tablet is used for induction and maintenance treatment of opioid (narcotic) dependence. It should be used in patients who have already been treated with buprenorphine sublingual tablets.

When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects if the narcotic is stopped suddenly. Severe withdrawal side effects can usually be prevented when a person is switched to buprenorphine and naloxone combination. It acts on the central nervous system (CNS) to help prevent the withdrawal side effects.

This medicine is available only with your doctor’s prescription.

Before using buprenorphine/naloxone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of buprenorphine and naloxone buccal film, sublingual film, or sublingual tablet in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of buprenorphine and naloxone combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine and naloxone combination.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil
Cisapride
Dronedarone
Fluconazole
Ketoconazole
Levoketoconazole
Mesoridazine
Nalmefene
Naltrexone
Pimozide
Piperaquine
Posaconazole
Safinamide
Samidorphan
Saquinavir
Sparfloxacin
Terfenadine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide
Acepromazine
Aclidinium
Adagrasib
Alfentanil
Alfuzosin
Almotriptan
Alprazolam
Amantadine
Amiloride
Amineptine
Amiodarone
Amisulpride
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amprenavir
Anagrelide
Anileridine
Apalutamide
Apomorphine
Aprepitant
Aripiprazole
Aripiprazole Lauroxil
Armodafinil
Arsenic Trioxide
Asenapine
Astemizole
Atazanavir
Atropine
Azithromycin
Baclofen
Bedaquiline
Belladonna
Bemetizide
Bendroflumethiazide
Benperidol
Bentazepam
Benzhydrocodone
Benzphetamine
Benzthiazide
Benztropine
Biperiden
Boceprevir
Bosentan
Bromazepam
Bromopride
Brompheniramine
Bumetanide
Bupropion
Buserelin
Buspirone
Butabarbital
Butorphanol
Calcium Oxybate
Cannabidiol
Cannabis
Canrenoate
Canrenone
Carbamazepine
Carbinoxamine
Cariprazine
Carisoprodol
Carphenazine
Cenobamate
Ceritinib
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chloroquine
Chlorothiazide
Chlorpheniramine
Chlorpromazine
Chlorthalidone
Chlorzoxazone
Cimetidine
Ciprofloxacin
Citalopram
Clarithromycin
Clemastine
Clidinium
Clobazam
Clofazimine
Clomipramine
Clonazepam
Clopamide
Clopidogrel
Clorazepate
Clothiapine
Cloxazolam
Clozapine
Cobicistat
Cocaine
Codeine
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclopenthiazide
Cyclopentolate
Cyclosporine
Cyclothiazide
Cyproheptadine
Dabrafenib
Dantrolene
Daridorexant
Darifenacin
Darunavir
Dasatinib
Degarelix
Delamanid
Delavirdine
Delorazepam
Desipramine
Deslorelin
Desmopressin
Desvenlafaxine
Deutetrabenazine
Dexamethasone
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diacetylmorphine
Diazepam
Diazoxide
Dibenzepin
Dichloralphenazone
Dicyclomine
Difenoxin
Diltiazem
Dimenhydrinate
Diphenhydramine
Diphenoxylate
Dipyrone
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Doxylamine
Droperidol
Duloxetine
Duvelisib
Ebastine
Efavirenz
Elagolix
Eletriptan
Encorafenib
Enflurane
Entrectinib
Enzalutamide
Eplerenone
Eribulin
Erythromycin
Escitalopram
Esketamine
Eslicarbazepine Acetate
Estazolam
Eszopiclone
Ethacrynic Acid
Ethchlorvynol
Ethopropazine
Ethylmorphine
Etozolin
Etrasimod
Etravirine
Famotidine
Felbamate
Fenfluramine
Fentanyl
Fesoterodine
Fexinidazole
Fingolimod
Flavoxate
Flecainide
Flibanserin
Flunitrazepam
Fluoxetine
Fluphenazine
Flurazepam
Fluspirilene
Fluvoxamine
Formoterol
Fosamprenavir
Fosaprepitant
Foscarnet
Fosnetupitant
Fosphenytoin
Fospropofol
Fostemsavir
Frovatriptan
Furosemide
Gabapentin
Gabapentin Enacarbil
Galantamine
Gatifloxacin
Gemifloxacin
Gepirone
Glasdegib
Glycopyrrolate
Glycopyrronium Tosylate
Gonadorelin
Goserelin
Granisetron
Halazepam
Halofantrine
Haloperidol
Halothane
Hexobarbital
Histrelin
Homatropine
Hydrochlorothiazide
Hydrocodone
Hydroflumethiazide
Hydromorphone
Hydroquinidine
Hydroxyamphetamine
Hydroxychloroquine
Hydroxytryptophan
Hydroxyzine
Hyoscyamine
Ibutilide
Idelalisib
Iloperidone
Imatinib
Imipramine
Indapamide
Indinavir
Inotuzumab Ozogamicin
Ipratropium
Isocarboxazid
Isoflurane
Itraconazole
Ivabradine
Ivacaftor
Ivosidenib
Josamycin
Ketamine
Ketazolam
Ketobemidone
Lacosamide
Lapatinib
Larotrectinib
Lasmiditan
Lefamulin
Lemborexant
Lenacapavir
Lenvatinib
Lesinurad
Letermovir
Leuprolide
Levocetirizine
Levofloxacin
Levomilnacipran
Levorphanol
Linezolid
Lisdexamfetamine
Lithium
Lofepramine
Lofexidine
Lomitapide
Lonafarnib
Lopinavir
Loprazolam
Lorazepam
Lorcaserin
Lorlatinib
Lormetazepam
Loxapine
Lumacaftor
Lumefantrine
Lurasidone
Macimorelin
Magnesium Oxybate
Meclizine
Medazepam
Mefloquine
Melitracen
Melperone
Mepenzolate
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Metaclazepam
Metaxalone
Methadone
Methamphetamine
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Methyclothiazide
Methylene Blue
Metoclopramide
Metolazone
Metronidazole
Mibefradil
Midazolam
Mifepristone
Milnacipran
Mirtazapine
Mitotane
Mizolastine
Mobocertinib
Modafinil
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Nafarelin
Nafcillin
Nalbuphine
Naldemedine
Naloxegol
Naratriptan
Nefazodone
Nelfinavir
Netupitant
Nevirapine
Nicomorphine
Nilotinib
Nitrazepam
Nitrous Oxide
Nordazepam
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Olanzapine
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Osilodrostat
Osimertinib
Oxaliplatin
Oxazepam
Oxcarbazepine
Oxitropium Bromide
Oxybutynin
Oxycodone
Oxymorphone
Ozanimod
Pacritinib
Palbociclib
Paliperidone
Palonosetron
Panobinostat
Papaveretum
Papaverine
Paregoric
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Pentazocine
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Phenelzine
Phenobarbital
Phenytoin
Pimavanserin
Pinazepam
Pipamperone
Pipenzolate Bromide
Piperacetazine
Pipotiazine
Pirenzepine
Piretanide
Piritramide
Pitolisant
Polythiazide
Ponesimod
Potassium Oxybate
Prazepam
Prednisone
Pregabalin
Primidone
Probucol
Procainamide
Procarbazine
Prochlorperazine
Procyclidine
Promazine
Promethazine
Propafenone
Propantheline
Propiverine
Propofol
Protriptyline
Quazepam
Quetiapine
Quinethazone
Quinidine
Quinine
Quizartinib
Ramelteon
Ranitidine
Ranolazine
Rasagiline
Relugolix
Remifentanil
Remimazolam
Remoxipride
Ribociclib
Rifabutin
Rifampin
Rifapentine
Risperidone
Ritonavir
Rizatriptan
Ropeginterferon Alfa-2b-njft
Schisandra sphenanthera
Scopolamine
Secobarbital
Selegiline
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Sibutramine
Siponimod
Sodium Oxybate
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
Spironolactone
St John’s Wort
Stramonium
Sufentanil
Sulpiride
Sultopride
Sumatriptan
Sunitinib
Suvorexant
Tacrolimus
Tamoxifen
Tapentadol
Telaprevir
Telavancin
Telithromycin
Telotristat Ethyl
Temazepam
Terodiline
Tetrabenazine
Tetrazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Thiothixene
Tianeptine
Tilidine
Tiotropium
Tizanidine
Tolonium Chloride
Tolterodine
Topiramate
Toremifene
Torsemide
Tramadol
Tranylcypromine
Trazodone
Treosulfan
Triamterene
Triazolam
Trichlormethiazide
Triclabendazole
Trifluoperazine
Trifluperidol
Triflupromazine
Trihexyphenidyl
Trimeprazine
Trimipramine
Triptorelin
Troleandomycin
Tropicamide
Trospium
Tryptophan
Tucatinib
Umeclidinium
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Verapamil
Vilanterol
Vilazodone
Vinflunine
Voclosporin
Voriconazole
Vorinostat
Vortioxetine
Voxelotor
Xipamide
Zaleplon
Ziprasidone
Zolmitriptan
Zolpidem
Zopiclone
Zotepine
Zuclopenthixol
Zuranolone

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Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Clonidine
Yohimbine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper use of buprenorphine/naloxone

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you are using the buccal film:

Use your tongue to wet the side of your cheek or rinse your mouth with water in the area where you will place the film.
Do not cut or tear the film. Hold the film on a clean, dry finger. If you are using Bunavail®, hold with the text (BN2, BN4, or BN6) facing up.
Place the side of the film against the inside of your cheek. If you are using Bunavail®, place with the text (BN2, BN4, or BN6) against the inside of your cheek.
Press the film and hold it there for 5 seconds.
Leave the film in place until it dissolves. Do not touch, move, chew, or swallow it.
If you must use more than one film, place the second film on the other side of your mouth. Do not place more than 2 buccal films to the inside of one cheek at a time.
Do not eat or drink anything until the film is completely dissolved.
After the film has completely dissolved, take a sip of water, swish gently around your teeth and gums, and swallow. Wait at least one hour before brushing your teeth.

If you are using the sublingual tablet:

Do not cut, crush, chew, or swallow it.
Place the tablet under the tongue until it is dissolved.
If you take 2 or more tablets at a time, place all of the tablets in different places under the tongue at the same time.
If this is uncomfortable, place 2 tablets at a time under the tongue and repeat the process until all the tablets have been taken.
Do not eat or drink anything until the tablets are completely dissolved.
Rinse your mouth with water and swallow. Wait at least one hour before brushing your teeth.

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If you are using the sublingual film:

Drink water before taking this medicine to help moisten your mouth.
Place the film under the tongue until it is dissolved.
If you need to take an additional film, place the new film on the opposite side from the first film.
Do not eat or drink anything until the film is completely dissolved.
Do not cut, chew, swallow, or move the film after placing it under the tongue.
After the film has completely dissolved, take a sip of water, swish gently around your teeth and gums, and swallow. Wait at least one hour before brushing your teeth.

Check with your doctor first before changing dosage forms (eg, films, tablets) or dosage strengths. These forms are very different from each other.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For buccal dosage form (film):
- For induction treatment of opioid dependence:
  - Adults—On Day 1, your doctor may give you an induction dosage up to 4.2 milligrams (mg) of buprenorphine and 0.7 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 8.4 mg of buprenorphine and 1.4 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting, or long-acting opioid medicines, your doctor may recommend you to take buprenorphine alone.
  - Children—Use and dose must be determined by your doctor.
- For maintenance treatment of opioid dependence:
  - Adults—8.4 milligrams (mg) of buprenorphine and 1.4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
  - Children—Use and dose must be determined by your doctor.
For buccal or sublingual dosage form (film):
- For induction treatment of opioid dependence:
  - Adults—On Day 1, your doctor may give you an induction dosage up to 8 milligrams (mg) of buprenorphine and 2 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 16 mg of buprenorphine and 4 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting, or long-acting opioid medicines, your doctor may recommend you to take buprenorphine alone.
  - Children—Use and dose must be determined by your doctor.
- For maintenance treatment of opioid dependence:
  - Adults—16 milligrams (mg) of buprenorphine and 4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
  - Children—Use and dose must be determined by your doctor.
For sublingual dosage form (tablets):
- For induction treatment of opioid dependence:
  - Adults—On Day 1, your doctor may give you an induction dosage up to 5.7 milligrams (mg) of buprenorphine and 1.4 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 11.4 mg of buprenorphine and 2.9 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting or long-acting opioid medicines, your doctor may recommend you take buprenorphine alone.
  - Children—Use and dose must be determined by your doctor.
- For maintenance treatment of opioid dependence:
  - Suboxone®:
    - Adults—16 milligrams (mg) of buprenorphine and 4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
    - Children—Use and dose must be determined by your doctor.
  - Zubsolv®:
    - Adults—11.4 milligrams (mg) of buprenorphine and 2.9 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
    - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Precautions while using buprenorphine/naloxone

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused films or tablets in a safe and secure place. People who are addicted to drugs might want to steal this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Using too much of this medicine may cause an overdose, which can be life-threatening. Symptoms of an overdose include: blurred vision, confusion, difficult or trouble breathing, dizziness, faintness, or lightheadedness when getting up suddenly from a lying position or sitting position, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils, sleepiness, sweating, unusual tiredness or weakness. In case of an overdose, call your doctor right away. Your doctor may also give naloxone to treat an overdose.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

This medicine may cause serious tooth problems. Tell your doctor right away if you have cavities, tooth decay, tooth pain, tooth infection, tooth erosion, tooth fracture, or tooth loss. Schedule regular dental checkups while taking this medicine.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Serious unwanted effects can occur if certain medicines are given together with buprenorphine and naloxone combination.

This medicine will add to the effects of alcohol and other CNS depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the medicines listed above while you are using this medicine.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Using this medicine while you are pregnant may cause neonatal opioid withdrawal syndrome in your newborn baby. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

This medicine may cause adrenal insufficiency. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, hives, itching, hoarseness, trouble with breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Do not suddenly stop using it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, including anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble with sleeping.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of buprenorphine/naloxone

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Chills
cough
feeling faint, dizzy, or lightheaded
feeling of warmth or heat
fever
flushing or redness of the skin, especially on the face and neck
headache
hoarseness
lower back or side pain
painful or difficult urination
sweating

Incidence not known

Agitation
bloating or swelling of the face, arms, hands, lower legs, or feet
chest tightness
darkening of the skin
diarrhea
difficulty swallowing
dizziness
fainting
fast heartbeat
hives, itching, skin rash
loss of appetite
mental depression
nausea
overactive reflexes
poor coordination
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid weight gain
restlessness shivering talking or acting with excitement you cannot control
tingling of the hands or feet
toothache
trembling or shaking twitching
unusual weight gain or loss
vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision
confusion
difficult or trouble breathing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
irregular, fast, slow, or shallow breathing
pale or blue lips, fingernails, or skin
pinpoint pupils
relaxed and calm feeling
sleepiness
unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty having a bowel movement
lack or loss of strength
stomach pain
trouble sleeping

Less common

Back pain
diarrhea
runny or stuffy nose
sneezing

Incidence not known

Burning or sore mouth
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings inside the mouth
decline or loss of libido or sexual desire
irritability
mood swings
poor concentration
redness, swelling, or soreness of the tongue
reduced muscle strength
swelling, inflammation, or redness of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Commonly used brand name(s)

In the U.S.

Cassipa
Suboxone
Zubsolv

Available Dosage Forms:

Tablet
Film

Buprenorphine

Sama Mohamed — Tue, 10 Feb 2026 22:33:00 +0000

What is buprenorphine?

Buprenorphine is an opioid medication used to treat opioid use disorder (OUD), acute pain, and chronic pain.

Buprenorphine is used for opioid addiction to reduce cravings and withdrawal symptoms without causing euphoria or dangerous side effects and helps prevent relapse. It works by being a substitute for the drug being abused, so the patient has minimal discomfort, which allows the patient to focus on their recovery. Buprenorphine for OUD is used as part of a complete treatment program that also includes counseling and behavioral therapy.

For opioid use disorder, buprenorphine is available as long-acting injections (Sublocade, Brixadi) and sublingual tablets (Subutex discontinued, generics available).

Buprenorphine is used to treat acute pain that is severe enough to require an opioid analgesic and moderate to severe chronic pain that is not controlled by other medicines. For chronic around-the-clock pain, it is available as buprenorphine skin patches (Butrans) and buprenorphine buccal films (Belbuca), and for acute pain is available as an injection (Buprenex).

Buprenorphine-naloxone combinations are also available to be used for opioid addication and include sublingual film (Bunavail), sublingual film and sublingual tablets (Suboxone), and sublingual tablets (Zubsolv).

Buprenorphine’s mechanism of action is that is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor.

Is buprenorphine a controlled substance?

Yes, buprenorphine is a Schedule III controlled drug, which means it has a potential for abuse more than those in Schedules 4 and 5. If abused, it may lead to moderate or low physical dependence or high psychological dependence.

Warnings

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep buprenorphine in a place where others cannot get to it.
Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose. Patients should have access to naloxone to treat opioid overdose based on the patient’s risk factors for overdose, such as currently using a CNS depressant, a history of an opioid use disorder, or previous opioid overdose. Having naloxone available is important if the patient has household members (including children) or other close contacts at risk for accidental exposure or overdose.

Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medication with alcohol or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use this medicine if you are allergic to buprenorphine or:

If you have used another narcotic drug within the past 4 hours.

To make sure this medication is safe for you, tell your doctor if you have ever had:

methadone treatment;
breathing problems, sleep apnea;
abnormal curvature of the spine that affects breathing;
liver disease (especially hepatitis B or C);
kidney disease;
enlarged prostate, urination problems;
a head injury or brain tumor;
alcoholism, hallucinations, mental illness; or
problems with your stomach, gallbladder, adrenal gland, or thyroid.

Pregnancy

If you use buprenorphine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Infertility

Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible

Breastfeeding

Buprenorphine can pass into breast milk and may cause drowsiness and breathing problems in a nursing baby. Ask your doctor about any risk to your baby.

How should I take buprenorphine?

Use buprenorphine exactly as it was prescribed for you. Follow the directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Never use this medication in larger amounts, or for longer than prescribed.

Opioid Use Disorder

Buprenorphine Sublingual (for OUD)

Buprenorphine sublingual is usually taken only at the start of treatment for addiction (induction phase). Most people are later switched to long-acting buprenorphine (Sublocade injection or Brixadi injection) or another medicine that contains buprenorphine with naloxone (Bunavail, Suboxone, Zubsolv). You may receive your first doses of buprenorphine sublingual in a hospital or clinic setting until your condition improves. Use dry hands when handling the tablet. Place the tablet under your tongue and allow it to dissolve with your mouth closed. Do not chew the tablet or swallow it whole. If your doctor has prescribed more than 2 tablets per dose, place the correct number of tablets under your tongue at the same time and allow them to dissolve completely. Do not eat or drink anything until the tablet has completely dissolved in your mouth. Never crush or break a pill to inhale the powder or mix it into a liquid to inject the drug into your vein. Doing so could result in death.

Extended-release buprenorphine subcutaneous injection (for OUD)

Buprenorphine extended-release injection is given subcutaneously (just under the skin). Sublocade and Brixadi can be given in the abdomen, thigh, buttock, or the back of the upper arm.

Sublocade should only be used when patients have received treatment with at least one dose (eg, 4 mg) of an oral transmucosal (used under the tongue or inside the cheek) buprenorphine-containing medicine. Sublocade is injected as a liquid. After the injection, Sublocade changes to a solid form called a depot. The depot may be seen or felt as a small bump under your skin at the injection site on your abdomen, thigh, buttock, or back of the upper arm, for several weeks. The depot will get smaller over time. Do not try to remove the depot, and do not rub or massage the injection site. Sublocade is part of a complete treatment plan that should include counseling.

Brixadi should only be used if you are currently receiving buprenorphine treatment or if your healthcare provider has given you a test dose of buprenorphine first to see if you are able to tolerate it. If you are new to Brixadi treatment, the upper arm should only be used after 4 doses of Brixadi in your buttock, thigh, or stomach. Brixadi is injected as a liquid; after the injection, the liquid changes to a gel form called a depot. The depot is not always felt under the skin. Do not try to remove the depot. Brixadi is part of a complete treatment plan that should include counseling.

Pain

Buprenex (buprenorphine injection) is used for pain, it is given by deep intramuscular or slow (over at least 2 minutes) intravenous injection at up to 6-hour intervals, as needed.

Butrans skin patch is used for chronic around-the-clock pain. It is applied once a week and worn continuously for 1 week. Do not change your dose. Apply Butrans exactly as prescribed by your healthcare provider. Your doctor will prescribe you the lowest effective dose for the shortest time needed. Do not take hot baths or sunbathe, use hot tubs, saunas, heating pads, electric blankets, heated waterbeds, or tanning lamps as these can cause an overdose that can lead to death.

Belbuca buccal films are used for around-the-clock treatment of moderate to severe chronic pain. Using a finger, place the yellow side of the Belbuca buccal film against the inside of your moistened cheek. Press and hold the Belbuca buccal film in place for 5 seconds and then take your finger away. Once in place, the film will dissolve completely in about 30 minutes. Do not eat or drink anything until the Belbuca film has completely dissolved in your mouth. Rinse your mouth with water after the medicine dissolves. Wait one hour after the film dissolves to brush your teeth to prevent damage to the teeth and gums. Do not chew the Belbuca film or swallow it whole. You should receive regular dental checkups while using Belbuca.

General information about using this medicine.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

You may need frequent blood tests to check your liver function.

If you need surgery, tell the surgeon ahead of time that you are using this medicine.

Any medical care provider who treats you should know that you are being treated for opioid addiction and that you are on buprenorphine. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.

Do not stop using this medication suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep track of your medicine. Buprenorphine is a drug of abuse, and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

For detailed dosing information click the link below.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . A buprenorphine overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Overdose symptoms may include extreme drowsiness or weakness, cold or clammy skin, pinpoint pupils, slow heart rate, weak pulse, very slow breathing, or coma.

What to avoid

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how buprenorphine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Buprenorphine side effects

Get emergency medical help if you have signs of an allergic reaction to buprenorphine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

opioid withdrawal symptoms – shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain;
noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
slow heartbeat or weak pulse;
a light-headed feeling, like you might pass out;
chest pain, trouble breathing;
low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
liver problems – nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common buprenorphine side effects may be more likely to occur, such as:

constipation, nausea, vomiting;
headache;
increased sweating;
sleep problems (insomnia); or
pain anywhere in your body.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect buprenorphine?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Buprenorphine can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
other narcotic medications – opioid pain medicine or prescription cough medicine;
a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
drugs that affect serotonin levels in your body – a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

Buprenex Injection

Sama Mohamed — Tue, 10 Feb 2026 22:24:01 +0000

What is Buprenex?

Buprenex is an opioid medicine used to treat moderate to severe pain in adults and children at least 2 years old. An opioid is sometimes called a narcotic.

Buprenex Injection is used to relieve moderate pain that is severe enough to require an opiate pain killer and for which other medicines (e.g., non-opiate pain killers or opiate-containing combination medicines) have not been, or are not expected to be sufficient.

Buprenorphine belongs to a class of medications called opiate partial agonists. Buprenex works by changing the way the body senses pain.acute pain.

This medication guide provides information about the Buprenex brand of buprenorphine injection. Sublocade is another brand of buprenorphine injection used to treat opioid addiction.

Buprenex side effects

Get emergency medical help if you have signs of an allergic reaction to Buprenex: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

To make sure Buprenex is safe for you, tell your doctor if you have ever had:

confusion, cold and clammy skin, slow breathing (breathing may stop);
feeling light-headed;
fast or uneven heart rate, shortness of breath;
blue lips or fingernails; or
severe constipation.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Common Buprenex side effects may include:

drowsiness, slow breathing;
nausea, vomiting;
dizziness, vertigo (spinning sensation);
pinpoint pupils;
increased sweating; or
headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Buprenex may be habit-forming. Misuse can cause addiction, overdose, or death.

Using Buprenex during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use Buprenex if you are allergic to buprenorphine, or if you have:

severe asthma or breathing problems; or
a stomach or bowel obstruction (including paralytic ileus).

To make sure Buprenex is safe for you, tell your doctor if you have ever had:

chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
a head injury, brain tumor, high pressure inside the skull, or seizures;
problems with your bile duct, gallbladder, pancreas, thyroid, or adrenal gland;
heart problems, an electrolyte imbalance (such as low blood levels of potassium or magnesium);
a drug or alcohol addiction, or mental illness;
enlarged prostate, urination problems;
curvature of the spine that affects breathing; or
liver or kidney disease.

Tell your doctor if you also use stimulant medicine, other opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with buprenorphine could cause a serious condition called serotonin syndrome.

If you use buprenorphine during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Do not breastfeed. Buprenorphine in breast milk can cause life-threatening side effects in a nursing baby.

How is Buprenex given?

Buprenex is injected into a muscle or given as an infusion into a vein. A healthcare provider will give you this injection. Buprenex is usually given by injection only if you are unable to take the medicine by mouth or use another form of buprenorphine.

Buprenex is usually given at evenly spaced intervals, up to 6 hours apart. Tell your doctor if Buprenex does not relieve your pain within 1 hour after an injection.

Buprenex can cause irritation if it gets on your skin. If this occurs, remove any clothing the medicine has spilled onto, and rinse your skin with water.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely. You may need other medical tests.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Dosing information

Usual Adult Dose of Buprenex for Pain:

Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat this dose once after 30 to 60 minutes if needed; then, 0.3 mg IV/IM every 6 hours as needed
-A single 0.6 mg IM dose may be given to patients who are not in a high risk category (see Warnings)
Maximum single dose: 0.3 mg (IV) or 0.6 mg (IM)

Usual Pediatric Dose of Buprenex for Pain:

2 to 12 years:
Initial dose: 2 to 6 mcg/kg IM or slow IV every 4 to 6 hours
-Some patients may not need to be remedicated for 6 to 8 hours; fixed interval or round the clock dosing should not be used until the proper inter-dose interval has been established

Over 12 years:
Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat this dose once after 30 to 60 minutes if needed; then, 0.3 mg IV/IM every 6 hours as needed
Maximum single dose: 0.3 mg

Comments:
-Use extra caution with IV administration, especially the first dose.
-Monitor closely for respiratory depression, especially within the first 24 to 72 hours.
-Use the lowest effective dose for the shortest duration consistent with the individual patient’s treatment goals.

Use: For the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

What happens if I miss a dose?

In a medical setting you are not likely to miss a dose.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving Buprenex?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how Buprenex will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

What other drugs will affect Buprenex?

You may have a fatal buprenorphine overdose if you start or stop using certain other medicines. Tell your doctor about all your medications.

Many other drugs can be dangerous when used with opioid medicine. Tell your doctor if you also use:

medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;
other opioid medicines;
a benzodiazepine sedative like Valium, Klonopin, or Xanax; or
sleep medicine, muscle relaxers, or other drugs that make you drowsy.

Bupivacaine

Sama Mohamed — Tue, 10 Feb 2026 22:17:00 +0000

What is bupivacaine?

Bupivacaine is an anesthetic (numbing medicine) that is used as a local (in only one area) anesthetic.

Bupivacaine is given as an epidural injection into the spinal column to produce numbness during labor, surgery, or certain medical procedures.

Bupivacaine is also used as an anesthetic for dental procedures.

Bupivacaine may also be used for purposes not listed in this medication guide.

Bupivacaine side effects

Get emergency medical help if you have signs of an allergic reaction: hives, red rash, itching; sneezing, difficulty breathing; severe dizziness, vomiting; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

feeling anxious, restless, confused, dizzy, drowsy, or like you might pass out;
ringing in your ears, problems with speech or vision;
metallic taste in your mouth, numbness or tingling around your mouth;
muscle twitching, tremors, seizure (convulsions);
weak or shallow breathing;
fast heart rate, gasping, feeling unusually hot;
slow heart rate, weak pulse; or
little or no urination.

Seek medical attention right away if you develop a serious condition called methemoglobinemia. Symptoms include headache, fast heartbeats, shortness of breath, feeling tired or light-headed, or skin that looks pale, gray, or blue-colored.

Common side effects include:

weakness, long-lasting numbness or tingling;
feeling restless or drowsy;
tremors;
headache, blurred vision;
fast or slow heartbeats;
breathing problems;
chills or shivering;
back pain; or
nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Tell your doctor if you have ever had an allergic reaction to any type of numbing medicine.

Some epidural numbing medications can have long-lasting or permanent effects on certain body processes such as sexual function, bowel or bladder control, and movement or feeling in your legs or feet. Talk with your doctor about your specific risk of nerve damage from bupivacaine.

Before taking this medicine

Tell your doctor if you have ever had an allergic reaction to any type of numbing medicine, or if you’ve ever had:

anemia (lack of red blood cells);
kidney or liver disease;
a bleeding or blood clotting disorder;
syphilis, polio, a brain or spinal cord tumor;
numbness or tingling;
chronic back pain, headache caused by surgery;
low or high blood pressure;
abnormal curvature of the spine; or
arthritis.

