What is fluoxetine?

Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) antidepressant. Fluoxetine inhibits the uptake of serotonin by a nerve cells (neurons) and helps people with depression, panic, anxiety, or obsessive-compulsive symptoms.

Fluoxetine is a  prescription medicine used to treat major depressive disorder, bulimia nervosa (an eating disorder), obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder (PMDD).

Fluoxetine is sometimes used together with another medication called olanzapine (Zyprexa) to treat manic depression caused by bipolar disorder. This combination is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.

If you also take olanzapine (Zyprexa), read the Zyprexa medication guide and all patient warnings and instructions provided with that medication.

Warnings

You should not use fluoxetine if you also take pimozide or thioridazine, or if you are being treated with methylene blue injection.

Do not use fluoxetine if you have used an MAO inhibitor in the past 14 days (such as isocarboxazid, rasagiline, selegiline, phenelzine, or transcypromine). Do not use fluoxetine with thioridazine, linezolid, pimozide, or methylene blue injection.

You must wait at least 14 days after stopping an MAO inhibitor before you take fluoxetine. You must wait 5 weeks after stopping fluoxetine before you can take thioridazine or an MAOI.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms.

Fluoxetine could impair judgment, thinking, or motor skills. Use caution when operating machinery.

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 fluoxetine without first asking your doctor.

Before taking this medicine

You should not use this medicine if you are allergic to fluoxetine, if you also take pimozide or thioridazine.

Do not use fluoxetine 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, and tranylcypromine. You must wait at least 14 days after stopping an MAO inhibitor before you take fluoxetine. You must wait 5 weeks after stopping fluoxetine before you can take thioridazine or an MAOI.

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

• cirrhosis of the liver;
• urination problems;
• diabetes;
• narrow-angle glaucoma;
• seizures or epilepsy;
• sexual problems;
• bipolar disorder (manic depression);
• drug abuse or suicidal thoughts; or
• electroconvulsive therapy (ECT).

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

Older adults may be more sensitive to the effects of fluoxetine.

Ask your doctor about taking fluoxetine if you are pregnant. Taking an SSRI antidepressant during late pregnancy may cause serious medical complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of fluoxetine on the baby.

If you are breastfeeding, tell your doctor if you notice agitation, fussiness, feeding problems, or poor weight gain in the nursing baby.

How should I take fluoxetine?

Take fluoxetine 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.

Swallow the delayed-release capsule whole and do not crush, chew, break, or open it.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

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 fluoxetine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using fluoxetine.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Bulimia:

Immediate-release oral formulations: 60 mg orally once a day in the morning

Comments:
-Some patients may need to be started at a lower dose and titrated up over several days to the recommended dose.
-Daily doses greater than 60 mg have not been systematically studied for the treatment of bulimia.

Use: Acute and maintenance treatment of binge-eating and vomiting behaviors in moderate to severe bulimia nervosa

Usual Adult Dose for Depression:

Immediate-release oral formulations:
Initial dose: 20 mg orally once a day in the morning, increased after several weeks if sufficient clinical improvement is not observed
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 80 mg orally per day

Delayed release oral  capsules:
Initial dose: 90 mg orally once a week, commenced 7 days after the last daily dose of immediate-release fluoxetine 20 mg formulations.

Comments:
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon.
-The full effect may be delayed until after at least 4 weeks of treatment.
-If a satisfactory response with the once weekly oral fluoxetine is not maintained, a change back to daily fluoxetine dosing using the immediate-release oral formulations should be considered.
-Acute episodes of Major Depressive Disorder (MDD) require several months or longer of sustained pharmacologic therapy.
-Whether the dose needed to induce remission is the same as the dose needed to maintain and/or sustain euthymia is unknown.

Use: Acute and maintenance treatment of MDD

Usual Adult Dose for Obsessive Compulsive Disorder:

Immediate-release oral formulations:
-Initial dose: 20 mg orally once a day in the morning, increased after several weeks if sufficient clinical improvement is not observed.
-Maintenance dose: 20 to 60 mg orally per day
-Maximum dose: 80 mg orally per day

Comments:
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon.
-The full effect may be delayed until after at least 5 weeks of treatment.

Use: Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD)

Usual Adult Dose for Panic Disorder:

Immediate-release oral formulations:
-Initial dose: 10 mg orally once a day, increased after one week to 20 mg orally once a day
-Maintenance dose: 20 to 60 mg orally per day
-Maximum dose: 60 mg orally per day

Comments:
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon.
-A dose increase may be considered after several weeks if clinical improvement is not observed.
-Doses greater than 60 mg per day have not been systematically studied for the treatment of panic disorder.

Use: Acute treatment of panic disorder with/without agoraphobia

Usual Adult Dose for Premenstrual Dysphoric Disorder:

Immediate-release oral formulations:
Initial dose:
-Continuous regimen: 20 mg orally once a day on every day of the menstrual cycle
-Cyclic regimen: 20 mg orally once a day starting 14 days prior to the anticipated start of menstruation through to the first full day of menses, and repeated with each new cycle
Maintenance dose: 20 to 60 mg per day for either the continuous or intermittent regimens
Maximum dose: 80 mg orally per day

Comments:
-A daily dose of 60 mg has not been shown to be significantly more effective than 20 mg daily.
-Daily doses above 60 mg have not been systematically studied in patients with this condition.
-The 20 mg daily dosage has been shown to be effective for up to 6 months of treatment.

Use: Treatment of premenstrual dysphoric disorder (PMDD)

Usual Pediatric Dose for Depression:

Immediate-release oral formulations:
8 to 18 years:
Initial dose: 10 to 20 mg orally once a day; the 10 mg daily dose may be increased after one week to 20 mg orally once a day

Lower weight children:
-Initial dose: 10 mg orally once a day, increased to 20 mg orally once a day after several weeks if sufficient clinical improvement is not observed
-Maintenance dose: 10 to 20 mg orally once a day

Comments:
-The full effect may be delayed until after at least 4 weeks of treatment.
-The potential risks versus clinical need should be assessed prior to using this drug in children and adolescents.

Use: Acute and maintenance treatment of MDD

Usual Pediatric Dose for Obsessive Compulsive Disorder:

Immediate-release oral formulations:
7 to 17 years:
Adolescents and higher weight children:
-Initial dose: 10 mg orally once a day, increased to 20 mg orally once a day after 2 weeks
-Maintenance dose: 20 to 60 mg orally per day
-Maximum dose: 60 mg orally per day

Lower weight children:
-Initial dose: 10 mg orally once a day, increased after several weeks if sufficient clinical improvement is not observed
-Maintenance dose: 20 to 30 mg orally once a day
-Maximum dose: 60 mg orally per day

Comments:
-Additional dose increases may be considered after several more weeks if clinical improvement is insufficient.
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon.
-In lower weight children, there is minimal experience with doses greater than 20 mg per day, and none with doses greater than 60 mg per day.
-The full effect may be delayed until after at least 5 weeks of treatment.
-The potential risks versus clinical need should be assessed prior to using this drug in children and adolescents.

What is fluphenazine?

Fluphenazine is a phenothiazine (FEEN-oh-THYE-a-zeen) antipsychotic medicine that is used to treat psychotic disorders such as schizophrenia.

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

Fluphenazine side effects

Get emergency medical help if you have signs of an allergic reaction (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).

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

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

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• extreme drowsiness or light-headed feeling (like you might pass out);
• strange dreams, or if you feel restless or excited;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• painful or difficult urination;
• severe constipation, stomach pain, bloating;
• jaundice (yellowing of the skin or eyes);
• a seizure; or
• low white blood cell counts–fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing, feeling light-headed.

Common side effects of fluphenazine may include:

• drowsiness, headache, blurred vision;
• problems with balance or muscle movement;
• nausea, loss of appetite, constipation;
• swelling, weight changes;
• stuffy nose, dry mouth, or drooling;
• increased sweating or urination;
• breast swelling or tenderness; or
• impotence, trouble having an orgasm.

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

Warnings

You should not use fluphenazine if you have liver disease, brain damage, severe depression, a blood cell disorder, or if you are also using large amounts of alcohol or medicines that make you sleepy.

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

Call your doctor at once if you have uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects.

Before taking this medicine

You should not use fluphenazine if you are allergic to fluphenazine or other phenothiazines (chlorpromazine, perphenazine, prochlorperazine, promethazine, thioridazine, trifluoperazine), or if you have:

• liver disease;
• brain damage;
• severe depression; or
• a blood cell disorder (such as low platelets or low red or white blood cell counts).

Do not use fluphenazine if you have recently used large amounts of alcohol or medicine that makes you sleepy.

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

Tell your doctor if you have ever had:

• heart problems;
• liver or kidney disease;
• low white blood cell (WBC) counts;
• breast cancer;
• glaucoma;
• Parkinson’s disease;
• seizures; or
• pheochromocytoma (tumor of the adrenal gland).

Tell your doctor if you will be exposed to extreme heat or cold, or to insecticide poisons while you are using fluphenazine.

Fluphenazine is not approved for use by anyone younger than 12 years old.

Using antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop using fluphenazine without your doctor’s advice.

