Concerta is a central nervous system stimulant prescription medicine. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Concerta extended-release tablets are used to treat attention deficit hyperactivity disorder (ADHD) in children 6 years of age and older, adolescents, and in adults up to the age of 65.

Concerta should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Is Concerta a controlled substance?

Yes, Concerta (methylphenidate) is a Schedule 2 controlled substance and therefore has a high potential for abuse. It has a currently accepted medical use in the United States or a currently accepted medical use with severe restrictions. Abuse may lead to severe psychological or physical dependence. There may be variations in CSA schedules between individual states.

Warnings

You should not use Concerta if you have glaucoma, tics or Tourette’s syndrome, or severe anxiety, tension, or agitation.

Methylphenidate may be habit-forming, and this medicine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse. Keep the medication where others cannot get to it.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect. Call your doctor right away if you have chest pain or feel lightheaded or short of breath while taking Concerta.

Do not use Concerta if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine or have used a methylene blue injection.

Concerta may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder. Call your doctor right away if you have signs of psychosis such as paranoia, aggression, new behavior problems, or seeing or hearing things that are not real.

Before taking this medicine

You should not use Concerta if you are allergic to methylphenidate.

You should not take Concerta if you have:

• glaucoma;
• severe high blood pressure or a heart problem;
• overactive thyroid;
• a personal or family history of tics (muscle twitches) or Tourette’s syndrome; or
• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;
• high blood pressure; or
• a family history of heart disease or sudden death.

Do not use Concerta 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, and tranylcypromine.

Tell your doctor if you also use 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 methylphenidate could cause a serious condition called serotonin syndrome.

Tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
• blood circulation problems in the hands or feet; or
• alcoholism or drug addiction.

To make sure Concerta is safe for you, tell your doctor if you have:

• problems with the esophagus, stomach, or intestines; or
• seizures, epilepsy, or an abnormal brain wave test (EEG).

Becoming dependent on this medicine during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of methylphenidate on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine. If you are breastfeeding, tell your doctor if you notice symptoms in the baby such as agitation, sleep problems, feeding problems, or reduced weight gain.

Concerta is not approved for use by anyone younger than 6 years old.

How should I take Concerta?

Take Concerta 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.

Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away Concerta is against the law.

Take Concerta once each day in the morning. Concerta is an extended-release tablet. It releases medication into your or your child’s body throughout the day.

Concerta can be taken with or without food, but take it the same way each time.

Do not chew, crush, or break the Concerta tablets. Swallow the tablets whole with water or other liquids. Tell your doctor if you or your child cannot swallow the tablet whole. A different medicine may need to be prescribed.

The Concerta tablet does not dissolve completely in the body after all the medicine has been released. You or your child may sometimes notice the empty tablet in a bowel movement. This is normal.

Children should have their height and weight checked often while taking this medicine.

Tell your doctor if you have a planned surgery.

Your treatment may also include counseling or other treatments.

Your doctor will need to check your progress on a regular basis. From time to time, your doctor may stop treatment for a while to check ADHD symptoms. Your heart and blood pressure may also need to be checked often.

Store Concerta tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.

Do not keep leftover medicine. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.

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 overdose of methylphenidate could be fatal.

Overdose symptoms may include nausea, dry mouth, vomiting, diarrhea, anxiety, agitation, restlessness, tremor, muscle twitches, rapid breathing, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma.

What should I avoid while taking Concerta?

Avoid drinking alcohol.

Avoid driving or hazardous activity until you know how Concerta will affect you. Your reactions could be impaired.

Concerta side effects

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

Call your doctor at once if you have:

• signs of heart problems – chest pain, trouble breathing, feeling like you might pass out;
• signs of psychosis – hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
• signs of circulation problems – numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or
• penis erection that is painful or lasts 4 hours or longer.

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.

Methylphenidate can affect growth in children. Your child’s height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate.

Common Concerta side effects may include:

• sweating, increased blood pressure;
• mood changes, anxiety, feeling nervous or irritable, trouble sleeping;
• fast heart rate, pounding heartbeats or fluttering in your chest;
• loss of appetite, weight loss;
• dry mouth, nausea, vomiting, stomach pain, indigestion; or
• headache, dizziness.

Cobenfy (xanomeline and trospium chloride) is a new treatment for schizophrenia used to improve positive and negative symptoms. Cobenfy contains xanomeline, which helps schizophrenia symptoms, and trospium, which works to reduce the side effects. Cobenfy is a new class of medicine and works differently than traditional schizophrenia medications so it does not have a boxed warning and atypical antipsychotic class warnings and precautions.

Schizophrenia is related to imbalances in messenger systems in the brain involving muscarinic acetylcholine and dopamine. It is thought that Cobenfy works by xanomeline activating muscarinic receptors  (M1 and M4) in the brain (central nervous system), which improves schizophrenia. Trospium chloride cannot enter the brain easily, so it works mainly around the body, reducing side effects by blocking muscarinic receptors.

Cobenfy has two mechanisms of action (MOA). Cobenfy’s active ingredient xanomeline’s MOA is a muscarinic agonist that selectively targets M1 and M4 receptors in the brain without blocking D2 receptors. Cobenfy’s active ingredient trospium chloride’s MOA is a muscarinic antagonist that blocks the muscarinic receptors primarily in the peripheral tissues.

Cobenfy FDA approval is for the treatment of schizophrenia in adults. Cobenfy capsules are taken twice daily on an empty stomach, at least 1 hour before a meal or at least 2 hours after a meal. During drug development, it was named KarXT, and once approved, Bristol Myers Squibb renamed it Cobenfy.

What is the schizophrenia?

Schizophrenia is a mental illness that affects how you think, feel, and behave. Signs and symptoms usually appear first in the teenage years or early adulthood. There are three main areas of symptoms areas, which are positive (hallucinations and delusions), negative (social withdrawal, lack of enjoyment in life), and cognitive impairment (problems with concentration, memory, and decision-making).
Tradition schizophrenia medicines mainly target positive symptoms, whereas Cobenfy helps to improve positive and negative symptoms.

Cobenfy side effects 

Common Cobenfy side effects

The most common Cobenfy side effects were:

• feeling sick (nausea),
• indigestion (dyspepsia),
• constipation,
• vomiting,
• high blood pressure (hypertension),
• abdominal pain,
• diarrhea,
• fast heart rate (tachycardia),
• dizziness,
• and heartburn (gastrointestinal reflux disease).

These side effects occurred in 5% or more of patients, and at least twice the placebo rates in clinical trials.