It is not known whether bupivacaine will harm an unborn baby. If you are not receiving bupivacaine during childbirth, tell your doctor if you are pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How is bupivacaine given?

Bupivacaine is injected through a needle directly into or near the area to be numbed. You will receive this injection in a dental or hospital setting.

For an epidural, bupivacaine is given as an injection through a needle placed into an area of your middle or lower back near your spine.

Your breathing, blood pressure, oxygen levels, or other vital signs will be watched closely.

For a dental procedure, bupivacaine is injected directly into the mouth near the tooth or teeth your dentist will be working on.

What happens if I miss a dose?

Since bupivacaine is given as needed before a surgery or dental procedure, you are not likely to be on a dosing schedule.

What happens if I overdose?

Since bupivacaine is given in a medical setting, you will be watched closely to make sure you do not receive too much of bupivacaine. Your caregivers will quickly treat you if you have overdose symptoms.

What should I avoid after receiving bupivacaine?

This medicine can cause numbness over a large portion of your body. After an epidural you not be able to feel or move your lower body. Take care to avoid injury while you are still numb.

After a dental procedure, avoid eating, chewing gum, or drinking a hot beverage until your mouth is no longer numb.

What other drugs will affect bupivacaine?

Tell your doctor about all other medicines you use, especially:

an antidepressant or antipsychotic medication;
anti-nausea medicine such as prochlorperazine (Compazine) or promethazine (Phenergan);
blood pressure medicine–carteolol, carvedilol, labetalol, nadolol, propranolol, sotalol, timolol;
a blood thinner such as warfarin (Coumadin, Jantoven);
ergot medicine–dihydroergotamine, ergotamine, ergonovine, methylergonovine; or
an MAO inhibitor–isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Bunavail

Sama Mohamed — Mon, 09 Feb 2026 21:49:02 +0000

What is Bunavail?

Bunavail buccal films contains a combination of buprenorphine and naloxone. Buprenorphine is an opioid medication, sometimes called a narcotic. Naloxone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.

Bunavail buccal films are used to treat opioid addiction.

Bunavail is not for use as a pain medication.

Warnings

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Using Bunavail during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use Bunavail with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use Bunavail if you are allergic to buprenorphine or naloxone (Narcan).

To make sure Bunavail is safe for you, tell your doctor if you have ever had:

tooth problems, including a history of cavities;
breathing problems, sleep apnea;
enlarged prostate, urination problems;
liver or kidney disease;
abnormal curvature of the spine that affects breathing;
problems with your gallbladder, adrenal gland, or thyroid;
a head injury, brain tumor, or seizures; or
alcoholism or drug addiction.

If you use Bunavail while you are pregnant, your baby could become dependent on this medicine. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Ask a doctor before using Bunavail if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

How should I take Bunavail?

Use Bunavail buccal films exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use Bunavail in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share Bunavail with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away Bunavail is against the law.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Rinse your mouth with water after the Bunavail film dissolves. Wait one hour after the medicine dissolves to brush your teeth to prevent damage to the teeth and gums. You should receive regular dental checkups while using Bunavail.

If you switch between medicines containing buprenorphine, you may not use the same dose for each one. Follow all directions carefully.

Do not stop using Bunavail suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

You will need frequent blood tests to check your liver function.

All your medical care providers should know that you are being treated for opioid addiction, and that you take Bunavail. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.

Never crush or break a Bunavail pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

Store Bunavail films in the foil pouch at room temperature, away from moisture and heat. Discard an empty pouch in a place children and pets cannot get to. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using Bunavail accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, remove any unused films from the foil pack and flush the films down the toilet. Throw the empty foil pack into the trash.

Dosing information

Usual Adult Dose for Opiate Dependence: Buprenorphine monotherapy is generally used for induction. Bunavail may be used for induction in patients dependent on heroin or short-acting opioid products. Note – one Bunavail 4.2 mg/0.7 mg buccal film provides the equivalent buprenorphine exposure to one Suboxone 8 mg/2 mg sublingual tablet.

INDUCTION dose: Day 1: Initial dose: 2.1 mg/0.3 mg buccally; followed in intervals of approximately 2 hours with additional doses to a total dose of 4.2 mg/0.7 mg to control acute withdrawal symptoms
Day 2: a single dose up to 8.4 mg/1.4 mg buccally.

MAINTENANCE Treatment: Doses should be adjusted to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms; doses should be titrated to clinical effectiveness as rapidly as possible as gradual titration may lead to higher drop-out rates.
-Progressively adjust in increments/decrements of 2.1 mg/0.3 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms.
-Recommended target dose: 8.4 mg/1.4 mg buccally once a day; range 2.1 mg/0.3 mg to 12.6 mg/2.1 mg
Maximum dose: 12.6 mg/ 2.1 mg buccally once a day.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An opioid overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

What should I avoid while taking Bunavail?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how Bunavail will affect you. Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Buprenorphine and naloxone side effects

Get emergency medical help if you have signs of an allergic reaction to Bunavail: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once or seek emergency medical attention if you have:

any problems with your teeth or gums;
weak or shallow breathing, breathing that stops during sleep;
a light-headed feeling, like you might pass out;
confusion, loss of coordination, extreme weakness;
blurred vision, slurred speech;
liver problems – upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
high levels of serotonin in the body – agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea;
low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
opioid withdrawal symptoms – shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain.

Serious breathing problems may be more likely in older adults and those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common Bunavail side effects may include:

dizziness, drowsiness, blurred vision, feeling drunk, trouble concentrating;
withdrawal symptoms;
tongue pain, redness or numbness inside your mouth;
nausea, vomiting, constipation;
headache, back pain;
fast or pounding heartbeats, increased sweating; or
sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Bunavail?

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
other opioids – opioid pain medicine or prescription cough medicine;
a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, and others;
drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
drugs that affect serotonin levels in your body – a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

Bumex

Sama Mohamed — Mon, 09 Feb 2026 21:39:40 +0000

Bumex Description

Bumex ®(bumetanide) is a loop diuretic available as 0.5 mg (light green), 1 mg (yellow) and 2 mg (peach) tablets for oral administration; each tablet also contains anhydrous lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc, with the following dye systems: 0.5 mg—D&C Yellow No. 10 aluminum lake and FD&C Blue No. 1 aluminum lake; 1 mg—D&C Yellow No. 10 aluminum lake; 2 mg—red iron oxide.

Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula:

FDA-approved impurity specifications differ from the USP.

Bumex – Clinical Pharmacology

Bumex is a loop diuretic with a rapid onset and short duration of action. Pharmacological and clinical studies have shown that 1 mg Bumex has a diuretic potency equivalent to approximately 40 mg furosemide. The major site of Bumex action is the ascending limb of the loop of Henle.

The mode of action has been determined through various clearance studies in both humans and experimental animals. Bumex inhibits sodium reabsorption in the ascending limb of the loop of Henle, as shown by marked reduction of free-water clearance (CH 2O) during hydration and tubular free-water reabsorption (T CH 2O) during hydropenia. Reabsorption of chloride in the ascending limb is also blocked by Bumex, and Bumex is somewhat more chloruretic than natriuretic.

Potassium excretion is also increased by Bumex, in a dose-related fashion.

Bumex may have an additional action in the proximal tubule. Since phosphate reabsorption takes place largely in the proximal tubule, phosphaturia during Bumex induced diuresis is indicative of this additional action. This is further supported by the reduction in the renal clearance of Bumex by probenecid, associated with diminution in the natriuretic response. This proximal tubular activity does not seem to be related to an inhibition of carbonic anhydrase. Bumex does not appear to have a noticeable action on the distal tubule.

Bumex decreases uric acid excretion and increases serum uric acid. Following oral administration of Bumex the onset of diuresis occurs in 30 to 60 minutes. Peak activity is reached between 1 and 2 hours. At usual doses (1 mg to 2 mg) diuresis is largely complete within 4 hours; with higher doses, the diuretic action lasts for 4 to 6 hours. Diuresis starts within minutes following an intravenous injection and reaches maximum levels within 15 to 30 minutes.

Several pharmacokinetic studies have shown that bumetanide, administered orally or parenterally, is eliminated rapidly in humans, with a half-life of between 1 and 1½ hours. Plasma protein-binding is in the range of 94% to 96%.

Oral administration of carbon-14 labeled Bumex to human volunteers revealed that 81% of the administered radioactivity was excreted in the urine, 45% of it as unchanged drug. Urinary and biliary metabolites identified in this study were formed by oxidation of the N-butyl side chain. Biliary excretion of Bumex amounted to only 2% of the administered dose.

Pediatric Pharmacology

Elimination of bumetanide appears to be considerably slower in neonatal patients compared with adults, possibly because of immature renal and hepatobiliary function in this population. Small pharmacokinetic studies of intravenous bumetanide in preterm and full-term neonates with respiratory disorders have reported an apparent half-life of approximately 6 hours, with a range up to 15 hours and a serum clearance ranging from 0.2 mL/min/kg to 1.1 mL/min/kg. In a population of neonates receiving bumetanide for volume overload, mean serum clearance rates were 2.2 mL/min/kg in patients less than 2 months of age and 3.8 mL/min/kg in patients aged 2 to 6 months. Mean serum half-life of bumetanide was 2.5 hours and 1.5 hours in patients aged less than 2 months and those aged 2 to 6 months, respectively. Elimination half-life decreased considerably during the first month of life, from a mean of approximately 6 hours at birth to approximately 2.4 hours at 1 month of age.

In preterm neonates, mean serum concentrations following a single 0.05 mg/kg dose ranged from 126 μg/L at 1 hour to 57 μg/L at 8 hours. In another study, mean serum concentrations following a single 0.05 mg/kg dose were 338 ng/mL at 30 minutes and 176 ng/mL after 4 hours. A single dose of 0.1 mg/kg produced mean serum levels of 314 ng/mL at 1 hour, and 195 ng/mL at 6 hours. Mean volume of distribution in neonates and infants has been reported to range from 0.26 L/kg to 0.39 L/kg.

The degree of protein binding of bumetanide in cord sera from healthy neonates was approximately 97%, suggesting the potential for bilirubin displacement. A study using pooled sera from critically ill neonates found that bumetanide at concentrations of 0.5 μg/mL to 50 μg/mL, but not 0.25 μg/mL, caused a linear increase in unbound bilirubin concentrations.

In 56 infants aged 4 days to 6 months, bumetanide doses ranging from 0.005 mg/kg to 0.1 mg/kg were studied for pharmacodynamic effect. Peak bumetanide excretion rates increased linearly with increasing doses of drug. Maximal diuretic effect was observed at a bumetanide excretion rate of about 7 μg/kg/h, corresponding to doses of 0.035 mg/kg to 0.040 mg/kg. Higher doses produced a higher bumetanide excretion rate but no increase in diuretic effect. Urine flow rate peaked during the first hour after drug administration in 80% of patients and by 3 hours in all patients.

Geriatric Pharmacology

In a group of ten geriatric subjects between the ages of 65 and 73 years, total bumetanide clearance was significantly lower (1.8 ± 0.3 mL/min·kg) compared with younger subjects (2.9 ± 0.2 mL/min·kg) after a single oral bumetanide 0.5 mg dose. Maximum plasma concentrations were higher in geriatric subjects (16.9 ± 1.8 ng/mL) compared with younger subjects (10.3 ± 1.5 ng/mL). Urine flow rate and total excretion of sodium and potassium were increased less in the geriatric subjects compared with younger subjects, although potassium excretion and fractional sodium excretion were similar between the two age groups. Nonrenal clearance, bioavailability, and volume of distribution were not significantly different between the two groups.

Indications and Usage for Bumex

Bumex tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.

Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route.

Successful treatment with Bumex tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.

Contraindications

Bumex is contraindicated in anuria. Although Bumex can be used to induce diuresis in renal insufficiency, any marked increase in blood urea nitrogen or creatinine, or the development of oliguria during therapy of patients with progressive renal disease, is an indication for discontinuation of treatment with Bumex. Bumex is also contraindicated in patients in hepatic coma or in states of severe electrolyte depletion until the condition is improved or corrected. Bumex is contraindicated in patients hypersensitive to this drug.

Warnings

Volume and Electrolyte Depletion

The dose of Bumex should be adjusted to the patient’s need. Excessive doses or too frequent administration can lead to profound water loss, electrolyte depletion, dehydration, reduction in blood volume and circulatory collapse with the possibility of vascular thrombosis and embolism, particularly in elderly patients.

Hypokalemia

Hypokalemia can occur as a consequence of Bumex administration. Prevention of hypokalemia requires particular attention in the following conditions: patients receiving digitalis and diuretics for congestive heart failure, hepatic cirrhosis and ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, certain diarrheal states, or other states where hypokalemia is thought to represent particular added risks to the patient, i.e., history of ventricular arrhythmias.

In patients with hepatic cirrhosis and ascites, sudden alterations of electrolyte balance may precipitate hepatic encephalopathy and coma. Treatment in such patients is best initiated in the hospital with small doses and careful monitoring of the patient’s clinical status and electrolyte balance. Supplemental potassium and/or spironolactone may prevent hypokalemia and metabolic alkalosis in these patients.

Ototoxicity

In cats, dogs and guinea pigs, bumetanide has been shown to produce ototoxicity. In these test animals bumetanide was 5 to 6 times more potent than furosemide and, since the diuretic potency of bumetanide is about 40 to 60 times furosemide, it is anticipated that blood levels necessary to produce ototoxicity will rarely be achieved. The potential exists, however, and must be considered a risk of intravenous therapy, especially at high doses, repeated frequently in the face of renal excretory function impairment. Potentiation of aminoglycoside ototoxicity has not been tested for bumetanide. Like other members of this class of diuretics, bumetanide probably shares this risk.

Allergy to Sulfonamides

Patients allergic to sulfonamides may show hypersensitivity to Bumex.

Thrombocytopenia

Since there have been rare spontaneous reports of thrombocytopenia from postmarketing experience, patients should be observed regularly for possible occurrence of thrombocytopenia.

Precautions

General

Serum potassium should be measured periodically and potassium supplements or potassium sparing diuretics added if necessary. Periodic determinations of other electrolytes are advised in patients treated with high doses or for prolonged periods, particularly in those on low-salt diets.

Hyperuricemia may occur; it has been asymptomatic in cases reported to date. Reversible elevations of the BUN and creatinine may also occur, especially in association with dehydration and particularly in patients with renal insufficiency. Bumex may increase urinary calcium excretion with resultant hypocalcemia.

Diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.

Laboratory Tests

Studies in normal subjects receiving Bumex revealed no adverse effects on glucose tolerance, plasma insulin, glucagon and growth hormone levels, but the possibility of an effect on glucose metabolism exists. Periodic determinations of blood sugar should be done, particularly in patients with diabetes or suspected latent diabetes.

Patients under treatment should be observed regularly for possible occurrence of blood dyscrasias, liver damage or idiosyncratic reactions, which have been reported occasionally in foreign marketing experience. The relationship of these occurrences to Bumex use is not certain.

Drug Interactions

Drugs with Ototoxic Potential

Especially in the presence of impaired renal function, the use of parenterally administered bumetanide in patients to whom aminoglycoside antibiotics are also being given should be avoided, except in life-threatening conditions.

Drugs with Nephrotoxic Potential

There has been no experience with the concurrent use of Bumex with drugs known to have a nephrotoxic potential. Therefore, the simultaneous administration of these drugs should be avoided.

Lithium

Lithium should generally not be given with diuretics (such as Bumex) because they reduce its renal clearance and add a high risk of lithium toxicity.

Probenecid

Pretreatment with probenecid reduces both the natriuresis and hyperreninemia produced by Bumex. This antagonistic effect of probenecid on Bumex natriuresis is not due to a direct action on sodium excretion but is probably secondary to its inhibitory effect on renal tubular secretion of bumetanide. Thus, probenecid should not be administered concurrently with Bumex.

Indomethacin

Indomethacin blunts the increases in urine volume and sodium excretion seen during Bumex treatment and inhibits the bumetanide-induced increase in plasma renin activity. Concurrent therapy with Bumex is thus not recommended.

Antihypertensives

Bumex may potentiate the effect of various antihypertensive drugs, necessitating a reduction in the dosage of these drugs.

Digoxin

Interaction studies in humans have shown no effect on digoxin blood levels.

Anticoagulants

Interaction studies in humans have shown Bumex to have no effect on warfarin metabolism or on plasma prothrombin activity.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Bumex was devoid of mutagenic activity in various strains of Salmonella typhimurium when tested in the presence or absence of an in vitrometabolic activation system. An 18-month study showed an increase in mammary adenomas of questionable significance in female rats receiving oral doses of 60 mg/kg/day (2000 times a 2-mg human dose). A repeat study at the same doses failed to duplicate this finding.

Reproduction studies were performed to evaluate general reproductive performance and fertility in rats at oral dose levels of 10, 30, 60 or 100 mg/kg/day. The pregnancy rate was slightly decreased in the treated animals; however, the differences were small and not statistically significant.

Pregnancy

Teratogenic Effects

Bumex is neither teratogenic nor embryocidal in mice when given in doses up to 3400 times the maximum human therapeutic dose.

Bumex has been shown to be nonteratogenic, but it has a slight embryocidal effect in rats when given in doses of 3400 times the maximum human therapeutic dose and in rabbits at doses of 3.4 times the maximum human therapeutic dose. In one study, moderate growth retardation and increased incidence of delayed ossification of sternebrae were observed in rats at oral doses of 100 mg/kg/day, 3400 times the maximum human therapeutic dose. These effects were associated with maternal weight reductions noted during dosing. No such adverse effects were observed at 30 mg/kg/day (1000 times the maximum human therapeutic dose). No fetotoxicity was observed at 1000 to 2000 times the human therapeutic dose.

In rabbits, a dose-related decrease in litter size and an increase in resorption rate were noted at oral doses of 0.1 mg/kg/day and 0.3 mg/kg/day (3.4 and 10 times the maximum human therapeutic dose). A slightly increased incidence of delayed ossification of sternebrae occurred at 0.3 mg/kg/day; however, no such adverse effects were observed at the dose of 0.03 mg/kg/day. The sensitivity of the rabbit to Bumex parallels the marked pharmacologic and toxicologic effects of the drug in this species.

Bumex was not teratogenic in the hamster at an oral dose of 0.5 mg/kg/day (17 times the maximum human therapeutic dose). Bumetanide was not teratogenic when given intravenously to mice and rats at doses up to 140 times the maximum human therapeutic dose.

There are no adequate and well-controlled studies in pregnant women. A small investigational experience in the and marketing experience in other countries to date have not indicated any evidence of adverse effects on the fetus, but these data do not rule out the possibility of harmful effects. Bumex should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while the patient is on Bumex since it may be excreted in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 18 have not been established.

In vitrostudies using pooled sera from critically ill neonates have shown bumetanide to be a potent displacer of bilirubin . The administration of bumetanide could present a particular concern if given to critically ill or jaundiced neonates at risk for kernicterus.

Geriatric Use

Clinical studies of Bumex did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions/Side Effects

The most frequent clinical adverse reactions considered probably or possibly related to Bumex are muscle cramps (seen in 1.1% of treated patients), dizziness (1.1%), hypotension (0.8%), headache (0.6%), nausea (0.6%) and encephalopathy (in patients with pre-existing liver disease) (0.6%). One or more of these adverse reactions have been reported in approximately 4.1% of patients treated with Bumex.

Serious skin reactions (i.e., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in association with bumetanide use.

Less frequent clinical adverse reactions to Bumex are impaired hearing (0.5%), pruritus (0.4%), electrocardiogram changes (0.4%), weakness (0.2%), hives (0.2%), abdominal pain (0.2%), arthritic pain (0.2%), musculoskeletal pain (0.2%), rash (0.2%) and vomiting (0.2%). One or more of these adverse reactions have been reported in approximately 2.9% of patients treated with Bumex.

Other clinical adverse reactions, which have each occurred in approximately 0.1% of patients, are vertigo, chest pain, ear discomfort, fatigue, dehydration, sweating, hyperventilation, dry mouth, upset stomach, renal failure, asterixis, itching, nipple tenderness, diarrhea, premature ejaculation and difficulty maintaining an erection.

Laboratory abnormalities reported have included hyperuricemia (in 18.4% of patients tested), hypochloremia (14.9%), hypokalemia (14.7%), azotemia (10.6%), hyponatremia (9.2%), increased serum creatinine (7.4%), hyperglycemia (6.6%), and variations in phosphorus (4.5%), CO content (4.3%), bicarbonate (3.1%) and calcium (2.4%). Although manifestations of the pharmacologic action of Bumex, these conditions may become more pronounced by intensive therapy.

Also reported have been thrombocytopenia (0.2%) and deviations in hemoglobin (0.8%), prothrombin time (0.8%), hematocrit (0.6%), WBC (0.3%) and differential counts (0.1%). There have been rare spontaneous reports of thrombocytopenia from postmarketing experience.

Diuresis induced by Bumex may also rarely be accompanied by changes in LDH (1.0%), total serum bilirubin (0.8%), serum proteins (0.7%), SGOT (0.6%), SGPT (0.5%), alkaline phosphatase (0.4%), cholesterol (0.4%) and creatinine clearance (0.3%). Increases in urinary glucose (0.7%) and urinary protein (0.3%) have also been seen.

Overdosage

Overdosage can lead to acute profound water loss, volume and electrolyte depletion, dehydration, reduction of blood volume and circulatory collapse with a possibility of vascular thrombosis and embolism. Electrolyte depletion may be manifested by weakness, dizziness, mental confusion, anorexia, lethargy, vomiting and cramps. Treatment consists of replacement of fluid and electrolyte losses by careful monitoring of the urine and electrolyte output and serum electrolyte levels.

Bumex Dosage and Administration

Individualize dosage with careful monitoring of patient response.

Oral Administration

The usual total daily dosage of Bumex tablets is 0.5 mg to 2 mg and in most patients is given as a single dose.

If the diuretic response to an initial dose of Bumex tablets is not adequate, in view of its rapid onset and short duration of action, a second or third dose may be given at 4- to 5-hour intervals up to a maximum daily dose of 10 mg. An intermittent dose schedule, whereby Bumex tablets are given on alternate days or for 3 to 4 days with rest periods of 1 to 2 days in between, is recommended as the safest and most effective method for the continued control of edema. In patients with hepatic failure, keep the dosage to a minimum.

Because cross-sensitivity with furosemide has rarely been observed, bumetanide can be substituted at approximately a 1:40 ratio of bumetanide in proportion to furosemide in patients allergic to furosemide.

Parenteral Administration

Bumetanide injection may be administered parenterally (intravenously and intramuscularly) to patients in whom gastrointestinal absorption may be impaired or in whom oral administration is not practical.

Terminate parenteral treatment and institute oral treatment as soon as possible.

How is Bumex supplied

Bumex Tablets for oral administration are elliptical, flat-faced, and bevel-edged, available as:

Dosage	Color	Engraving	NDC 30698-xxx-xx
			Bottle of 100	Bottle of 500
0.5 mg	Light Green	BUMEX 0.5	630-01	—
1 mg	Yellow	BUMEX 1	631-01	631-05
2 mg	Peach	BUMEX 2	632-01	632-05

Store at 68° to 77°F (20° to 25°C); excursions permitted between 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature].

Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.

Manufactured for andDistributed by:
Validus Pharmaceuticals LLC
Parsippany, NJ 07054
info@validuspharma.com
www.validuspharma.com
1-866-982-5438

Product of Italy

60018-05 November 2023

PRINCIPAL DISPLAY PANEL

NDC 30698-630-01
Bumex ®
(bumetanide) Tablets
0.5 mg
100 Tablets
Rx Only

PRINCIPAL DISPLAY PANEL

NDC 30698-631-01
Bumex ®
(bumetanide) Tablets
1 mg
100 Tablets
Rx Only

NDC 30698-631-05
Bumex ®
(bumetanide) Tablets
1 mg
500 Tablets
Rx Only

PRINCIPAL DISPLAY PANEL

NDC 30698-632-01
Bumex ®
(bumetanide) Tablets
2 mg
100 Tablets
Rx Only

NDC 30698-632-05
Bumex ®
(bumetanide) Tablets
2 mg
500 Tablets
Rx Only

BUMEX
bumetanide tablet

Product InformationProduct TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:30698-630Route of AdministrationORAL

Active Ingredient/Active MoietyIngredient NameBasis of StrengthStrengthBUMETANIDE (UNII: 0Y2S3XUQ5H) (BUMETANIDE – UNII:0Y2S3XUQ5H)BUMETANIDE0.5 mg

Inactive IngredientsIngredient NameStrengthANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)MAGNESIUM STEARATE (UNII: 70097M6I30)MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)STARCH, CORN (UNII: O8232NY3SJ)TALC (UNII: 7SEV7J4R1U)D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product CharacteristicsColorgreen (light green)Scoreno scoreShapeOVALSize11mmFlavorImprint CodeBUMEX;0;5Contains

Packaging#Item CodePackage DescriptionMarketing Start DateMarketing End Date1NDC:30698-630-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/28/1983

Marketing InformationMarketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End DateNDANDA01822502/28/1983

BUMEX
bumetanide tablet

Product InformationProduct TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:30698-631Route of AdministrationORAL

Active Ingredient/Active MoietyIngredient NameBasis of StrengthStrengthBUMETANIDE (UNII: 0Y2S3XUQ5H) (BUMETANIDE – UNII:0Y2S3XUQ5H)BUMETANIDE1 mg

Product CharacteristicsColoryellowScoreno scoreShapeOVALSize11mmFlavorImprint CodeBUMEX;1Contains

Packaging#Item CodePackage DescriptionMarketing Start DateMarketing End Date1NDC:30698-631-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/28/19832NDC:30698-631-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/17/2024

Marketing InformationMarketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End DateNDANDA01822502/28/1983

BUMEX
bumetanide tablet

Product InformationProduct TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:30698-632Route of AdministrationORAL

Active Ingredient/Active MoietyIngredient NameBasis of StrengthStrengthBUMETANIDE (UNII: 0Y2S3XUQ5H) (BUMETANIDE – UNII:0Y2S3XUQ5H)BUMETANIDE2 mg

Product CharacteristicsColororange (peach)Scoreno scoreShapeOVALSize13mmFlavorImprint CodeBUMEX;2Contains

Packaging#Item CodePackage DescriptionMarketing Start DateMarketing End Date1NDC:30698-632-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/28/19832NDC:30698-632-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/17/2024

Marketing InformationMarketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End DateNDANDA01822502/28/1983

Bumetanide

Sama Mohamed — Mon, 09 Feb 2026 21:33:13 +0000

Bumetanide Description

Bumetanide is a loop diuretic, available as 4 mL vials and 10 mL vials (0.25 mg/mL) for intravenous or intramuscular injection as a sterile solution.

Each mL contains 0.25 mg bumetanide compounded with 0.85% sodium chloride and 0.4% ammonium acetate as buffers; 0.01% edetate disodium; 1% benzyl alcohol as preservative in water for injection and pH adjusted to 6.8 to 7.8 with sodium hydroxide.

Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white or almost white, crystalline powder having a calculated molecular weight of 364.42, and the following structural formula:

Bumetanide – Clinical Pharmacology

Bumetanide is a loop diuretic with a rapid onset and short duration of action. Pharmacological and clinical studies have shown that 1 mg bumetanide has a diuretic potency equivalent to approximately 40 mg furosemide. The major site of bumetanide action is the ascending limb of the loop of Henle.

The mode of action has been determined through various clearance studies in both humans and experimental animals. Bumetanide inhibits sodium reabsorption in the ascending limb of the loop of Henle, as shown by marked reduction of free-water clearance (CH2O) during hydration and tubular free-water reabsorption (TcH2O) during hydropenia. Reabsorption of chloride in the ascending limb is also blocked by bumetanide, and bumetanide is somewhat more chloruretic than natriuretic.

Potassium excretion is also increased by bumetanide, in a dose-related fashion.

Bumetanide may have an additional action in the proximal tubule. Since phosphate reabsorption takes place largely in the proximal tubule, phosphaturia during bumetanide induced diuresis is indicative of this additional action. This is further supported by the reduction in the renal clearance of bumetanide by probenecid, associated with diminution in the natriuretic response. This proximal tubular activity does not seem to be related to an inhibition of carbonic anhydrase. Bumetanide does not appear to have a noticeable action on the distal tubule.

Bumetanide decreases uric acid excretion and increases serum uric acid. Diuresis starts within minutes following an intravenous injection and reaches maximum levels within 15 to 30 minutes.