Fluphenazine may cause false results on a pregnancy test. Tell your doctor if you think you might be pregnant.

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

How should I use fluphenazine?

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

Fluphenazine oral is taken by mouth.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Fluphenazine oral concentrate solution must be mixed with at least 2 ounces (1/4 cup) of a liquid such as milk, tomato juice, fruit juice (but not apple juice), or a soft drink that does not contain caffeine.

Fluphenazine injection is injected into a muscle or under the skin by a healthcare provider. Fluphenazine is usually given by injection only after you have taken the medicine by mouth for a certain period of time.

Fluphenazine injection stays in your body longer than the oral form, and the injections are not given daily. Follow your doctor’s dosing instructions very carefully.

You may need frequent medical tests. Your next dose may be delayed based on the results.

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

Do not stop using fluphenazine 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, heat, and light. Do not allow liquid medicine to freeze.

Fluphenazine dosing information

Usual Adult Dose for Psychosis:

Oral:
-Initial dose: 2.5 to 10 mg orally in divided doses every 6 to 8 hours
-Maintenance dose: 1 to 5 mg/day
-Maximum dose: Up to 40 mg/day

Oral Comments:
-Maintenance doses may be given as single daily doses.
-Many patients achieve therapeutic effect with doses of less than 20 mg. Patients who are severely disturbed or inadequately controlled may require a dose of up to 40 mg/day.

Parenteral:
Fluphenazine Decanoate for Injection:
-Initial dose: 12.5 to 25 mg deep IM injection into the gluteal region
-Maintenance dose: 12.5 to 100 mg IM, usually every 3 to 4 weeks
-Maximum dose: 100 mg/injection

Fluphenazine HCl for Injection:
-Initial dose: 2.5 to 10 mg IM, given as divided doses every 6 to 8 hours
-Maximum dose: Up to 10 mg/day

Parenteral Comments:
-Patients may switch from Fluphenazine HCl for Injection to oral formulations when symptoms are controlled. The dose of an oral formulation is approximately 2 to 3 times the dose of fluphenazine HCl for injection.

-Fluphenazine decanoate for injection may be given subcutaneously.

Uses:
-Management of manifestations of schizophrenia
-Management of patients requiring prolonged parenteral neuroleptic therapy (e.g., patients with chronic schizophrenia)

Usual Geriatric Dose for Psychosis:

Oral:
-Initial dose: 1 to 2.5 mg orally, given in divided doses every 6 to 8 hours
-Maintenance dose: 1 to 5 mg/day
-Maximum dose: Up to 40 mg

Comments:
-Maintenance doses may be given as a single dose.
-Many patients achieve therapeutic effect with doses less than 20 mg. Patients who are severely disturbed or inadequately controlled may require a dose of up to 40 mg/day.

Use: Management of manifestations of schizophrenia

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.

Call your doctor for instructions if you miss an appointment for your fluphenazine injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using fluphenazine?

Avoid driving or hazardous activity until you know how fluphenazine 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.

Drinking alcohol with this medicine can cause side effects.

Fluphenazine could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect fluphenazine?

Using fluphenazine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

What is flutamide?

Flutamide is a nonsteroidal antiandrogen (testosterone blocker) medicine.

Flutamide capsules are used to treat prostate cancer.

Flutamide is given in combination with another medicine called a luteinizing (LOO-tee-in-ize-ing) hormone-releasing hormone, or LHRH. LHRH helps prevent the testicles from producing testosterone.

Warnings

Flutamide can cause serious liver problems. Call your doctor at once if you have upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Before taking this medicine

You should not use flutamide if you are allergic to it, or if you have severe liver problems.

Flutamide should never be taken by a woman or a child.

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

• liver disease;
• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency;
• hemoglobin M disease;
• if you smoke; or
• if you also take a blood thinner (warfarin, Coumadin, Jantoven).

Although flutamide is not for use by women, this medicine can cause birth defects if a woman is exposed to it during pregnancy.

How should I take flutamide?

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

Flutamide is usually taken every 8 hours.

Follow your doctor’s dosing instructions very carefully.

Drink plenty of liquids. Your doctor may recommend a special diet to help prevent diarrhea.

You will need frequent medical tests.

It is recommended you get blood tests: before starting treatment with flutamide, every month for the first 4 months of treatment, and periodically after the first 4 months.

Call your doctor if you have severe or ongoing diarrhea. Your doctor may recommend an anti-diarrhea medicine.

You should not stop using flutamide suddenly. Stopping suddenly may make your condition worse.

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

Dosing information

Usual Adult Dose for Prostate Cancer:

250 mg orally every 8 hours

Comments:
-This drug may be taken with or without food.
-Stage B2-C Prostatic Carcinoma: Treatment with this drug and the goserelin acetate implant starting 8 weeks prior to initiating radiation therapy and continue during radiation therapy.
-Stage D2 Metastatic Carcinoma: This drug should be initiated with the LHRH-agonist and continued until progression.

Use: Locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate

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.

Call your doctor for instructions if you miss an appointment for your LHRH injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking flutamide?

To help prevent diarrhea, avoid dairy products such as milk, cheese, and yogurt. Do not use laxatives while taking flutamide.

Flutamide side effects

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

Flutamide can cause serious liver problems. Call your doctor at once if you have:

• nausea, upper stomach pain, loss of appetite;
• itching, tiredness, flu-like symptoms;
• dark urine, clay-colored stools; or
• jaundice (yellowing of the skin or eyes).

Common flutamide side effects may include:

• breast swelling or tenderness;
• hot flashes;
• vomiting, nausea, diarrhea; or
• impotence, loss of interest in sex.

What is fluticasone and salmeterol inhalation?

Fluticasone and salmeterol inhalation is a steroid and bronchodilator combination medicine that is used to prevent asthma attacks. It is also used to prevent flare-ups or worsening of chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and/or emphysema.

In people with COPD, fluticasone and salmeterol is for long-term treatment. In people with asthma, fluticasone and salmeterol is for short-term treatment until symptoms are well controlled with with other medicines.

Advair Diskus is for use in adults and children who are at least 4 years old. Advair HFA and AirDuo Respiclick are for use in adults and children who are at least 12 years old.

Fluticasone and salmeterol may also be used for purposes not listed in this medication guide.

Fluticasone and salmeterol side effects

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

Fluticasone and salmeterol may cause serious side effects. Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;
• fever, chills, cough with mucus, feeling short of breath;
• chest pain, fast or irregular heartbeats, severe headache, pounding in your neck or ears;
• tremors, nervousness;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• signs of thrush (a fungal infection)–sores or white patches in your mouth or throat, trouble swallowing;
• high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor;
• low potassium level–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
• signs of a hormonal disorder–worsening tiredness or weakness, feeling light-headed, nausea, vomiting.

Fluticasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Common side effects of fluticasone and salmeterol may include:

• headache, muscle pain, bone pain, back pain;
• nausea, vomiting;
• thrush, throat irritation;
• ongoing cough, hoarseness or deepened voice;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• ear infection (in a child)–fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness.

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

Warnings

Fluticasone and salmeterol is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack.

Seek medical attention you have worsening breathing problems, or if you think your medications are not working as well.

Before taking this medicine

You should not use fluticasone and salmeterol if you are allergic to fluticasone or salmeterol, or:

• if you have a severe allergy to milk proteins; or
• if you are having an asthma attack or severe COPD symptoms.

Fluticasone can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Tell your doctor if you have ever had:

• glaucoma or cataracts;
• heart disease or high blood pressure;
• a seizure;
• diabetes;
• a food or drug allergy;
• a weak immune system;
• any type of infection (bacterial, fungal, viral, or parasitic);
• osteoporosis;
• a thyroid disorder; or
• liver or kidney disease.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough  vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk.

Tell your doctor if you are pregnant. It is not known whether this medicine will harm an unborn baby. However, having untreated or uncontrolled asthma during pregnancy may cause complications such as low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

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

Do not give this medicine to a child without medical advice.

How should I use fluticasone and salmeterol?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Using too much of this medicine can cause life-threatening side effects.

Fluticasone and salmeterol is not a rescue medicine for asthma or bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

 Advair Diskus is a powder form of fluticasone and salmeterol that comes with a special inhaler device pre-loaded with blister packs containing measured doses of the medicine.  Advair HFA and AirDuo Respiclick each come in a canister that is used with an actuator inhaler device.

Use the medicine at the same time each day. Use only the inhaler device provided with your medication.

Shake the Advair HFA inhaler for at least 5 seconds before each spray.

Do not allow a young child to use this medicine without help from an adult.

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 without swallowing after each use of your inhaler.

Your dose needs may change due to surgery, illness, stress, or a recent asthma attack. Do not change your medication dose or schedule without your doctor’s advice.

If you also use an oral steroid medication, you should not stop using it suddenly. Follow your doctor’s instructions about tapering your dose.

If you use a peak flow meter at home, tell your doctor if your numbers are lower than normal.

Your vision and your bone mineral density may need to be checked often.

Store your medicine at room temperature, away from moisture, heat, and sunlight. Avoid high heat, such as open flame or in a car on a hot day. Carefully follow all storage and disposal directions provided with your medicine.