Serious Cobenfy side effects

Urinary Retention: Cobenfy cause the side effect of urinary retention. Patients may be at increased risk of urinary retention if they are geriatric patients, patients with clinically significant bladder outlet obstruction and incomplete bladder emptying (e.g., patients with benign prostatic hyperplasia (BPH), or diabetic cytopathic patients). It should not be used in patients with pre-existing urinary retention and is not recommended in patients with moderate or severe renal impairment.

Patients with Hepatic Impairment: Patients with hepatic impairment have higher systemic exposures of xanomeline, a component of Cobenfy, compared to patients with normal hepatic function, which may result in an increased incidence of adverse reactions.

It should not be used in patients with moderate or severe hepatic impairment and is not recommended in patients with mild hepatic impairment. Assess liver enzymes before starting treatment and as clinically indicated during treatment.

Biliary Disease: In clinical studies with Cobenfy, side effects included transient increases in liver enzymes with rapid decline occurred, consistent with transient biliary obstruction due to biliary contraction and possible gallstone passage.

It is not recommended for patients with active biliary disease, such as symptomatic gallstones. Assess liver enzymes and bilirubin before starting treatment and as clinically indicated during treatment. The occurrence of symptoms such as dyspepsia, nausea, vomiting, or upper abdominal pain should prompt assessment for gallbladder disorders, biliary disorders, and pancreatitis, as clinically indicated.

Cobenfy should be stopped in the presence of signs or symptoms of substantial liver injury, such as jaundice, pruritus, or alanine aminotransferase levels more than five times the upper limit of normal or five times baseline values.

Decreased Gastrointestinal Motility: Cobenfy contains trospium chloride which like other antimuscarinic agents, may decrease gastrointestinal motility. Use this medicine with caution in patients with gastrointestinal obstructive disorders due to the risk of gastric retention. Use these capsules with caution in patients with conditions such as ulcerative colitis, intestinal atony, and myasthenia gravis.

Risk of Angioedema: Angioedema of the face, lips, tongue, and/or larynx has been reported with Cobenfy and trospium chloride, an ingredient of Cobenfy. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, discontinue medicine and initiate appropriate therapy and/or measures necessary to ensure a patent airway. This medicine is contraindicated in patients with a history of hypersensitivity to trospium chloride.

Patients with Narrow-angle Glaucoma: Pupillary dilation may occur due to the anticholinergic effects of this medicine. This may trigger an acute angle closure attack in patients with anatomically narrow angles. In patients known to have anatomically narrow angles, Cobenfy should only be used if the potential benefits outweigh the risks and with careful monitoring.

Increases in Heart Rate: Cobenfy can increase heart rate so assess heart rate at baseline and as clinically indicated during treatment with this medicine.

Anticholinergic Adverse Reactions in Patients with Renal Impairment: Trospium chloride, an active ingredient in this medicine, is substantially excreted by the kidney. It is not recommended in patients with moderate or severe renal impairment (estimated glomerular filtration rate (eGFR) <60 mL/min). Systemic exposure of trospium chloride is higher in patients with moderate and severe renal impairment. Therefore, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate and severe renal impairment.

Central Nervous System Effects: Trospium chloride, an active ingredient in this medicine is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported with trospium chloride, including dizziness, confusion, hallucinations, and somnolence. Monitor patients for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Patients should not to drive or operate heavy machinery until they know how this medicine affects them. If a patient experiences anticholinergic CNS effects, consider dose reduction or drug discontinuation.

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

Who should not take this medicine?

Cobenfy should not be taken if you have:

• urinary retention 
• moderate or severe hepatic impairment 
• gastric retention  
• history of hypersensitivity to Cobenfy or trospium chloride (4) 
• untreated narrow-angle glaucoma 

Before taking this medicine

Before taking this Cobenfy, tell your healthcare provider about all of your medical conditions, including if you: 

• have an enlarged prostate, problems passing urine, or a blockage in your urinary bladder 
• have liver problems 
• have or had gallstones or problems with your bile ducts or pancreas 
• have stomach or intestinal problems including constipation, ulcerative colitis, slow emptying of your stomach, or myasthenia gravis 
• have an eye condition called narrow-angle glaucoma 
• have kidney problems 

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant, as it is not known if this Cobenfy may harm your unborn baby. If you become pregnant or think you are pregnant during treatment with this medicine, tell your healthcare provider. There is a pregnancy exposure registry for women who take this medicine during pregnancy. The purpose of this registry is to collect information about the health of women exposed to Cobenfy and their baby. If you become pregnant during treatment while taking this medicine, your healthcare provider will register you by calling 1-866-961-2388. 

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Cobenfy passes into your breast milk or if it can harm your baby.

How should I take Cobenfy?

• Take capsule 2 times each day at least 1 hour before a meal or at least 2 hours after a meal. 
• Do not open the capsules. 
• Take this medicine exactly as your healthcare provider tells you. Do not change the dose or stop taking this medicine without first talking to your healthcare provider. 

Cobenfy Dosing Information

Recommended starting Cobenfy dosage

•  50mg/20mg orally twice daily for at least two days, then increase the dosage to 100mg/20mg twice daily for at least five days.
• Dosage may be increased to 125 mg/30 mg orally twice daily based on patient tolerability and response. 
• See the full prescribing information for the recommended titration and maximum recommended dosage.

Geriatric patients: Recommended starting dosage is 50 mg/20mg orally twice daily. Consider a slower titration. The maximum recommended dosage is 100mg/20mg twice daily. (2.3)

General dosing information

• Take at least 1 hour before a meal or at least 2 hours after a meal. 
• Do not open capsules. (2.2) 
• Assess liver enzymes and bilirubin before starting treatment with this medicine and as clinically indicated during treatment. 
• Assess heart rate at baseline and as clinically indicated during treatment with Cobenfy.

Cobenfy capsules are available in strengths: 50mg/20mg, 100mg/20mg, 125mg/30mg (xanomeline/trospium chloride)

What happens if I overdose?

If you take too much Cobenfy call your healthcare provider or Poison Help Line at 1-800-222-1222, or go to the nearest hospital emergency room right away.

Interactions

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Cobenfy and other medicines may affect each other, causing side effects. Know the medicines you take and keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

Medications that interact with Cobenfy include:

Drugs Eliminated by Active Tubular Secretion: Monitor for increased frequency and/ or severity of adverse reactions related to Cobenfy and to drugs eliminated by active tubular secretion. 

Strong CYP2D6 Inhibitors: Monitor for increased frequency and/or severity of Cobenfy related adverse reactions.