Oral administration of carbon-14 labeled bumetanide to human volunteers revealed that 81% of the administered radioactivity was excreted in the urine, 45% of it as unchanged drug. Urinary and biliary metabolites identified in this study were formed by oxidation of the N-butyl side chain. Biliary excretion of bumetanide amounted to only 2% of the administered dose.

Pediatric Pharmacology

Elimination of bumetanide appears to be considerably slower in neonatal patients compared with adults, possibly because of immature renal and hepatobiliary function in this population. Small pharmacokinetic studies of intravenous bumetanide in preterm and full-term neonates with respiratory disorders have reported an apparent half-life of approximately 6 hours, with a range up to 15 hours and a serum clearance ranging from 0.2 to 1.1 mL/min/kg. In a population of neonates receiving bumetanide for volume overload, mean serum clearance rates were 2.17 mL/min/kg in patients less than 2 months of age and 3.8 mL/min/kg in patients aged 2 to 6 months. Mean serum half-life of bumetanide was 2.5 hours and 1.5 hours in patients aged less than 2 months and those aged 2 to 6 months, respectively. Elimination half-life decreased considerably during the first month of life, from a mean of approximately 6 hours at birth to approximately 2.4 hours at 1 month of age.

In preterm neonates, mean serum concentrations following a single 0.05 mg/kg dose ranged from 126 mcg/L at 1 hour to 57 mcg/L at 8 hours. In another study, mean serum concentrations following a single 0.05 mg/kg dose were 338 ng/mL at 30 minutes and 176 ng/mL after 4 hours. A single dose of 0.1 mg/kg produced mean serum levels of 314 ng/mL at 1 hour, and 195 ng/mL at 6 hours. Mean volume of distribution in neonates and infants has been reported to range from 0.26 L/kg to 0.39 L/kg.

The degree of protein binding of bumetanide in cord sera from healthy neonates was approximately 97%, suggesting the potential for bilirubin displacement. A study using pooled sera from critically ill neonates found that bumetanide at concentrations of 0.5 to 50 mcg/mL, but not 0.25 mcg/mL, caused a linear increase in unbound bilirubin concentrations.

In 56 infants aged 4 days to 6 months, bumetanide doses ranging from 0.005 mg/kg to 0.1 mg/kg were studied for pharmacodynamic effect. Peak bumetanide excretion rates increased linearly with increasing doses of drug. Maximal diuretic effect was observed at a bumetanide excretion rate of about 7 mcg/kg/hr, corresponding to doses of 0.035 to 0.040 mg/kg. Higher doses produced a higher bumetanide excretion rate but no increase in diuretic effect. Urine flow rate peaked during the first hour after drug administration in 80% of patients and by 3 hours in all patients.

Geriatric Pharmacology

In a group of ten geriatric subjects between the ages of 65 and 73 years, total bumetanide clearance was significantly lower (1.8 ± 0.3 mL/min/kg) compared with younger subjects

(2.9 ± 0.2 mL/min/kg) after a single oral bumetanide 0.5 mg dose. Maximum plasma concentrations were higher in geriatric subjects (16.9 ± 1.8 ng/mL) compared with younger subjects (10.3 ± 1.5 ng/mL). Urine flow rate and total excretion of sodium and potassium were increased less in the geriatric subjects compared with younger subjects, although potassium excretion and fractional sodium excretion were similar between the two age groups. Nonrenal clearance, bioavailability, and volume of distribution were not significantly different between the two groups.

Indications and Usage for Bumetanide

Bumetanide injection, USP is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.

Successful treatment with bumetanide injection, USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.

Contraindications

Bumetanide is contraindicated in anuria. Although bumetanide can be used to induce diuresis in renal insufficiency, any marked increase in blood urea nitrogen or creatinine, or the development of oliguria during therapy of patients with progressive renal disease, is an indication for discontinuation of treatment with bumetanide. Bumetanide is also contraindicated in patients in hepatic coma or in states of severe electrolyte depletion until the condition is improved or corrected. Bumetanide is contraindicated in patients hypersensitive to this drug.

Warnings

Volume and Electrolyte Depletion

The dose of bumetanide should be adjusted to the patient’s need. Excessive doses or too frequent administration can lead to profound water loss, electrolyte depletion, dehydration, reduction in blood volume and circulatory collapse with the possibility of vascular thrombosis and embolism, particularly in elderly patients.

Hypokalemia

Hypokalemia can occur as a consequence of bumetanide administration. Prevention of hypokalemia requires particular attention in the following conditions: patients receiving digitalis and diuretics for congestive heart failure, hepatic cirrhosis and ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, certain diarrheal states, or other states where hypokalemia is thought to represent particular added risks to the patient, i.e., history of ventricular arrhythmias.

Ototoxicity

In cats, dogs and guinea pigs, bumetanide has been shown to produce ototoxicity. In these test animals, bumetanide was 5 to 6 times more potent than furosemide and, since the diuretic potency of bumetanide is about 40 to 60 times furosemide, it is anticipated that blood levels necessary to produce ototoxicity will rarely be achieved. The potential exists, however, and must be considered a risk of intravenous therapy, especially at high doses, repeated frequently in the face of renal excretory function impairment. Potentiation of aminoglycoside ototoxicity has not been tested for bumetanide. Like other members of this class of diuretics, bumetanide probably shares this risk.

Allergy to Sulfonamides

Patients allergic to sulfonamides may show hypersensitivity to bumetanide.

Thrombocytopenia

Since there have been rare spontaneous reports of thrombocytopenia from postmarketing experience, patients should be observed regularly for possible occurrence of thrombocytopenia.

Precautions

General

Serum potassium should be measured periodically and potassium supplements or potassium-sparing diuretics added if necessary. Periodic determinations of other electrolytes are advised in patients treated with high doses or for prolonged periods, particularly in those on low-salt diets.

Hyperuricemia may occur; it has been asymptomatic in cases reported to date. Reversible elevations of the BUN and creatinine may also occur, especially in association with dehydration and particularly in patients with renal insufficiency. Bumetanide may increase urinary calcium excretion with resultant hypocalcemia.

Diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.

Laboratory Tests

Studies in normal subjects receiving bumetanide revealed no adverse effects on glucose tolerance, plasma insulin, glucagon and growth hormone levels, but the possibility of an effect on glucose metabolism exists. Periodic determinations of blood sugar should be done, particularly in patients with diabetes or suspected latent diabetes.

Drug Interactions

Drugs with Ototoxic Potential

Drugs with Nephrotoxic Potential

There has been no experience with the concurrent use of bumetanide with drugs known to have a nephrotoxic potential. Therefore, the simultaneous administration of these drugs should be avoided.

Lithium

Lithium should generally not be given with diuretics (such as bumetanide) because they reduce its renal clearance and add a high risk of lithium toxicity.

Probenecid

Pretreatment with probenecid reduces both the natriuresis and hyperreninemia produced by bumetanide. This antagonistic effect of probenecid on bumetanide natriuresis is not due to a direct action on sodium excretion but is probably secondary to its inhibitory effect on renal tubular secretion of bumetanide. Thus, probenecid should not be administered concurrently with bumetanide.

Indomethacin

Indomethacin blunts the increases in urine volume and sodium excretion seen during bumetanide treatment and inhibits the bumetanide-induced increase in plasma renin activity. Concurrent therapy with bumetanide is thus not recommended.

Antihypertensives

Bumetanide may potentiate the effect of various antihypertensive drugs, necessitating a reduction in the dosage of these drugs.

Digoxin

Interaction studies in humans have shown no effect on digoxin blood levels.

Anticoagulants

Interaction studies in humans have shown bumetanide to have no effect on warfarin metabolism or on plasma prothrombin activity.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Bumetanide was devoid of mutagenic activity in various strains of Salmonella typhimurium when tested in the presence or absence of an in vitro metabolic activation system. An 18-month study showed an increase in mammary adenomas of questionable significance in female rats receiving oral doses of 60 mg/kg/day (2000 times a 2-mg human dose). A repeat study at the same doses failed to duplicate this finding.

Pregnancy

Teratogenic Effects

Bumetanide is neither teratogenic nor embryocidal in mice when given in doses up to 3400 times the maximum human therapeutic dose.

Bumetanide has been shown to be nonteratogenic, but it has a slight embryocidal effect in rats when given in doses of 3400 times the maximum human therapeutic dose and in rabbits at doses of 3.4 times the maximum human therapeutic dose. In one study, moderate growth retardation and increased incidence of delayed ossification of sternebrae were observed in rats at oral doses of 100 mg/kg/day, 3400 times the maximum human therapeutic dose. These effects were associated with maternal weight reductions noted during dosing. No such adverse effects were observed at 30 mg/kg/day (1000 times the maximum human therapeutic dose). No fetotoxicity was observed at 1000 to 2000 times the human therapeutic dose.

In rabbits, a dose-related decrease in litter size and an increase in resorption rate were noted at oral doses of 0.1 and 0.3 mg/kg/day (3.4 and 10 times the maximum human therapeutic dose). A slightly increased incidence of delayed ossification of sternebrae occurred at 0.3 mg/kg/day; however, no such adverse effects were observed at the dose of 0.03 mg/kg/day. The sensitivity of the rabbit to bumetanide parallels the marked pharmacologic and toxicologic effects of the drug in this species.

Bumetanide was not teratogenic in the hamster at an oral dose of 0.5 mg/kg/day (17 times the maximum human therapeutic dose). Bumetanide was not teratogenic when given intravenously to mice and rats at doses up to 140 times the maximum human therapeutic dose.

There are no adequate and well-controlled studies in pregnant women. A small investigational experience in the United States and marketing experience in other countries to date have not indicated any evidence of adverse effects on the fetus, but these data do not rule out the possibility of harmful effects. Bumetanide should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while the patient is on bumetanide since it may be excreted in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 18 have not been established.

In vitro studies using pooled sera from critically ill neonates have shown bumetanide to be a potent displacer of bilirubin [see Clinical Pharmacology: Pediatric Pharmacology]. The administration of bumetanide could present a particular concern if given to critically ill or jaundiced neonates at risk for kernicterus.

Geriatric Use

Clinical studies of bumetanide did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions/Side Effects

The most frequent clinical adverse reactions considered probably or possibly related to bumetanide are muscle cramps (seen in 1.1% of treated patients), dizziness (1.1%), hypotension (0.8%), headache (0.6%), nausea (0.6%) and encephalopathy (in patients with preexisting liver disease) (0.6%). One or more of these adverse reactions have been reported in approximately 4.1% of patients treated with bumetanide.

Less frequent clinical adverse reactions to bumetanide are impaired hearing (0.5%), pruritus (0.4%), electrocardiogram changes (0.4%), weakness (0.2%), hives (0.2%), abdominal pain (0.2%), arthritic pain (0.2%), musculoskeletal pain (0.2%), rash (0.2%) and vomiting (0.2%). One or more of these adverse reactions have been reported in approximately 2.9% of patients treated with bumetanide.

Laboratory abnormalities reported have included hyperuricemia (in 18.4% of patients tested), hypochloremia (14.9%), hypokalemia (14.7%), azotemia (10.6%), hyponatremia (9.2%), increased serum creatinine (7.4%), hyperglycemia (6.6%), and variations in phosphorus (4.5%), CO2 content (4.3%), bicarbonate (3.1%) and calcium (2.4%). Although manifestations of the pharmacologic action of bumetanide, these conditions may become more pronounced by intensive therapy.

Diuresis induced by bumetanide may also rarely be accompanied by changes in LDH (1.0%), total serum bilirubin (0.8%), serum proteins (0.7%), SGOT (0.6%), SGPT (0.5%), alkaline phosphatase (0.4%), cholesterol (0.4%) and creatinine clearance (0.3%). Increases in urinary glucose (0.7%) and urinary protein (0.3%) have also been seen.

Overdosage

Bumetanide Dosage and Administration

Dosage should be individualized with careful monitoring of patient response.

Parenteral Administration

Bumetanide Injection may be administered parenterally (IV or IM) to patients in whom gastrointestinal absorption may be impaired or in whom oral administration is not practical.

Parenteral treatment should be terminated and oral treatment instituted as soon as possible.

The usual initial dose is 0.5 mg to 1 mg intravenously or intramuscularly. Intravenous administration should be given over a period of 1 to 2 minutes. If the response to an initial dose is deemed insufficient, a second or third dose may be given at intervals of 2 to 3 hours, but should not exceed a daily dosage of 10 mg.

Miscibility and Parenteral Solutions

The compatibility tests of bumetanide injection with 5% dextrose in water, 0.9% sodium chloride and lactated Ringer’s solution in both glass and plasticized PVC (Viaflex) containers have shown no significant absorption effect with either containers, nor a measurable loss of potency due to degradation of the drug. However, solutions should be freshly prepared and used within 24 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

How is Bumetanide supplied

Bumetanide Injection USP, 0.25 mg/mL is a sterile, clear, colorless to slightly yellow solution free from visible particulate matter supplied in amber vials as follows:

4 mL Single Dose Vial packaged in 10s (NDC 70748-323-10)

Discard unused portion.

10 mL Multiple Dose Vial packaged in 10s (NDC 70748-323-11)

This container closure is not made with natural rubber latex.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light.

To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Naples, FL 34108

United States

Manufactured by:

Lupin Limited

Nagpur – 441108

India

Revised: November 2024 #ID: 278600

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bumetanide Injection, USP

1 mg/4 mL (0.25 mg/mL)

4 mL Single Dose Vial

NDC 70748-323-01

Bumetanide Injection, USP

1 mg/4 mL (0.25 mg/mL)

10 x 4 mL Single Dose Vials

NDC 70748-323-10

Bumetanide Injection, USP

2.5 mg/10 mL (0.25 mg/mL)

10 mL Multiple Dose Vial

NDC 70748-323-02

Bumetanide Injection, USP

2.5 mg/10 mL (0.25 mg/mL)

10 x 10 mL Multiple Dose Vials

NDC 70748-323-11

BUMETANIDE
bumetanide injection

Product InformationProduct TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70748-323Route of AdministrationINTRAMUSCULAR, INTRAVENOUS

Active Ingredient/Active MoietyIngredient NameBasis of StrengthStrengthBUMETANIDE (UNII: 0Y2S3XUQ5H) (BUMETANIDE – UNII:0Y2S3XUQ5H)BUMETANIDE0.25 mg in 1 mL

Inactive IngredientsIngredient NameStrengthAMMONIUM ACETATE (UNII: RRE756S6Q2)4 mg in 1 mLBENZYL ALCOHOL (UNII: LKG8494WBH)10 mg in 1 mLEDETATE DISODIUM (UNII: 7FLD91C86K)0.1 mg in 1 mLSODIUM CHLORIDE (UNII: 451W47IQ8X)8.5 mg in 1 mLSODIUM HYDROXIDE (UNII: 55X04QC32I)WATER (UNII: 059QF0KO0R)

Packaging#Item CodePackage DescriptionMarketing Start DateMarketing End Date1NDC:70748-323-1010 in 1 CARTON11/11/202414 mL in 1 VIAL; Type 0: Not a Combination Product2NDC:70748-323-1110 in 1 CARTON11/11/2024210 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing InformationMarketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End DateANDAANDA21715311/11/2024

Budesonide, glycopyrrolate, and formoterol inhaler

Sama Mohamed — Mon, 09 Feb 2026 21:23:25 +0000

What is a budesonide, glycopyrrolate, and formoterol inhaler?

A budesonide, glycopyrrolate, and formoterol inhaler (Breztri Aerosphere) combines 3 medicines into 1 inhaler and is used as a long-term treatment for COPD (chronic obstructive pulmonary disease) in adults. The 3 medicines are:

an inhaled corticosteroid (ICS) medicine (budesonide)
an anticholinergic medicine (glycopyrrolate)
a long-acting beta₂-adrenergic agonist (LABA) medicine (formoterol).

Budesonide, glycopyrrolate, and formoterol gained FDA approval under the brand name Breztri Aerosphere on July 23, 2020. There is no generic.

How do budesonide, glycopyrrolate, and formoterol work together?

The 3 ingredients in a budesonide, glycopyrrolate, and formoterol inhaler have different mechanisms of action and work together to help control COPD symptoms.

Budesonide decreases lung inflammation, which can lead to breathing problems.
Glycopyrrolate blocks the neurotransmitter acetylcholine in the lungs, allowing the airways to relax and widen, making breathing easier.
Formoterol activates beta2-adrenergic receptors on the smooth muscle cells in the airways, allowing the airways to widen, making breathing easier. Formoterol has a long-lasting effect, typically lasting 12 hours or more, which provides sustained symptom relief throughout the day for COPD patients.

Clinical trials have not been done using a budesonide, glycopyrrolate, and formoterol for asthma, and this inhaler is not approved for asthma, only for COPD.

This inhaler should not be used to relieve sudden breathing problems and will not replace a rescue inhaler, such as albuterol. If you do not have a rescue inhaler, talk to your healthcare provider.

Budesonide, glycopyrrolate, and formoterol side effects

The most common side effects of a budesonide, glycopyrrolate, and formoterol inhaler are:

upper respiratory tract infections (such as sinusitis) or the flu
lung infections (such as pneumonia)
back pain
oral thrush. Wash your mouth out with water and spit out after using the inhaler to help prevent this
joint pain or muscle spasms
headache
high blood sugar levels
a cough or hoarseness
gastrointestinal effects such as diarrhea or nausea
signs of a urinary tract infection including painful and frequent urination
difficulty sleeping
feeling anxious
heart palpitations.

Tell your healthcare provider about any side effect that bothers you or does not go away.

Serious side effects and warnings

A budesonide, glycopyrrolate, and formoterol inhaler can cause the following serious side effects.

Fungal infections in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using your budesonide, glycopyrrolate, and formoterol inhaler to help reduce your chance of getting thrush.

Pneumonia. People with COPD have a higher chance of getting pneumonia. Budesonide, glycopyrrolate, and formoterol Aerosphere may increase your chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:

an increase in sputum production
change in the color of your mucus
fever
chills
increased cough
increased breathing problems.

A weakened immune system and an increased chance of getting infections (immunosuppression). Budesonide, glycopyrrolate, and formoterol may make it harder for your immune system to fight infections.

Reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an ICS (such as budesonide, glycopyrrolate, and formoterol inhaler). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death.
Symptoms of adrenal insufficiency include:

feeling tired
lack of energy
weakness
nausea and vomiting
low blood pressure (hypotension).

Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after using your budesonide, glycopyrrolate, and formoterol inhaler, stop using it and call your healthcare provider right away.

Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction after using your budesonide, glycopyrrolate, and formoterol inhaler:

rash
hives
swelling of your face, mouth, and tongue
breathing problems.

Budesonide, glycopyrrolate, and formoterol may affect your heart. Tell your healthcare provider immediately if your blood pressure increases or you develop a fast or irregular heartbeat or chest pain after using this inhaler.

Budesonide, glycopyrrolate, and formoterol may affect your nervous system. Tell your healthcare provider immediately if you develop a tremor or if you find yourself more anxious or nervous after using this inhaler.

Bone thinning or weakness (osteoporosis). Budesonide, glycopyrrolate, and formoterol may reduce your bone density and cause thinning or weakness.

Budesonide, glycopyrrolate, and formoterol may cause new or worsened eye problems including acute narrow-angle glaucoma and cataracts. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:

eye pain or discomfort
nausea or vomiting
blurred vision
seeing halos or bright colors around lights
red eyes.

If you have these symptoms, call your healthcare provider right away before taking another dose.

Urinary retention. People who take budesonide, glycopyrrolate, and formoterol inhaler may develop new or worsening urinary retention. Symptoms of urinary retention may include:

- difficulty urinating
- urinating frequently
- painful urination
- urination in a weak stream or drips

If you have these symptoms of urinary retention, stop taking budesonide, glycopyrrolate, and formoterol Aerosphere and call your healthcare provider right away before taking another dose.

Changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia) have been reported after using a Budesonide, glycopyrrolate, and formoterol inhaler. Low levels of potassium may cause symptoms of muscle spasm, muscle weakness, or abnormal heart rhythm.

These are not all the possible side effects of budesonide, glycopyrrolate, and formoterol. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects.

Before taking

A budesonide, glycopyrrolate, and formoterol inhaler should not be used in children because clinical trials have not been conducted in children, and it is not known if this medicine is safe and effective in this age group.

Do not use a budesonide, glycopyrrolate, and formoterol inhaler if you are allergic to budesonide, glycopyrrolate, formoterol, or any of the other ingredients in you’re inhaler. See “What are the ingredients in Breztri Aerosphere?” at the end of this page for a complete list of ingredients.

Before using budesonide, glycopyrrolate, and formoterol Aerosphere, tell your healthcare provider about all of your medical conditions, including if you:

have heart problems
have high blood pressure
have seizures
have thyroid problems
have diabetes
have liver problems
have kidney problems
have weak bones (osteoporosis)
have an immune system problem
have eye problems such as glaucoma or cataracts. Using a budesonide, glycopyrrolate, and formoterol inhaler may make your glaucoma worse
have prostate or bladder problems, or problems passing urine. Using a budesonide, glycopyrrolate, and formoterol inhaler may make these problems worse
have a viral, bacterial, parasitic, or fungal infection
are exposed to chickenpox or measles
are pregnant, or plan to become pregnant. It is not known if budesonide, glycopyrrolate, and formoterol inhaler may harm your unborn baby
are breastfeeding. It is not known if the medicines in budesonide, glycopyrrolate, and formoterol inhaler pass into your breast milk and if they can harm your baby. You and your healthcare provider should decide if you will take budesonide, glycopyrrolate, and formoterol inhaler while breastfeeding.

How should I use budesonide, glycopyrrolate, and formoterol inhaler?

A budesonide, glycopyrrolate, and formoterol inhaler is used as 2 puffs in the morning and 2 puffs in the evening.

to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).

Before using budesonide, glycopyrrolate, and formoterol inhaler, make sure your healthcare provider has taught you how to use the inhaler and that you understand how to use it correctly.
Use this medicine exactly as your healthcare provider tells you to use it. Do not use it more often than prescribed.
Use 2 inhalations of budesonide, glycopyrrolate, and formoterol inhaler, 2 times each day (2 puffs in the morning and 2 puffs in the evening).
Do not take more than 2 inhalations of this inhaler 2 times each day.
If a dose (2 puffs) is missed, it should be taken as soon as possible and the next dose should be taken at the usual time. Do not take more than one dose to make up for a forgotten dose.
Rinse your mouth with water and spit the water out after each dose (2 puffs). Do not swallow the water. This will help to reduce the chance of getting a fungus infection (thrush) in the mouth and throat.
If you take too much budesonide, glycopyrrolate, and formoterol inhaler, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
Do not spray the budesonide, glycopyrrolate, and formoterol inhaler into your eyes. If it gets in your eyes, rinse them well with water. If redness continues, call your healthcare provider.
Do not use other medicines that contain a LABA or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic-containing medicines.
Do not change or stop any medicines used to control or treat your breathing problems. Your healthcare provider will change your medicines as needed.
A budesonide, glycopyrrolate, and formoterol inhaler will not relieve sudden breathing problems and you should not take extra doses to relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
Call your healthcare provider or get emergency medical care right away if:
- your breathing problems get worse.
- you need to use your rescue inhaler more often than usual.
- your rescue inhaler does not work as well to relieve your symptoms.

What other drugs will affect budesonide, glycopyrrolate, and formoterol?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Budesonide, glycopyrrolate, and formoterol inhaler and certain other medicines may interact with each other. This may cause serious side effects.

Especially tell your healthcare provider if you take:

anticholinergics (including tiotropium, ipratropium, aclidinium, and umeclidinium)
other LABAs (including salmeterol, formoterol, arformoterol tartrate, vilanterol, olodaterol, and indacaterol)
atropine
antifungal or anti-HIV medicines.

Budesonide, glycopyrrolate, and formoterol should not be used with other combination inhalers, such as Trelegy . Budesonide, glycopyrrolate, and formoterol may be used with rescue inhalers, such as albuterol.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

Budesonide, glycopyrrolate, and formoterol inhaler storage

Store your budesonide, glycopyrrolate, and formoterol inhaler at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Keep in a dry place away from heat and sunlight. Keep the inhaler in its unopened foil pouch and only open when ready to use.

Do not use or store your budesonide, glycopyrrolate, and formoterol inhaler near heat or a flame. Temperatures above 120ºF (49ºC) may cause the canister to burst.

Do not throw the canister into a fire or an incinerator. Do not put a hole in the canister.

Throw away the budesonide, glycopyrrolate, and formoterol inhaler 3 months after you open the foil pouch (for the 120-inhalation canister), or 3 weeks after you open the foil pouch (for the 28-inhalation canister), or when the dose indicator reaches zero “0”, whichever comes first.

Budesonide and formoterol (Inhalation)

Sama Mohamed — Mon, 09 Feb 2026 21:16:01 +0000

Uses for budesonide and formoterol

Budesonide and formoterol combination is used to help control the symptoms of asthma and improve lung function. It is used when a patient’s asthma has not been controlled sufficiently on other asthma medicines, or when a patient’s condition is so severe that more than one medicine is needed every day.

Budesonide and formoterol combination is also used as long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This medicine helps improve and reduce the number of flare-ups of the symptoms of COPD.

Inhaled budesonide belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing inflammation (swelling) in the lungs that causes an asthma attack.

Formoterol belongs to the family of medicines known as long-acting bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, and trouble breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor’s prescription.

Before using budesonide and formoterol

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Symbicort Aerosphere® inhaler in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Symbicort® inhaler in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Symbicort Aerosphere® inhaler in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Symbicort® inhaler in the elderly. However, elderly patients with heart problems may require special caution when receiving budesonide and formoterol combination.

Breast Feeding

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil
Cisapride
Desmopressin
Dronedarone
Levoketoconazole
Mesoridazine
Pimozide
Piperaquine
Rotavirus Vaccine, Live
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Ziprasidone

Acebutolol
Aceclofenac
Acemetacin
Adagrasib
Alfuzosin
Amineptine
Amiodarone
Amisulpride
Amitriptyline
Amitriptylinoxide
Amoxapine
Amtolmetin Guacil
Anagrelide
Apomorphine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asenapine
Aspirin
Astemizole
Atazanavir
Atenolol
Azithromycin
Balofloxacin
Bedaquiline
Belzutifan
Bemetizide
Bemiparin
Bendroflumethiazide
Benzthiazide
Besifloxacin
Betaxolol
Bisoprolol
Boceprevir
Bromfenac
Bufexamac
Bumetanide
Buprenorphine
Bupropion
Buserelin
Carteolol
Carvedilol
Celecoxib
Celiprolol
Ceritinib
Chloroquine
Chlorothiazide
Chlorpromazine
Chlorthalidone
Choline Salicylate
Ciprofloxacin
Citalopram
Clarithromycin
Clofazimine
Clomipramine
Clonixin
Clopamide
Clothiapine
Clozapine
Cobicistat
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclopenthiazide
Cyclosporine
Cyclothiazide
Dabrafenib
Darunavir
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Deutetrabenazine
Dexibuprofen
Dexketoprofen
Dexmedetomidine
Diazoxide
Dibenzepin
Diclofenac
Diflunisal
Dipyrone
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Droperidol
Droxicam
Duvelisib
Ebastine
Efavirenz
Encorafenib
Enoxacin
Entrectinib
Eribulin
Erythromycin
Escitalopram
Esmolol
Ethacrynic Acid
Etodolac
Etofenamate
Etoricoxib
Etozolin
Etrasimod
Famotidine
Fedratinib
Felbamate
Felbinac
Fenoprofen
Fepradinol
Feprazone
Fexinidazole
Fingolimod
Flecainide
Fleroxacin
Floctafenine
Fluconazole
Flufenamic Acid
Flumequine
Fluoxetine
Flurbiprofen
Foscarnet
Fosnetupitant
Fosphenytoin
Fostemsavir
Furosemide
Galantamine
Gatifloxacin
Gemifloxacin
Gepirone
Glasdegib
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Histrelin
Hydrochlorothiazide
Hydroflumethiazide
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibuprofen
Ibutilide
Idelalisib
Iloperidone
Imipramine
Indapamide
Indinavir
Indomethacin
Inotuzumab Ozogamicin
Isocarboxazid
Itraconazole
Ivabradine
Ivosidenib
Ketoconazole
Ketoprofen
Ketorolac
Labetalol
Lapatinib
Larotrectinib
Lefamulin
Lenacapavir
Lenvatinib
Leuprolide
Levobunolol
Levofloxacin
Linezolid
Lofepramine
Lofexidine
Lomefloxacin
Lopinavir
Lorlatinib
Lornoxicam
Loxoprofen
Lumacaftor
Lumefantrine
Lumiracoxib
Lutetium Lu 177 Dotatate
Macimorelin
Mavacamten
Meclofenamate
Mefenamic Acid
Mefloquine
Melitracen
Meloxicam
Methacholine
Methadone
Methotrimeprazine
Methyclothiazide
Methylene Blue
Metipranolol
Metolazone
Metoprolol
Metronidazole
Mifepristone
Mirtazapine
Mizolastine
Mobocertinib
Moricizine
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Interactions with Food/Tobacco/Alcohol

Grapefruit Juice

Proper use of budesonide and formoterol

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Do not stop using this medicine without telling your doctor. To do so may make your condition worse.