Once your asthma is under control, your doctor may want you to stop using this medicine. Do not stop using the medicine unless your doctor tells you to.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include chest pain, fast heart rate, and feeling shaky or short of breath.

Long term use of an inhaled steroid can lead to glaucoma, cataracts, thinning skin, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using fluticasone and salmeterol?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using a steroid such as fluticasone.

Do not use a second inhaled bronchodilator unless your doctor tells you to. This includes formoterol (Perforomist, Symbicort, Bevespi, Dulera), arformoterol (Brovana), indacaterol (Arcapta), olodaterol (Striverdi,  Stiolto Respimat), salmeterol (Serevent), or vilanterol (Anoro Ellipta, Breo Ellipta, Trelegy Ellipta).

What other drugs will affect fluticasone and salmeterol?

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

Tell your doctor about all your other medicines, especially:

• antifungal medicine; or
• medicine to treat HIV or AIDS.

What is fluvoxamine?

Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI).

Fluvoxamine is used to treat symptoms of obsessive compulsive disorder (OCD) in adults and children at least 8 years old.

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

Fluvoxamine side effects

Get emergency medical help if you have signs of an allergic reaction: skin rash, blisters, or hives; fever, joint pain; 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.

Call your doctor at once if you have;

• anxiety, racing thoughts, risk-taking behavior, sleep problems (insomnia), feelings of extreme happiness or irritability;
• blurred vision, eye pain or redness, seeing halos around lights;
• a seizure;
• changes in weight or appetite;
• easy bruising or unusual bleeding; 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

Fluvoxamine can affect growth in children. Your child’s height and weight should be checked often.

Common side effects of fluvoxamine may include:

• drowsiness, dizziness, weakness;
• anxiety, depression, agitation, trouble sleeping;
• shaking, increased muscle movements;
• upset stomach, gas, loss of appetite;
• nausea, vomiting, diarrhea;
• dry mouth, yawning, sore throat;
• muscle pain;
• sweating, rash;
• heavy menstrual periods; or
• sexual problems.

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

Warnings

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.

Do not stop using fluvoxamine without first asking your doctor.

Before taking this medicine

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

Do not use fluvoxamine within 14 days before or 14 days after you have taken an MAO inhibitor. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

Some drugs should not be used with fluvoxamine. Your treatment plan may change if you also use:

• alosetron;
• ramelteon;
• thioridazine; or
• tizanidine.

Tell your doctor if you have ever had:

• bipolar disorder (manic depression);
• a seizure;
• glaucoma;
• sexual problems;
• liver or kidney disease;
• heart disease, high blood pressure, or a stroke;
• bleeding problems; or
• low levels of sodium in your blood (an electrolyte imbalance).

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.

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 fluvoxamine could cause a serious condition called serotonin syndrome.

Taking fluvoxamine during pregnancy could harm the baby, but stopping the medicine may not be safe for you. Do not start or stop fluvoxamine without asking your doctor.

Do not breastfeed.

How should I take fluvoxamine?

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

Take fluvoxamine at bedtime, with or without food.

Swallow the  capsule whole and do not crush, chew, break, or open it.

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 fluvoxamine suddenly, or you could have unpleasant symptoms (such as agitation, confusion, tingling or electric shock feelings). Ask your doctor before stopping the medicine.

Store tightly closed at room temperature, away from moisture and heat.

Fluvoxamine dosing information

Usual Adult Dose for Obsessive Compulsive Disorder:

Initial immediate-release tablet dose: 50 mg orally once a day at bedtime
Initial extended-release capsule dose: 100 mg orally once a day at bedtime
Maintenance dose: 100 to 300 mg orally per day
Maximum dose: 300 mg/day

Comments:
-The dose may be increased in 50 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved.
-A total daily dose of more than 100 mg should be given in two divided doses. If the doses are not equal, the larger dose should be given at bedtime.

Use: Treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV

Usual Pediatric Dose for Obsessive Compulsive Disorder:

8 to 11 years:
-Initial dose: 25 mg orally once a day at bedtime
-Maintenance dose: 25 to 200 mg orally per day
-Maximum dose: 200 mg/day

11 to 17 years:
-Initial dose: 25 mg orally once a day at bedtime
-Maintenance dose: 25 to 300 mg orally per day
-Maximum dose: 300 mg/day

Comments:
The dose may be increased in 25 mg increments every 4 to 7 days, as tolerated, up to a maximum daily dose.
-Total daily doses of more than 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.
-Lower doses may be effective in female versus male patients.

Use: Treatment of obsessions and compulsions in patients with OCD, as defined in DSM-III-R or DSM-IV

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 .

Overdose may cause vomiting, diarrhea, breathing problems, slow heartbeats, or seizure.

What should I avoid while taking fluvoxamine?

Drinking alcohol can increase certain side effects.

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 fluvoxamine may cause you to bruise or bleed easily.

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

What other drugs will affect fluvoxamine?

Using fluvoxamine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your current medicines. Many drugs can affect fluvoxamine, especially:

• methadone, mexiletine, St. John’s wort, theophylline, tramadol;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• a blood thinner (warfarin, Coumadin, Jantoven);
• a diuretic or “water pill”;
• a “triptan” migraine headache medicine, such as Imitrex or Maxalt; or
• medicine to treat anxiety, mood disorders, thought disorders, or mental illness (such as clozapine, lithium, antidepressants, or antipsychotics).

What is Focalin?

Focalin is a mild stimulant to the central nervous system. It affects chemicals in the brain that contribute to hyperactivity and impulse control.

Focalin is a  prescription medicine used to treat attention deficit hyperactivity disorder (ADHD).

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

Warnings

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

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

Focalin may be habit-forming, and dexmethylphenidate 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 such as Focalin have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Focalin may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

Focalin may cause blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems–chest pain, feeling light-headed or short of breath; signs of psychosis – paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems – unexplained wounds on your fingers or toes.

Before taking this medicine

You should not take Focalin if you are allergic to dexmethylphenidate or methylphenidate (Ritalin, Concerta).

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 Focalin 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 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 Focalin 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.

Becoming dependent on Focalin 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 dexmethylphenidate on the baby.

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

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

How should I take Focalin?

Take Focalin 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.

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

Focalin is usually taken twice per day, at least 4 hours apart.

You may take Focalin with or without food. Take the regular tablet twice daily, at least 4 hours apart. Take the extended-release  capsule once daily in the morning.

Swallow the extended-release capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and mix the medicine with applesauce. Swallow the mixture right away without chewing.

Your doctor will need to check your progress on a regular basis. Your heart and blood pressure may also need to be checked often.

Tell your doctor if you have a planned surgery.

Your treatment may also include counseling or other treatments.

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

Dosing information

Usual Adult Dose of Focalin for Attention Deficit Disorder:

Immediate-Release:
For patients NEW to methylphenidate or on stimulants other than methylphenidate:
-Initial dose: 2.5 mg orally twice a day, at least 4 hours apart
For patients CURRENTLY on methylphenidate:
-Initial dose: One-half the total daily dose of methylphenidate; divide dose and administer orally twice a day at least 4 hours apart
Adjust dose in increments of 2.5 to 5 mg weekly according to needs and responses
Maximum dose: 20 mg/day (10 mg twice a day)

Extended Release (XR):
For patients NEW to this drug or methylphenidate, or on stimulants other than methylphenidate:
-Initial dose: 10 mg orally once a day
For patients CURRENTLY on methylphenidate:
-Initial dose: One-half of the total daily dose of methylphenidate orally once a day
For patients CURRENTLY on dexmethylphenidate immediate-release (IR):
-Initial dose: Same dexmethylphenidate IR daily dose orally once a day
Adjust dose weekly in 10 mg increments according to the needs and responses
-Maximum dose: 40 mg/day.

Usual Pediatric Dose of Focalin for Attention Deficit Disorder:

Age 6 years or older:

Immediate-Release:
For patients NEW to methylphenidate or on stimulants other than methylphenidate:
-Initial dose: 2.5 mg orally twice a day, at least 4 hours apart
For patients CURRENTLY on methylphenidate:
-Initial dose: One-half the total daily dose of methylphenidate; divide dose and administer orally twice a day at least 4 hours apart
Adjust dose in increments of 2.5 to 5 mg weekly according to needs and responses
Maximum dose: 20 mg/day

Extended Release (XR):
For patients NEW to this drug or methylphenidate, or on stimulants other than methylphenidate:
-Initial dose: 5 mg orally once a day
For patients CURRENTLY on methylphenidate:
-Initial dose: One-half of the total daily dose of methylphenidate orally once a day
For patients CURRENTLY on dexmethylphenidate immediate-release (IR):
-Initial dose: Same dexmethylphenidate IR daily dose orally once a day
Adjust dose weekly in 5 mg increments according to the needs and responses
-Maximum dose: 30 mg/day

Comments:
-The dose should be individualized according to the needs and response of the patient.
-The immediate-release tablets should be taken twice a day at least 4 hours apart (with or without food); the extended-release  capsules should be taken once a day in the morning (with or without food); if necessary, the capsule may be opened and sprinkled onto applesauce (see Administration Advice).
-If paradoxical aggravation of symptoms or other adverse reactions occur, dose reduction or discontinuation may be necessary.
-If improvement is not observed after 1-month of optimal dosing, this drug should be discontinued.