Sensitive Substrates of CYP3A4 or P-glycoprotein: Monitor for increased frequency and/ or severity of adverse reactions from these substrates. 

Antimuscarinic Drugs: Monitor for increased frequency or severity of anticholinergic adverse reactions.

Not all possible interactions are listed here. Other drugs may interact with Cobenfy, including prescription and over-the-counter medicines, vitamins, and herbal products. 

Storage

Store at room temperature between 68°F to 77°F (20°C to 25°C)

Cobenfy ingredients 

Active ingredients:  xanomeline and trospium chloride 

Inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, and talc Capsule shell: contains black iron oxide (only100mg/20mg), hypromellose, red iron oxide, titanium dioxide, and yellow iron oxide (only 50mg/20mg and 100mg/20mg)

Clozapine is an antipsychotic medicine. It works by changing the actions of chemicals in the brain.

Clozapine is used to treat schizophrenia in adults after other treatments have failed.

Clozapine is also used to reduce the risk of suicidal behavior in adults with schizophrenia or similar disorders.

Warnings

Clozapine affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, sore throat, weakness, or lack of energy.

Clozapine can increase your risk of seizure, especially at high doses. Avoid any activity that could be dangerous if you have a seizure or lose consciousness.

Clozapine can cause serious heart problems. Call your doctor right away if you have chest pain, trouble breathing, fast or pounding heartbeats or sudden dizziness.

Clozapine is not approved for use in older adults with dementia-related psychosis.

Before taking this medicine

Clozapine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

You should not take clozapine if you are allergic to it.

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

• heart problems, high blood pressure,
• a heart attack or stroke (including “mini-stroke”);
• long QT syndrome (in you or a family member);
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• a seizure, head injury, or brain tumor;
• diabetes, or risk factors such as being overweight or having a family history of diabetes;
• high cholesterol or triglycerides;
• constipation or problems with your bowel movements;
• liver or kidney disease;
• an enlarged prostate or urination problems;
• glaucoma;
• malnourishment or dehydration; or
• if you smoke.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you get pregnant, tell your doctor right away. Do not stop taking clozapine without your doctor’s advice.

You should not breastfeed while using this medicine.

Clozapine is not approved for use by anyone younger than 18 years old.

How should I take clozapine?

Take clozapine 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.

You may take clozapine with or without food.

Shake the oral suspension (liquid) for 10 seconds before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

Clozapine affects your immune system and can have long lasting effects on your body. You may get infections more easily, even serious or fatal infections. You may need frequent medical tests while using this medicine and for a short time after your last dose.

You should not stop using clozapine suddenly. Follow your doctor’s instructions about tapering your dose.

If you start taking clozapine again after 2 or more days off the medicine, you may need to use a lower dose than when you stopped. Follow your doctor’s dosing instructions very carefully.

Your doctor may recommend you use a laxative while taking clozapine. Use only the type of laxative your doctor recommends.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Schizophrenia:

Initial dose: 12.5 mg orally once or twice a day
Titration and Maintenance dose: May increase total daily dose in increments of 25 mg to 50 mg per day to a target dose of 300 mg to 450 mg per day (administered in divided doses) by the end of week 2. Subsequent dose increases can be in increments of up to 100 mg once or twice weekly.
Maximum dose: 900 mg per day

Comments:
-The absolute neutrophil count (ANC) must be 1500/microL or greater for the general population and at least 1000/microL for patients with documented Benign Ethnic Neutropenia (BEN) prior to initiating treatment; to continue therapy, the ANC must be monitored regularly.
-A low starting dose, gradual titration, and divided doses are necessary to minimize the risk of orthostatic hypotension, bradycardia, and syncope.
-When therapy is interrupted for 2 or more days, re-initiate with 12.5 mg once or twice a day; based on tolerability, a dose that is restarted may be increased to a previously therapeutic dose more quickly than it was for initial treatment.

Uses:
-For the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment
-To reduce the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder, who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state

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 miss taking clozapine for more than 2 days in a row, call your doctor before you start taking it again.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include drowsiness, confusion, fast heartbeats, feeling light-headed, weak or shallow breathing, drooling, choking, or seizure.

What to avoid

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

Avoid coffee, tea, cola, energy drinks or other sources of caffeine.

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

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Clozapine side effects

Get emergency medical help if you have signs of an allergic reaction to clozapine (hives, 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).

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, flu-like symptoms, extreme weakness;
• mouth sores, skin sores;
• new or worsening cough, trouble breathing;
• pain or burning when you urinate; or
• vaginal itching or discharge.

Further doses may be delayed until your infection clears up.

High doses or long-term use of clozapine can cause a serious movement disorder that may not be reversible. The longer you use clozapine, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Clozapine can increase your risk of seizure, especially at high doses. Avoid any activity that could be dangerous if you have a seizure or lose consciousness.

Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• a seizure (blackout or convulsions);
• severe constipation;
• dry or hard bowel movements, or painful gas;
• nausea, vomiting, stomach pain or bloating;
• heart problems – chest pain, fast or pounding heartbeats, fluttering in your chest, slow heartbeats, shortness of breath, and sudden dizziness (like you might pass out);
• liver problems – loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out; or
• signs of a blood clot in the lung – chest pain, sudden cough, wheezing, rapid breathing, coughing up blood.

Untreated constipation may lead to serious bowel complications, hospitalization, or death. Tell your doctor right away if you are not having bowel movements at least 3 times per week.

Common clozapine side effects may include:

• weight gain;
• dizziness, tremor;
• fast heart rate;
• headache, drowsiness;
• nausea, constipation;
• dry mouth, or increased salivation;
• vision problems; or
• fever, increased sweating.

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 clozapine?

When you start or stop taking clozapine, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Clozapine can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using clozapine with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, cold or allergy medicine, or medicine for anxiety or seizures.

Many drugs can affect clozapine. This includes prescription and 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.

Citalopram is a prescription medicine used in adults to treat depression.

Citalopram is also used to treat major depressive disorder (MDD).

Citalopram belongs to a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Citalopram side effects

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

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Citalopram may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• blurred vision, eye pain or redness, seeing halos around lights;
• fast or pounding heartbeats, pain or fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• a seizure;
• unusual bleeding – nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop;
• manic episodes – racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative;
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors; or
• low blood sodium – headache, confusion, problems with thinking or memory, weakness, feeling unsteady.

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.