Inhaled fluticasone and salmeterol is used to prevent asthma attacks and treat chronic obstructive pulmonary disease (COPD). It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.

This medicine comes with a patient information leaflet or patient instructions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor or pharmacist to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

When you use the Symbicort® inhaler for the first time, or if you have not used it for 7 days or longer, or if the inhaler has been dropped, it may not deliver the right amount of medicine with the first inhalation. Therefore, before using the inhaler, prime it by spraying the medicine 2 times into the air away from the face, and shaking it well for 5 seconds before each spray.

To use the Symbicort® inhaler:

Take the inhaler out of the moisture-protective foil pouch before you use it for the first time.
Do not use the inhaler for this medicine with any other medicine.
Prime the inhaler before use by shaking the inhaler well for 5 seconds and then releasing a test spray. Once again, shake the inhaler and release a second test spray.
Breathe out to the end of a normal breath (exhale). Do not breathe into the inhaler.
Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.
While pressing down firmly and fully on the grey top of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath for as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
Release your finger from the grey top and then turn your head away from the inhaler. Breathe out slowly to the end of a normal breath. Do not breathe into the inhaler.
Shake the inhaler again for 5 seconds and take the second inhalation following exactly the same steps you used for the first inhalation.
Replace the mouthpiece cover after using the medicine.
Gargle and rinse your mouth with water after each dose. This will help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.
Clean the inhaler every 7 days by wiping the mouthpiece with a dry cloth. Do not put the inhaler into water or try to take it apart. However, you must use a new inhaler with each refill of your medicine.

The dose counter at the top of the Symbicort® inhaler will turn yellow when the inhaler has 20 or fewer doses left. Throw the inhaler when it reaches 0, or if it has been 3 months since you last opened the foil pouch.

When you use the Symbicort Aerosphere® inhaler for the first time, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine 4 times into the air away from the face, and shaking it well before each spray. If you have not used it for 7 days or longer or if you’ve dropped it, re-prime by spraying the medicine 2 times into the air away from the face, and shaking it well before each spray.

To use the Symbicort Aerosphere® inhaler:

This medicine comes in a sealed foil pouch. Do not open the foil pouch until you are ready to use a dose of this medicine.
Once opened, remove the inhaler from the pouch.
Take the cap off the mouthpiece. Check the mouthpiece to make sure it is clear.
Press the center of the dose indicator all the way down and release it. You may hear a soft click from the dose indicator as it counts down during use.
To inhale this medicine, breathe out fully and try to get as much air out of your lungs as possible. Put your lips tightly around the mouthpiece and breathe in quickly and deeply until the canister stops moving in the actuator and a puff of medicine has been released.
Remove the inhaler from your mouth and hold your breath for as long as is comfortable, and then breathe out slowly through your nose.
Rinse your mouth with water after each dose. This will help prevent infection in the mouth. Do not swallow the water after rinsing.
Clean the actuator at least once a week with warm water for 30 seconds. Shake off the excess water. Let the actuator air-dry overnight. Do not let the canister get wet.

The dose display window of the Symbicort Aerosphere® inhaler will turn red when the inhaler has 20 or fewer doses left. Throw the inhaler when it reaches 0, or if it has been 3 months since you last opened the foil pouch.

Dosing

For inhalation dosage form (aerosol):
- For preventing an asthma attack:
  - Adults and children 12 years of age and older—Two puffs in the morning and another 2 puffs in the evening. Each inhalation contains 80 or 160 micrograms (mcg) of budesonide and 4.5 mcg of formoterol.
  - Children 6 to 11 years of age—Two puffs in the morning and another 2 puffs in the evening. Each inhalation contains 80 mcg of budesonide and 4.5 mcg of formoterol.
  - Children younger than 6 years of age—Use and dose must be determined by your child’s doctor.
- For treatment and prevention of worsening attacks of COPD:
  - Adults—Two puffs in the morning and another 2 puffs in the evening. Each inhalation contains 160 micrograms (mcg) of budesonide and 4.8 mcg of formoterol.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the inhaler with the mouthpiece down.

Precautions while using budesonide and formoterol

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Although this medicine decreases the number of asthma episodes, it may increase the chances of a severe asthma attack when they do occur. Be sure to read about these risks in the patient information leaflet and talk to your doctor about any questions or concerns that you have.

This medicine should not be used if you are having a sudden COPD attack, or if symptoms of COPD attack has already started. Your doctor will give you a short-acting inhaler to use for this condition. If the short-acting inhaler is not working, tell your doctor right away.

Tell your doctor if you are also using any other medicine for your COPD. Your doctor may want you to use it only during a severe COPD attack. Follow your doctor’s instructions on how you should take your medicine.

Talk to your doctor or get medical care right away if:

Your symptoms do not improve after using this medicine for a few days or if they become worse.
Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often.

Do not use this medicine together with other inhaled medicines for COPD, including arformoterol (Brovana®), formoterol (Foradil®, Perforomist®), indacaterol (Arcapta® Neohaler®), olodaterol, salmeterol (Serevent®), or vilanterol.

Do not change your dose or stop using your medicine without first asking your doctor.

You may get infections more easily while using this medicine. Tell your doctor right away if you or your child have been exposed to someone with chickenpox or measles.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you or your child have white patches in the mouth or throat, or pain when eating or swallowing.

Patients with COPD may be more likely to have pneumonia when taking this medicine. Check with your doctor if you start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or an increase in breathing problems.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

This medicine may cause paradoxical bronchospasm, which may be life-threatening. Check with your doctor right away if you or your child are having a cough, difficulty with breathing, or wheezing.

If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor right away.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

This medicine may cause children to grow more slowly than usual. Talk to your child’s doctor if you have any concerns.

This medicine may cause heart or blood vessel problems, including heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain.

Call your doctor right away if blurred vision, difficulty in reading, seeing halos around lights, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may affect blood sugar and potassium levels. If you notice a change in the results of your blood or urine sugar or potassium tests or if you have any questions, check with your doctor.

Your doctor may want you to carry a medical identification (ID) card stating that you or your child are using this medicine and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of budesonide and formoterol

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain
chest tightness
chills
cough
difficulty with breathing
ear congestion
fever
headache
loss of voice
muscle aches
pain or tenderness around the eyes and cheekbones
sneezing
sore throat
stuffy or runny nose
unusual tiredness or weakness

Less common

Bladder pain
bloody or cloudy urine
congestion
cough producing mucus
diarrhea
difficult, burning, or painful urination
dryness of the throat
fast, irregular, pounding, or racing heartbeat or pulse
frequent urge to urinate
general feeling of discomfort or illness
hoarseness
joint pain
loss of appetite
lower back or side pain
nausea
noisy breathing
shakiness in the legs, arms, hands, or feet
shivering
sore mouth or tongue
stomach pain
sweating
tender, swollen glands in the neck
trembling or shaking of the hands or feet
trouble with sleeping
trouble with swallowing
voice changes
vomiting
white patches in the mouth or on the tongue

Rare

Blurred vision
confusion
decreased urine
dizziness or lightheadedness when getting up suddenly from a lying or sitting position
dry mouth
enlarged pupils
fainting
flushed, dry skin
fruit-like breath odor
increased hunger
increased sensitivity of the eyes to light
increased sweating, possibly with fever or cold, clammy skin
increased thirst
increased urination
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
muscle cramps
nervousness
numbness or tingling in the hands, feet, or lips
pounding in the ears
seizures
severe chest pain
severe headache
slow, fast, pounding, or irregular heartbeat or pulse
stiff or sore neck
unexplained weight loss

Incidence not known

Blindness
decreased vision
eye pain
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
tearing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Arm, back, or jaw pain
chest pain or discomfort
darkening of the skin
drowsiness
mental depression
rapid, deep breathing
restlessness
skin rash
stomach cramps

More common

Stomach discomfort

Less common

Belching
difficulty with moving
heartburn
indigestion
muscle spasms or stiffness
pain in the arms or legs
stomach upset
swollen joints

Rare

Bad, unusual, or unpleasant (after) taste
change in taste
deep or fast breathing with dizziness
fear
hives or welts, itching skin
irritability
large, flat, blue, or purplish patches in the skin
numbness in the feet, hands, and around the mouth
redness of the skin

Budesonide (oral)

Sama Mohamed — Mon, 09 Feb 2026 21:09:16 +0000

What is budesonide?

Oral budesonide is used to treat the following conditions with inflammation as a symptom:

Eosinophilic esophagitis (EoE) in adults and children 11 years and older for up to 12 weeks (Eohilia [budesonide oral suspension 2 mg/10 mL])
Active, mild to moderate Crohn’s disease (CD) that involves the ileum and/or ascending colon in adults and children 8 years and older who weigh at least 55 pounds (25 kg). Also used in adults for up to 3 months to maintain clinical remission in CD (Entocort EC, generic, and Ortikos [budesonide extended-release capsules 3 mg, 6 mg, 9 mg])
Active, mild to moderate ulcerative colitis in adults, to help induce remission (Uceris and generic [budesonide extended-release tablets 9 mg])
Primary immunoglobulin A nephropathy (IgAN) to reduce the loss of kidney function in those who are at risk for disease progression (Tarpeyo [budesonide delayed release capsules 4 mg])

Budesonide works by preventing the activation of inflammatory cells (such as mast cells, eosinophils, and neutrophils) and blocking inflammatory mediators such as histamine and cytokines, which are involved in allergic responses. Exactly how it works for EoE is not fully understood, but inflammation plays a key role in EoE development. It belongs to the drug class called corticosteroids.

Budesonide is a potent anti-inflammatory corticosteroid, 200 times stronger than cortisol and 15 times stronger than prednisolone. It has high glucocorticoid effects (strong effects on inflammation, immune system, wound healing, and intermediary metabolism) and weak mineralocorticoid effects (less effects on water, salt, and mineral metabolism).

Budesonide oral FDA approvals are as follows:

Eohilia (budesonide oral suspension 2 mg/10 mL; February 9, 2024). No generic.
Entocort EC (budesonide extended-release capsule 3 mg; October 2, 2001). Generic available.
Ortikos (budesonide extended-release capsule 6 mg, 9 mg; June 13, 2019 [discontinued]).
Uceris (budesonide extended-release tablet 9 mg; January 14, 2013). Generic available.
Tarpeyo (budesonide delayed-release capsule 4 mg; December 15, 2021). No generic.

Budesonide side effects

The most common side effects of budesonide oral suspension (Eohilia) are:

respiratory tract infection
sore throat
fungal infections of the mouth, throat, and esophagus (thrush)
adrenal suppression
headache
acid-related damage to the lining of the esophagus (erosive esophagitis)
infection of the stomach and intestine (gastroenteritis).

The most common side effects of budesonide extended-release capsules (Entocort EC, Ortikos, generic) are:

headache
infection in your air passages (respiratory infection)
nausea
back pain
indigestion
dizziness
stomach area (abdominal) pain
gas
vomiting
tiredness
pain.

The most common side effects of budesonide delayed-release capsules (Tarpeyo) are:

swelling of the lower legs, ankles, and feet
high blood pressure
muscle spasms
acne
headache
upper respiratory tract infection
swelling of the face
weight increase
indigestion
irritation or inflammation of the skin
joint pain
increased white blood cell count

The most common side effects of budesonide extended release tablets (Uceris, generic) are:

headache
nausea
decreased blood cortisol levels
stomach-area pain
tiredness
stomach or intestinal gas
bloating
acne
urinary tract infection
joint pain
constipation.

Serious side effects and warnings

Budesonide (oral) may cause the following serious side effects:

Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-term use of budesonide may cause you to have elevated levels of corticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms:
- acne
- thicker body hair and facial hair
- bruise easily
- a fatty pad or hump between your shoulders (buffalo hump)
- rounding of your face
- pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms
- ankle swelling.
Adrenal suppression. Long-term use of budesonide can cause a condition in which the adrenal glands do not make enough steroid hormones (adrenal suppression). Tell your healthcare provider if you are under stress or if you have any of the following signs or symptoms:
- tiredness
- nausea and vomiting
- weakness
- low blood pressure.
Decreased ability of your body to fight infections (immunosuppression) and increased risk of infection. Corticosteroid medicines, including budesonide, lower the ability of your immune system to fight infections and increase the risk of infections caused by viruses, bacteria, fungi, protozoans, or certain parasites. Corticosteroid medicines, including budesonide, can also:
- make current infections worse
- increase the risk of infections spreading (disseminated)
- increase the risk of making infections active again or making infections worse that have not been active (latent)
- hide (mask) some signs of infection

These infections can be mild, but can also be severe and lead to death. Your healthcare provider should check you closely for signs and symptoms of an infection while taking budesonide. Tell your healthcare provider right away about any signs or symptoms of a new or worsening infection while taking budesonide, including flu-like symptoms such as:

- fever
- cough
- chills
- pain
- stomach area (abdominal) pain
- feeling tired
- aches
- nausea and vomiting
- diarrhea.
Tuberculosis: If you have inactive (latent) tuberculosis, your tuberculosis may become active again while taking budesonide. Your healthcare provider should check you closely for signs and symptoms of tuberculosis while taking budesonide.
Chicken pox and measles: People taking corticosteroid medicines, including budesonide, who have not had chicken pox or measles, should avoid contact with people who have these diseases. Tell your healthcare provider right away if you come in contact with anyone who has chicken pox or measles.
Hepatitis B virus (HBV) reactivation: If you are a carrier of HBV, the virus can become an active infection again while taking budesonide. Your healthcare provider will test you for HBV before you start taking budesonide.
Amebiasis: Inactive (latent) amebiasis may become an active infection while taking budesonide. Your healthcare provider should check you for amebiasis before you start taking budesonide if you have spent time in the tropics or have unexplained symptoms.
Fungal infections of the mouth (thrush), throat, and esophagus in patients using budesonide may occur. Symptoms of infection include
- white spots in the mouth, a burning or painful sensation in your mouth, redness inside of your mouth, difficulty with eating or
- swallowing, loss of taste, and a feeling like cotton is in your mouth. Tell your healthcare provider if any of the above symptoms occur.
Erosive esophagitis. Budesonide can cause acid-related damage to the lining of the esophagus. Tell your healthcare provider if you notice any new or worsening signs or symptoms such as:
- heartburn
- chest pain
- trouble swallowing.
Effect on growth. Taking corticosteroids can affect your child’s growth. Tell your healthcare provider if you are worried about your child’s growth. Your healthcare provider may monitor the growth of your child while taking budesonide.
Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to budesonide may cause your allergies to come back. These allergies may include a skin condition called eczema or inflammation inside your nose (rhinitis). Tell your healthcare provider if any of your allergies become worse while taking budesonide.
Kaposi’s sarcoma: Kaposi’s sarcoma has happened in people who receive corticosteroid therapy, most often for treatment of long-lasting (chronic) conditions.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Before taking this medicine

You should not use budesonide if you are allergic to budesonide, Eohilia, Ortikos, Tarpeyo, Uceris, Entocort EC, or any of the excipients in oral budesonide products.

Before you take budesonide tell your healthcare provider if you have any other medical conditions including if you:

have liver problems
are planning to have surgery
have chicken pox or measles, or have recently been near anyone with chicken pox or measles
have certain kinds of infections that have not been treated, including fungal infections, bacterial infections, and viral infections
parasitic infections, including threadworm (Strongyloides) infections
herpes simplex infection of the eye (ocular herpes simplex)
have or had tuberculosis
have malaria of the brain (cerebral malaria)
have an infection of the mouth, throat, or esophagus
have diabetes or glaucoma, or have a family history of diabetes or glaucoma
have cataracts
have high blood pressure (hypertension)
have low bone mineral density or osteoporosis
have stomach ulcers
have a weak immune system
have unexplained diarrhea
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed.

Steroids can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have. Tell your doctor about any recent, active, or chronic illness, especially any type of infection caused by bacteria, virus, fungus, or parasites, including threadworm.

Pregnancy

Budesonide may harm your unborn baby. Talk to your healthcare provider about the possible risk to your unborn baby if you take budesonide when you are pregnant. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during your treatment with budesonide.

Breastfeeding

It is not known if budesonide passes into your breast milk or if it will affect your baby. Talk to your healthcare provider about the best way to feed your baby if you take budesonide.

The Tarpeyo Prescribing information recommends routine monitoring of linear growth in infants with long-term use of budesonide in women who are breastfeeding.

How should I take budesonide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

How you take budesonide depends on your condition and the formulation or brand you are prescribed.

Budesonide oral suspension

Eohilia stick packs

See the detailed Instructions for Use that comes with Eohilia for information about how to prepare and take Eohilia and how to properly store and throw away (dispose of) used Eohilia stick packs. Take Eohilia exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Eohilia to take.

Eohilia is taken 2 times a day (1 time in the morning and 1 time in the evening).
Shake the stick pack for at least 10 seconds before opening. After opening the top, squeeze the stick pack from bottom to top to dispense contents directly into the mouth.
Repeat this 2 to 3 times until the stick pack is empty. Swallow all of the suspension and avoid eating or drinking anything for 30 minutes.
After 30 minutes, rinse your mouth with water and spit out the contents without swallowing.

Do not mix Eohilia with food or liquid.

Do not eat or drink at the same time as taking Eohilia. Wait to eat or drink at least 30 minutes after taking Eohilia.

Your healthcare provider may change your dose if needed. Do not change your dose or stop taking Eohilia unless your healthcare provider tells you.

Budesonide extended-release capsules

Entocort EC extended-release capsules and generic

Take Entocort EC exactly as your healthcare provider tells you. Your healthcare provider will tell you how many Entocort EC capsules to take. Your healthcare provider may change your dose if needed.

Take Entocort EC 1 time each day in the morning.
Swallow the capsules whole. Do not chew or crush the capsules before swallowing.

For patients unable to swallow a whole capsule, Entocort EC capsules can be opened and administered as follows:

Place 1 tablespoonful of applesauce into a clean container, such as an empty bowl. The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
Open the capsule. You may need to use more than 1 Entocort EC capsule for the dose prescribed by your healthcare provider.
Carefully empty all of the granules inside the capsule on the applesauce.
Stir the granules with the applesauce.
Swallow the applesauce and granules mixture within 30 minutes after preparing it. Follow the applesauce and granules immediately with a glass (8 ounces) of cool water to help with complete swallowing of the granules. Do not chew or crush the granules.
Do not save the applesauce and granules for later use.

Ortikos extended-release capsules

Take Ortikos exactly as your healthcare provider tells you. Your healthcare provider will tell you how many capsules to take. Your healthcare provider may change your dose if needed.

Take Ortikos 1 time each day, in the morning.
Swallow the capsules whole. Do not chew or crush the capsules before swallowing.

Budesonide extended-release tablets

Uceris extended-release tablets and generic

Take Uceris extended-release tablets exactly as your healthcare provider tells you to take them.

Take Uceris 1 time each day in the morning with or without food.
Swallow the tablets whole with water. Do not chew, crush, or break the tablets before swallowing.

Budesonide delayed-release capsules

Tarpeyo delayed-release capsules

Take Tarpeyo exactly as your healthcare provider tells you. Your healthcare provider will decide how long you should take Tarpeyo. Do not stop taking Tarpeyo without first talking with your healthcare provider.

Take Tarpeyo 1 time each day in the morning, at least 1 hour before a meal.
Swallow Tarpeyo capsules whole. Do not open, chew, crush, or break Tarpeyo capsules before swallowing.

Dosing information

The dosage of budesonide depends on your condition and the formulation or brand you are prescribed.

Budesonide oral suspension 2 mg/10 mL

Dosage for EOS (Eohilia): 2 mg twice daily for 12 weeks.

2mg is contained in one Eohilia stick pack.

Budesonide extended-release capsules

Dosage for the treatment of Crohn’s disease (Entocort EC, Ortikos, generic):

Adults: 9 mg once daily for up to 8 weeks
Repeat 8-week courses with recurring episodes of active disease
Children 8 through 17 years (weight > 25 kg): 9 mg once daily for up to 8 weeks followed by 6 mg once daily for 2 weeks.

Dosage for the maintenance of clinical remission of Crohn’s disease (Entocort EC, Ortikos, generic):

Adults: 6 mg once daily for up to 3 months.
Taper to complete cessation after 3 months.
Continued treatment for more than 3 months has not been shown to provide substantial clinical benefit.
When switching from oral prednisolone, begin tapering prednisolone concomitantly with initiating Ortikos.

Budesonide delayed-release tablets

Dosage for ulcerative colitis (Uceris, generic)

9 mg once daily in the morning with or without food for up to 8 weeks.

Budesonide delayed-release capsules

Dosage for the treatment of IgAN in adults (Tarpeyo)

16 mg once daily
Take in the morning at least 1 hour before food.
The recommended duration of therapy is 9 months.
When discontinuing, reduce the dosage to 8 mg once daily for the last 2 weeks.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

If you take budesonide for primary immunoglobulin A nephropathy, skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I take too much budesonide?

If you take too much budesonide, call your healthcare provider right away or go to the nearest hospital emergency room.

What should I avoid while taking budesonide?

Grapefruit may interact with budesonide and cause side effects. Avoid consuming grapefruit products.

Avoid receiving a “live” vaccine and being near people who are sick or have infections. The vaccine may not work as well while you are using budesonide. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Also call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using budesonide.

What other drugs will affect budesonide?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially if you use stomach acid reducers.

This list is not complete. Other drugs may affect budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products.

Storage

Eohilia: Store between 36°F to 77°F (2°C to 25°C). May be refrigerated. Do not freeze.

Entocort EC and generic: Store at room temperature between 68°F to 77°F (20°C to 25°C).

Ortikos: Store at room temperature between 68° to 77°F (20° to 25°C). Keep in a tightly closed container.

Uceris and generic: Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed.

Tarpeyo: Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed.

Keep all medicines out of the reach of children.

Ingredients

Eohilia ingredients

Active ingredient: budesonide

Inactive ingredients: acesulfame potassium, ascorbic acid, Avicel® RC-591, cherry flavor, citric acid, dextrose, disodium ethylenediaminetetraacetic acid (EDTA), glycerin, Magnasweet® 110, maltodextrin, polysorbate 80, potassium sorbate, sodium ascorbate, sodium benzoate, sodium citrate, and purified water. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

Entocort EC ingredients

Active ingredient: budesonide

Inactive ingredients: ethylcellulose, acetyltributyl citrate, methacrylic acid copolymer type C, triethyl citrate, antifoam M, polysorbate 80, talc, and sugar spheres.

The capsule shell contains: gelatin, iron oxide, and titanium dioxide.

Ortikos ingredients

Active ingredient: budesonide

Inactive ingredients: acetyl tributyl citrate, corn starch, ethylcellulose aqueous dispersion, methacrylic acid and ethyl acrylate copolymer dispersion, polysorbate 80, simethicone emulsion, sucrose, talc, and triethyl citrate.

Capsule shell contains gelatin, iron oxide black (for 6 mg), iron oxide red, iron oxide yellow, sodium lauryl sulphate, and titanium dioxide.

The imprinting ink contains black iron oxide, potassium hydroxide, and shellac.

Uceris ingredients

Active Ingredient: budesonide

Inactive ingredients: stearic acid, lecithin, microcrystalline cellulose, hydroxypropyl cellulose, lactose, silicon dioxide, magnesium stearate, methacrylic acid copolymer types A and B, talc, triethyl citrate, and titanium dioxide.

Tarpeyo ingredients

Active ingredient: budesonide

Inactive ingredients: sugar spheres (sucrose and starch), hypromellose, polyethylene glycol, citric acid monohydrate, ethyl cellulose, medium chain triglycerides and oleic acid.

The capsules contain: hypromellose and titanium oxide (E171).

The printing ink on the capsules contains: shellac, propylene glycol and black iron oxide (E172).

The enteric coating on the capsules contains: methacrylic acid and methacrylate copolymer, talc and dibutyl sebacate.

Who makes budesonide?

Budesonide is made by various manufacturers.

Budesonide oral suspension (2 mg/10 mL, Eohilia) is made by Takeda Pharmaceuticals America, Inc., in Lexington, MA.

Budesonide extended-release oral capsules (3 mg, Entocort EC brand) are made by Perrigo. They acquired the rights to this medication from AstraZeneca in 2015. Perrigo is headquartered in Dublin, Ireland, with U.S. operations based in Michigan, USA.

A generic Entocort 3mg delayed-release oral capsule 3 mg is available manufactured by Aurobindo Pharma USA, Zydus Pharma, Amneal Pharma, Dr Reddys Labs SA, and Rising.

Budesonide extended-release oral capsules (6 mg, 9 mg, Ortikos brand) were made by Sun Pharmaceutical Industries Ltd., in Gujarat, India.

Budesonide extended-release oral tablets (9 mg, Uceris brand) are made by Bausch Health Companies Inc. (formerly known as Valeant Pharmaceuticals). Salix Pharmaceuticals is the specific division or subsidiary of Bausch Health Companies that markets and distributes Uceris tablets.

A generic Uceris extended-release oral tablet 9 mg is made by Actavis Labs FL Inc., and Mylan.

Budesonide delayed release capsules (4mg, Tarpeyo) are made by Calliditas Therapeutics AB, with headquarters in Stockholm, Sweden.

Bryhali

Sama Mohamed — Mon, 09 Feb 2026 21:01:49 +0000

What is Bryhali?

Bryhali is a high-potency, Class I corticosteroid lotion that may be used by adults to reduce inflammation and itching caused by plaque psoriasis. It contains 0.01% halobetasol propionate.

Bryhali was approved on November 6, 2018. It contains a lower concentration than other halobetasol propionate lotions which limits its risk of side effects.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Bryhali (halobetasol propionate 0.01% lotion) is a highly potent, Class I corticosteroid that can be absorbed through the skin into the bloodstream and cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency, including Cushing’s syndrome, hyperglycemia, and glucosuria. Do not use for longer than 2 weeks and do not exceed the recommended dose. Periodic monitoring for HPA suppression may be required.

Before taking this medicine

You should not use halobetasol topical if you are allergic to it.

Bryhali should not be applied to lesions that are exuding serum or to skin folds (where two areas of skin touch each other).

Tell your doctor if you have ever had:

any type of skin infection;
a skin reaction to any steroid medicine;
liver disease; or
an adrenal gland disorder.

Topical corticosteroids can increase the glucose (sugar) levels in your blood or urine. Tell your doctor if you have diabetes.

Children are more susceptible to systemic absorption of topical corticosteroids. Bryhali is not approved for use by anyone younger than 18 years old.

It is not known whether halobetasol topical will harm an unborn baby. Tell your doctor if you are pregnant. If you are instructed to use Bryhali, use only a small amount for the shortest time possible.

It may not be safe to breastfeed while using this medicine. If you are instructed to use Bryhali, use only a small amount for the shortest time possible. Do not apply to the breasts.

How do I use Bryhali?

Apply Bryhali exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Do not take it by mouth or use it intravaginally. Topical medicine is for use only on the skin. Do not use on open wounds or sunburned, windburned, dry, or irritated skin. Rinse with water if Bryhali gets in your eyes or mouth.

Wash your hands before and after using Bryhali, unless you are using this medicine to treat the skin on your hands.
Apply a thin layer of Bryhali lotion to the affected areas once daily. Rub in gently and completely. Do not apply this medicine over a large area of skin unless your doctor has told you to.

Do not cover the treated skin area with a bandage or other covering unless your doctor tells you to. Covering treated areas can increase the amount of medicine absorbed through your skin and may cause harmful effects.

Bryhali lotion is for short-term use only (up to 8 weeks). Follow your doctor’s dosing instructions very carefully. Clinical trials have shown Bryhali continues to provide relief from psoriasis for up to 4 weeks after stopping using it.

Call your doctor if your symptoms do not improve after 8 weeks, or if they get worse. Stop using the product if your symptoms improve sooner.

What happens if I miss a dose?

Apply the product as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line if anyone has accidentally swallowed the medication.

High doses or long-term use of Bryhali lotion can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using Bryhali?

Avoid applying Bryhali to your face, scalp, underarms, or groin area. Do not use it to treat any skin condition that has not been checked by your doctor.
Avoid using other topical steroid medications on the areas you treat with Bryhali unless your doctor tells you to.
Do not use more than 50 grams per week.

What are the side effects of Bryhali?