Use: For the treatment of attention deficit hyperactivity disorder (ADHD).

What happens if I miss a dose?

Take Focalin 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 dexmethylphenidate could be fatal.

Overdose symptoms may include dry mouth, vomiting, agitation, tremor, muscle twitches, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, seizure (convulsions), or coma.

What should I avoid while taking Focalin?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Focalin side effects

Get emergency medical help if you have signs of an allergic reaction to Focalin: fever; 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 thought or 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.

Dexmethylphenidate 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 Focalin side effects may include:

• loss of appetite;
• nausea, stomach pain; or
• fever.

What is folic acid?

Folic acid (vitamin B9) is a B vitamin supplement that may be used to prevent and treat folate deficiency (low blood levels of folate) that can cause megaloblastic anemia. Folic acid may also be used to control high levels of homocysteine, prevent serious birth defects in pregnant women or women who think they may be pregnant, and prevent methotrexate-induced folate deficiency in people prescribed methotrexate.

Folic acid has been FDA approved since 1947.

Folate vs folic acid

Folate is the natural form of vitamin B9 found in various foods. Folic acid is the man-made form of vitamin B9 created in a laboratory that is added to fortified foods or used as a supplement. Folic acid is more stable and easier to absorb than naturally occurring folate in food. When you take folic acid, your body turns it into folate.

Folic acid benefits

Vitamin B9 (folate, folic acid) plays a crucial role in healthy red blood cell production and is also vital for cell growth, repair, and DNA synthesis.

• Red blood cells carry oxygen throughout your body, and folate deficiency can lead to a type of anemia called folate-deficiency anemia. Symptoms of this anemia include fatigue, weakness, shortness of breath, and pale skin.
• Folate is especially important during periods of rapid cell division, such as pregnancy and fetal development.

Benefits of folic acid supplementation include:

Preventing and treating folate-deficiency anemia. Folate is vital for the production of red blood cells (RBCs) and low levels of folate can cause folate-deficiency anemia (known medically as megaloblastic anemia), characterized by RBCs that are unusually large, structurally abnormal, and do not function properly. There are also fewer of them.

Preventing neural tube and other birth defects in the developing fetus in pregnant women. Folic acid helps ensure the proper closure of the neural tube early in pregnancy. The neural tube forms the brain, spinal cord, and surrounding structures and closes 28 to 32 days after a baby is conceived, which is often before many women know they are pregnant. This is why the CDC recommends all people capable of becoming pregnant get 400 micrograms (mcg) of folic acid daily.

• This means women should start taking folic acid BEFORE they are pregnant, at the time they decide to try for a baby.

Lowering high levels of homocysteine in the blood (hyperhomocysteinemia). This can be caused by low dietary intake of folic acid, folate, vitamin B6, vitamin B12, thyroid disease, kidney disease, psoriasis, genetic reasons, or some medications. High homocysteine levels can damage the lining of the arteries and make blood clot more easily which can increase your risk of cardiovascular disease.

Reducing toxicity caused by the drug methotrexate. Methotrexate can cause low levels of folate in the body which can increase the risk of side effects such as nausea, vomiting, and mouth sores. Taking folic acid 5mg weekly, on a different day to the methotrexate dose seems to reduce these side effects.

Potential Other Benefits. Research is ongoing, but folic acid may have other benefits, such as reducing the risk of certain cancers, supporting mood and cognitive function, and possibly reducing the risk of dementia and the development of autism spectrum disorder (ASD).

What are the symptoms of folate deficiency?

Folate deficiency can be caused by not enough folate in the diet, a problem absorbing folate, or an increased need for folate (for example pregnant or breastfeeding women). Folate deficiency symptoms include:

• fatigue, feeling tired, or rundown
• heart palpitations or a fast heartbeat
• shortness of breath
• mouth ulcers, or an inflamed and painful tongue
• mood changes, such as depression or irritability
• sleep problems, such as insomnia,
• cognitive problems, such as a decline in thinking and memory.

Pregnant women who are folate deficient or do not consume enough daily dietary folate or folic acid during the first few weeks of pregnancy have an increased risk of their baby having a birth defect, such as spina bifida (incomplete closure of the spinal cord), anencephaly (misinformation of the brain or skull), congenital heart disease (malformation of the heart), cleft lip and palate (abnormal closure of the lip and palate), problems with the development of the arms and legs, or an abnormal formation of the kidneys or bladder (obstructive uropathies).

Folic acid foods

Folic acid is added to some staple foods to ensure broader access to this crucial vitamin and prevent birth defects.

• Since 1998, the United States has mandated the fortification of cereal grains with folic acid. Fortified foods high in folic acid are labeled “enriched” and include flour (including corn masa flour used to make corn tortillas) pasta, bread, rice, and breakfast cereal.
• Some other foods also have folic acid added under voluntary fortification rules, but these manufacturers need to follow the FDA food additive regulations.

Certain natural food sources remain excellent sources of folate. Folate-rich foods include:

• Leafy green vegetables such as spinach, kale, collard and mustard greens, and turnip greens.
• Other vegetables including okra, asparagus, and brussels sprouts are good choices.
• Fruits while not as high as vegetables, certain fruits like oranges, papayas, and strawberries contribute folate.
• Beans and legumes such as lentils, black beans, peanuts, black-eyed peas, kidney beans, and chickpeas
• Other folate-containing foods include yeast, mushrooms, animal liver and kidney, orange juice, and tomato juice.

Folic acid supplement side effects

Folic acid side effects are more likely to occur with higher dosages of folic acid (up to 15 mg/day) and include:

• nausea
• loss of appetite
• bloating or gas
• stomach pain
• bitter or unpleasant taste in your mouth
• confusion or trouble concentrating
• sleep problems
• mood changes, such as depression or excitement
• impaired judgment.

Low vitamin B12 levels may occur in patients receiving prolonged folic acid therapy.

Serious side effects and warnings

Folic acid is relatively nontoxic in humans but rare instances of an allergic reaction to folic acid have been reported. You should not use this medication if you have ever had an allergic reaction to folic acid. Get emergency medical help if you have signs of an allergic reaction to folic acid: hives, rash, itching, skin redness, wheezing, difficulty breathing, swelling of your face, lips, tongue, or throat.

May increase the risk of seizures in some people with epilepsy receiving phenobarbital, primidone, or diphenylhydantoin.

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

Before taking this medicine

You should not use this medicine if you have ever had an allergic reaction to folic acid.

Ask a doctor or pharmacist if this medicine is safe to use if you have ever had:

• epilepsy or other seizure disorder
• cirrhosis or other liver disease
• kidney disease (or if you are on dialysis)
• hemolytic anemia
• pernicious anemia
• anemia that has not been diagnosed by a doctor and confirmed with laboratory testing
• a condition that affects how well you absorb nutrients, such as celiac disease or inflammatory bowel disease
• an infection or
• alcoholism.

Tell your doctor if you are pregnant or breastfeeding.

These conditions may be causing folate deficiency, require additional medications or a higher dose of folic acid, or further laboratory investigation. For example:

• Folic acid in dosages above 0.4mg daily may hide laboratory changes caused by pernicious anemia without halting the progression of neurological changes. This may result in severe nervous system damage before the correct diagnosis is made.

Pregnancy

Folic acid requirements markedly increase during pregnancy and deficiency will cause harm to the unborn baby. Studies in pregnant women have not shown that folic acid increases the risk of fetal abnormalities if
administered during pregnancy.

Breastfeeding

Folic acid is excreted in the milk of breastfeeding mothers. During lactation, folic acid requirements are
markedly increased; however, amounts present in human milk are adequate to fulfill infant requirements,
although supplementation may be needed in low-birth-weight infants, in those who are breast-fed by
mothers with folic acid deficiency (50 mcg daily), or in those with infections or prolonged diarrhea.

Fertility

Long-term studies to evaluate the effect of folic acid on fertility have not been conducted.

How should I use folic acid supplements?

Take folic acid exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow all directions on your medicine label and package.

Oral administration of folic acid is preferred.

• Although most patients with malabsorption cannot absorb food folates, they can absorb folic acid given orally.
• Administration by injection is not usually recommended but may be necessary for some people receiving parenteral or enteral nutrition.

Folic acid tablets are usually taken by mouth with a full glass of water.

Folic acid injection is given into a muscle, under the skin, or into a vein. A healthcare provider will give you this injection.

Your doctor may occasionally change your dose depending on your blood tests to make sure you get the best results from this medication.

Folic acid is sometimes used in combination with other medications to treat pernicious anemia.

Folic Acid Dosing

Folic acid is an important nutrient and folate or folic acid should be consumed daily.