Citalopram can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common citalopram side effects may include:

• sexual problems;
• dizziness, drowsiness;
• dry mouth, thirst, increased sweating or urination;
• loss of appetite, nausea, diarrhea, constipation;
• feeling anxious, agitated, or shaky;
• feeling weak or tired, sleep problems (insomnia), yawning;
• increased muscle movement;
• nosebleed, heavy menstrual bleeding; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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

Warnings

Do not stop taking citalopram without your doctor’s advice.

Citalopram can cause a serious heart problem. Call your doctor right away if you have chest pain, fast or pounding heartbeats, shortness of breath, and sudden dizziness.

You should not use citalopram if you also take pimozide, as the combination can cause problems with your heart rhythm.

Do not use citalopram if you have used a MAO inhibitor in the past 14 days (such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine) or have received a methylene blue injection. A fatal reaction may occur.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, 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.

Do not stop using citalopram without first asking your doctor.

Before taking this medicine

You should not use this medicine if you are allergic to citalopram or escitalopram (Lexapro), or if you also take pimozide.

Do not use citalopram 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, and tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before you take citalopram.

Tell your doctor if you also use stimulant medicine, 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 citalopram could cause a serious condition called serotonin syndrome.

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

• heart problems, high blood pressure, long QT syndrome;
• a stroke;
• bleeding problems;
• sexual problems;
• narrow-angle glaucoma;
• seizures or epilepsy;
• bipolar disorder (manic depression) in you or a family member;
• an electrolyte imbalance (such as low levels of potassium, magnesium, or sodium in your blood); or
• liver or kidney disease.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Taking this medicine during the last 3 months of pregnancy may harm the unborn baby, but stopping the medicine may not be safe for you. Do not start or stop citalopram without asking your doctor.

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

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take citalopram?

Take citalopram 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.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

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

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Your symptoms may not improve for up to 4 weeks.

Tell your doctor if you have any changes in sexual function, such as loss of interest in sex, trouble having an orgasm, or (in men) problems with erections or ejaculation. Some sexual problems can be treated.

Do not stop using citalopram suddenly, or you could have unpleasant symptoms (such as agitation, confusion, tingling or electric shock feelings). Follow your doctor’s instructions about tapering your dose.

You may need frequent vision exams before starting treatment.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Citalopram dosing information

Usual Adult Dose for Depression:

Initial dose: 20 mg orally once a day
Maintenance dose: 20 to 40 mg orally once a day
Maximum dose: 40 mg orally per day

Comments:
-The initial dose may be increased if necessary to 40 mg once a day after at least 1 week of therapy.
-Doses of 60 mg/day did not demonstrate an advantage in efficacy over 40 mg/day doses.
-Acute episodes of depression may require several months or more of sustained pharmacologic therapy

Use: Treatment of depression

Usual Geriatric Dose for Depression:

Over 60 years of age:
Recommended dose: 20 mg orally once a day

Comments:
-Doses of 60 mg/day did not demonstrate an advantage in efficacy over 40 mg/day doses.
-Acute episodes of depression may require several months or more of sustained pharmacologic therapy.

Use: Treatment of depression

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 .

What should I avoid while taking citalopram?

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with citalopram may cause you to bruise or bleed easily.

Do not drink alcohol.

Avoid driving or hazardous activity until you know how citalopram will affect you. Your reactions could be impaired.

What other drugs will affect citalopram?

Citalopram can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your current medicines. Many drugs can interact with citalopram, especially:

• cimetidine;
• a blood thinner (warfarin, Coumadin, Jantoven);
• a diuretic or “water pill”; or
• gatifloxacin or moxifloxacin.

Celexa is a prescription medicine used to treat severe depression in adults, called major depressive disorder (MDD).

Celexa is a selective serotonin reuptake inhibitor (SSRI) that blocks the reuptake of serotonin (5-HT) by the nerves of the central nervous system, which enhances serotonergic activity. The exact way it works in depression is unclear.

Celexa belongs to a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). Citalopram works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Celexa side effects

Common Celexa side effects may include:

• sexual problems;
• dizziness, drowsiness;
• dry mouth, thirst, increased sweating or urination;
• loss of appetite, nausea, diarrhea, constipation;
• feeling anxious, agitated, or shaky;
• feeling weak or tired, sleep problems (insomnia), yawning;
• increased muscle movement;
• nosebleed, heavy menstrual bleeding; or
• cold symptoms such as stuffy nose, sneezing, or sore throat.

Serious side effects

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

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Citalopram may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• blurred vision, eye pain or redness, seeing halos around lights;
• fast or pounding heartbeats, pain or fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• a seizure;
• unusual bleeding – nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop;
• manic episodes – racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative;
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors; or
• low blood sodium – headache, confusion, problems with thinking or memory, weakness, feeling unsteady.

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.

Citalopram can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Celexa.

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

Warnings

Do not stop taking Celexa without your doctor’s advice.

Citalopram can cause a serious heart problem. Call your doctor right away if you have chest pain, fast or pounding heartbeats, shortness of breath, and sudden dizziness.

You should not use Celexa if you also take pimozide, as the combination can cause problems with your heart rhythm.

Do not use Celexa if you have used an MAO inhibitor in the past 14 days (such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine) or have received a methylene blue injection. A fatal reaction may occur.

Antidepressants, such as Celexa, increase the risk of suicidal thoughts and behaviors in young adults. People with depression or mental illness may have thoughts about suicide. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Report any new or worsening symptoms to your doctor, such as mood or behavior changes, anxiety, 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.

SSRIs, including Celexa, may cause sexual problems. Symptoms in males may include delayed ejaculation or inability to have an ejaculation, decreased sex drive, problems getting or keeping an erection. Symptoms in females may include decreased sex drive, delayed orgasm, or inability to have an orgasm. Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with Celexa. There may be treatments your healthcare provider can suggest.

Do not stop using Celexa without first asking your doctor.

Before taking this medicine

You should not use Celexa if you are allergic to citalopram or escitalopram (Lexapro), or if you also take pimozide.

Do not use Celexa 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, and tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before you take Celexa.

Tell your doctor if you also use stimulant medicine, 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 citalopram could cause a serious condition called serotonin syndrome.

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

• heart problems, high blood pressure, long QT syndrome;
• a stroke;
• bleeding problems;
• sexual problems;
• narrow-angle glaucoma;
• seizures or epilepsy;
• bipolar disorder (manic depression) in you or a family member;
• an electrolyte imbalance (such as low levels of potassium, magnesium, or sodium in your blood); or
• liver or kidney disease
• are pregnant or intending to become pregnant
• are breastfeeding.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Pregnancy

Taking this medicine during the last 3 months of pregnancy may harm the unborn baby, but stopping the medicine may not be safe for you. Do not start or stop Celexa without asking your doctor.