Get emergency medical help if you have signs of an allergic reaction to Bryhali such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

worsening of your skin condition;
redness, warmth, swelling, oozing, or severe irritation of any treated skin;
blurred vision, tunnel vision, eye pain, or seeing halos around lights;
high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor; or
possible signs of absorbing this medicine through your skin – weight gain (especially in your face or your upper back and torso), slow wound healing, thinning or discolored skin, increased body hair, muscle weakness, nausea, diarrhea, tiredness, mood changes, menstrual changes, sexual changes.

Common Bryhali side effects may include:

upper respiratory tract infection
burning, stinging, itching, or dryness of treated skin
high blood sugar levels.

Other side effects that may occur with topical corticosteroids include:

acne
discoloration of the skin where the tape has been applied
dryness
excessive hair growth
miliaria
ophthalmic side effects such as cataracts or glaucoma
perioral dermatitis and allergic contact dermatitis
redness or crusting around your hair follicles (folliculitis)
skin thinning
spider veins
stretch marks.

Topical corticosteroids can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency.

If you develop a skin infection while using Bryhali your doctor may give you an antimicrobial cream to use as well. If this does not resolve the infection, your doctor may discontinue the tape until the infection has cleared.

Brukinsa

Sama Mohamed — Mon, 09 Feb 2026 20:56:52 +0000

What is Brukinsa?

Brukinsa is used to treat adults with mantle cell lymphoma, Waldenström’s macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, and follicular lymphoma. It is an oral capsule or tablet that is taken once or twice a day.

Brukinsa (zanubrutinib) was first approved in 2019. There is no generic.

FDA approvals and indications

Brukinsa is a prescription oral capsule or tablet used to treat adults with:

Chronic lymphocytic leukemia (CLL)
Small lymphocytic lymphoma (SLL)
Follicular lymphoma (FL), in combination with obinutuzumab, whose disease has come back or did not respond to treatment (relapsed or refractory) and who have received at least 2 prior treatments
Mantle cell lymphoma (MCL), who have received at least 1 prior treatment for their cancer.
Waldenström’s macroglobulinemia (WM)
Marginal zone lymphoma (MZL), when the disease has come back or did not respond to treatment (relapsed or refractory), and who have received at least one anti-CD20-based regimen.

It is not known if this medicine is safe and effective in children.

How does Brukinsa work?

Brukinsa is a targeted treatment, not a chemotherapy drug, and works by directly blocking an enzyme, called Bruton’s tyrosine kinase (BTK), preventing its activity.

BTK is a signaling molecule for pathways that cause an increase in B cells, a type of white blood cell that makes infection-fighting antibodies.
Inhibition of BTK reduces the growth and spread of malignant B cells.

Brukinsa belongs to the drug class called BTK inhibitors.

Side effects

The most common side effects of Brukinsa are:

diarrhea or constipation
low platelet or other blood cell counts
easy bruising or bleeding
musculoskeletal pain
high blood pressure
a rash
cold or flu symptoms, such as stuffy nose, sneezing, sore throat, or cough.

Serious side effects and warnings

Get emergency medical help if you have signs of an allergic reaction to Brukinsa. Symptoms may include hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Brukinsa can cause the following serious or life-threatening side effects:

Severe bleeding. Bleeding problems are common with Brukinsa, and can be serious and may
lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:
- blood in your stools or black stools (looks like tar)
- pink or brown urine
- unexpected bleeding, or bleeding that is severe or you cannot control
- increased bruising
- dizziness
- weakness
- confusion
- vomit blood or vomit that looks like coffee grounds
- cough up blood or blood clots
- change in speech
- headache that lasts a long time.
Infections that can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, or flu-like symptoms
Decrease in blood cell counts (white blood cells, platelets, and red blood cells). Your healthcare provider should do blood tests during treatment with Brukinsa to check your blood counts.
Second primary cancers. New cancers have happened in people during treatment with Brukinsa, including cancers of the skin or other organs. Your healthcare provider will check you for other cancers during treatment. Use sun protection when you are outside in sunlight.
Heart rhythm problems (atrial fibrillation, atrial flutter, and ventricular arrhythmias) that can be serious and may lead to death. Tell your healthcare provider if you have any of the following signs or symptoms:
- your heartbeat is fast or irregular
- feel lightheaded or dizzy
- pass out (faint)
- shortness of breath
- chest discomfort.
Liver problems. Liver problems, which may be severe or life-threatening, or lead to death, can happen in people treated with Brukinsa. Your healthcare provider will do blood tests to check your liver before and during treatment. Tell your healthcare provider or get medical help right away if you have any signs of liver problems, including stomach pain or discomfort, dark-colored urine, or yellow skin and eyes.

Brukinsa can cause fetal harm when administered to a pregnant woman, including malformations. Women should use effective contraception and avoid becoming pregnant while taking Brukinsa and for 1 week after the last dose. Men should avoid fathering a child during treatment and for 1 week after the last dose.

It is not known if Brukinsa is safe and effective in children.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Before taking

Before you start treatment with Brukinsa, tell your healthcare provider about all of your medical conditions, including if you:

have bleeding problems
have had recent surgery or plan to have surgery. Your healthcare provider may stop Brukinsa for any planned medical, surgical, or dental procedure
have an infection
have or had heart rhythm problems
have high blood pressure
have liver problems, including a history of hepatitis B virus (HBV) infection
take any other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed.

Pregnancy

Brukinsa can harm your unborn baby. If you can become pregnant, your healthcare provider may do a pregnancy test before starting treatment with this medicine.

You may need to have a negative pregnancy test before you start using Brukinsa. Females should not become pregnant during treatment and for at least 1 week after the last dose. You should use effective birth control (contraception) during treatment and for at least 1 week after the last dose.

Males should avoid getting female partners pregnant during treatment and for at least 1 week after the last dose of Brukinsa. You should use effective birth control (contraception) during treatment and for at least 1 week after the last dose.

Breastfeeding

It is not known if Brukinsa passes into your breast milk. Do not breastfeed during treatment and for at least 2 weeks after your last dose.

How should I take Brukinsa?

Take exactly as directed by your healthcare provider.

Take the capsules/tablets once or twice daily as directed.
Swallowed the capsules whole with a full glass of water. Do not open, break, or chew the capsules.
The tablets can be split in half down the score line as prescribed by your healthcare provider. Do not chew or crush the tablets.
May be taken with or without food.
The dosage may need to be reduced in those with severe liver disease.
Take until disease progression or unacceptable toxicity occurs.

Dosing information

Adult dose of Brukinsa for MCL, WM, MZL, CLL, SLL, and FL:

160 mg twice a day or 320 mg once a day.
May be taken with or without food.

Available as 80 mg capsules and 160 mg tablets.

Dosage reduction

The recommended dosage in severe liver disease is 80 mg twice daily.

No dosage reduction is necessary in patients with mild or moderate hepatic impairment (Child-Pugh class A or B).

The dose also needs to be reduced when used with CYP3A Inhibitors or Inducers .

What happens if I miss a dose?

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not use 2 doses in one day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What other drugs will affect Brukinsa?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Common medications that may interact with Brukinsa include:

Moderate to strong CYP3A Inhibitors, such as clarithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, ritonavir, grapefruit juice, erythromycin, or verapamil
Moderate to strong CYP3A inducers, such as glucocorticoids, rifampin, carbamazepine, phenobarbital, and phenytoin. Avoid coadministration.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Brukinsa with certain other medications may affect how zanubrutinib works and can cause side effects.

Bromfed Dm

Sama Mohamed — Wed, 04 Feb 2026 08:49:03 +0000

Bromfed DM Description

Bromfed DM (Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Oral Syrup) is a pink, sugar free syrup with a melon flavor.

Each 5 mL (1 teaspoonful) contains:

Brompheniramine Maleate, USP . . . . . . . . 2 mg

Pseudoephedrine Hydrochloride, USP . . . . . 30 mg

Dextromethorphan Hydrobromide, USP . . . 10 mg

Inactive Ingredients:citric acid anhydrous, FD&C Red #40, glycerin, melon flavoring, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose.

C 16H 19BrN 2•C 4H 4O 4M.W. 435.31
Brompheniramine Maleate, USP
(±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1)

C 10H 15NO•HCl M.W. 201.69
Pseudoephedrine Hydrochloride, USP
(+)-Pseudoephedrine hydrochloride

C 18H 25NO•HBr•H 2O M.W. 370.32
Dextromethorphan Hydrobromide, USP
3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate

Antihistamine/ Nasal Decongestant/ Antitussive syrup for oral administration.

Bromfed DM – Clinical Pharmacology

Brompheniramine maleate is a histamine antagonist, specifically an H1-receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells. Brompheniramine also has anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergic response (vasodilation, increased vascular permeability, increased mucus secretion) of nasal tissue. Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after single, oral dose of 4 mg reached in 5 hours; urinary excretion is the major route of elimination, mostly as products of biodegradation; the liver is assumed to be the main site of metabolic transformation.

Pseudoephedrine acts on sympathetic nerve endings and also on smooth muscle, making it useful as a nasal decongestant. The nasal decongestant effect is mediated by the action of pseudoephedrine on α-sympathetic receptors, producing vasoconstriction of the dilated nasal arterioles. Following oral administration, effects are noted within 30 minutes with peak activity occurring at approximately one hour.

Dextromethorphan acts centrally to elevate the threshold for coughing. It has no analgesic or addictive properties. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration.

Indications and Usage for Bromfed DM

Bromfed DM (Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Oral Syrup) is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Contraindications

Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan in patients receiving monoamine oxidase inhibitors (MAOIs) .

Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

Warnings

Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.

Antihistamines may diminish mental alertness. In the young child, they may produce excitation.

Precautions

General

Because of its antihistamine component, Bromfed DM Syrup (Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Oral Syrup) should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, Bromfed DM Syrup should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.

Information for Patients

Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.

Drug Interactions

Monoamine oxidase inhibitors (MAOIs)

Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAOIs and products containing dextromethorphan. In addition, MAOIs prolong and intensify the anticholinergic (drying) effects of antihistamines and may enhance the effect of pseudoephedrine. Concomitant administration of Bromfed DM Syrup and MAOIs should be avoided.

Central nervous system (CNS) depressants

Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.).

Antihypertensive drugs

Sympathomimetic may reduce the effects of antihypertensive drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies of Bromfed DM Syrup to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.

Pregnancy

Teratogenic Effects

Animal reproduction studies have not been conducted with Bromfed DM Syrup. It is also not known whether Bromfed DM Syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.

Reproduction studies of brompheniramine maleate (a component of Bromfed DM Syrup) in rats and mice at doses up to 16 times the maximum human doses have revealed no evidence of impaired fertility or harm to the fetus.

Nursing Mothers

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Bromfed DM Syrup is contraindicated in nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 months have not been established

Geriatric Use

Clinical studies of Bromfed DM Syrup (Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients. The elderly are also more likely to experience adverse reactions to sympathomimetics. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions/Side Effects

The most frequent adverse reactions to Bromfed DM Syrup (Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup) are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:

Dermatologic:Urticaria, drug rash, photosensitivity, pruritus.

Cardiovascular System:Hypotension, hypertension, cardiac arrhythmias, palpitation.

CNS:Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria.

G.U. System:Urinary frequency, difficult urination.

G.I. System:Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.

Respiratory System:Tightness of chest and wheezing, shortness of breath.

Hematologic System:Hemolytic anemia, thrombocytopenia, agranulocytosis.

Overdosage

Signs and Symptoms:

Central nervous system effects from overdosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted. Toxic doses of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias; signs of CNS depression may occasionally be seen. Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures.

Toxic Doses:

Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug. A 2½-year-old child survived the ingestion of 21 mg/kg of dextromethorphan exhibiting only ataxia, drowsiness, and fever, but seizures have been reported in 2 children following the ingestion of 13–17 mg/kg. Another 2½-year-old child survived a dose of 300–900 mg of brompheniramine. The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg.

Treatment:

Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances tracheostomy may be necessary prior to lavage. Naloxone hydrochloride 0.005 mg/kg intravenously may be of value in reversing the CNS depression that may occur from an overdose of dextromethorphan. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated.

Bromfed DM Dosage and Administration

Adults and pediatric patients 12 years of age and over:10 mL (2 teaspoonfuls) every 4 hours.

Children 6 to under 12 years of age:5 mL (1 teaspoonful) every 4 hours.

Children 2 to under 6 years of age:2.5 mL (½ teaspoonful) every 4 hours.

Infants 6 months to under 2 years of age:Dosage to be established by a physician.

Do not exceed 6 doses during a 24-hour period.

How is Bromfed DM supplied

Bromfed DM Syrup (Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup) is a pink, sugar free syrup with a melon flavor. Each 5 mL (1 teaspoonful) contains: brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following sizes:

4 fl oz (118 mL) NDC 69437-605-04
16 fl oz (473 mL) NDC 69437-605-16

Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

KEEP TIGHTLY CLOSED

Dispense in a tight, light-resistant container as defined in the USP.

Rx Only

Distributed by:

Alpharetta, GA 30004

1-800-844-302-5227

500544-01

PRINCIPAL DISPLAY PANEL

NDC 69437-605-04

Bromfed DM 4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL

NDC 69437-605-16

Bromfed DM 16 fl oz (473 mL)

BROMFED DM
brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide syrup

Product InformationProduct TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69437-605Route of AdministrationORAL

Active Ingredient/Active MoietyIngredient NameBasis of StrengthStrengthBROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE – UNII:H57G17P2FN)BROMPHENIRAMINE MALEATE2 mg in 5 mLPSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE – UNII:7CUC9DDI9F)PSEUDOEPHEDRINE HYDROCHLORIDE30 mg in 5 mLDEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN – UNII:7355X3ROTS)DEXTROMETHORPHAN HYDROBROMIDE10 mg in 5 mL

Inactive IngredientsIngredient NameStrengthGLYCERIN (UNII: PDC6A3C0OX)METHYLPARABEN (UNII: A2I8C7HI9T)PROPYLENE GLYCOL (UNII: 6DC9Q167V3)SODIUM BENZOATE (UNII: OJ245FE5EU)SUCRALOSE (UNII: 96K6UQ3ZD4)ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)WATER (UNII: 059QF0KO0R)FD&C RED NO. 40 (UNII: WZB9127XOA)

Product CharacteristicsColorpinkScoreShapeSizeFlavorWATERMELONImprint CodeContains

Packaging#Item CodePackage DescriptionMarketing Start DateMarketing End Date1NDC:69437-605-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/11/20232NDC:69437-605-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/11/2023

Marketing InformationMarketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End DateANDAANDA20337504/11/2023

Labeler – Canton Laboratories, LLC (079589614)

Name	Address	ID/FEI	Business Operations
Establishment
Sovereign Pharmaceuticals, LLC		623168267	manufacture(69437-605)

Briviact

Sama Mohamed — Wed, 04 Feb 2026 08:40:41 +0000

What is Briviact?

Briviact (brivaracetam) is an anti-epileptic drug (also called an anticonvulsant) that may be used to treat partial onset seizures in adults and children 1 month and older with epilepsy.

Briviact is often used along with other seizure medicines to give better control over seizures.

Briviact works in the brain to help control seizures and is thought to target a specific protein called SV2A that helps nerve cells communicate with each other. By attaching to this protein, Briviact helps balance the brain’s electrical activity and this mechanism can stop the sudden bursts of electricity that cause seizures.

Briviact gained FDA approval on February 18, 2016. There is currently no Briviact generic available.

Is Briviact a controlled substance?

Briviact is a federally controlled substance (Schedule V) because it can be abused or lead to dependence.

Keep Briviact in a safe place to prevent misuse and abuse. Selling or giving away Briviact may harm others and is against the law.

Briviact side effects

The most common side effects of Briviact are:

sleepiness
dizziness
feeling tired
nausea and vomiting.

Side effects of Briviact in children 1 month to less than 16 years of age are similar to those seen in adults.

Serious side effects and warnings

Briviact may cause the following serious side effects.

Suicidal thoughts and behaviors. Like other antiepileptic drugs, Briviact may cause suicidal thoughts or actions in a very small number of people; about 1 in 500 people taking it. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying
new or worse depression
feeling agitated or restless
trouble sleeping (insomnia)
acting aggressive, feeling angry, or being violent
an extreme increase in activity and talking (mania)
attempts to commit suicide
new or worse anxiety
panic attacks
new or worse irritability
acting on dangerous impulses
other unusual changes in behavior or mood.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop Briviact without first talking to a healthcare provider. Stopping Briviact suddenly can cause seizures that will not stop (status epilepticus).

Nervous system problems. Drowsiness, tiredness, and dizziness are common with Briviact but can be severe. Do not drive or operate machinery until you know how Briviact affects you. Briviact can also cause problems with balance and coordination.

Mental (psychiatric) symptoms. Briviact can cause mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. Irritability and anxiety are common with Briviact and can be severe. People who take Briviact can also get psychotic symptoms such as hallucinations (seeing or hearing things that are not there), delusions (false or strange thoughts or beliefs), and unusual behavior.

Get emergency medical help if you have signs of an allergic reaction to Briviact: hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

These are not all the possible side effects of Briviact. For more information, ask your healthcare provider or
pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects.

Before taking this medicine

You should not use Briviact if you are allergic to brivaracetam, Briviact, or any of the inactive ingredients in the formulation you are taking/receiving.

Before taking Briviact, tell your healthcare provider about all of your medical conditions, including if you:

have or had depression, mood problems, or suicidal thoughts or behavior
have liver problems
have abused or been dependent on prescription medicines, street drugs, or alcohol
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed.

Briviact is not approved for use by anyone younger than 1 month of age.

Pregnancy

It is not known if Briviact will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Briviact. You and your healthcare provider will have to decide if you should take Briviact while you are pregnant. Follow your doctor’s instructions about taking seizure medication if you are pregnant. Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking this medicine without your doctor’s advice, and tell your doctor right away if you become pregnant.

If you do become pregnant while taking Briviact, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of Briviact and other antiepileptic medicines during pregnancy.

Breastfeeding

Briviact passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Briviact.

How should I take Briviact?

Take Briviact exactly as prescribed by your doctor. Your healthcare provider will tell you how much Briviact to take and when to take it. Your healthcare provider may change your dose if needed. Do not change your dose without talking to your healthcare provider.

Briviact is usually taken/given 2 times a day.

Take Briviact oral tablets or oral solution with or without food.

Swallow Briviact tablets whole with a liquid and do not chew or crush the tablets before swallowing.
Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Briviact injection is given as an infusion into a vein. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

Briviact may be habit-forming and is a federally controlled substance (Schedule V). Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Do not stop using Briviact suddenly, even if you feel fine. Stopping suddenly may cause serious medical problems or increased seizures. Follow your doctor’s instructions about tapering your dose.

Briviact dosing information

Usual Briviact Adult Dose for Epilepsy

Initial oral dose: Briviact 50 mg orally 2 times a day

Adjust the dose up or down based on individual patient tolerability and response.

Maintenance dose: 25 mg to 100 mg orally twice a day based on clinical response and tolerability

Maximum dose: 200 mg/day

IV Administration: Briviact 50 mg by IV injection over 2 to 15 minutes

May be used when oral administration is temporarily not feasible.
Administer at the same dose and frequency as oral formulations.
Experience with IV injection is limited to 4 consecutive days of treatment.

Usual Briviact Child Dose for Epilepsy

Briviact doses are based on weight in children. Your child’s dose needs may change if the child gains or loses weight.

Briviact ablets, oral solution, and injection can be used interchangeably.

1 month to 16 years

Weight: Less than 11 kg: Initial dose: Briviact 0.75 to 1.5 mg/kg orally twice a day; Maintenance dose: 0.75 to 3 mg/kg orally twice a day
Weight: 11 kg to less than 20 kg: Initial dose: Briviact 0.5 to 1.25 mg/kg orally twice a day; Maintenance dose: 0.5 to 2.5 mg/kg orally twice a day
Weight: 20 kg to less than 50 kg: Initial dose: Briviact 0.5 to 1 mg/kg orally twice a day; Maintenance dose: 0.5 to 2 mg/kg orally twice a day
Weight: 50 kg or greater: Initial dose: Briviact 25 to 50 mg orally twice a day; Maintenance dose: 25 to 100 mg orally twice a day

16 years of age and older

Initial dose: Briviact 50 mg orally 2 times a day.
Maintenance dose: 25 mg to 100 mg orally twice a day.

IV Administration may be used in patients 16 years or older when oral administration is temporarily not feasible.

Administer at the same dose and same frequency as oral formulations.
Experience with the IV injection is limited to 4 consecutive days of treatment.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I take too much Briviact?

If you take too much Briviact call your Poison Control Center or go to the nearest emergency room right away.

What to avoid

Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

What other drugs will affect Briviact?

Other drugs may interact with brivaracetam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your other medicines. Especially tell your healthcare provider if you take:

Rifampin — the dosage of Briviact may need to be increased
Carbamazepine — the dosage of carbamazepine may need to be reduced
Phenytoin — the dosage of phenytoin may need to be reduced.

Levetiracetam — Briviact had no added therapeutic benefit when coadministered with levetiracetam.

When you start or stop taking Briviact, your doctor may need to adjust the doses of any other medicines you take regularly.

Not all possible drug interactions are listed here. See the Briviact Prescribing Information for a full list of interactions.

Storage

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze. Throw away unused liquid after 5 months.

Briviact ingredients

Active ingredient: brivaracetam

Tablet inactive ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, and magnesium stearate.

Tablet film coating contains the inactive ingredients listed below:

10 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide
25 mg and 100 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, black iron oxide
50 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide
75 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide.

Oral solution inactive ingredients: sodium citrate, anhydrous citric acid, methylparaben, sodium
carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water.

Briumvi

Sama Mohamed — Wed, 04 Feb 2026 08:34:37 +0000

What is Briumvi?

Briumvi is used to treat relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It is given as an intravenous infusion every 6 months by a healthcare provider.

Clinical trials report that Briumvi is superior to teriflunomide at reducing relapses and significantly reducing brain lesions on magnetic resonance imaging (MRI).

49 % to 59 % fewer relapses were reported with Briumvi vs teriflunomide in 2 clinical trials.
Both studies also reported near complete (97%) suppression of brain lesions (T1 Gd+ lesions) per MRI over 2 years.
Zero relapses were reported in 86% to 87% of people taking Briumvi.

Briumvi (ublituximab-xiiy) gained FDA approval on December 28, 2022. There is no generic or biosimilar.

How does Briumvi work?

Briumvi’s mechanism of action involves targeting and destroying B cells (a type of immune cell) in the body. It does this by binding to a protein called CD20 on the B cells’ surface. By reducing B cells, Briumvi helps mitigate the immune system’s effect on the nervous system, which drives MS symptoms.

Briumvi belongs to the drug class called CD20 monoclonal antibodies.

Briumvi side effects

The most common Briumvi side effects are:

infusion reactions, which may include symptoms such as dizziness, nausea, light-headed, itchy, sweaty, headache, chest tightness, back pain, trouble breathing, or swelling in your face;
cold sores around your mouth (herpes infections), skin sores or blisters, itching, tingling, burning pain in your thigh or lower back;
cold symptoms such as stuffy nose, sneezing, sore throat;
pain in your hands and feet;
sleep problems (insomnia); or
tiredness.

Serious side effects and warnings

Briumvi can cause the following serious side effects.

Infusion reactions. Infusion reactions are one of the most common side effects of Briumvi. Infusion reactions can be serious and may require you to be hospitalized. You will be monitored during your infusion and may be monitored after each infusion of Briumvi for signs and symptoms of an infusion reaction. Tell your healthcare provider if you get any of these symptoms:

fever
itchy skin
wheezing
chills
dizziness
nausea
headache
feeling faint
abdominal pain
flu-like symptoms
swelling of the tongue or throat
throat irritation
fast heartbeat
trouble breathing
red face or skin
hives.

These infusion reactions can happen over 24 hours after your infusion. You must call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get an infusion reaction, your healthcare provider may need to stop or slow down the rate of your infusion.

Infections. Infections are a common side effect, and upper respiratory tract infections are one of the most common side effects of Briumvi. Briumvi increases your risk of getting infections caused by bacteria or viruses that may be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection, including fever, chills, a cough that does not go away, or painful urination. Your healthcare provider should delay your treatment with Briumvi until your infection is gone.

Hepatitis B virus (HBV) reactivation: Before starting treatment with Briumvi, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had a hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with Briumvi. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving Briumvi.

Weakened immune system: Briumvi taken before or after other medicines that weaken the immune system could increase your risk of getting infections.

Progressive Multifocal Leukoencephalopathy (PML): PML may happen with Briumvi. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks. PML can result in death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These symptoms may include weakness on one side of your body, loss of coordination in arms and legs, vision problems, and changes in thinking and memory, which may lead to confusion, and personality changes.

Low immunoglobulins: Briumvi may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

Briumvi may also cause an allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Briumvi, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

It is not known if Briumvi is safe or effective in children.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Before receiving this medicine

Do not receive Briumvi if you:

have had a life-threatening allergic reaction to ublituximab, Briumvi, or any of the inactive ingredients in the infusion
have an active hepatitis B virus (HBV) infection.

Before receiving, tell your healthcare provider about all your medical conditions, including if you:

have or think you have an infection
take or plan to take medicines that affect your immune system. These medicines may increase your risk of getting an infection
have ever had hepatitis B or you are a carrier of the hepatitis B virus
have had a recent vaccination or are scheduled to receive any vaccinations.
- Make sure all your vaccinations are up to date before starting Briumvi. You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with Briumvi. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with Briumvi and until your healthcare provider tells you that your immune system is no longer weakened.
- When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with Briumvi. If you would like to receive any non-live vaccines while you are being treated with Briumvi, talk to your healthcare provider.
- If you have a baby and you received Briumvi during your pregnancy, it is important to tell your baby’s healthcare provider about receiving Briumvi so they can decide when your baby should be vaccinated.
are pregnant, think that you might be pregnant, or plan to become pregnant
are breastfeeding, or plan to breastfeed.

Pregnancy

Briumvi may harm your unborn baby. You should use birth control (contraception) during treatment with Briumvi and for at least 6 months after your last infusion of Briumvi. Talk with your healthcare provider about what birth control method is right for you during this time. You may need to have a negative pregnancy test before each infusion of Briumvi.

Pregnancy Registry. There is a pregnancy registry for women who take Briumvi during pregnancy. If you become pregnant while receiving Briumvi or within 6 months following the last dose of Briumvi, tell your healthcare provider right away. Talk to your healthcare provider about registering with the Briumvi Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Either you or your healthcare provider can enroll you in this registry by calling 1-877-411-4546 or visiting www.briumvipregnancyregistry.com.

Breastfeeding

It is not known if Briumvi passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Briumvi.

How will I receive Briumvi?

Briumvi is given through a needle placed in your vein (intravenous infusion) in your arm.

Your healthcare provider may do a pregnancy test before each infusion of Briumvi.
Before treatment with Briumvi, you will receive a corticosteroid and an antihistamine medicine to help reduce the risk of infusion reactions by making them less frequent and less severe.
You may also receive other medicines to help reduce the risk of an infusion reaction.

Your first dose of Briumvi will last about 4 hours.

Your second dose of Briumvi will be given 2 weeks after your first dose. This infusion will last about 1 hour.
Your next doses of Briumvi will be given as 1 infusion every 24 weeks. These infusions will last about 1 hour.

Dosing information

Dose of Briumvi for Multiple Sclerosis (Adults):

First Infusion: 150 mg IV over at least 4 hours.
Second Infusion (2 weeks after the first infusion): 450 mg IV over at least 1 hour.
Subsequent Infusions (24 weeks after the first infusion and every 24 weeks thereafter): 450 mg IV every 24 weeks over at least 1 hour.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Briumvi injection.

What should I avoid while receiving Briumvi?

Avoid receiving a “live” vaccine while you are being treated with Briumvi, and for at least 4 weeks before your treatment. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Avoid receiving a “non-live” vaccine for at least 2 weeks before your treatment with Briumvi.

What other drugs will affect Briumvi?

Tell your doctor about all your other medicines, especially:

Drugs that weaken the immune system, such as cancer medications, steroids, and medicines to prevent organ transplant rejection.

Brilinta

Sama Mohamed — Wed, 04 Feb 2026 08:27:54 +0000

What is Brilinta?

Brilinta prevents platelets in your blood from sticking together to form an unwanted blood clot that could block an artery.

Brilinta is used to lower your risk of heart attack, stroke, or death due to a blocked artery or a prior heart attack.

Brilinta is also used to lower your risk of blood clots if you have coronary artery disease (decreased blood flow to the heart) and have been treated with stents to open clogged arteries.

Brilinta is also used to lower your risk of a first heart attack or stroke if you have decreased blood flow to the heart.

Brilinta is also used to lower the risk of stroke and death in adults with a blockage or decreased blood flow in an artery that supplies blood to the brain.

This medicine is usually given together with low-dose aspirin. Carefully follow your doctor’s dosing instructions. Using too much aspirin can make ticagrelor less effective.