• The recommended dietary allowance (RDA) of folic acid for adults is 400 mcg DFE (dietary folate equivalents) daily.
  • 1 mcg DFE is the same as 1 mcg of folate in food or 0.6 mcg of folic acid supplements. This is because you absorb more from folic acid supplements than you do from food.
• In pregnancy, the RDA of folic acid is 600 mcg DFE daily (some sources recommend 400 to 800 mcg DFE)
• In breastfeeding, the RDA of folic acid is 500 mcg DFE daily.
• In children, the RDA depends on age.
  • Birth to 6 months: 65 mcg DFE
  • Infants 7–12 months: 80 mcg DFE
  • Children 1–3 years: 150 mcg DFE
  • Children 4–8 years: 200 mcg DFE
  • Children 9–13 years: 300 mcg DFE
  • Teens 14–18 years: 400 mcg DFE
  • Adults 19+ years: 400 mcg DFE.

Megaloblastic Anemia

• Adults: 1 mg folic acid once a day.
  • Rule out B12 deficiency.
  • Dosages of up to 5 mg may be used if indicated.
  • May continue until clinical symptoms of folate deficiency and the hematological profile have normalized.

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?

Except during pregnancy and lactation, folic acid should not be given in dosages higher than 0.4 mg daily until pernicious anemia has been ruled out.

Call your healthcare provider, seek emergency medical attention, or call the Poison Help line if you take more folic acid than recommended.

What should I avoid while taking folic acid?

Follow your doctor’s instructions about any food, beverages, or activity restrictions.

What other drugs will affect folic acid?

Ask a doctor or pharmacist before using folic acid with any other medications, especially:

• methotrexate
• nitrofurantoin
• pyrimethamine
• tetracycline. False low serum and red cell folate levels may occur with some antibiotics that suppress the growth of Lactobacillus casei.
• a barbiturate such as phenobarbital or secobarbital
• seizure medicine such as phenytoin or primidone. The anticonvulsant action of some seizure medications can be antagonized by folic acid and increased dosages of the anticonvulsant may be needed
• sulfasalazine. May reduce the body’s ability to absorb folate.

Uses for formoterol

Formoterol is used together with other medicines (eg, inhaled corticosteroids) to treat asthma and prevent bronchospasm in patients with asthma. When used regularly every day, inhaled formoterol decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Formoterol is also used for the long-term maintenance treatment of air flow blockage in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (wheezing or difficulty with breathing).

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

Formoterol is also used to prevent troubled breathing or wheezing caused by exercise (exercise-induced bronchospasm or EIB).

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

Before using formoterol

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of formoterol inhalation powder in children 5 years of age and older. Safety and efficacy have not been established for children younger than 5 years of age.

Formoterol inhalation solutionis not indicated for use 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 formoterol in the elderly. However, elderly patients are more likely to have age-related heart or blood vessel disease, which may require caution in patients receiving formoterol.

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
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

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.

• Acebutolol
• Adagrasib
• Alfuzosin
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Atenolol
• Azithromycin
• Bedaquiline
• Bemetizide
• Bendroflumethiazide
• Benzthiazide
• Betaxolol
• Bisoprolol
• Bumetanide
• Buprenorphine
• Buserelin
• Carteolol
• Carvedilol
• Celiprolol
• Ceritinib
• Chloroquine
• Chlorothiazide
• Chlorpromazine
• Chlorthalidone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clopamide
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Cyclopenthiazide
• Cyclothiazide
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Diazoxide
• Dibenzepin
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Esmolol
• Ethacrynic Acid
• Etozolin
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Furosemide
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Indapamide
• Inotuzumab Ozogamicin
• Isocarboxazid
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Labetalol
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levobunolol
• Levofloxacin
• Linezolid
• Lofepramine
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Melitracen
• Methacholine
• Methadone
• Methotrimeprazine
• Methyclothiazide
• Methylene Blue
• Metipranolol
• Metolazone
• Metoprolol
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nadolol
• Nafarelin
• Nebivolol
• Nelfinavir
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Opipramol
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxprenolol
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Penbutolol
• Pentamidine
• Perphenazine
• Phenelzine
• Phenobarbital
• Pimavanserin
• Pindolol
• Pipamperone
• Piretanide
• Pitolisant
• Polythiazide
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Procarbazine
• Prochlorperazine
• Promethazine
• Propafenone
• Propranolol
• Protriptyline
• Quetiapine
• Quinethazone
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Rasagiline
• Relugolix
• Ribociclib
• Risperidone
• Ritonavir
• Safinamide
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tianeptine
• Timolol
• Tolterodine
• Toremifene
• Torsemide
• Tranylcypromine
• Trazodone
• Trichlormethiazide
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Xipamide
• Zotepine
• Zuclopenthixol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Acute asthma attack or
• COPD attack, severe—Should not be used if you are having an acute asthma attack, severe COPD attack, or if symptoms of an asthma or COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute asthma or COPD attack.
• Allergy to milk proteins or lactose intolerance—Use with caution. The capsule form of this medicine contains lactose (milk sugar) and milk proteins.

• Angina (severe chest pain) or
• Diabetes or
• Heart or blood vessel disease (eg, aneurysm) or
• Heart rhythm problems (eg, arrhythmia, QT prolongation) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (an overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Ketoacidosis (high ketones in the blood) or
• Pheochromocytoma (adrenal gland problem) or
• Seizures—Use with caution. May make these conditions worse.

Proper use of formoterol

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor. Using the medicine more often may increase the chance of serious unwanted effects.

Inhaled formoterol is used to prevent asthma or COPD attacks. It is not used to relieve an attack that has already started. For relief of an asthma or COPD attack that has already started, you should use another medicine. If you do not have another medicine to use, or if you have any questions about this, check with your doctor.

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

Do not stop using this medicine or other asthma or COPD medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

The formoterol inhalation solution should be used with a jet nebulizer that is connected to an air compressor with good air flow. The inhalation solution comes with a patient information leaflet and patient instructions. Read and follow the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the nebulizer, ask your doctor to show you what to do. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly.

To use the inhalation solution in the nebulizer:

• Use the medicine immediately after opening the foil pouch.
• Twist the cap off the vial and squeeze all the medicine in the nebulizer medicine cup.
• Do not mix Perforomist® inhalation solution with other medicines in the nebulizing machine.
• Connect the nebulizer to the face mask or mouthpiece, then connect the nebulizer to the compressor.
• To inhale the medicine, place the mouthpiece in your mouth, then turn on the compressor. Breathe in deeply and steadily until no more mist is formed in the nebulizer reservoir.
• Use the nebulizer for about 9 minutes, or until the medicine in the nebulizer cup is gone.
• Clean all the parts of the nebulizer after each use.

Formoterol inhalation powder is used with a special inhaler and usually comes with a Medication Guide and patient instructions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly.

To use the formoterol inhalation powder:

• Dry your hands before handling this medicine.
• Open the foil pouch containing a blister card of capsules. Do not remove a capsule until you are ready for a dose.
• Place the capsule only in the capsule-chamber in the base of the inhaler. Do not swallow the capsule and do not place a capsule directly into the mouthpiece.
• Hold the mouthpiece of the inhaler upright and press both buttons at the same time. Press the buttons only once. You should hear a click as the capsule is being pierced.
• Breathe out fully. Do not exhale into the mouthpiece.
• Tilt your head slightly backwards. Keep the inhaler level, with the blue buttons to the left and right. Place the mouthpiece in your mouth then close your lips around the mouthpiece.
• Breathe in quickly and deeply.
• Remove the inhaler from your mouth. Hold your breath as long as you can and then exhale.
• Open the inhaler after using it, and remove and discard the empty capsule. Do not leave the used capsule inside the chamber.
• Close the mouthpiece and then replace the cover.
• Do not wash the inhaler. Keep it dry.
• Do not use a spacer with this medicine.
• You may reuse your inhaler. But use a new inhaler with each refill of your medicine.
• Do not use the inhaler for this medicine with any other medicine.

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 inhalation dosage form (powder):
  • For preventing an asthma attack:
    • Adults and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation every 12 hours.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
  • For preventing exercise-induced bronchospasm (EIB):
    • Adults and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation at least 15 minutes before exercise, as needed.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
  • For maintenance treatment of COPD:
    • Adults and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation every 12 hours.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
• For inhalation dosage form (solution):
  • For maintenance treatment of COPD:
    • Adults—20 micrograms (mcg) (1 vial) in the nebulizer 2 times a day (morning and evening). Do not use more than 2 vials (40 mcg) per day.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

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

Store Foradil® capsules at room temperature, away from heat, light, or moisture. Keep capsules stored in the blister packaging, and do not remove from blister until right before use.

Store the Perforomist® solution in the refrigerator. You may also keep it at room temperature, away from direct heat or light for up to 3 months. Throw away any unused solution after 3 months.

Precautions while using formoterol

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

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

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

This medicine should not be used if you are having a severe COPD attack, or if symptoms of a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.

This medicine should not be used together with similar inhaled medicines such as arformoterol (Brovana), budesonide/formoterol (Symbicort®), indacaterol (Arcapta® Neohaler®), salmeterol (Serevent®), or salmeterol/fluticasone (Advair®).

This medicine should only be used as an additional treatment for patients who cannot be treated with other asthma medicines (such as inhaled corticosteroids) or for asthma patients that require two medicines, including formoterol. Ask your doctor if you have any questions.