If you are pregnant, there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. You can register by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants.

There is a less than 2-fold increased risk for severe bleeding after delivery (postpartum hemorrhage) in mothers exposed to SSRIs, particularly in the month before delivery.

Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with Celexa. There may be treatments your healthcare provider can suggest.

Breastfeeding

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take Celexa?

Take Celexa 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.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

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

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Your symptoms may not improve for up to 4 weeks.

Tell your doctor if you have any changes in sexual function, such as loss of interest in sex, trouble having an orgasm, or (in men) problems with erections or ejaculation. Some sexual problems can be treated.

Do not stop using Celexa suddenly, or you could have unpleasant symptoms (such as agitation, confusion, tingling or electric shock feelings). Follow your doctor’s instructions about tapering your dose.

You may need frequent vision exams before starting treatment.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Celexa dosing information

Usual Adult Dose for Depression:

Initial dose: 20 mg orally once a day
Maintenance dose: 20 to 40 mg orally once a day
Maximum dose: 40 mg orally per day

Comments:
-The initial dose may be increased if necessary to 40 mg once a day after at least 1 week of therapy.
-Doses of 60 mg/day did not demonstrate an advantage in efficacy over 40 mg/day doses.
-Acute episodes of depression may require several months or more of sustained pharmacologic therapy

Usual Senior Dose for Depression:

Over 60 years of age:
Recommended dose: 20 mg orally once a day

Comments:
-Doses of 60 mg/day did not demonstrate an advantage in efficacy over 40 mg/day doses.
-Acute episodes of depression may require several months or more of sustained pharmacologic therapy.

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 .

What should I avoid while taking Celexa?

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with citalopram may cause you to bruise or bleed easily.

Do not drink alcohol.

Avoid driving or hazardous activity until you know how Celexa will affect you. Your reactions could be impaired.

What other drugs will affect Celexa?

Citalopram can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your current medicines. Many drugs can interact with citalopram, especially:

• cimetidine;
• a blood thinner (warfarin, Coumadin, Jantoven);
• a diuretic or “water pill”;
• methadone, fentanyl, or other opioids; or
• gatifloxacin or moxifloxacin.

SSRIs, including Celexa, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, such as MAOIs. Serotonin syndrome can also occur when these drugs are used alone.

Caplyta is used to treat adults with schizophrenia, depression associated with bipolar I or bipolar II disorder (manic depression), or along with antidepressant medicines to treat major depressive disorder (MDD). Caplyta is a once-daily capsule. When used to treat bipolar disorder, this medicine can be used alone or with lithium or valproic acid.

Clinical trials have reported improvement in the positive and negative symptoms of schizophrenia within one week of starting Caplyta (lumateperone), but symptoms may take longer to resolve when used for depression .

Important Information

Caplyta carries a Boxed Warning for increased risk of death in elderly patients with dementia-related psychosis and an increased risk of suicidal thoughts and behaviors in younger patients.

• Increased risk of death in elderly people with dementia related psychosis. Medicines like Caplyta can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Caplyta is not approved for the treatment of people with dementia-related psychosis.
• Increased risk of suicidal thoughts and actions. Caplyta 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.

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

• • Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when Caplyta 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 has any of the following symptoms, especially if they are new, worse, or worry you:

• • Thoughts about suicide or dying
  • New or worse depression
  • Feeling very agitated or restless
  • Trouble sleeping
  • Acting aggressively, being angry, or violent
  • An extreme increase in activity and talking (mania)
  • Suicide attempts
  • New or worse anxiety
  • Panic attacks
  • New or worse irritability
  • Acting on dangerous impulses
  • Other unusual changes in behavior or mood.

Side Effects

Common side effects

The most common side effects of Caplyta are:

• Sleepiness
• Dizziness
• Nausea
• Dry mouth
• Feeling tired
• Diarrhea.

Caplyta may cause fertility problems in females and males. Talk to your healthcare provider if this is a concern for you.

Caplyta does not appear to be associated with weight gain like many other antipsychotics are.

Serious Side Effects

Caplyta can also cause the following other serious side effects:

• Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis, which can lead to death. Caplyta is not approved for the treatment of people with dementia-related psychosis.
• Neuroleptic malignant syndrome (NMS) a serious condition that can lead to death. 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
  • Confusion
  • Changes in your breathing, heart rate, and blood pressure
  • Stiff muscles
  • Increased sweating.
• Uncontrolled body movements (tardive dyskinesia). Caplyta 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 Caplyta. Tardive dyskinesia may also start after you stop taking Caplyta.
• Problems with your metabolism, such as:
  • High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take Caplyta. 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 Caplyta, and then regularly during long-term treatment with Caplyta.

Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with Caplyta:

• • • Feel very thirsty
    • Need to urinate more than usual
    • Feel very hungry
    • Feel weak or tired
    • Feel sick to your stomach
    • 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 Caplyta, and then periodically during treatment with Caplyta.
  • Weight gain. Weight gain is uncommon, but you and your healthcare provider should check your weight before you start and regularly during treatment with Caplyta.
• Low white blood cell counts. Your healthcare provider may do blood tests during the first few months of treatment with Caplyta.
• Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position after taking Caplyta.
• Falls. Caplyta 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). Caplyta may increase your risk of seizures.
• Sleepiness, drowsiness, feeling tired, difficulty thinking, and doing normal activities.
• Difficulty swallowing, which can cause food or liquid to get into your lungs. Tell your healthcare provider immediately if this happens.
• Problems controlling your body temperature so that you feel too warm.

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

How Does Caplyta Work?

Caplyta works by changing the activity of neurotransmitters in the brain, such as dopamine, glutamate, and serotonin, to increase or balance their levels. This helps to relieve symptoms such as hallucinations, delusions, and disorganized thoughts associated with schizophrenia, and low mood associated with depression. 

Caplyta belongs to the drug class called atypical antipsychotics.

Caplyta Cost and Insurance Coverage

Eligible patients may pay as little as $0 for 30-day or 90-day prescriptions with the Caplyta Savings Card. 

• Text Caplyta to 26789 to download a digital Caplyta Savings Card to your phone and receive useful text messages about your prescription.
• 90% of Americans with commercial insurance have coverage for Caplyta.
• Caplyta is covered for more than 99% of people with Medicaid and Medicare Part D.