Warnings

You should not use Brilinta if you have any active bleeding (including a bleeding stomach ulcer), or a history of bleeding in the brain. Do not use this medicine just before heart bypass surgery (coronary artery bypass graft, or CABG).

You may need to stop using this medicine for a short time before having surgery or dental work, to prevent excessive bleeding. Do not stop taking Brilinta without first talking to your doctor, even if you have signs of bleeding. Stopping this medicine may increase your risk of a heart attack or stroke.

Brilinta may cause you to bleed more easily, which can be severe or life-threatening. Avoid activities that may increase your risk of bleeding or injury.

Call your doctor or seek emergency medical attention if you have bleeding that will not stop. You may also have bleeding on the inside of your body, such as in your stomach or intestines. Call your doctor at once if you have black or bloody stools, red or pink urine, or if you cough up blood or vomit that looks like coffee grounds. These could be signs of internal bleeding.

Many drugs (including some over-the-counter medicines and herbal products) can cause serious medical problems if you take them with Brilinta. It is very important to tell your doctor about all medicines you have recently used.

Before taking this medicine

You should not use Brilinta if you are allergic to ticagrelor, or if you have:

any active bleeding; or
a history of bleeding in the brain (such as from a head injury).

Tell your doctor if you have ever had:

a stroke;
heart problems;
high cholesterol;
bleeding problems;
a stomach ulcer or colon polyps;
liver disease; or
kidney disease;
asthma, COPD (chronic obstructive pulmonary disorder) or other breathing problems;
recent surgery or serious injuries; or
if you are planning to have surgery or a dental procedure; or

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Brilinta passes into breastmilk. Talk to your doctor before using Brilinta if you are breastfeeding.

How should I take Brilinta?

Take Brilinta exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Brilinta is taken together with aspirin. Use these medicines exactly as directed.

Do not take more aspirin than your doctor has prescribed. Taking too much aspirin can make Brilinta less effective.

Take this medicine at the same time each day, with or without food.

If you cannot swallow a tablet whole, crush the pill and mix it with water. Stir and drink this mixture right away. Add more water to the glass, stir, and drink right away.

Brilinta keeps your blood from coagulating (clotting) and can make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have any bleeding that will not stop.

To prevent excessive bleeding, you may need to stop using Brilinta for a short time before a surgery, medical procedure, or dental work. Any healthcare provider who treats you should know that you are taking ticagrelor.

Do not stop taking Brilinta without first talking to your doctor, even if you have signs of bleeding. Stopping the medicine could increase your risk of a heart attack or stroke.

Ticagrelor may affect medical testing for platelets in your blood and you may have false results. Tell the laboratory staff that you use Brilinta.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Acute Coronary Syndrome:

Following an acute coronary syndrome (ACS) event:

Loading dose: 180 mg orally once
Maintenance dose: 90 mg orally twice a day for 1 year
Maintenance dose after 1 year: 60 mg orally twice a day

Comments:
-This drug should be taken in conjunction with a daily maintenance dose of aspirin 75 to 100 mg orally once a day.
-For at least the first 12 months following ACS, this drug is superior to clopidogrel.

Uses:
-To reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction.
-To reduce the rate of stent thrombosis in patients who have been stented for treatment of ACS.

Usual Adult Dose for Prevention of Atherothrombotic Events:

Usual Adult Dose for Thromboembolic Stroke Prophylaxis:

60 mg orally twice a day

Use: To reduce the risk of a first myocardial infarction (MI) or stroke in patients with coronary artery disease (CAD) at high risk for such events; while use is not limited to this setting, efficacy of this drug was established in a population with type 2 diabetes mellitus (T2DM).

Usual Adult Dose for Coronary Artery Disease:

Usual Adult Dose for Myocardial Infarction — Prophylaxis:

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Overdose can cause excessive bleeding.

What to avoid

Drinking alcohol while taking aspirin can increase your risk of stomach bleeding.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

While taking Brilinta with aspirin, avoid using medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to aspirin (such as salicylates, ibuprofen, ketoprofen, or naproxen). Taking certain products together can cause you to get too much aspirin which can increase your risk of bleeding.

Brilinta side effects

Get emergency medical help if you have signs of an allergic reaction to Brilinta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

chest pain;
fainting or dizzy spells;
nosebleeds, or any bleeding that will not stop;
shortness of breath even with mild exertion or while lying down;
easy bruising, unusual bleeding, purple or red spots under your skin;
red, pink, or brown urine;
black, bloody, or tarry stools; or
coughing up blood or vomit that looks like coffee grounds.

Common Brilinta side effects may include:

bleeding; or
shortness of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Brilinta?

Tell your doctor about all your current medicines. Many drugs can interact with Brilinta, especially:

antifungal medicine (including ketoconazole, itraconozole, voriconazole, and others);
antibiotic medication (including clarithromycin);
antiviral medicine to treat HIV or AIDS;
other blood thinners;
cholesterol medication (including simvastatin or lovastatin);
heart or blood pressure medication;
opioid medication;
seizure medicine; or
tuberculosis medicine (especially rifampin).

Breyanzi

Sama Mohamed — Wed, 04 Feb 2026 07:36:06 +0000

What is Breyanzi?

Breyanzi is used to treat 5 types of non-Hodgkin lymphoma, including large B-cell lymphoma (LBCL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and relapsed or refractory mantle cell lymphoma (MCL), with relapsed or refractory (R/R) marginal zone lymphoma (MZL) in specific patients.

Breyanzi is a one-time infusion of CAR T cell therapy that may help you have complete and lasting remission.

Breyanzi is a cancer treatment created using immune cells, called T cells, collected from the patient’s own blood. The T cells are modified to become CAR T cells and are then infused back into the patient’s body. The CART T cells can attach to the cancer cells and kill them, helping clear the cancer from the body. Before your infusion, you will have chemotherapy to prepare your body for your treatment.

Breyanzi FDA approval was first received on February 5, 2021, for the company Bristol Myers Squibb (BMS). It contains lisocabtagene maraleuce. The most recent approval was for relapsed or refractory marginal zone lymphoma (MZL) on December 4, 2025.

What is Breyanzi used for?

Breyanzi is FDA-approved to treat five types of non-Hodgkin lymphoma: large B-cell lymphoma, relapsed or refractory chronic CLL/SLL, relapsed or refractory follicular lymphoma (FL), and relapsed or refractory mantle cell lymphoma (MCL), and relapsed or refractory (R/R) marginal zone lymphoma (MZL) in specific patients.

Large B-cell lymphoma

Breyanzi is used to treat large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, in adults. You can only be treated with Breyanzi if:

your first treatment has not worked, or your cancer returned within a year of your first treatment, OR
your first treatment has not worked, or your cancer returned after the first treatment, and you are not eligible for hematopoietic stem cell transplantation because of medical conditions or age, OR
two or more kinds of treatment have not worked or stopped working.

It is not indicated for the treatment of primary central nervous system lymphoma.

Relapsed or refractory chronic CLL/SLL

Breyanzi is used to treat relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have:

received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
This is an accelerated FDA approval.

Relapsed or refractory follicular lymphoma (FL)

Breyanzi is used to treat relapsed or refractory follicular lymphoma (FL) in adults who have:

received 2 or more prior lines of systemic therapy.
This is an accelerated FDA approval.

Relapsed or Refractory Mantle Cell Lymphoma (MCL)

It is approved for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.

Relapsed or refractory (R/R) marginal zone lymphoma (MZL)

Breyanzi is approved for adult patients who have received at least two prior lines of systemic therapy.

Breyanzi side effects

Common Breyanzi side effects

Common Breyanzi side effects may include:

headache, dizziness;
confusion, problems with speech or thinking;
fever, chills, shaking;
nausea, vomiting, stomach pain;
diarrhea, constipation;
fast or irregular heartbeats;
cough, trouble breathing;
swelling; or
pain in your bones, joint, or muscles.

Serious Bryanzi side effects

Get emergency medical help if you have signs of an allergic reaction, hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

A common but serious side effect of this medicine is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, dizziness, confusion, vomiting, diarrhea, fast heartbeats, trouble breathing, or feeling very weak or tired. Your caregivers will have medication available to treat CRS if it occurs.

Breyanzi may cause other serious side effects. Call your doctor at once if you have:

problems with speech;
confusion, trouble concentrating, memory problems;
decreased consciousness;
tremors, or a seizure; or
signs of infection – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Breyanzi may increase your risk of developing certain cancers. Talk to your doctor about the risks of receiving this medication. This medication may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online .

How will I receive Breyanzi?

Breyanzi is a one-time cancer treatment made from your own white blood cells. The process takes several weeks and involves collecting, modifying, and then infusing those cells back into your body, with close monitoring for side effects.

Breyanzi is a liquid medicine given intravenously (into a vein) by a doctor or nurse. It is usually given as two infusions over about 30 minutes total as a one-time dose.

Breyanzi treatment process

Step 1: T Cell collection

T cells, which are a type of white blood cell, are collected using a procedure called leukapheresis (a process that removes white blood cells from the body).

Step 2: T Cell activation

The collected T cells are sent away and modified so they can better recognize and attack cancer cells.
This modification process takes about 3–4 weeks.

Step 3: Preparation for infusion

You will receive chemotherapy medicines a few days before Breyanzi to prepare your body; this is called lymphodepleting chemotherapy.

Step 4: Breyanzi infusion

The modified cells are then infused back into your body as Breyanzi. Because the treatment is made from your own cells, it must only be given to you.

Step 5: Follow-up

Your healthcare provider will check if the treatment is working and monitor for side effects.
You should plan to stay near the treatment center for at least 4 weeks after receiving Breyanzi.

It is very important not to miss your cell collection or treatment appointment

Before taking this medicine

Tell your doctor if you have ever had:

hepatitis B or C; or
if you have received a vaccine within the past 6 weeks.

Using Breyanzi may increase your risk of developing other cancers. Ask your doctor about this risk.

Tell your doctor if you are pregnant or breastfeeding.

You may need to have a negative pregnancy test before starting this treatment.

Warnings

Breyanzi has a boxed warning for cytokine release syndrome(CRS), neurologic toxicity, and secondary hematological malignancies.

Cytokine release syndrome (CRS): This is a common but serious side effect of this medicine is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to treat this condition if it occurs.

Breyanzi may cause severe or life-threatening central nervous system reactions. These reactions can occur after treatment with this medicine. Tell your doctor if you have or have ever had seizures, a stroke, or memory loss. If you experience any of the following symptoms, tell your doctor immediately: headache, dizziness, difficulty falling asleep or staying asleep, restlessness, confusion, anxiety, uncontrollable shaking of a part of the body, loss of consciousness, agitation, seizures, loss of balance, or difficulty speaking.

T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including this therapy.

What should I avoid after receiving Breyanzi?

Avoid driving or operating machinery for at least 2 weeks after receiving this treatment. This medicine can cause weakness, drowsiness, confusion, problems with memory or coordination, and seizures.

Do not donate blood, organs, tissues, or cells for transplantation.

Do not have any vaccinations without talking to your doctor for at least 6 weeks before starting chemotherapy, during your Breyanzi treatment, and until your doctor tells you your immune system has recovered

What other drugs will affect Breyanzi?

Other drugs may affect this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. You should keep a written list of all the prescription and nonprescription (over-the-counter) medicines you take, along with any products such as vitamins, minerals, or other dietary supplements. Remember to bring this list with you each time you see a doctor or are hospitalized. This information is important to have on hand for emergencies.

Brexpiprazole

Sama Mohamed — Wed, 04 Feb 2026 07:26:52 +0000

What is brexpiprazole?

Brexpiprazole is used to treat major depressive disorder in adults (in addition to other medications), schizophrenia in adults and children aged 13 years and older, and agitation that may happen with dementia due to Alzheimer’s disease. It is an oral tablet taken once a day.

Brexpiprazole belongs to the drug class called atypical antipsychotics.

Brexpiprazole first gained FDA approval on July 10, 2015 under the brand name Rexulti. There is a generic brexpiprazole but it is only approved for adults with depression or schizophrenia. The brand Rexulti has additional approvals for adolescents 13 years and older with schizophrenia and for Alzheimer’s disease-related agitation.

Mechanism

Brexpiprazole works by correcting the imbalance of natural chemical messengers (neurotransmitters), such as dopamine and serotonin in the brain. This imbalance is thought to be associated with several psychiatric disorders such as schizophrenia, depression, and agitation associated with Alzheimer’s disease.

Brexpiprazole uses

Brexpiprazole is an atypical antipsychotic used:

along with antidepressant medicines to treat major depressive disorder (MDD) in adults
to treat schizophrenia in adults and children ages 13 years and older
to treat agitation that may happen with dementia due to Alzheimer’s disease.

Brexpiprazole should not be used as an “as needed” treatment for agitation that may happen with dementia due to Alzheimer’s disease.

Clinical trials have not been conducted in children so it is not known if brexpiprazole is safe and effective for the treatment of MDD in children under the age of 18 or for the treatment of schizophrenia in children under 13 years.

Brexpiprazole side effects

The most common side effects of brexpiprazole are:

weight gain
sleepiness
dizziness
common cold symptoms
restlessness or feeling like you need to move (akathisia).

Serious side effects and warnings

Brexpiprazole carries a Boxed Warning for an increased risk of death in elderly patients with dementia-related psychosis.

Increased risk of death in elderly people with dementia-related psychosis. Trials have reported medicines like brexpiprazole can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Brexpiprazole is not approved for dementia-related psychosis without agitation that may happen with Alzheimer’s disease.

Increased risk of suicidal thoughts and actions. Brexpiprazole and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.

Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when brexpiprazole or the antidepressant medicine is started or when the dose is changed.
Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying
attempts to commit suicide
new or worsening depression
new or worsening anxiety
feeling very agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worsening irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity or talking (mania)
other unusual changes in behavior or mood.

Other serious side effects of brexpiprazole include the following.

Cerebrovascular problems (these involve the blood vessels of the brain), including stroke, in elderly people with dementia-related psychosis that can lead to death.

Neuroleptic malignant syndrome (NMS), which is a rare and life-threatening reaction to antipsychotic drugs. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:

high fever
stiff muscles
confusion
changes in your pulse, blood pressure, heart rate, and breathing
increased sweating.

Uncontrolled body movements (tardive dyskinesia). Brexpiprazole may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking brexpiprazole. Tardive dyskinesia may also start after you stop taking brexpiprazole.

Brexpiprazole may also cause problems with your metabolism such as:

High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take brexpiprazole. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start, or soon after you start brexpiprazole and then regularly during long term treatment with brexpiprazole. Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with brexpiprazole:
- feel very thirsty
- feel very hungry
- feel sick to your stomach
- need to urinate more than usual
- feel weak or tired
- feel confused, or your breath smells fruity
Increased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start, or soon after you start brexpiprazole, and then periodically during treatment with brexpiprazole.
Weight gain. You and your healthcare provider should check your weight before you start and often during treatment with brexpiprazole.

Unusual and uncontrollable (compulsive) urges. Some people taking brexpiprazole have had strong unusual urges, to gamble and gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that you are having new or unusual strong urges or behaviors, talk to your healthcare provider.

Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with brexpiprazole.

Decreased blood pressure (orthostatic hypotension) and fainting. You may feel dizzy, lightheaded, or pass out (faint) when you rise too quickly from a sitting or lying position.

Falls. Brexpiprazole may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.

Seizures (convulsions). Brexpiprazole may increase your risk of seizures.

Problems controlling your body temperature so that you feel too warm. See “What should I avoid while taking brexpiprazole?”

Difficulty swallowing that can cause food or liquid to get into your lungs.

Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. See “What should I avoid while taking brexpiprazole?”

Brexpiprazole may harm an unborn baby.

These are not all the possible side effects of brexpiprazole. Call your doctor for medical advice about side effects.

Before taking

Do not take brexpiprazole if you are allergic to brexpiprazole, Rexulti, or any inactive ingredient in the tablets.

Before taking brexpiprazole, tell your healthcare provider about all of your medical conditions, including if you:

have or have had heart problems or a stroke
have or have had low or high blood pressure
have or have had diabetes or high blood sugar or a family history of diabetes or high blood sugar.
have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol
have or have had seizures (convulsions)
have or have had kidney or liver problems
have or have had a low white blood cell count
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed.

Pregnancy

Brexpiprazole may harm your unborn baby. Taking brexpiprazole during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take brexpiprazole during pregnancy.

Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with brexpiprazole.

There is a pregnancy exposure registry for women who are exposed to brexpiprazole during pregnancy. If you become pregnant during treatment with brexpiprazole, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/.

Breastfeeding

It is not known if brexpiprazole passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with brexpiprazole.

How should I take brexpiprazole?

Take brexpiprazole exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose if needed. Do not change the dose or stop taking brexpiprazole without first talking to your healthcare provider.

Take brexpiprazole 1 time each day.
Brexpiprazole may be taken with or without food.

Brexpiprazole dosing

The dosage of Brexpiprazole varies depending on the condition being treated and the age of the patient.

The dosage may need to be adjusted for moderate to severe liver disease, kidney disease, and interacting medications.

Note that generic brexpiprazole is only approved for depression and schizophrenia in adults, not for all the uses Rexulti is approved for.

Indication	Form	Starting dosage	Target dosage	Maximum dosage
Major depressive disorder	RexultiGeneric brexpiprazole	0.5 or 1 mg daily	2 mg daily	3 mg daily
Schizophrenia (adults)	RexultiGeneric brexpiprazole	1 mg daily	2 to 4 mg daily	4 mg daily
Schizophrenia (age 13-17 years)	Rexulti	0.5 mg daily	2 to 4 mg daily	4 mg daily
Agitation associated with dementia	Rexulti	0.5 mg daily	2 mg daily	3 mg daily

What should I avoid while taking brexpiprazole?

Do not drive a car, operate machinery, or do other dangerous activities until you know how brexpiprazole affects you. Brexpiprazole may make you feel drowsy.

Do not become too hot or dehydrated during treatment with brexpiprazole.

Do not exercise too much.
In hot weather, stay inside in a cool place if possible.
Stay out of the sun.
Do not wear too much clothing or heavy clothing.
Drink plenty of water.

What happens if I take too much brexpiprazole?

If you take too much brexpiprazole, call your healthcare provider or Poison Help Line or go to the nearest hospital emergency room right away.

What other drugs affect brexpiprazole?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Brexpiprazole and other medicines may affect each other causing possible serious side effects. Brexpiprazole may affect the way other medicines work, and other medicines may affect how brexpiprazole works. Especially tell your healthcare provider if you take:

Strong CYP2D6 or CYP3A4 inhibitors, such as clarithromycin, diltiazem, erythromycin, itraconazole, ketoconazole, paroxetine, fluoxetine, or bupropion. Administer half the recommended dosage of brexpiprazole
Strong/moderate CYP2D6 with strong/moderate CYP3A4 inhibitors: Administer one-quarter of the recommended dosage of brexpiprazole
strong/moderate CYP3A4 inhibitors and you are a known CYP2D6 poor metabolizer: Administer one-quarter of the recommended dosage of brexpiprazole
Strong CYP3A4 inducers, such as phenobarbital, phenytoin, rifampicin, St. John’s Wort, or glucocorticoids. Double the recommended dosage of brexpiprazole and further adjust based on the clinical response.

Your healthcare provider can tell you if it is safe to take brexpiprazole with your other medicines. Do not start or stop any medicines during treatment with brexpiprazole without first talking to your healthcare provider. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Storage

Store brexpiprazole tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep out of the reach of children.

Ingredients

Brexpiprazole is available as the brand Rexulti and as generic brexpiprazole.

Active ingredient: brexpiprazole

Inactive ingredients (Rexulti brand): lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, hypromellose, and talc. For color: titanium dioxide, iron oxide, and ferrosoferric oxide.

Inactive ingredients (generic brexpiprazole [Ajanta Pharma USA Inc.]: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose unspecified, low-substituted hydroxypropyl cellulose unspecified, magnesium stearate, Hypromellose unspecified, talc, titanium dioxide, propylene glycol, ferric oxide red

Inactive ingredients (generic brexpiprazole [Amneal Pharmaceuticals NY LLC]: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose unspecified, lactose monohydrate, microcrystalline cellulose, magnesium stearate, corn starch, talc, titanium dioxide.

Who makes brexpiprazole?

Rexulti (the brand of brexpiprazole) is manufactured through a partnership between two pharmaceutical companies:

Otsuka Pharmaceutical (Tokyo, Japan)
- Also makes Abilify, Samsca, and other medications
Lundbeck (Copenhagen, Denmark)
- Also makes Lexapro, Vyepti, and other medications.

These companies have a long-standing partnership in developing psychiatric medications, with Rexulti being one of their major joint products.

Generic brexpiprazole is packaged by Ajanta Pharma USA Inc. and Amneal Pharmaceuticals NY LLC.

Breo Ellipta

Sama Mohamed — Mon, 02 Feb 2026 09:58:19 +0000

What is Breo Ellipta?

Breo Ellipta inhalation powder contains a combination of fluticasone and vilanterol. Fluticasone is a steroid that prevents the release of substances in the body that cause inflammation. Vilanterol is a bronchodilator that works by relaxing muscles in the airways to improve breathing.

Breo Ellipta is a once-daily combination medicine used to treat asthma or COPD (chronic obstructive pulmonary disease), it helps improve breathing, reduce COPD flare-ups, and help prevent and control asthma symptoms. For asthma, it can be used by patients 5 years and older.

Breo Ellipta is not used to treat sudden, severe symptoms of COPD or asthma and does not replace a rescue inhaler

Vilanterol, when used alone, may increase the risk of death in people with asthma. However, this risk is not increased when fluticasone and vilanterol are used together as a combination product.

Warnings

Breo Ellipta is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Breo Ellipta may interact with other medicines and this may cause serious side effects. Tell your healthcare provider if you take antifungal or anti-HIV medicines.

Before taking this medicine

You should not use Breo Ellipta if you are allergic to fluticasone, vilanterol, or milk proteins.

Fluticasone can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

To make sure Breo Ellipta is safe for you, tell your doctor if you have:

glaucoma or cataracts;
a weak immune system;
heart disease, high blood pressure;
liver disease;
a thyroid disorder;
a seizure;
diabetes;
any type of infection (bacterial, fungal, viral, or parasitic); or
osteoporosis.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk.

Tell your doctor if you are pregnant. It is not known whether Breo Ellipta will harm an unborn baby. However, having untreated or uncontrolled asthma during pregnancy may cause complications such as low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Breo Ellipta is not approved for use by anyone younger than 4 years old.

How should I use Breo Ellipta?

Use Breo Ellipta inhalation powder exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Breo Ellipta is not a rescue medicine for asthma or bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Breo Ellipta is a powder that comes with a special inhaler device preloaded with blister packs containing measured doses of the medicine. The device opens and loads a blister of Breo Ellipta each time you use the inhaler. Follow the patient instructions provided with the inhaler device.

Use the medicine at the same time each day, and not more than once in a 24-hour period.

Your dose needs may change due to surgery, illness, stress, or a recent asthma attack. Do not change your Breo Ellipta dose or dosage schedule without your doctor’s advice.

Always rinse out your mouth with water after using the inhaler device, to help prevent thrush (a fungal infection in the mouth or throat).

While using Breo Ellipta, your doctor will need to check your lung function on a regular basis. Your vision and your bone mineral density may also need to be checked.

Once your asthma is under control, your doctor may want you to stop using Breo Ellipta. Keep all follow-up appointments and do not stop using the medicine unless your doctor tells you to.

Store Breo Ellipta at room temperature away from moisture, heat, and light. Keep the inhaler device in the sealed foil tray until ready to start using it.

Throw the inhaler device away 6 weeks after you have taken it out of the foil pouch, or if the dose indicator shows a zero, whichever comes first.

Breo Ellipta Dosage Information

Maintenance treatment of COPD: 1 actuation of 100/25 mcg once daily administered by oral inhalation.

Maintenance treatment of asthma in adult patients aged 18 years and older: 1 actuation of 100/25 mcg or 200/25 mcg once daily administered by oral inhalation.

Maintenance treatment of asthma in pediatric patients aged 12 to 17 years: 1 actuation of 100/25 mcg once daily administered by oral inhalation.

Maintenance treatment of asthma in pediatric patients aged 5 to 11 years: 1 actuation of 50/25 mcg once daily administered by oral inhalation.

Breo Ellipta is available as

50 mcg fluticasone furoate and 25 mcg vilanterol (50/25 mcg) per actuation
100 mcg fluticasone furoate and 25 mcg vilanterol (100/25 mcg) per actuation
200 mcg fluticasone furoate and 25 mcg vilanterol (200/25 mcg) per actuation

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include chest pain, fast heart rate, and feeling shaky or short of breath.

Long term use of an inhaled steroid can lead to glaucoma, cataracts, thinning skin, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using Breo Ellipta?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid such as fluticasone.

Breo Ellipta side effects

Get emergency medical help if you have signs of an allergic reaction to Breo Ellipta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

wheezing, choking, or other breathing problems after using this medicine;
chest pain, fast or pounding heartbeats, pounding in your neck or ears;
sores or white patches in your mouth and throat, pain when swallowing;
fever, chills, cough with yellow or green mucus;
blurred vision, tunnel vision, eye pain, or seeing halos around lights.
high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor;
low potassium level – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
signs of a hormonal disorder – worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting.

Common Breo Ellipta side effects may include:

headache, back pain, joint pain;
fever, flu symptoms;
increased blood pressure;
runny or stuffy nose, sore throat, cough; or
a hoarse voice.

Botox

Sama Mohamed — Mon, 02 Feb 2026 09:49:57 +0000

What is Botox? Medical & Cosmetic Uses

Botox is used to smooth wrinkles and treat or prevent certain medical conditions, such as chronic migraines, severe underarm sweating, overactive bladder, strabismus, and muscle spasticity.

Effects typically last for 3 to 4 months.
Botox has a well-established safety profile when administered by a licensed provider.
FDA-approved.

Botox Injection Uses

Botox Cosmetic is FDA-approved for use in Appearance Medicine for:

Frown lines
Crow’s feet
Forehead wrinkles
Neck bands

It may also be used off-label for bunny lines and jaw slimming .

Botox Therapeutic is FDA-approved for the following medical conditions:

Overactive bladder (OAB) and urinary incontinence
Chronic migraine prevention (15+ headache days/month)
Muscle spasticity in adults and children 2+
Cervical dystonia (neck muscle spasms)
Severe underarm sweating (axillary hyperhidrosis)
Eye conditions: blepharospasm, strabismus
Neurogenic detrusor overactivity in children 5+.

Important Note: Although these formulations contain the same active ingredient, they are not interchangeable.

Pharmacist Tip

To ensure your Botox treatment is safe and effective, always get your injections from a licensed healthcare professional. This protects you from counterfeit Botox and minimizes side effect risks.

Results

Before and After Botox Cosmetic

What to Expect During Botox Treatment

Botox injections typically take just 10-30 minutes in your doctor’s office.

Most people describe the sensation as a slight pinch, with minimal discomfort and no downtime.
You’ll see initial results within 3-7 days, with full effects visible at 2 weeks.

How Much Does Botox Cost?

Botox Cosmetic treatments typically cost $300-$600 per treatment area and are not usually covered by insurance.

Botox Medical treatments are often covered by insurance when medically necessary for conditions like chronic migraine, overactive bladder, or cervical dystonia. Prior authorization may be required.

Financial support can be provided by AbbVie Patient Access Support in certain circumstances.

Primary Medical Uses

Overactive bladder (OAB) and urinary incontinence
Chronic migraine prevention (15+ headache days/month)
Muscle spasticity in adults and children 2+
Cervical dystonia (neck muscle spasms)
Severe underarm sweating (axillary hyperhidrosis)
Eye conditions: blepharospasm, strabismus
Neurogenic detrusor overactivity in children 5+

Primary Cosmetic Uses

Frown lines (glabellar lines)
Crow’s feet (lateral canthal lines)
Forehead wrinkles
Neck bands (platysma bands)

How Does Botox Work?

Botox (onabotulinumtoxinA) works by temporarily blocking nerve signals to muscles or sweat glands, relaxing them and providing cosmetic improvement for facial wrinkles and lines, and therapeutic relief from certain medical conditions.

For Medical Conditions:

Relaxes overactive muscles (spasticity, dystonia)
Improves bladder capacity (overactive bladder)
Prevents migraine headaches (chronic migraine)
Reduces excessive sweating (hyperhidrosis)
Corrects eye alignment (strabismus)
Controls muscle spasms (blepharospasm).

For Cosmetic Enhancement:

Smooths forehead lines and crow’s feet
Reduces frown lines between eyebrows
Softens neck bands (platysma)
Creates a refreshed, youthful appearance.