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

• Your or your child’s symptoms do not improve after using this medicine for 1 week or if they become worse.
• Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often (eg, you use 1 whole canister of your short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of your short-acting inhaler for 2 or more days in a row).
• You have a significant decrease in your peak flow when measured as directed by your doctor.

You or your child may also be using an anti-inflammatory medicine, such as a steroid, together with this medicine. Do not stop using the anti-inflammatory medicine even if your asthma seems better, unless you are told to do so by your doctor.

Although this medicine decreases the number of asthma episodes, this medicine may also increase the chances of a severe asthma episode when they do occur. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have.

Perforomist® may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma who take this medicine without an inhaled steroid medicine. Talk to your doctor if you have concerns about this.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

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

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

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have more than one of the following symptoms: convulsions (seizures), decreased urine, dry mouth, increased thirst, irregular heartbeat, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, shortness of breath, or unusual tiredness or weakness.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

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 formoterol

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

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

More common

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• hoarseness
• loss of voice
• runny or stuffy nose
• sneezing
• sore throat
• unusual tiredness or weakness

Less common

• Chest pain or discomfort
• cough-producing mucous
• dry throat
• labored breathing
• pain or tenderness around the eyes and cheekbones
• tender, swollen glands in the neck
• tightness in the chest
• trauma
• trouble with swallowing
• voice changes

Rare

• Decreased urine
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• increased thirst
• loss of appetite
• noisy breathing
• seizures

Incidence not known

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• hives, itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sweating

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

Symptoms of overdose

• Arm, back, or jaw pain
• chest tightness or heaviness
• diarrhea
• general feeling or discomfort or illness
• increased hunger
• increased urination
• loss of consciousness
• muscle pain
• muscle spasm or jerking of all extremities
• nausea
• no blood pressure or pulse
• numbness or tingling in the hands, feet, or lips
• palpitations or pounding in the ears
• pounding or racing heartbeat or pulse
• slow heartbeat
• stopping of the heart
• sudden loss of consciousness
• trouble sleeping
• vomiting

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:

Less common

• Agitation
• back pain
• increased mucous in the throat and lungs
• leg cramps
• muscle cramps
• redness of the skin
• restlessness
• shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

Uses for formoterol

Formoterol is used together with other medicines (eg, inhaled corticosteroids) to treat asthma and prevent bronchospasm in patients with asthma. When used regularly every day, inhaled formoterol decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Formoterol is also used for the long-term maintenance treatment of air flow blockage in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (wheezing or difficulty with breathing).

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

Formoterol is also used to prevent troubled breathing or wheezing caused by exercise (exercise-induced bronchospasm or EIB).

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

Before using formoterol

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.

Buy vitamins and supplements

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of formoterol inhalation powder in children 5 years of age and older. Safety and efficacy have not been established for children younger than 5 years of age.

Formoterol inhalation solutionis not indicated for use 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 formoterol in the elderly. However, elderly patients are more likely to have age-related heart or blood vessel disease, which may require caution in patients receiving formoterol.

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
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

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.

• Acebutolol
• Adagrasib
• Alfuzosin
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Atenolol
• Azithromycin
• Bedaquiline
• Bemetizide
• Bendroflumethiazide
• Benzthiazide
• Betaxolol
• Bisoprolol
• Bumetanide
• Buprenorphine
• Buserelin
• Carteolol
• Carvedilol
• Celiprolol
• Ceritinib
• Chloroquine
• Chlorothiazide
• Chlorpromazine
• Chlorthalidone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clopamide
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Cyclopenthiazide
• Cyclothiazide
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Diazoxide
• Dibenzepin
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Esmolol
• Ethacrynic Acid
• Etozolin
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Furosemide
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Indapamide
• Inotuzumab Ozogamicin
• Isocarboxazid
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Labetalol
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levobunolol
• Levofloxacin
• Linezolid
• Lofepramine
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Melitracen
• Methacholine
• Methadone
• Methotrimeprazine
• Methyclothiazide
• Methylene Blue
• Metipranolol
• Metolazone
• Metoprolol
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nadolol
• Nafarelin
• Nebivolol
• Nelfinavir
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Opipramol
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxprenolol
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Penbutolol
• Pentamidine
• Perphenazine
• Phenelzine
• Phenobarbital
• Pimavanserin
• Pindolol
• Pipamperone
• Piretanide
• Pitolisant
• Polythiazide
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Procarbazine
• Prochlorperazine
• Promethazine
• Propafenone
• Propranolol
• Protriptyline
• Quetiapine
• Quinethazone
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Rasagiline
• Relugolix
• Ribociclib
• Risperidone
• Ritonavir
• Safinamide
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tianeptine
• Timolol
• Tolterodine
• Toremifene
• Torsemide
• Tranylcypromine
• Trazodone
• Trichlormethiazide
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Xipamide
• Zotepine
• Zuclopenthixol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Acute asthma attack or
• COPD attack, severe—Should not be used if you are having an acute asthma attack, severe COPD attack, or if symptoms of an asthma or COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute asthma or COPD attack.
• Allergy to milk proteins or lactose intolerance—Use with caution. The  capsule form of this medicine contains lactose (milk sugar) and milk proteins.

• Angina (severe chest pain) or
• Diabetes or
• Heart or blood vessel disease (eg, aneurysm) or
• Heart rhythm problems (eg, arrhythmia, QT prolongation) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (an overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Ketoacidosis (high ketones in the blood) or
• Pheochromocytoma (adrenal gland problem) or
• Seizures—Use with caution. May make these conditions worse.

Proper use of formoterol

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor. Using the medicine more often may increase the chance of serious unwanted effects.

Inhaled formoterol is used to prevent asthma or COPD attacks. It is not used to relieve an attack that has already started. For relief of an asthma or COPD attack that has already started, you should use another medicine. If you do not have another medicine to use, or if you have any questions about this, check with your doctor.

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

Do not stop using this medicine or other asthma or COPD medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

The formoterol inhalation solution should be used with a jet nebulizer that is connected to an air compressor with good air flow. The inhalation solution comes with a patient information leaflet and patient instructions. Read and follow the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the nebulizer, ask your doctor to show you what to do. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly.

To use the inhalation solution in the nebulizer:

• Use the medicine immediately after opening the foil pouch.
• Twist the cap off the vial and squeeze all the medicine in the nebulizer medicine cup.
• Do not mix Perforomist® inhalation solution with other medicines in the nebulizing machine.
• Connect the nebulizer to the face mask or mouthpiece, then connect the nebulizer to the compressor.
• To inhale the medicine, place the mouthpiece in your mouth, then turn on the compressor. Breathe in deeply and steadily until no more mist is formed in the nebulizer reservoir.
• Use the nebulizer for about 9 minutes, or until the medicine in the nebulizer cup is gone.
• Clean all the parts of the nebulizer after each use.

Formoterol inhalation powder is used with a special inhaler and usually comes with a Medication Guide and patient instructions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly.

To use the formoterol inhalation powder:

• Dry your hands before handling this medicine.
• Open the foil pouch containing a blister card of  capsules. Do not remove a capsule until you are ready for a dose.
• Place the capsule only in the capsule-chamber in the base of the inhaler. Do not swallow the capsule and do not place a capsule directly into the mouthpiece.
• Hold the mouthpiece of the inhaler upright and press both buttons at the same time. Press the buttons only once. You should hear a click as the capsule is being pierced.
• Breathe out fully. Do not exhale into the mouthpiece.
• Tilt your head slightly backwards. Keep the inhaler level, with the blue buttons to the left and right. Place the mouthpiece in your mouth then close your lips around the mouthpiece.
• Breathe in quickly and deeply.
• Remove the inhaler from your mouth. Hold your breath as long as you can and then exhale.
• Open the inhaler after using it, and remove and discard the empty  capsule. Do not leave the used capsule inside the chamber.
• Close the mouthpiece and then replace the cover.
• Do not wash the inhaler. Keep it dry.
• Do not use a spacer with this medicine.
• You may reuse your inhaler. But use a new inhaler with each refill of your medicine.
• Do not use the inhaler for this medicine with any other medicine.

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 inhalation dosage form (powder):
  • For preventing an asthma attack:
    • Adults and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation every 12 hours.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
  • For preventing exercise-induced bronchospasm (EIB):
    • Adults and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation at least 15 minutes before exercise, as needed.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
  • For maintenance treatment of COPD:
    • Adults and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation every 12 hours.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
• For inhalation dosage form (solution):
  • For maintenance treatment of COPD:
    • Adults—20 micrograms (mcg) (1 vial) in the nebulizer 2 times a day (morning and evening). Do not use more than 2 vials (40 mcg) per day.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

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

Store Foradil® capsules at room temperature, away from heat, light, or moisture. Keep capsules stored in the blister packaging, and do not remove from blister until right before use.

Store the Perforomist® solution in the refrigerator. You may also keep it at room temperature, away from direct heat or light for up to 3 months. Throw away any unused solution after 3 months.

Precautions while using formoterol

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

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

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

This medicine should not be used if you are having a severe COPD attack, or if symptoms of a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.