Before taking this medicine

Do not use Caplyta if you are allergic to Caplyta, lumateperone, or any of the ingredients in the capsules. Caplyta may also increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Before taking Caplyta, tell your healthcare provider about all 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 a low white blood cell count
• Have or have had seizures (convulsions)
• Have or have had kidney or liver problems
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed.

Pregnancy

Caplyta may harm your unborn baby. Taking Caplyta 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 Caplyta during pregnancy.

• Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with Caplyta.
• There is a pregnancy registry for females who are exposed to Caplyta during pregnancy. If you become pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to https://womensmentalhealth.org/research/pregnancyregistry/

Breastfeeding

Caplyta passes into your breast milk. Talk to your healthcare provider about the risks and benefits of breastfeeding and the best way to feed your baby during treatment with Caplyta.

Fertility

This medicine may affect fertility in both men and women.

How should I take Caplyta?

Take Caplyta as prescribed by your healthcare provider. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

• Take Caplyta 1 time each day with or without food.
• You can take Capylta in the morning or at night, but try to take it around the same time each day.

What happens if I miss a dose?

Take Caplyta 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?

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

Dosing Information

Dose of Caplyta for Schizophrenia

• 42 mg orally once daily with or without food.

Dose of Caplyta for Depression Associated with MDD or Bipolar I or II Disorder

• 42 mg orally once daily with or without food.
• Use in addition to antidepressants for MDD.
• Use as monotherapy or as adjunctive therapy with lithium or valproate for Bipolar I or II disorder.

Liver Impairment

• Moderate to severe liver disease: 21 mg orally once daily with or without food.

What to avoid while taking Caplyta?

Do not drive, operate machinery, or do other dangerous activities until you know how Caplyta affects you. Caplyta may make you drowsy.

Do not become too hot or dehydrated during treatment with Caplyta.

• 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 other drugs will affect Caplyta?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Caplyta and other medicines may affect each other, causing possible serious side effects. Caplyta may affect the way other medicines work, and other medicines may affect how Caplyta works. Especially tell your doctor if you take:

• An antibiotic, antifungal, or antiviral medicine
• Blood pressure medication
• Bronchodilator asthma medication
• Cold or allergy medicine (Benadryl and others)
• Medicine to treat depression, anxiety, mood disorders, or mental illness
• Medicine to treat an overactive bladder
• Medicine to treat Parkinson’s disease
• Medicine to treat stomach problems, motion sickness, or irritable bowel syndrome
• Seizure medication

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.

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.

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 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.

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.

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 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 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

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

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison disease (adrenal gland problem) or
• Alcohol abuse or dependence, or history of or
• Asthma, severe or
• Brain tumor, history of or
• Breathing problems, severe (eg, hypoxia, hypercapnia, sleep apnea) or
• Chronic obstructive pulmonary disease (COPD) or
• Cor pulmonale (serious heart condition) or
• Depression, history of or
• Drug abuse or dependence, especially with narcotics, or history of or
• Enlarged prostate (BPH, prostatic hypertrophy) or
• Gallbladder problems or
• Head injuries, history of or
• Heart disease (eg, angina, congestive heart failure) or
• Heart rhythm problems (eg, atrial fibrillation, slow heartbeat, long QT syndrome) or
• Hepatitis B or C, history of or
• Hypomagnesemia (low magnesium in the blood), severe or
• Hypothyroidism (an underactive thyroid) or
• Hypovolemia (low blood volume) or
• Increased pressure in the head or
• Kyphoscoliosis (curvature of the spine with breathing problems) or
• Mental health problems, history of or
• Problems with passing urine or
• Stomach problems—Use with caution. May increase risk for more serious side effects.

• Hypotension (low blood pressure)—Use with caution. May make this condition worse.
• Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
• Liver disease, severe—Should not be used in patients with this condition.

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.

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 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.

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?

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.

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.

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.

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.

Avonex is a disease-modifying therapy (DMT) used to treat relapsing multiple sclerosis (MS) in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease). Avonex injection (interferon beta-1a injection) is given intramuscularly (into a muscle), usually once weekly at bedtime.

For people living with MS, Avonex helps manage the disease by resembling the mechanism of action of interferons, which are proteins naturally produced by our immune system that help regulate the body’s immune response and fight viral infections.

• Avonex contains interferon beta 1-a, which is a man-made form of interferon that works in the same way, binding to specific receptors on cell surfaces and decreasing the activity of immune cells that attack the myelin sheath, reducing inflammation in the central nervous system, and helping to suppress the autoimmune response that characterizes MS.
• Avonex belongs to the drug class called interferons. It may also be called an immunomodulator.

Important: Avonex injection will not cure MS; it will only decrease the frequency of relapse symptoms.

Avonex (interferon beta-1a) gained FDA approval on May 17, 1996. There is no Avonex generic (more correctly called a biosimilar).

• Another form of interferon beta-1a, called Rebif, also used for MS, is given 3 times a week by subcutaneous (under the skin) injection.

Avonex and MS

Multiple sclerosis (MS) is an autoimmune disease that occurs when the immune system attacks the myelin sheath protecting nerve fibers, disrupting brain-body communication and causing MS symptoms like vision problems, muscle weakness, and coordination difficulties.

Avonex for MS addresses this disease process by modulating the immune response. The interferon beta-1a reduces immune attacks on myelin, decreases central nervous system inflammation, and prevents new MS lesions. For MS patients, this means fewer relapses, reduced disease activity, and slower disability progression.

Warnings

Liver Damage: Avonex injection can harm your liver. Call your doctor if you have symptoms such as nausea, loss of appetite, tiredness, confusion, easy bruising or bleeding, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Mental Health: Some MS patients using interferon beta-1a have thoughts about suicide. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before using Avonex injection, tell your doctor if you are allergic to any drugs, or if you have liver disease, a thyroid disorder, epilepsy or other seizure disorder, heart disease, chest pain (angina), congestive heart failure, a heart rhythm disorder, or a history of depression or suicidal behavior.

Before taking this medicine

Do not use Avonex injection if you are allergic to natural or recombinant interferon beta or albumin.

To make sure Avonex injection is safe for you, tell your doctor if you have:

• depression, mental illness, or suicidal thoughts or actions;
• liver disease;
• bleeding problems or a blood clot;
• low blood cell counts;
• heart disease;
• a thyroid disorder;
• a latex allergy;
• an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis;
• a seizure; or
• if you drink alcohol.

Plasma-derived products: Some brands of interferon beta-1a contain donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risks.

Tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding.

Interferon beta-1a is not approved for use by anyone younger than 18 years old.

How to Give an Avonex Injection

Use Avonex 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.