Side Effects

Common Side Effects

The most common side effects of Botox are:

Mild injection site reactions (slight bruising, tenderness)
Temporary headache
Mild fatigue.

These typically resolve within 24-48 hours.

Medical Use Specific Side Effects

Bladder Treatment:

Urinary tract infections
Painful urination
Incomplete bladder emptying (may require temporary catheterization)
Blood/bacteria in urine (pediatric patients).

Eye Treatment:

Double vision or blurred vision
Drooping eyelids (ptosis)
Decreased eyesight
Dry eyes
Eyelid swelling

Serious Side Effects & Important Safety Information

Botox carries a Boxed Warning for distant spread of toxin effect.

Distant Spread of Toxin Effects (Boxed Warning)

Life-threatening botulism-like symptoms can rarely occur when onabotulinumtoxinA spreads away from the injection site. Seek urgent medical attention if you experience:

Muscle weakness throughout the body
Difficulty breathing or swallowing
Vision problems: double vision, drooping eyelids
Speech difficulties (dysarthria)
Voice changes (dysphonia)
Loss of bladder control.

Respiratory & Swallowing Problems

Respiratory and swallowing problems can occur hours to weeks after a Botox injection. People with pre-existing breathing/swallowing problems are at a higher risk. Severe cases may require a feeding tube, and rarely, death may occur if there are severe complications.

Allergic Reactions

Allergic reactions may happen with Botox. Seek immediate medical attention if you develop:

Itching, rash, hives
Wheezing or asthma symptoms
Dizziness or fainting.

Tell your healthcare provider if you have any side effects that bother you or do not go away. These are not all the possible side effects of Botox. For more information, ask your doctor or pharmacist. Call your healthcare provider for medical advice about side effects.

Before Receiving

Absolute Contraindications

Do NOT receive Botox if you have:

An allergy to onabotulinumtoxinA or the other ingredients in Botox Cosmetic or Botox Therapeutic
An active skin infection at the injection site
A previous allergic reaction to other botulinum products such as:
- Dysport (abobotulinumtoxinA)
- Xeomin (incobotulinumtoxinA)
- Myobloc (rimabotulinumtoxin B)
- Jeuveau (prabotulinumtoxinA-xvfs)
- Daxxify (daxibotulinumtoxinA-lanm)
- Letybo (letibotulinumtoxinA-wlbg).

Caution Needed

Tell your healthcare provider about all your medical conditions, including if you have:

Neuromuscular disorders: ALS, myasthenia gravis, Lambert-Eaton syndrome
Breathing problems: asthma, emphysema
Swallowing difficulties
Bleeding disorders
Planned surgery or recent facial surgery
Drooping eyelids or facial asymmetry
Pregnancy plans. It is not known if Botox or Botox Cosmetic can harm your unborn baby
Breastfeeding plans. It is not known if Botox or Botox Cosmetic passes into breastmilk.

How is Botox Administered?

Before Treatment

You’ll meet with a certified provider for a consultation. They’ll review your medical history, check for allergies, evaluate the treatment area, and go over the consent process and what to expect.

During Treatment

Your provider will clean the injection sites and administer Botox using very fine needles. The process takes 5 to 30 minutes, depending on the treatment area. Discomfort is minimal, and anesthesia typically isn’t needed.

After Treatment

Don’t rub the injection sites. Stay upright for 4 hours. Avoid exercise and facial treatments for 24 hours. Your provider will schedule a follow-up as needed.

Results Timeline

Initial effects start within 24 to 48 hours. Noticeable improvement appears in 3 to 7 days. Results peak at 2 weeks and gradually wear off over 3 to 6 months. Repeat treatments can be done as needed, with at least 3 months between sessions.

Age Restrictions

Botox is not approved for those aged:

<18 years with urinary incontinence, chronic migraine, or overactive bladder
<18 years for cosmetic purposes
<5 years with NDO
<16 years with cervical dystonia
<12 years with strabismus or blepharospasm
<2 years with spasticity.

Botox for Medical Use Has Not Been Established For:

Episodic migraine (≤14 days/month)
Severe sweating anywhere other than your armpits.

What should I avoid while receiving Botox?

Botox may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving the injection. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Avoid exercise and facial treatments for 24 hours.

Botox Cosmetic FDA Approvals: Dosing Information

Frown Lines (Glabellar Lines)

Dosage: 20 Units (5 injection sites)
Target: Corrugator and procerus muscles
Results: Smoother forehead appearance

Crow’s Feet (Lateral Canthal Lines)

Dosage: 24 Units (6 injection sites total)
Target: Orbicularis oculi muscle
Results: Reduced eye wrinkles

Forehead Lines

Dosage: 40 Units total (5 injection sites forehead + 5 injection sites glabellar)
Target: Frontalis muscle
Results: Smoother forehead wrinkles

Platysma Bands (Neck Bands)

Dosage: 26-36 Units total (18-28 injection sites)
Target: Platysma muscle
Results: Reduced vertical neck banding

Off-Label Cosmetic Uses

While not FDA-approved, common uses include:

Lip lines (perioral wrinkles)
Bunny lines (nasal wrinkles)
Masseter Botox (jawline slimming)
Gummy smile correction.

Botox Medical FDA Approvals: Dosing Information

Overactive Bladder (OAB) Treatment

Indication: Adults with inadequate response to anticholinergics
Dosage: 100 Units (5 units across 20 injection sites)
Benefits: Reduces urgency, frequency, and incontinence

Neurogenic Detrusor Overactivity

Adult dosage: 200 Units (6-7 units across 30 injection sites)
Pediatric dosage (≥5 years): Weight-based dosing
Conditions: Spinal cord injury, multiple sclerosis

Chronic Migraine Prevention

Indication: Adults with 15+ headache days/month
Dosage: 155 Units divided among 7 head/neck muscles
Injection sites: 31 sites total
Effectiveness: Reduces migraine frequency and severity
Not approved for episodic migraine (≤14 days/month)

Muscle Spasticity Treatment

Adult upper limb: Up to 400 Units
Adult lower limb: 300-400 Units
Pediatric spasticity (≥2 years): 3-8 Units/kg
Conditions: Post-stroke, cerebral palsy, brain injury

Cervical Dystonia (Torticollis)

Average dose: 198-300 Units split between affected muscles
Benefits: Reduces abnormal head position and neck pain
Duration: 3-4 months between treatments

Severe Axillary Hyperhidrosis

Dosage: 50 Units per armpit (split over 10 to 20 sites per armpit)
Indication: Inadequate response to topical treatments
Effectiveness: Significantly reduces underarm sweating
Not approved for severe sweating anywhere other than your armpits.

Eye Conditions

Blepharospasm (Eyelid Spasms)

Dosage: 1.25-2.5 Units per site (3 sites per eye)
Age: Adults and children 12+

Strabismus (Crossed Eyes)

Dosage: Dosage varies based on prism diopter correction or previous response.
Age: Adults and children 12+

Botox vs. Other Treatments

Treatment	Duration	Best For	FDA Approved
Botox	3-4 months	Wrinkles, migraines, spasticity	Yes
Dysport	3-4 months	Similar to Botox	Yes
Xeomin	3-4 months	Cervical dystonia, wrinkles	Yes
Daxxify	6-9 months	Facial wrinkles	Yes
Dermal Fillers	6-18 months	Volume loss, deep lines	Yes

What other drugs affect Botox?

Tell your doctor about all your medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using Botox with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received Botox in the past. Especially tell your doctor if you:

Have received any other botulinum toxin product in the last four months
Have received injections of botulinum toxin, such as Myobloc (rimabotulinumtoxinB), Dysport (abobotulinumtoxinA), Xeomin (incobotulinumtoxinA), Jeuveau (prabotulinumtoxinA-xvfs), Daxxify (daxibotulinumtoxinA-lanm), or Letybo (letibotulinumtoxinA-wlbg) in the past. This may not be a complete list of all botulinum toxin products. Be sure your doctor knows exactly which product you received
Have recently received an antibiotic by injection
Take muscle relaxants
Take an allergy or cold medicine
Take a sleep medicine
Take antiplatelets (aspirin-like products) or anti-coagulants (blood thinners).

Ask your doctor if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Ingredients

Botox Therapeutic Ingredients

Active ingredient: onabotulinumtoxinA

Inactive ingredients: human albumin and sodium chloride.

Available as 100 Units or 200 Units as a vacuum-dried powder in a single-dose vial.

Botox Cosmetic Ingredients

Active ingredient: onabotulinumtoxinA

Inactive ingredients: human albumin and sodium chloride.

Available as 50 Units or 100 Units in a vacuum-dried powder in a single-dose vial for reconstitution.

Manufacturer

Botox is made by AbbVie, which acquired the previous manufacturer, Allergan, in 2020. AbbVie is headquartered in North Chicago, Illinois, USA.

Common Questions About Botox

What is Botox?

Botox is a cosmetic treatment used to reduce the appearance of facial wrinkles and treat medical conditions like migraines and excessive sweating.

How much does Botox cost?

The price varies, but most providers charge between $10 and $25 per unit. A typical session costs between $300 and $600, depending on the area being treated.

How long does Botox last?

Results typically appear within 1 to 2 weeks and last about 3 to 4 months, though this can vary.

What are the side effects of Botox?

Common side effects include mild bruising or redness. Serious side effects are rare but may include drooping eyelids or difficulty swallowing.

Will I look frozen or unnatural?

When properly administered by a skilled provider, Botox provides natural-looking results while maintaining facial expression

Can I get Botox while pregnant?

Safety in pregnancy is unknown; discuss with your healthcare provider.

Botox Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Botox.Botox (onabotulinumtoxinA) – AbbVie Inc.

Formulation type	Strength
Single-Dose Vial	100 units
Single-Dose Vial	200 units
Single-Dose Vial	50 units Discontinued

Botox C

Boniva

Sama Mohamed — Mon, 02 Feb 2026 09:42:36 +0000

What is Boniva?

Boniva is a bisphosphonate medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures.

Boniva is prescription medicine used to treat or prevent osteoporosis in women after menopause. Ibandronate helps increase bone mass and helps reduce the chance of having a spinal fracture.

It is not known how long Boniva works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if this medicine is still right for you.

Warnings

You should not use Boniva if you have severe kidney disease or low levels of calcium in your blood.

Do not take a tablet if you have problems with your esophagus, or if you cannot sit upright or stand for at least 60 minutes after taking the tablet.

Boniva tablets can cause serious problems in the stomach or esophagus. Stop taking Boniva and call your doctor at once if you have chest pain, new or worsening heartburn, or pain when swallowing.

Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

Boniva side effects

Get emergency medical help if you have signs of an allergic reaction to Boniva: hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

chest pain, new or worsening heartburn;
difficulty or pain when swallowing;
pain or burning under the ribs or in the back;
severe heartburn, burning pain in your upper stomach, or coughing up blood;
new or unusual pain in your thigh or hip;
jaw pain, numbness, or swelling;
severe joint, bone, or muscle pain; or
low calcium levels – muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common Boniva side effects may include:

heartburn, stomach pain, diarrhea;
back pain, bone pain, muscle or joint pain;
pain in your arms or legs;
headache; or
fever, chills, tiredness, flu-like symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Before taking this medicine

You should not use Boniva if you are allergic to ibandronate, or if you have:

severe kidney disease; or
low blood levels of calcium (hypocalcemia).

Do not take an Boniva tablet if you have problems with your esophagus, or if you cannot sit upright or stand for at least 60 minutes. Ibandronate can cause serious problems in the stomach or esophagus. You must stay upright for at least 1 full hour after taking this medicine.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

trouble swallowing;
problems with your stomach or digestion;
hypocalcemia;
a dental problem (you may need a dental exam before you begin using Boniva);
kidney disease; or
any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use Boniva, the more likely you are to develop this condition.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.

Talk with your doctor about the risks and benefits of using this medication.

It is not known whether ibandronate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ibandronate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use Boniva?

Use Boniva exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Boniva tablets are taken once per month. The injection is given into a vein through an IV once every 3 months. The tablets can be taken at home, but a healthcare provider must give the injection.

Take the tablet first thing in the morning, at least 60 minutes before you eat or drink anything or take any other medicine. Take the medicine on the same day each month and always first thing in the morning.

Take the tablet with a full glass (6 to 8 ounces) of plain water. Do not use coffee, tea, soda, juice, or mineral water. Do not eat or drink anything other than plain water.

Do not crush, chew, or suck on a tablet. Swallow it whole.

For at least 60 minutes (1 full hour) after taking a tablet:

Do not lie down or recline.
Do not take any other medicine including vitamins, calcium, or antacids.

Pay special attention to your dental hygiene while using Boniva. Brush and floss your teeth regularly. Consult your dentist before starting Boniva to ensure that you don’t need dental work soon. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using this medicine.

Boniva is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin supplements. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat.

Your doctor will determine how long to treat you with this medicine. Ibandronate is often given for only 3 to 5 years.

Dosing information

Usual Adult Dose for Osteoporosis:

Oral:
150 mg orally once a month on the same day each month

IV Injection:
3 mg by IV injection over 15 to 30 seconds every three months.

Comments:
-The IV injection should not be administered more frequently than once every 3 months.
-Obtain serum creatinine prior administration of each IV injection.
-Perform a routine oral examination prior administration of IV injection

Uses: Treatment and prevention of postmenopausal osteoporosis, to increase bone mineral density (BMD) and to reduce the incidence of vertebral fractures

Usual Adult Dose for Prevention of Osteoporosis:

What happens if I miss a dose?

Boniva tablets: If you forget to take a tablet first thing in the morning on your scheduled day, do not take it later in the day. Wait until the next morning to take the missed dose. Then return to your regular monthly schedule on your chosen dose day. If your next scheduled dose is less than 7 days away, wait until then and skip the missed dose. Do not take two (2) doses in one week.

Boniva injections: Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?

For Boniva tablets: Drink a full glass of milk and seek emergency medical attention or call the Poison Help line . Do not make yourself vomit and do not lie down.

Since the injections are given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What to avoid

Avoid taking any other medicines for at least 60 minutes after taking Boniva. This includes vitamins, calcium, and antacids. Some medicines can make it harder for your body to absorb ibandronate.

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

What other drugs will affect Boniva?

Tell your doctor about all your current medicines and any you start or stop using, especially:

aspirin; or
NSAIDs (nonsteroidal anti-inflammatory drugs) – ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with ibandronate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Talk with your doctor about the best dosing schedule for your other medicines.

Blincyto

Sama Mohamed — Mon, 02 Feb 2026 09:35:31 +0000

What is Blincyto?

Blincyto (blinatumomab) is an injectable immunotherapy treatment that may be used to treat B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children aged 1 month and older. It is a biologic treatment that is usually given after other cancer treatments have been tried without success.

Blincyto’s mechanism of action is to connect the protein CD3 found on the surface of T cells (a type of white blood cell that is an essential part of our immune system) to another protein, CD19 found on cancerous and non-cancerous B-cells. This activates the T-cell and Blincyto works by causing the destruction (lysis) of CD19 cells. Blincyto is a bispecific CD19-directed CD3 T-cell engager. In one study, 81% of patients with B-cell precursor ALL with minimal residual disease receiving Blincyto had no detectable cancer after 4 weeks.

Blincyto was FDA-approved on December 3, 2014. There is no generic Blincyto available.

What is Blincyto used for?

Blincyto is used to treat adults and children 1 month and older with:

B-cell precursor ALL in remission when only a small number of cancer cells remain in the body (minimal residual disease [MRD])
B-cell precursor ALL that has come back or did not respond to previous treatments
Philadelphia-chromosome negative B-cell precursor ALL in the consolidation phase of chemotherapy treatment with multiple phases.

It is not known if Blincyto is safe and effective in children under 1 month of age.

Blincyto side effects

The most common side effects of Blincyto include:

fever
infusion-related reactions (see below)
headache
infections
muscle, joint, and bone pain
low white or red blood cell counts (neutropenia or anemia)
low platelet count (thrombocytopenia)
diarrhea.

Some side effects may occur during the Blincyto injection. Tell your healthcare provider right away if you feel dizzy, nauseated, light-headed, chilled or feverish, or if you have a headache, skin rash, trouble breathing, or swelling in your face.

Serious side effects and warnings

Get emergency medical help if you have signs of an allergic reaction to Blincyto such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Blincyto may cause serious side effects, including:

Cytokine release syndrome (CRS) and infusion reactions. CRS can occur when your immune system responds to immunotherapy medications such as Blincyto more aggressively than it should and symptoms may be similar to infusion reactions. Tell your healthcare provider right away if you develop a fever, chills, wheezing or difficulty breathing, dizziness, headache, low blood pressure, nausea or vomiting, body aches, diarrhea, facial swelling, a skin rash, or feel tired or light-headed.

Neurologic problems. Blincyto may affect your nerves and can cause some serious neurological disorders including a potentially life-threatening neurotoxicity called immune effector cell-associated neurotoxicity syndrome (ICANS). Tell your healthcare provider right away if you experience:

seizures
difficulty in speaking or slurred speech
loss of consciousness
trouble sleeping
confusion and disorientation
loss of balance
headache
difficulty with facial movements, hearing, vision, or swallowing
tremors.

People with Down Syndrome over the age of 10 years may have a higher risk of seizures with Blincyto.

Life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop any signs or symptoms of an infection.

Tumor Lysis Syndrome (TLS) is caused by the fast breakdown of cancer cells. It can be life-threatening
and may lead to death. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with Blincyto, including:

nausea and vomiting
confusion
shortness of breath
irregular heartbeat
dark or cloudy urine
reduced amount of urine
unusual tiredness
muscle cramps.

Low white blood cell counts (neutropenia) are common with Blincyto treatment and may sometimes be life-threatening. They can increase your risk of infection. Your healthcare provider will do blood tests to check your white blood cell counts during treatment. Tell your healthcare provider right away if you get a fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands or feet, or feel light-headed or short of breath.

Abnormal liver blood tests. Your healthcare provider will do blood tests to check your liver before you start Blincyto and during treatment.

Inflammation of the pancreas (pancreatitis). Pancreatitis may happen in people treated with Blincyto and
corticosteroids. It may be severe and lead to death. Tell your healthcare provider right away if you have severe stomach-area pain that does not go away. The pain may happen with or without nausea and vomiting.

People receiving Blincyto are at risk of seizures or losing consciousness and should not drive or engage in hazardous activities.

Blincyto may harm an unborn baby and should not be taken by females who are pregnant.

Before taking this medicine

You should not use Blincyto if you are allergic to blinatumomab, Blincyto, or any inactive ingredients in the injection.

To make sure Blincyto is safe for you, tell your doctor if you have:

nerve problems or a neurologic disorder, such as seizures, confusion, trouble speaking, or problems with balance
Down syndrome
a history of chemotherapy or radiation treatment to your brain
an infection
have recently received a vaccine or if you are scheduled for a booster dose
are pregnant or plan to become pregnant
are breastfeeding.

Pregnancy

Blincyto may harm an unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Blincyto. Females who are able to become pregnant should use an effective form of birth control (contraception) during treatment with Blincyto, and for 48 hours after their last dose. Do not use Blincyto if you are pregnant. If you inadvertently become pregnant while receiving Blincyto, tell your healthcare provider right away.

Breastfeeding

It is not known if Blincyto passes into your breast milk. You should not breastfeed while using this medicine and for at least 48 hours after your last dose.

How is Blincyto administered?

Blincyto will be given to you by a continuous intravenous (IV) infusion into your vein using a small portable infusion pump. This means you can still carry out daily activities as normal, although you should be careful not to drive or engage in hazardous tasks while receiving the infusion.

One induction treatment cycle is usually 4 weeks (28 days) of continuous infusion followed by 2 weeks (14 days) break without infusion.
For the first 3 to 9 days of the first cycle and the first 2 days of the second cycle, you will usually receive this in a hospital under the care of your healthcare provider.
For the rest of the cycle, your healthcare provider will decide if you receive your treatment at home or through an outpatient clinic or infusion center.
Your healthcare provider will decide the number of treatment cycles of Blincyto but a treatment course for MRD is usually 1 cycle of Blincyto for induction followed by up to 3 additional cycles for consolidation (continued therapy). This usually consists of one IV infusion for 4 weeks (28 days), followed by an 8-week (56 days) break during which you will not receive Blincyto. This is 1 consolidation treatment cycle (84 days).
Your healthcare provider may change your dose of Blincyto, delay, or completely stop treatment if you have certain side effects, and do blood tests during treatment to check you for side effects.

Before receiving Blincyto, you will be given a corticosteroid medicine to help reduce infusion reactions.

Before and during treatment, you may be given chemotherapy as an injection into the space that
surrounds the spinal cord and the brain (intrathecal injection) to help prevent central nervous system relapse of ALL.

It is very important to keep the area around the IV catheter clean to reduce the risk of getting an infection. Your healthcare provider will show you how to care for your catheter site.

Receiving Blincyto at home

If your healthcare provider has decided you can receive Blincyto at home, your infusion bag will be changed at an outpatient center or by your home healthcare provider.

Blincyto is available in 24-hour, 48-hour, and 7-day infusion bags. Your bag will need to be changed every day, every 2 days, or once a week based on what your doctor decides is best for you.
Call your doctor if you experience any problems or side effects.
Do not change the settings on your infusion pump, even if there is a problem with your pump or your pump alarm sounds. Any changes to your infusion pump settings may cause a dose that is too high or too low to be given.
Call your healthcare provider or nurse right away if you have any problems with your pump or your pump alarm sounds.
Keep Blincyto out of reach of children or pets in the household.

What happens if I miss a dose?

Call your healthcare provider if you do not receive your IV bags on time or if your home healthcare provider does not change the infusion bag in time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include fever, tremors, and headache.

What should I avoid while using Blincyto?

Do not receive a “live” vaccine while using Blincyto, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Ask your doctor how soon it is safe for you to receive a vaccine after you stop using this medicine.

Avoid driving or hazardous activity until you know how Blincyto will affect you. Blincyto increases your risk of seizures, losing consciousness, and a serious nerve toxicity syndrome called ICANS (see above).

What other drugs will affect Blincyto?

Other drugs may interact with blinatumomab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

No formal drug interaction studies have been conducted with Blincyto. The highest drug interaction risk is during the first 9 days of the first cycle and the first 2 days of the second cycle. People receiving medications with a narrow therapeutic index metabolized by the cytochrome p450 system, such as warfarin or cyclosporin should be monitored for increases in side effects and the dosage of the interacting drug adjusted if needed.

No formal drug interaction studies have been conducted with Blincyto, but starting Blincyto treatment causes the short-lived release of cytokines that may suppress CYP450 enzymes and affect medications with a narrow therapeutic index, such as warfarin.

Storage

Intravenous (IV) bags containing Blincyto for infusion will arrive in a special package.

Do not open the package.
Do not freeze the package.

The package containing Blincyto will be opened by your healthcare provider and stored in the refrigerator at 36°F to 46°F (2°C to 8°C).

The prepared preservative-free Blincyto infusion bag lasts for 48 hours at room temperature 73°F to 81°F (23°C to 27°C) or 8 days when refrigerated at 36°F to 46°F (2°C to 8°C).

The prepared preservative-containing Blincyto infusion bag lasts for 7 days at room temperature 73°F to 81°F (23°C to 27°C) or 14 days when refrigerated at 36°F to 46°F (2°C to 8°C).

Do not throw away (dispose of) any Blincyto in your household trash. Talk with your healthcare provider about the disposal of Blincyto and used supplies.

Keep out of reach of children.

Blincyto infusion ingredients

Active ingredient: blinatumomab.
Inactive ingredients: citric acid monohydrate, lysine hydrochloride, polysorbate 80, trehalose dihydrate, sodium hydroxide, and preservative-free sterile water for injection.
Inactive ingredients of IV solution stabilizer: citric acid monohydrate, lysine hydrochloride, polysorbate 80, sodium hydroxide, and water for injection.

Due to the addition of bacteriostatic saline, 7-day bags of Blincyto solution for infusion with a preservative contain benzyl alcohol and are not recommended for use in patients weighing less than 22 kg.

Available as Blincyto 35 mcg in a single-dose vial for reconstitution.

Who makes Blincyto?

Amgen Inc. makes Blincyto 35 mcg single-dose vials for reconstitution.

Blincyto Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Blincyto.Blincyto (blinatumomab) – Amgen Inc.

Formulation type	Strength
Single-Dose Vial	35 mcg

Bisoprolol

Sama Mohamed — Sun, 01 Feb 2026 11:10:05 +0000

What is bisoprolol?

Bisoprolol is a beta-blocker that affects the heart and circulation (blood flow through arteries and veins).

Bisoprolol is used to treat hypertension (high blood pressure).

Bisoprolol may also be used for purposes not listed in this medication guide.

Warnings

Do not skip doses or stop taking bisoprolol without first talking to your doctor. Stopping suddenly may make your condition worse or cause other serious heart problems.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using this medicine.

You should not use bisoprolol if you have a serious heart condition such as “AV block,” severe heart failure, or slow heartbeats that have caused you to faint.

Keep using bisoprolol as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Before taking this medicine

You should not use bisoprolol if you you are allergic to it, or if you have a serious heart condition such as:

“AV block”;
severe heart failure; or
slow heartbeats that have caused you to faint.

To make sure bisoprolol is safe for you, tell your doctor if you have:

congestive heart failure or other heart problems;
coronary artery disease;
circulation problems (such as Peripheral Vascular Disease or Raynaud’s syndrome);
asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;
diabetes (taking bisoprolol can make it harder for you to tell when you have low blood sugar);
liver or kidney disease;
a thyroid disorder; or
a history of allergies.

It is not known whether bisoprolol is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether bisoprolol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Bisoprolol is not approved for use by anyone younger than 18 years old.

How should I take bisoprolol?

Take bisoprolol exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not skip doses or stop taking bisoprolol without first talking to your doctor. Stopping suddenly may make your condition worse or cause other serious heart problems.

If you need surgery, tell the surgeon ahead of time that you are using bisoprolol.

Your blood pressure will need to be checked often.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store bisoprolol at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Minimize drinking alcohol. It can increase some of the side effects of bisoprolol.

Bisoprolol side effects

Get emergency medical help if you have signs of an allergic reaction to bisoprolol: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

shortness of breath (even with mild exertion), swelling, rapid weight gain;
slow heart rate;
pounding heartbeats or fluttering in your chest;
numbness, tingling, or cold feeling in your hands or feet;
a light-headed feeling, like you might pass out;
eye pain, vision problems; or
bronchospasm (wheezing, chest tightness, trouble breathing).

Common bisoprolol side effects may include:

headache;
feeling tired;
sleep problems (insomnia);
joint pain;
swelling; or
cold symptoms such as stuffy nose, runny nose, cough, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect bisoprolol?

Tell your doctor about all your current medicines and any you start or stop using, especially:

insulin or oral diabetes medicine;
rifampin; or
heart or blood pressure medicine–clonidine, digitalis, digoxin, diltiazem, reserpine, or verapamil.

Bisacodyl

Sama Mohamed — Sun, 01 Feb 2026 11:04:07 +0000

Contraindications

CONTRAINDICATIONS The HalfLytely and Bisacodyl Tablets Bowel Prep Kit is contraindicated in the following conditions: •Known allergies to polyethylene glycol or other components of the kit •Gastrointestinal (GI) obstruction •Bowel perforation •Toxic colitis •Toxic megacolon Toxic megacolon (4)

Warnings and Precautions

There have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. The seizure cases were associated with severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients.

Warnings

Precautions

PRECAUTIONS Neurologic (5.1)Gastrointestinal There have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. The seizure cases were associated with severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients. (5.2) Renal Insufficiency Use with caution in patient with severe ulcerative colitis, ileus or gastric retention. Observe patients with impaired gag reflex and patients prone to regurgitation or aspiration during administration of HalfLytely solution. If GI obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration. There have been reports of ischemic colitis in patients with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit. If patients develop severe abdominal pain or rectal bleeding, patients should be evaluated as soon as possible. (5.3) Allergic Reaction Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes (sodium, potassium, calcium, BUN and creatinine). (5.4)Allergic Reaction Hives and skin rashes have been reported with PEG-3350 based products which are suggestive of an allergic reaction.

Adverse Reactions/Side Effects

ADVERSE REACTIONS Most common adverse reactions (< 3%) are abdominal pain/cramping, nausea,vomiting and headache (6)To report SUSPECTED ADVERSE REACTIONS, contact BraintreeLaboratories, Inc.