This medicine should not be used together with similar inhaled medicines such as arformoterol (Brovana), budesonide/formoterol (Symbicort®), indacaterol (Arcapta® Neohaler®), salmeterol (Serevent®), or salmeterol/fluticasone (Advair®).

This medicine should only be used as an additional treatment for patients who cannot be treated with other asthma medicines (such as inhaled corticosteroids) or for asthma patients that require two medicines, including formoterol. Ask your doctor if you have any questions.

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

• Your or your child’s symptoms do not improve after using this medicine for 1 week or if they become worse.
• Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often (eg, you use 1 whole canister of your short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of your short-acting inhaler for 2 or more days in a row).
• You have a significant decrease in your peak flow when measured as directed by your doctor.

You or your child may also be using an anti-inflammatory medicine, such as a steroid, together with this medicine. Do not stop using the anti-inflammatory medicine even if your asthma seems better, unless you are told to do so by your doctor.

Although this medicine decreases the number of asthma episodes, this medicine may also increase the chances of a severe asthma episode when they do occur. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have.

Perforomist® may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma who take this medicine without an inhaled steroid medicine. Talk to your doctor if you have concerns about this.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

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

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

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have more than one of the following symptoms: convulsions (seizures), decreased urine, dry mouth, increased thirst, irregular heartbeat, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, shortness of breath, or unusual tiredness or weakness.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

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 formoterol

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

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

More common

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• hoarseness
• loss of voice
• runny or stuffy nose
• sneezing
• sore throat
• unusual tiredness or weakness

Less common

• Chest pain or discomfort
• cough-producing mucous
• dry throat
• labored breathing
• pain or tenderness around the eyes and cheekbones
• tender, swollen glands in the neck
• tightness in the chest
• trauma
• trouble with swallowing
• voice changes

Rare

• Decreased urine
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• increased thirst
• loss of appetite
• noisy breathing
• seizures

Incidence not known

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• hives, itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sweating

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

Symptoms of overdose

• Arm, back, or jaw pain
• chest tightness or heaviness
• diarrhea
• general feeling or discomfort or illness
• increased hunger
• increased urination
• loss of consciousness
• muscle pain
• muscle spasm or jerking of all extremities
• nausea
• no blood pressure or pulse
• numbness or tingling in the hands, feet, or lips
• palpitations or pounding in the ears
• pounding or racing heartbeat or pulse
• slow heartbeat
• stopping of the heart
• sudden loss of consciousness
• trouble sleeping
• vomiting

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:

Buy vitamins and supplements

Less common

• Agitation
• back pain
• increased mucous in the throat and lungs
• leg cramps
• muscle cramps
• redness of the skin
• restlessness
• shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

What is Forteo?

Forteo is a man-made form of parathyroid hormone that exists naturally in the body. Teriparatide increases bone mineral density and bone strength, which may prevent fractures.

Forteo is used to treat osteoporosis caused by menopause, steroid use, or gonadal failure.

Forteo is for use when you have a high risk of bone fracture due to osteoporosis.

Warnings

Forteo has caused bone cancer (osteosarcoma) in animals but it is not known whether this would occur in people using this medicine. Talk with your doctor about your own risk.

Tell your doctor if you have conditions such as Paget’s disease, high blood levels of calcium or alkaline phosphatase, or a history of bone cancer or radiation treatment involving your bones.

Avoid smoking cigarettes or drinking alcohol. Smoking or heavy drinking can reduce your bone mineral density, making fractures more likely.

Forteo side effects

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

Call your doctor at once if you have:

• bone pain;
• new or unusual swelling or lumps under your skin;
• a light-headed feeling, like you might pass out (may occur within 4 hours after injection);
• pounding heartbeats or fluttering in your chest after using an injection; or
• high calcium levels – confusion, muscle weakness, nausea, vomiting, lack of energy, constipation, increased thirst or urination, weight loss.

Common Forteo side effects may include:

• nausea;
• joint pain; 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. You may report side effects to FDA .

Before taking this medicine

You should not use Forteo if you are allergic to teriparatide.

Forteo is not for use in children or young adults whose bones are still growing.

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

• Paget’s disease or a bone disease other than osteoporosis;
• bone cancer or radiation treatment;
• a genetic condition that increases your risk of bone cancer;
• overactive parathyroid glands;
• high blood levels of calcium;
• a painful skin condition caused by too much calcium;
• kidney failure;
• a kidney stone; or
• an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis.

It is not known whether teriparatide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether teriparatide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Forteo.

How should I use Forteo?

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

Forteo is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Forteo is usually given once per day at the same time each day.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare the Forteo injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Your healthcare provider will show you where on your body to inject Forteo. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Use only the injection pen provided with Forteo. Do not transfer the medicine to a syringe or other injection device or you could get an overdose.

Teriparatide can cause you to feel dizzy or light-headed. Always give your injection at a time and place where you can sit or lie down for a short time afterward.

Each prefilled injection pen contains enough teriparatide for 28 separate injections. Throw the pen away after 28 injections, even if there is still medicine left inside.

Forteo may be only part of a complete treatment program that also includes diet, exercise, taking vitamin or mineral supplements, and changing certain behaviors. Follow your doctor’s instructions very closely.

Store the Forteo injection pen in a refrigerator when not in use. Take the pen out of the refrigerator only long enough to use it. After use, remove the needle, recap the pen, and return it to the refrigerator.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Do not freeze Forteo, and throw away the medicine if it has become frozen.

Your doctor will determine how long to treat you with this medicine. Forteo is sometimes given for only 2 years.

Forteo dosing information

Usual Adult Dose for Osteoporosis:

20 mcg subcutaneously once a day into the thigh or abdominal wall
-Duration of Therapy: Lifetime use greater than 2 years should only be considered if fracture risk remains high

Comments:
-This drug is indicated for men and women as described below who are at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.
-High fracture is defined as history of osteoporotic fracture or multiple risk factors for fracture.
-Supplemental calcium and vitamin D should be taken if daily dietary intake is inadequate.

Uses:
-For the treatment of postmenopausal women with osteoporosis
-To increase bone mass in men with primary or hypogonadal osteoporosis
-For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid (equivalent to prednisone 5 mg/day or greater)

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include nausea, vomiting, dizziness, headache, feeling light-headed, or fainting.

What should I avoid while using Forteo?

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

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

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

What other drugs will affect Forteo?

Tell your doctor about all your other medicines, especially:

• digoxin, digitalis.
• warfarin (Coumadin, Jantoven); or
• a steroid medicine (such as hydrocortisone, prednisone, methylprednisolone, and others).

What is Fosamax?

Fosamax is a bisphosphonate (bis FOS fo nayt) medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures.

Fosamax is used in women to treat or prevent osteoporosis caused by menopause and in men and women to treat osteoporosis caused by taking steroids.

Fosamax is also used to increase bone mass in men who have osteoporosis, and to treat Paget’s disease of bone in men and women.

Warnings

You should not take Fosamax if you have problems with your esophagus, or low levels of calcium in your blood.

Do not take Fosamax if you cannot sit upright or stand for at least 30 minutes after taking the medicine.

Fosamax can cause serious problems in the stomach or esophagus. Stop using this medicine and call your doctor at once if you have chest pain, new or worsening heartburn, or pain when swallowing.

In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw or a broken leg bone called a femur fracture. Symptoms of osteonecrosis include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. Symptoms of a femur fracture include leg or groin pain.

Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

Before taking this medicine

You should not take Fosamax if you are allergic to alendronate, or if you have:

• low levels of calcium in your blood (hypocalcemia); or
• problems with the muscles in your esophagus (the tube that connects your mouth and stomach).

Do not take Fosamax if you cannot sit upright or stand for at least 30 minutes. Fosamax can cause serious problems in the stomach or esophagus. You must stay upright for at least 30 minutes after taking this medicine.

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

• trouble swallowing;
• problems with your stomach or digestion;
• low levels of calcium in your blood;
• a dental problem (you may need a dental exam before you begin taking Fosamax);
• kidney disease; or
• any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use Fosamax, the more likely you are to develop this condition.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

Fosamax has also been reported to cause fractures, or broken bones, in the large bones of the leg. Tell your doctor if you have any leg or groin pain while using Fosamax.

Talk with your doctor about the risks and benefits of using this medication.

It is not known whether Fosamax will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Stop using the medicine and tell your doctor right away if you become pregnant.

It is not known whether alendronate passes into breast milk or if it could harm a nursing baby. Ask your doctor about any risk.

How should I take Fosamax?

Take Fosamax exactly as prescribed by your doctor. Fosamax is taken either once daily or once per week. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Fosamax first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. If you take this medicine only once per week, take it on the same day each week and always first thing in the morning.

Take with a full glass (6 to 8 ounces) of plain water. Do not use coffee, tea, soda, juice, or mineral water. Do not eat or drink anything other than plain water.

Do not crush, chew, or suck on an Fosamax tablet. Swallow the tablet whole.

For at least 30 minutes after taking Fosamax:

• Do not lie down or recline.
• Do not take any other medicine including  vitamins, calcium, or antacids.