Avonex Injection Guidelines:

• Frequency: Once weekly at bedtime, on the same day each week (such as every Monday)
• Method: Intramuscular injection into a muscle
• Injection devices: Available as a prefilled syringe or a prefilled autoinjector pen
• Site rotation: Use a different place each time you give an injection.

Avonex Injection Site Safety:

• Injection site reactions can occur with Avonex injections, including injection site necrosis
• About 2 hours after the Avonex injection, check for skin redness, swelling, or pain
• Report immediately: Any break in skin with blue-black discoloration, swelling, or drainage
• Call your doctor if the injection site reaction doesn’t go away within a few days.

Storage Instructions:

• Store in refrigerator, protect from light, do not freeze
• Prefilled syringe/autoinjector: Remove 30 minutes before injection to reach room temperature
• Do not leave the prefilled syringe/autoinjector out of the refrigerator for longer than 7 days.

Avonex Side Effects

Get emergency medical help if you have signs of an allergic reaction to Avonex (hives, itching, anxiety, 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).

Life-threatening blood clots: Interferon beta-1a can cause life-threatening blood clots in the small blood vessels inside your organs, such as your brain or kidneys. Seek medical help right away if you have symptoms of this condition, such as a fever, tiredness, decreased urination, bruising, or nosebleeds.

Call your doctor at once if you have:

• pain, swelling, bruising, redness, oozing, or skin changes where the injection was given;
• a light-headed feeling, like you might pass out;
• unusual changes in mood or behavior (feeling hopeless, anxious, nervous, irritable, or depressed);
• thoughts about suicide or hurting yourself;
• easy bruising, unusual bleeding;
• a seizure;
• heart problems – swelling, rapid weight gain, feeling short of breath, rapid heartbeats, chest pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems – nausea, loss of appetite, tiredness, confusion, easy bruising or bleeding, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes);
• signs of infection – fever, chills, cough with mucus, bloody diarrhea, pain or burning when you urinate; or
• thyroid problems – mood swings, trouble sleeping, tiredness, hunger, diarrhea, pounding heartbeats, muscle weakness, sweating, dry skin, thinning hair, menstrual changes, weight changes, puffiness in your face, feeling more sensitive to hot or cold temperatures
• breathing difficulties. Pulmonary arterial hypertension can occur with interferon beta products,
  including Avonex. Symptoms may include new or increasing fatigue or shortness of breath.

Common Avonex side effects may include:

• low blood cell counts;
• skin changes where the injection was given;
• depression;
• abnormal liver function tests;
• stomach pain; or
• flu symptoms – headache, fever, chills, chest pain, back pain, tiredness, weakness, muscle aches.

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

Dosing Information

Usual Adult Maintenance Dose of Avonex for MS

• 30 mcg intramuscularly once a week.

Titrate the dose as follows to reduce the incidence and severity of influenza-like symptoms:

• Week 1: 7.5 mcg intramuscularly once weekly
• Week 2: 15 mcg intramuscularly once weekly
• Week 3: 22.5 mcg intramuscularly once weekly
• Week 4+: 30 mcg intramuscularly once weekly.

Available forms: Avonex injection is available as a single-dose prefilled syringe and single-dose prefilled autoinjector.

Missed Dose

Use the medicine as soon as you can, but do not inject Avonex two days in a row. Do not use two doses at one time.

Overdose

Seek emergency medical attention or call the Poison Help line .

What other drugs will affect Avonex?

Other drugs may interact with interferon beta-1a, 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.

Avonex Injection Ingredients

Active ingredient: interferon beta-1a
Inactive ingredients: Avonex Single-Dose Prefilled Syringe: arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate trihydrate in water for injection.

Inactive ingredients: Avonex Single-Dose Prefilled Autoinjector Pen: arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate trihydrate in water for injection. 

Who makes Avonex?

Biogen Inc. makes Avonex.

Frequently Asked Questions

How long does it take for Avonex to work?

Avonex typically takes 3-6 months to show its full effect in reducing MS relapses. Some patients may notice improvements in fatigue and overall well-being within the first few weeks, but the medication’s primary benefit of reducing relapse frequency and slowing disability progression becomes more apparent over time. It’s important to continue treatment even if you don’t immediately notice changes, as the medication works to prevent future MS activity.

Can I travel with Avonex injections?

Yes, you can travel with Avonex, but it requires careful planning. Keep medication in its original packaging with prescription labels. For air travel, pack Avonex in carry-on luggage with a cooling pack (but not frozen). Bring a doctor’s letter explaining your medical need for the injection.

For international travel, research medication regulations in your destination country. Consider bringing extra supplies in case of delays. Avonex can be stored at room temperature for up to 7 days (prefilled syringe) or 30 days (vial) if refrigeration isn’t available.

What’s the difference between Avonex and Rebif?

Both Avonex and Rebif contain interferon beta-1a, but they differ in dosing and administration. Avonex is given once weekly by intramuscular injection (into the muscle), while Rebif is given three times weekly by subcutaneous injection (under the skin). Rebif typically has a higher cumulative weekly dose.

Both medications have similar effectiveness for MS treatment, but some patients may prefer the less frequent Avonex injections, while others may tolerate the smaller, more frequent Rebif doses better. Your neurologist can help determine which is best for your situation.

How can I manage flu-like symptoms from Avonex?

Flu-like symptoms are common, especially when starting Avonex, but usually improve over time. To minimize symptoms: take Avonex at bedtime so you sleep through the worst effects, pre-treat with over-the-counter pain relievers like acetaminophen or ibuprofen 30 minutes before injection and continue for 24 hours after, stay well-hydrated, use a heating pad for muscle aches, and ensure adequate rest.

The dose titration schedule (starting with lower doses) also helps reduce these symptoms. Most patients find flu-like effects diminish significantly after 2-3 months of treatment.

Can I drink alcohol while taking Avonex?

While there’s no absolute prohibition on alcohol with Avonex, you should use caution. Both Avonex and alcohol can affect liver function, so combining them may increase the risk of liver problems. Additionally, alcohol can worsen some MS symptoms like fatigue, balance problems, and depression. If you choose to drink, do so in moderation and discuss your alcohol consumption with your healthcare provider, especially if you have any liver function abnormalities or are taking other medications.

How to administer the Avonex injection?

Avonex is given by intramuscular injection, typically in the thigh (vastus lateralis muscle) or upper arm (deltoid muscle). Rotate between different sites to prevent tissue damage and injection site reactions.

For thigh injections, alternate between left and right thighs, and vary the exact location within each thigh. If using the upper arm, you may need assistance from someone else for proper injection technique.