Drug Interactions

DRUG INTERACTIONS
Oral medication administered within one hour of the start of administrationof HalfLytely solution may be flushed from the GI tract and the medicationmay not be absorbed. (7)
Do not take the bisacodyl delayed release tablets within one hour of takingan antacid. (7)See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labelingRevised: 10/2007
FULL PRESCRIBING INFORMATION: CONTENTS *
1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.
1 Neurologic
2 Gastrointestina
3 Renal Insufficiency

4 Allergic Reaction
5 ADVERSE REACTIONS

Clinical Studies

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. In a clinical study of HalfLytely and (10 mg vs. 20 mg) Bisacodyl Tablets Bowel Prep Kit multicentered, controlled clinical trials, abdominal pain/cramping, nausea, vomiting and headache were the most common adverse reactions ( 3%) after the administration of HalfLytely and (10 mg or 20 mg) Bisacodyl Tablets Bowel Prep Kit. Less than 1% of patients exposed to HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit reported vomiting and abdominal pain/cramping. The data in reflects exposure in 222 patients to HalfLytely and 10 mg bisacodyl tablets vs. 223 patients exposed to HalfLytely and 20 mg bisacodyl tablets. The HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit population was 20-85 years of age, 46% male, 54% female, 10% African American, 85% Caucasian, 8% Hispanic requiring a colonoscopy. The demographics of the comparator group were similar.

Use In Specific Populations

8.1 Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether HalfLytely and Bisacodyl Tablets Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be given to a pregnant or nursing woman only if clearly needed. 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness in pediatric patients has not been established. 8.5 Geriatric Use Of the 222 patients who received HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit in clinical trials, 73 (33%) were 65 years of age or older, while 18 (8%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.

PREGNANCY

Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether HalfLytely and Bisacodyl Tablets Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be given to a pregnant or nursing woman only if clearly needed

NURSING MOTHERS

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered to a nursing woman.

PEDIATRIC USE

Safety and effectiveness in pediatric patients has not been established

GERIATRIC USE

Of the 222 patients who received HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit in clinical trials, 73 (33%) were 65 years of age or older, while 18 (8%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.

Bisacodyl Description

Each HalfLytely and Bisacodyl Tablets Bowel Prep Kit [Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed release tablets] consists of one 2 liter bottle of HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and two 5 mg bisacodyl, delayed release tablets.
•Bisacodyl delayed release tablets: Each pink, round, enteric coated bisacodyl delayed release tablet (stamped “BRA”) contains 5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40.
Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, Eudragit L 30-55, polyethylene glycol 400, talc USP, gelatin, calcium sulfate (anhydrous) NF, confectioners sugar, kaolin USP, sucrose NF, Opalux pink, beeswax, and carnauba wax.
The bisacodyl delayed release tablets are administered orally prior to drinking the HalfLytely solution [see Dosage and Administration
( 2)].
•HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution): A white powder for reconstitution containing 210 grams of PEG-3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride and 1 gram of flavoring ingredient (if applicable). Flavor Packs are available in Cherry, Lemon-Lime and Orange. This preparation can be used without the addition of a Flavor Pack. When dissolved in water to a volume of 2 liters, the HalfLytely solution is isosmotic, clear, and colorless. The HalfLytely solution is administered orally after taking the two bisacodyl delayed release tablets [see Dosage and Administration
( 2)].

Bisacodyl – Clinical Pharmacology

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action HalfLytely and Bisacodyl Tablets Bowel Prep Kit induces diarrhea which cleanses the colon. 12.2 Pharmacodynamics Bisacodyl, a stimulant laxative, is hydrolyzed by intestinal brush border enzymes and colonic bacteria to form an active metabolite [bis-(p-hydroxyphenyl) pyridyl-2 methane; (BHPM)] that acts directly on the colonic mucosa to produce colonic peristalsis. 12.3 Pharmacokinetics The osmotic activity of HalfLytely solution results in no net absorption or excretion of ions or water.

MECHANISM OF ACTION

HalfLytely and Bisacodyl Tablets Bowel Prep Kit induces diarrhea which cleanses the colon

PHARMACODYNAMICS

Bisacodyl, a stimulant laxative, is hydrolyzed by intestinal brush border enzymes and colonic bacteria to form an active metabolite [bis-(p-hydroxyphenyl) pyridyl-2 methane; (BHPM)] that acts directly on the colonic mucosa to produce colonic peristalsis.

PHARMACOKINETICS

The osmotic activity of HalfLytely solution results in no net absorption or excretion of ions or water.

Nonclinical Toxicology

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of HalfLytely and Bisacodyl Tablets Bowel Prep Kit. Studies to evaluate its potential for impairment of fertility or its mutagenic potential have not been performed.

How is Bisacodyl supplied

Each HalfLytely and Bisacodyl Tablets Bowel Prep Kit contains:
One pack of bisacodyl delayed release tablets containing two pink, round, enteric coated 5 mg bisacodyl delayed release tablets, stamped “BRA”
One 2 liter bottle of HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution containing 210 grams of polyethylene glycol (PEG) 3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride, and 1 gram of flavoring ingredient (if applicable). After adding 2 liters of water, the reconstituted HalfLytely solution (clear and colorless) contains 31.3 mmol/L of PEG-3350, 65 mmol/L of sodium, 53 mmol/L of chloride, 17 mmol/L of bicarbonate and 5 mmol/L of potassium.
Lemon-Lime HalfLytely and Bisacodyl Tablets Bowel Prep Kit contains 1 gram lemon-lime flavoring ingredient. HalfLytely and
Bisacodyl Tablets Bowel Prep Kit with Flavor Packs contains 3 packs (1 gram each Cherry, Lemon-Lime and Orange flavors).
Storage: Store at 20-25°C (68-77°F). Excursions permitted between 15-30°C (59-86°F). The reconstituted HalfLytely solution, which may be refrigerated, should be used within 48 hours. Lemon-Lime HalfLytely and Bisacodyl Tablets

Storage and Handling

STORAGE AND HANDLING17
PATIENT COUNSELING INFORMATION17.4 FDA-Approved Patient Labeling * Sections or subsections omitted from the full prescribing information are not listed page 2 of 6 FULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGEHalfLytely and Bisacodyl Tablets Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults.
2 DOSAGE AND ADMINISTRATIONThe recommended HalfLytely and Bisacodyl Tablets Bowel Prep Kit oral dosage regimen for adults on the day prior to colonoscopy isas follows: Take two 5 mg bisacodyl delayed release tablets with water. Do NOT chew or crush the tablets.Add flavor pack of choice (if applicable) to the 2 liter container. No additional ingredients (other than flavor packs provided) shouldbe added to the solution.Prepare the HalfLytely solution by filling the container to the 2 liter mark with water.
Cap the container. Shake to dissolve thepowder.Wait for a bowel movement (or maximum of 6 hours) then drink the 2 liter HalfLytely solution at a rate of 8 ounces every 10minutes. Drink all of the solution.3 DOSAGE FORMS AND STRENGTHS Two pink, round, enteric coated 5 mg bisacodyl delayed release tablets, stamped 223BRA224 One 2 liter HalfLytely bottle with powder for reconstitution4 CONTRAINDICATIONSThe HalfLytely and Bisacodyl Tablets Bowel Prep Kit is contraindicated in the following conditions: Known allergies to polyethylene glycol or other components of the kit Gastrointestinal (GI) obstruction Bowel perforation Toxic colitis Toxic megacolon5 WARNINGS AND PRECAUTIONS5.
1 NeurologicThere have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparationproducts in patients with no prior history of seizures.
The seizure cases were associated with severe vomiting, excessive beverageconsumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia).
The neurologic abnormalities resolved withcorrection of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used withcaution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients withknown or suspected hyponatremia. Monitor baseline and post-colonoscopy.

LABORATORY TESTS

laboratory tests (sodium, potassium, calcium, creatinine,and BUN) in these patients.
5.2 GastrointestinalUse with caution in patient with severe ulcerative colitis, ileus or gastric retention. Observe patients with impaired gag reflex andpatients prone to regurgitation or aspiration during administration of HalfLytely solution. If GI obstruction or perforation is suspected,appropriate studies should be performed to rule out these conditions before administration. There have been reports of ischemic colitisin patients with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit. If patients develop severe abdominal pain or rectalbleeding, patients should be evaluated as soon as possible.
5.3 Renal InsufficiencyPatients with impaired water handling who experience severe vomiting should be closely monitored including measurement ofelectrolytes (sodium, potassium, calcium, BUN and creatinine).
5.4 Allergic ReactionHives and skin rashes have been reported with PEG-3350 based products which are suggestive of an allergic reaction. page 3 of 6 6 ADVERSE REACTIONS
6.1 Clinical Studies ExperienceBecause clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of adrug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.In a clinical study of HalfLytely and (10 mg vs. 20 mg) Bisacodyl Tablets Bowel Prep Kit multicentered, controlled clinical trials,abdominal pain/cramping, nausea, vomiting and headache were the most common adverse reactions (< 3%) after the administrationof HalfLytely and (10 mg or 20 mg) Bisacodyl Tablets Bowel Prep Kit. Less than 1% of patients exposed to HalfLytely and 10 mgBisacodyl Tablets Bowel Prep Kit reported vomiting and abdominal pain/cramping.The data in Table 1 reflects exposure in 222 patients to HalfLytely and 10 mg bisacodyl tablets vs. 223 patients exposed to HalfLytelyand 20 mg bisacodyl tablets. The HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit population was 20-85 years of age,46% male, 54% female, 10% African American, 85% Caucasian, 8% Hispanic requiring a colonoscopy. The demographics of thecomparator group were similar.Table
1: Adverse Reactions Observed in at Least 1% of Patients HalfLytely and 10 mgBisacodyl TabletsBowel Prep Kit (N=222) HalfLytely and 20 mgBisacodyl TabletsBowel Prep Kit (N=223) Abdominal pain/cramping 1% 2% Nausea 1% 2% Vomiting 1% 2% Headache 2% 1% Table 2 displays patient diary ratings of their symptoms associated with HalfLytely and Bisacodyl Tablets Bowel Prep Kits (10 mgbisacodyl vs. 20 mg bisacodyl tablets) in the controlled trial.Table 2: Percentage of Patients Reporting in their Diaries 223bothersome224 to 223severely distressing224 Symptoms in Controlled ClinicalHalfLytely and Bisacodyl Tablets Bowel Prep Kit Trial1 Half Lytely and 10 mgBisacodyl TabletsBowel Prep Kit (N=222) HalfLytely and 20 mgBisacodyl TabletsBowel Prep Kit (N=223) Nausea 13% 21% Abdominal cramping 7% 14% Abdominal fullness 11% 13% Vomiting 5% 8% Overall Discomfort 14% 20% 1 Patients were specifically asked about the occurrence of the following symptoms: nausea, abdominal cramping, fullness, vomiting,and overall discomfort.
6.2 Postmarketing ExperienceThe following adverse reactions have been identified during postapproval use of HalfLytely and Bisacodyl Tablets Bowel Prep Kit.Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate theirfrequency or establish a causal relationship to drug exposure.Allergic Reactions: Cases of urticaria, rhinorrhea, dermatitis and anaphylactic reactions have been reported with PEG-based productswhich may represent allergic reactions.Gastrointestinal:There are isolated reports of serious post-marketing events following the administration of PEG-based products in patients over60 years of age. These adverse reactions include upper GI bleeding from a Mallory-Weiss tear, esophageal perforation, asystole,and acute pulmonary edema after vomiting and aspirating the PEG-based solution. In addition, during administration of 4 liters ofPEG-3350 colon cleansing preparation the following serious adverse reactions were seen: two deaths in end stage renal failure patientswho developed diarrhea, vomiting and dysnatremia.Ischemic colitis has been reported with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit for colon preparation prior tocolonoscopy. However, a causal relationship between these ischemic colitis cases and the use of HalfLytely and Bisacodyl TabletsBowel Prep Kit has not been established. page 4 of 6 Neurologic: There have been reports of generalized tonic-clonic seizures associated with use of large volume (4 liter) PEG-basedcolon preparation products in patients with no prior history of seizures. Cases of dizziness and syncope have been reported [seeWarnings and Precautions (5.1)]
.7 DRUG INTERACTIONS Oral medication administered within one hour of the start of administration of HalfLytely solution may be flushed from the GI tractand the medication may not be absorbed.Do not take the bisacodyl delayed release tablets within one hour of taking an antacid.
8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether HalfLytely and BisacodylTablets Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HalfLytelyand Bisacodyl Tablets Bowel Prep Kit should be given to a pregnant or nursing woman only if clearly needed.
8.3 Nursing MothersIt is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should beexercised when HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered to a nursing woman.
8.4 Pediatric UseSafety and effectiveness in pediatric patients has not been established.
8.5 Geriatric UseOf the 222 patients who received HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit in clinical trials, 73 (33%) were 65 yearsof age or older, while 18 (8%) were 75 years of age or older. No overall differences in safety or effectiveness were observed betweengeriatric patients and younger patients, and other reported clinical experience has not identified differences in responses betweengeriatric patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.11 DESCRIPTIONEach HalfLytely and Bisacodyl Tablets Bowel Prep Kit [Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonateand potassium chloride for oral solution and bisacodyl delayed release tablets] consists of one 2 liter bottle of HalfLytely (PEG-3350,sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and two 5 mg bisacodyl,delayed release tablets.Bisacodyl delayed release tablets: Each pink, round, enteric coated bisacodyl delayed release tablet (stamped 223BRA224) contains5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40.

INACTIVE INGREDIENT

Bisacodyl delayed release tablets: Each pink, round, enteric coated bisacodyl delayed release tablet (stamped “BRA”) contains 5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40. Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, Eudragit L 30-55, polyethylene glycol 400, talc USP, gelatin, calcium sulfate (anhydrous) NF, confectioners sugar, kaolin USP, sucrose NF, Opalux pink, beeswax, and carnauba wax. The bisacodyl delayed release tablets are administered orally prior to drinking the HalfLytely solution [see Dosage and Administration].

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Bisacodyl
GENERIC: Bisacodyl
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 24236-199-30
STRENGTH:5 mg
COLOR: orange
SHAPE: ROUND
SCORE: No score
SIZE: 5 mm
IMPRINT: 30
QTY: 400

BISACODYL
bisacodyl tablet

Product InformationProduct TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24236-199(NDC:0904-7927-60)Route of AdministrationORAL

Active Ingredient/Active MoietyIngredient NameBasis of StrengthStrengthBisacodyl (UNII: 10X0709Y6I) (Bisacodyl – UNII:10X0709Y6I)Bisacodyl5 mg

Inactive IngredientsIngredient NameStrengthANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)MAGNESIUM STEARATE (UNII: 70097M6I30)PEG-8 LAURATE (UNII: 762O8IWA10)TALC (UNII: 7SEV7J4R1U)GELATIN (UNII: 2G86QN327L)CALCIUM SULFATE (UNII: WAT0DDB505)SUCROSE (UNII: C151H8M554)KAOLIN (UNII: 24H4NWX5CO)CARBOMER 934 (UNII: Z135WT9208)

Product CharacteristicsColororangeScoreno scoreShapeROUND (TABLET)Size5mmFlavorImprint Code5Contains

Packaging#Item CodePackage DescriptionMarketing Start DateMarketing End Date1NDC:24236-199-30400 in 1 CANISTER

Marketing InformationMarketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End DateANDAANDA07565908/04/2010

Biotin

Sama Mohamed — Sun, 01 Feb 2026 10:54:58 +0000

What is biotin?

Biotin, also known as Vitamin B7, is a form of vitamin B found in foods. Biotin helps the body break down fats, carbohydrates, and proteins into energy.

Biotin is likely effective in alternative medicine as an aid in treating or preventing low levels of biotin. Low levels of biotin can be caused by malnutrition, rapid weight loss, long-term tube feeding, and other medical conditions.

Biotin has also been used to treat the symptoms of multiple sclerosis (MS) and seborrhea (in babies). However, research has shown that biotin may not be effective in treating these conditions.

Other uses not proven with research have included treating brittle nails, hair loss, diabetes, nerve pain, depression, and other conditions.

Biotin may also be used in combination with other vitamins in adults and children as a dietary supplement.

It is not certain whether biotin is effective in treating any medical condition. Medicinal use of this product has not been approved by the FDA. Biotin should not be used in place of medication prescribed for you by your doctor.

Biotin is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Biotin may also be used for purposes not listed in this product guide.

Biotin side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Common side effects may include diarrhea or respiratory problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Follow all directions on the product label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use this product if you are allergic to biotin.

Before using biotin, talk to your healthcare provider. Your dose needs may be different if you:

have a deficiency of the enzyme called biotinidase;
smoke; or
kidney disease (or if you are on dialysis).

Ask a doctor before using this product if you are pregnant or breastfeeding.

Do not give any herbal/health supplement to a child without medical advice.

How should I take biotin?

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

If you choose to use biotin, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.

Biotin is available in tablet, liquid, and capsule formulations. Do not use different formulations of biotin at the same time without medical advice. Using different formulations together increases the risk of an overdose of biotin.

Do not swallow the orally disintegrating tablet, or sublingual tablet. Allow the orally disintegrating tablet to dissolve in your mouth without chewing. The sublingual tablet should be placed under your tongue to allow it to dissolve.

Measure biotin liquid with the supplied measuring device (not a kitchen spoon). Biotin may also be given through a feeding tube. Ask your doctor or pharmacist if you don’t understand these instructions.

Eating 2 or more raw egg whites for several months may prevent the body from absorbing biotin.

Biotin can cause cause false results on a drug-screening urine test. Tell the laboratory staff that you use biotin.

The recommended daily dose of biotin changes with age. Follow your healthcare provider’s instructions. You may also consult the Office of Dietary Supplements of the NIH, or the USDA Nutrient Database of recommended daily allowances for more information.

Call your doctor if the condition you are treating with biotin does not improve, or if it gets worse while using this product.

Biktarvy

Sama Mohamed — Sun, 01 Feb 2026 10:48:46 +0000

What is Biktarvy?

Biktarvy is a complete HIV-1 treatment in a once-a-day single tablet that contains the three antiviral medicines bictegravir, emtricitabine, and tenofovir alafenamide. Biktarvy works by preventing HIV from multiplying in your body, lowering HIV blood levels, and decreasing your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses, such as cancer or severe infections.

Biktarvy is a complete treatment and should not be used with any other HIV medicines. Human immunodeficiency virus type 1 (HIV-1) is the virus that can cause acquired immune deficiency syndrome (AIDS).

There is no Biktarvy generic available.

Who can take Biktarvy?

Biktarvy is used to treat HIV-1 infection in adults and pediatric patients who weigh at least 14 kg who:

have not taken HIV-1 medicine in the past OR
to replace their current HIV-1 medicine if they are virologically suppressed (HIV-1 RNA less than 50 copies per mL), on a stable antiretroviral regimen with no history of treatment failure and with no known substitutions associated with resistance to bictegravir or tenofovir.
have taken antiretroviral treatment in the past and are not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir.

Biktarvy’s FDA approval was first received on February 7, 2018, by Gilead Sciences, Inc. The latest expansion of FDA approval on July 30, 2025, makes Biktarvy a treatment option for patients with HIV who need to restart treatment and are not virologically suppressed.

Biktarvy is also recommended by the CDC as one of the preferred agents for PEP (post-exposure prophylaxis of HIV-1), despite it not being FDA-approved for this purpose.

How does Biktarvy work?

Biktarvy contains three antiviral active ingredients that prevent HIV replication, which decreases viral load.

Biktarvy’s mechanism of action is as an integrase strand transfer inhibitor (INSTI) for the active ingredient bictegravir, and as nucleoside reverse transcriptase inhibitors (NRTIs) for the active ingredients emtricitabine and tenofovir alafenamide.

Biktarvy Side Effects

Common Biktarvy side effects

The most common Biktarvy side effects include:

Diarrhea (6%)
Nausea (6%)
Headache (5%)
Tiredness (3%)
Abnormal dreams (3%)
dizziness (2%)
Sleep problems (2%)
Bloating abdomen (2%)

These common side effects occurred in 2% or more of Biktarvy patients in clinical trial 1489.

Biktarvy’s other side effects, of abdominal pain, gas (flatulence), indigestion (dyspepsia), and vomiting, occurred in less than 2% of patients in clinical trials 1489 and 1490.

Biktarvy side effects may also include laboratory abnormalities.

Serious Biktarvy side effects

If you are allergic to Biktarvy, get emergency medical help if you have signs of an allergic reaction, including rash, hives, shortness of breath, or swelling of your face, lips, tongue, or throat.

Biktarvy may cause other serious side effects. Call your doctor at once if you have:

Kidney problems – little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
Lactic acidosis – muscle pain or weakness, numbness or cold feeling, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, or feeling very weak or tired; or
Liver problems – swelling around your midsection, upper stomach pain, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Biktarvy affects your immune system, which may cause certain side effects (even weeks or months after you’ve taken this medicine). Tell your doctor if you have:

Signs of a new infection – fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
Trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
Swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

This is not a complete list of side effects, and others may occur. Talk to your doctor, pharmacist, or healthcare provider for medical advice about side effects.

Warnings

Biktarvy has a boxed warning for worsening of hepatitis B virus (HBV) infection after stopping treatment with Biktarvy. If you’ve ever had hepatitis B, it may become active or get worse after you stop using this medicine. You should have liver function tests with both clinical and laboratory follow-up before treatment and for several months after treatment to determine if you need to be prescribed medicine to treat hepatitis B. Always tell your prescriber about any new or unusual symptoms you may have after you stop taking this medicine.

Biktarvy is not recommended in patients with severe renal impairment, patients with end-stage renal disease who are not receiving chronic hemodialysis, or patients with no antiretroviral treatment history and end-stage renal disease (ESRD) who are receiving chronic hemodialysis

Do not run out of these tablets. Before your tablets are finished, you should refill your prescription or talk to your healthcare provider.

You should not stop taking these tablets without first talking to your doctor.

Before taking this medicine

You should not use this medicine if you are allergic to antiviral medicines bictegravir, emtricitabine, or tenofovir contained in medicines such as Atripla, Complera, Emtriva, Descovy, Genvoya, Odefsey, Stribild, or Truvada.

Some medicines can cause unwanted or dangerous effects when used with Biktarvy, and your doctor may need to change your treatment plan. Do not take Biktarvy if you also take a medicine that contains:

dofetilide; or
rifampin.

Tell your doctor if you have or ever had:

liver disease (especially cirrhosis)
hepatitis B virus (HBV)
kidney disease

Before starting treatment with this medicine, you will be tested for hepatitis B virus infection.

Before starting treatment and during treatment, your serum creatinine, estimated creatinine clearance, urine glucose, and urine protein will be monitored as clinically appropriate. In patients with chronic kidney disease, serum phosphorus will also be assessed.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant during treatment with this medicine. There is a pregnancy registry for women who take this medicine during pregnancy. The purpose of this registry is to collect information about your and your baby’s health. Talk with your healthcare provider about how you can take part in this registry by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258- 4263.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. This medicine passes to your baby in your breast milk. Talk to your healthcare provider about the following risks to your baby from breastfeeding during treatment with this medicine:

The HIV-1 virus may pass to your baby if your baby does not have HIV-1 infection.
The HIV-1 virus may become harder to treat if your baby has HIV-1 infection.
Your baby may get side effects from these tablets.

Talk with your healthcare provider about the best way to feed your baby.

How should I take Biktarvy?

Take one tablet once a day; it can be taken with or without food.
Children who have difficulty swallowing a whole tablet can have the tablet split in half and then swallow each part separately, as long as all parts are swallowed within about 10 minutes.
You should not change your dose or stop taking this medicine without first talking with your healthcare provider. Stay under a healthcare provider’s care during treatment with this medicine.
If you take other medicines, such as antacids or supplements, see the drug interaction section for specific advice.
For patients who are on dialysis, you should take your tablet following dialysis.
Do NOT let your tablets run out. When your medicine supply starts to run low, get more from your healthcare provider or pharmacy before you run out. If the medicine is stopped for even a short time, the amount of virus in your blood may increase, and the virus may develop resistance to this medicine and become harder to treat.
You will need frequent medical tests.
Do not miss a dose of Biktarvy.

Take Biktarvy exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Biktarvy is a complete HIV-1 treatment regimen. You should not take it with other HIV-1 medicines.

Biktarvy Dosage Information

Usual Biktarvy dose in adults and pediatric patients weighing at least 25 kg, or virologically-suppressed adults with estimated creatinine clearance below 15 mL/min receiving chronic hemodialysis:

Biktarvy (Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) one tablet once a day, with or without food.

Recommended Biktarvy dosage in pregnant individuals who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known substitutions associated with resistance to the individual components of Biktarvy:

Biktarvy (Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) one tablet once a day, with or without food.

Usual Biktarvy dose pediatric (weighing 14 kg to less than 25 kg):

Biktarvy (Bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15mg) one tablet once a day, with or without food.

Renal impairment: Biktarvy is not recommended in patients with an estimated creatinine clearance of 15 to below 30 mL/min, or below 15 mL/min who are not receiving chronic hemodialysis, or below 15 mL/min who have no antiretroviral treatment history.

Hepatic impairment: This medicine is not recommended in patients with severe hepatic impairment.

Comments:

For children who are at least 14 kg to less than 25 kg and are unable to swallow a whole tablet, the tablet can be split, and each part can be taken separately as long as all parts are ingested within about 10 minutes.

Biktarvy tablets are available in two different strengths:

30 mg bictegravir, 120 mg emtricitabine, 15 mg tenofovir alafenamide
50 mg bictegravir, 200 mg emtricitabine, 25 mg tenofovir alafenamide

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

When your tablets supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to this medicine and become harder to treat.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What other drugs will affect Biktarvy?

Sometimes, it is not safe to use certain medications at the same time as taking Biktarvy. Drugs can affect the blood levels of other drugs you take, which may increase side effects or make the medications less effective.

You should not take Biktarvy with

dofetilide; or
Rifampin.

It is not recommended to take Biktarvy with:

Rifabutin
Rifapentine
St. John’s wort

When taking Biktarvy, alternative anticonvulsants should be considered instead of:

carbamazepine
oxcarbazepine
phenobarbital
phenytoin.

Avoid taking these tablets with other medications that may also harm the kidneys. Serious side effects, such as acute renal failure, have been reported in postmarketing studies.

Antacids containing aluminium/magnesium:

Biktarvy can be taken at least 2 hours before or 6 hours after taking antacids containing aluminium/magnesium.

Supplements or Antacids containing Calcium or Iron:

Biktarvy and supplements or antacids containing calcium or iron can be taken together with food.

In pregnant individuals:

Antacids containing Al/Mg:

Biktarvy can be taken at least 2 hours before or 6 hours after antacids containing aluminium/magnesium regardless of food intake.

Supplements or Antacids containing Calcium or Iron:

Biktarvy and supplements or antacids containing calcium or iron can be taken together with food.
When Biktarvy is taken on an empty stomach it should be taken at least 2 hours before or 6 hours after supplements or antacids containing calcium or iron.

General interaction information

Many drugs can interact with Biktarvy. This includes prescription, over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Biktarvy Package Insert

HCPs and patients often use the Biktarvy Package Insert (PI) for more detailed information about this medicine. The Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called the Biktarvy Prescribing Information (PI) or FDA label.

Storage

Store tablets in the original bottle below 86°F (30 °C).
Keep the bottle tightly closed.
This medicine contains a desiccant packet to help keep your medicine dry (protect it from moisture). Keep the desiccant packet in the bottle. Do not eat the desiccant packet.
Store the tablets blister pack at room temperature between 68 °F to 77 °F (20 °C to 25 °C).
Keep tablets in their original bottle or blister pack.
Biktarvy comes in a child-resistant package.

Letter – B - Drugonomy™

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Warnings

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What happens if I miss a dose?

What happens if I overdose?

What should I avoid?

Bystolic side effects

What other drugs will affect Bystolic?

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Warnings

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Buspirone side effects

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Warnings

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BuSpar side effects

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Bupropion

What is bupropion?

What is bupropion used to treat?

Bupropion side effects

Common bupropion side effects

Serious bupropion side effects

Warnings

Before taking this medicine

Pregnancy

Breastfeeding

How should I take bupropion?

Bupropion hydrochloride dosing information

Usual Adult Bupropion Dose for Depression:

Usual Adult Bupropion Dose for Seasonal Affective Disorder:

Usual Adult Dose for Smoking Cessation:

What happens if I miss a dose?

What happens if I overdose?

What to avoid

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Buprenorphine/naloxone (Oromucosal, Sublingual)

Uses for buprenorphine/naloxone

Before using buprenorphine/naloxone

Allergies

Pediatric

Geriatric

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper use of buprenorphine/naloxone

Dosing

Missed Dose

Storage

Precautions while using buprenorphine/naloxone

Side Effects of buprenorphine/naloxone

Commonly used brand name(s)

Buprenorphine

What is buprenorphine?

Is buprenorphine a controlled substance?

Warnings

Before taking this medicine

Pregnancy

Infertility

Breastfeeding

How should I take buprenorphine?

Opioid Use Disorder

Pain

What happens if I miss a dose?

What happens if I overdose?

What to avoid