Keep a record of injection sites to ensure proper rotation. Never inject into areas that are red, bruised, infected, or have scar tissue.

What blood tests do I need while taking Avonex?

Regular monitoring is essential while taking Avonex. Typical tests include: complete blood count (CBC) to check for low white blood cells, red blood cells, or platelets; liver function tests to monitor for hepatotoxicity; and thyroid function tests since Avonex can affect thyroid function. Initially, these tests may be done monthly for the first few months, then every 3-6 months once you’re stable. Your neurologist will determine the appropriate testing schedule based on your individual situation and any side effects you experience.

Can I get pregnant while taking Avonex?

If you’re planning to become pregnant or become pregnant while taking Avonex, discuss this immediately with your healthcare provider. Avonex is pregnancy category C, meaning effects on pregnancy aren’t fully known. Some studies suggest interferons may increase risk of miscarriage.

Your neurologist will weigh the benefits of continued MS treatment against potential risks to pregnancy. There are alternative MS treatments that may be safer during pregnancy. Don’t stop Avonex abruptly without medical supervision, as this could lead to MS relapses.

Is there financial assistance available for Avonex?

Yes, several options exist to help with Avonex costs. Biogen, the manufacturer, offers the Avonex Patient Support Program which may provide co-pay assistance for eligible patients with commercial insurance. The program may cover up to a certain amount per prescription.

Additionally, patient assistance programs are available for uninsured or underinsured patients who meet income requirements. The National MS Society also provides information about financial assistance programs. Contact Biogen’s patient support services or speak with your healthcare provider’s financial counselor to explore available options.

What should I do if I experience injection site reactions?

Mild injection site reactions (redness, swelling, pain) are common and usually resolve within a few days. Apply ice before injection and heat afterward to minimize discomfort. However, watch for signs of serious reactions: persistent pain, increasing redness or swelling after 2-3 days, skin breakdown or ulceration, blue-black discoloration, or drainage from the injection site. These could indicate injection site necrosis, which requires immediate medical attention.

Always rotate injection sites and never inject into irritated or damaged skin. If reactions persist or worsen, contact your healthcare provider.

Can I receive vaccines while taking Avonex?

Generally, inactivated (killed) vaccines are safe while taking Avonex, but live vaccines should typically be avoided as they may pose risks for people on immunomodulatory therapy. Common safe vaccines include the flu shot (inactivated), the pneumonia vaccine, and the hepatitis B vaccine.

However, timing and specific recommendations can vary. Always inform healthcare providers that you’re taking Avonex before receiving any vaccine. Your neurologist and primary care provider should coordinate your vaccination schedule to ensure optimal protection while maintaining MS treatment safety.

Avonex 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 Avonex.Avonex (interferon beta-1a) – Biogen Inc.

Auvelity is a combination antidepressant medicine used to treat major depressive disorder (MDD) in adults. Auvelity contains dextromethorphan, an NMDA receptor antagonist, and bupropion, a norepinephrine-dopamine reuptake inhibitor (NDRI). 

Auvelity works by targeting multiple brain pathways involved in depression. Dextromethorphan works by blocking NMDA receptors, increasing the levels of glutamate, a chemical messenger (neurotransmitter),  to improve mood and brain connectivity. While bupropion helps dextromethorphan last longer in the body and increases dopamine and norepinephrine levels to improve depression symptoms.

Auvelity’s usual dose is 1 tablet taken once daily for 3 days, followed by 1 tablet twice daily, separated by at least 8 hours.  Tablets should be swallowed whole and not crushed or chewed.

Auvelity is a rapid-acting antidepressant that started working as early as 1 week, and patients’ depression symptoms continued to improve over time when compared to placebo in a 6-week clinical study for MDD (Study 1, NCT04019704).

Auvelity became an FDA-approved medicine on August 18, 2022, for adults with major depressive disorder (MDD).

How does Auvelity work?

Auvelity’s active ingredient, dextromethorphan, works as a N-methyl D-aspartate (NMDA) receptor antagonist and is also an agonist at the sigma-1 receptors. This helps to improve depressive symptoms by increasing glutamate levels, changing glutamate signalling, and regulating other neurotransmitters.

The second active ingredient, bupropion, helps dextromethorphan work more effectively by slowing how quickly it’s broken down in the body. It does this by blocking an enzyme called CYP2D6, allowing dextromethorphan to stay active longer. As a norepinephrine-dopamine reuptake inhibitor, bupropion also helps improve mood by increasing levels of dopamine and norepinephrine in the brain.

What is the cost of Auvelity?

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our price guide page for more information about the cost of Auvelity.

You may also be eligible for an Auvelity savings card or an Auvelity coupon. Ask your doctor or pharmacist if you qualify.

Auvelity side effects

Common Auvelity side effects

The most common Auvelity side effects include:

• dizziness
• diarrhea
• dry mouth
• excessive sweating
• headache
• feeling sleepy
• sexual function problems

Serious Auvelity side effects

Also, see Warnings.

Auvelity may cause serious side effects, including:

Seizures. There is a risk of seizures during treatment with this medicine. The risk is higher in people who:

• take higher doses of this medicine
• have certain medical problems
• take it with certain other medicines

Do not take Auvelity with other medicines unless your healthcare provider tells you to.
If you have a seizure during treatment, stop taking this medicine and call your healthcare provider right away. Do not take this medicine again if you have a seizure.

Increases in blood pressure (hypertension). Some people may get high blood pressure during treatment. Your healthcare provider should check your blood pressure before you start taking and during treatment.

Manic episodes. Manic episodes may happen in people with bipolar disorder who take Auvelity. Symptoms may include:

• greatly increased energy
• racing thoughts
• unusually grand ideas
• talking more or faster than usual
• severe trouble sleeping
• reckless behavior
• excessive happiness or irritability

Unusual thoughts or behaviors. One of the ingredients in Auvelity (bupropion), can cause unusual thoughts or behaviors, including delusions (believing you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider.

Eye problems (angle-closure glaucoma). Auvelity may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye.

Dizziness. this medicine may cause dizziness, increasing your fall risk.

Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take Auvelity with certain other medicines. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:

• agitation
• seeing or hearing things that are not there (hallucinations)
• confusion
• coma
• fast heartbeat
• changes in blood pressure
• dizziness
• sweating
• flushing
• high body temperature (hyperthermia)
• shaking (tremors), stiff muscles, or muscle twitching
• loss of coordination
• seizures
• nausea, vomiting, diarrhea