Pay special attention to your dental hygiene while taking Fosamax. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using alendronate.

Fosamax is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and  vitamin  supplements. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat.

Your doctor will determine how long to treat you with this medicine. Fosamax is often given for only 3 to 5 years.

What happens if I miss a dose?

Once-daily dosing: If you forget to take Fosamax first thing in the morning, do not take it later in the day. Wait until the following morning and skip the missed dose. Do not take two (2) doses in one day.

Once-per-week dosing: If you forget to take Fosamax on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take 2 doses in one day.

What happens if I overdose?

Drink a full glass of milk and seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Do not make yourself vomit and do not lie down.

What to avoid

Avoid taking any other medicines for at least 30 minutes after taking Fosamax. This includes vitamins, calcium, and antacids. Some medicines can make it harder for your body to absorb alendronate.

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

Fosamax side effects

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

Stop using Fosamax and call your doctor at once if you have:

• chest pain, new or worsening heartburn;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• severe heartburn, burning pain in your upper stomach, or coughing up blood;
• new or unusual pain in your thigh, hip or groin;
• jaw pain, numbness, or swelling;
• severe joint, bone, or muscle pain; or
• signs of low calcium levels – muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common Fosamax side effects may include:

• heartburn, upset stomach;
• stomach pain, nausea;
• diarrhea, constipation; or
• headaches; or
• bone pain, muscle or joint pain.

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

What other drugs will affect Fosamax?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• aspirin; or
• NSAIDs (nonsteroidal anti-inflammatory drugs) – ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or
• calcium supplements and antacids

What is furosemide?

Furosemide is a loop diuretic used to treat fluid retention (edema) in people with congestive heart failure, liver disease, or a chronic kidney disorder such as nephrotic syndrome. Furosemide is also used to treat high blood pressure (hypertension).

Furosemide works by increasing the amount of urine the body makes, which helps reduce swelling and symptoms of fluid retention and helps lower high blood pressure. Furosemide tablets are sometimes called water pills as they increase how much you urinate.

Furosemide is also known as frusemide in some countries. Furosemide became an FDA-approved medicine on July 1, 1966, and is available as tablets (Lasix), oral liquid, a subcutaneous injection (Furoscix), and an intravenous solution.

Furosemide side effects

Common furosemide side effects may include:

• diarrhea, constipation, loss of appetite;
• numbness or tingling;
• headache, dizziness; or
• blurred vision.

Serious furosemide side effects 

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

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

• a light-headed feeling, like you might pass out;
• ringing in your ears, hearing loss;
• muscle spasms or contractions;
• pale skin, easy bruising, unusual bleeding;
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor;
• kidney problems – swelling, urinating less, feeling tired or short of breath
• signs of liver or pancreas problems – loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, dark urine, jaundice (yellowing of the skin or eyes); or
• signs of an electrolyte imbalance – increased thirst or urination, constipation, muscle weakness, leg cramps, numbness or tingling, feeling jittery, fluttering in your chest.

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

Warnings

You should not use furosemide if you are unable to urinate.

Using more than your recommended dose will not make this medicine more effective. High doses of this medicine may cause irreversible hearing loss.

Before using this medicine, tell your doctor if you have kidney disease, enlarged prostate, urination problems, cirrhosis or other liver disease, an electrolyte imbalance, high cholesterol, gout, lupus, diabetes, or an allergy to sulfa drugs.

Tell your doctor if you have recently had an MRI (magnetic resonance imaging) or any type of scan using a radioactive dye that is injected into your veins. Do not take more of this medication than is recommended.

If you are being treated for high blood pressure, keep using this medicine even if you feel fine. High blood pressure often has no symptoms.

Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and the dose schedule must be adjusted to the individual patient’s needs

Tell your doctor about all your other medicines. Some drugs should not be used with furosemide.

Before taking this medicine

You should not use furosemide if you are allergic to it, are unable to urinate, or have hepatic cirrhosis.

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

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• enlarged prostate, bladder obstruction, or other urination problems;
• gout;
• lupus;
• diabetes;
• an allergy to sulfa drugs;
• kidney disease; or
• cirrhosis or other liver disease.

Tell your doctor if you have an MRI (magnetic resonance imaging) or any type of scan using a radioactive dye that is injected into a vein. Contrast dyes and furosemide can harm your kidneys.

Furosemide on-body infusor (Furoscix) may be used to treat congestion due to fluid overload in adults with chronic heart failure (HF) or chronic kidney disease, including the nephrotic syndrome. Furoscix should not be used for emergencies or in patients with acute pulmonary edema. 

Pregnancy 

It is not known if furosemide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Breastfeeding 

It may not be safe to breastfeed while using furosemide. Ask your doctor about any risk. Furosemide may slow breast milk production.

How should I use furosemide?

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

Furosemide oral tablets and liquid are taken by mouth. Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Furosemide injection is given in a muscle, under the skin, or in a vein. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

Furosemide subcutaneous infusion (Furoscix) is administered via the On-body infusor and will take about 5 hours.

• Do not get the On-body infusor wet. Do not bathe, shower, swim or exercise while wearing the infusor.
• Also, do not apply any products such as lotions or creams in the area where the infusor is placed.
• Furoscix is not for chronic use and should be replaced with oral diuretics as soon as practical.
• It is not recommended to travel by car or airplane while using Furoscix. Also do not use the infusor within 12 inches of mobile phones, tablets, computers, or wireless accessories such as remote control, or Bluetooth devices.

General furosemide dosing information.

Do not use more than your recommended dose. High doses of furosemide may cause irreversible hearing loss.

Doses are based on weight in children and teenagers. Your child’s dose may change if the child gains or loses weight.

This medicine will make you urinate more often and you may get dehydrated easily. Follow your doctor’s instructions about using potassium supplements or getting enough salt and potassium in your diet.

Your blood pressure will need to be checked often and you may need other medical tests.

If you have high blood pressure, keep using furosemide even if you feel well. High blood pressure often has no symptoms.

Dosing Information

Usual Adult Dose for Edema associated with Congestive Heart Failure, Cirrhosis of the Liver, and Chronic Renal Disease (including Nephrotic Syndrome):

Oral: Initial dose: 20 to 80 mg orally once; may repeat with the same dose or increase by 20 or 40 mg no sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained.
Maintenance dose: Administer the dose that provided the desired diuretic effect once or twice a day (e.g., at 8 am and 2 pm).
Comments: Edema may be most efficiently and safely mobilized by giving this drug on 2 to 4 consecutive days each week. When doses greater than 80 mg/day are given for prolonged periods of time, careful clinical observation and laboratory monitoring are particularly advisable.

Subcutaneous: Furoscix 30 mg over the first hour, then 12.5 mg per hour for the subsequent 4 hours.

• This dose is automatically delivered by the Furoscix On-Body Infusor
• Furoscix is not for chronic use and should be replaced with oral diuretics as soon as practical.

Usual Adult Dose for Pulmonary Edema:

IV: 40 mg IV slowly over 1 to 2 minutes; if a satisfactory response doesn’t occur within one hour, may increase to 80 mg IV slowly over 1 to 2 minutes.
Use: Adjunctive therapy in acute pulmonary edema. IV administration of this drug is indicated when a rapid onset of diuresis is desired (e.g., in acute pulmonary edema).

Usual Adult Dose for Hypertension:

Oral: Initial dose: 80 mg/day, usually divided into 40 mg orally twice a day
Use: Treatment of hypertension alone or in combination with other antihypertensive agents.

Usual Pediatric Oral Dose for Edema:

Initial dose: 2 mg/kg orally once; if the diuretic response to the initial dose is not satisfactory, may increase by 1 or 2 mg/kg and administer no sooner than 6 to 8 hours after the previous dose.
Maintenance dose: Adjust to minimum effective dose.
Use: Treatment of edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome, especially when an agent with greater diuretic potential is desired.

What happens if I miss a dose?

Furosemide is sometimes used only once, so you may not be on a dosing schedule. If you are using the medication regularly, use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include feeling very thirsty or hot, heavy sweating, hot and dry skin, extreme weakness, or fainting.

What should I avoid while using furosemide?

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

Avoid becoming dehydrated. Follow your doctor’s instructions about the type and amount of liquids you should drink while you are using furosemide.

Drinking alcohol with this medicine can cause side effects.

Furosemide could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

If you have high blood pressure, ask a doctor or pharmacist before taking any medicines that can raise your blood pressure, such as diet pills or cough-and-cold medicine.

What other drugs will affect furosemide?

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

If you also take sucralfate, take your furosemide dose 2 hours before or 2 hours after you take sucralfate.

Tell your doctor about all your other medicines, especially:

• another diuretic, especially ethacrynic acid;
• methotrexate;
• chloral hydrate;
• lithium;
• phenytoin;
• an antibiotic;
• cancer medicine, such as cisplatin;

What is Fycompa?

Fycompa is an anticonvulsant used to treat seizures in adults and children.

Fycompa is used to treat partial onset seizures that may or may not develop into general seizures in people with epilepsy who are at least 4 years old.

Fycompa is also used with other medications to treat primary generalized tonic-clonic (PGTC) seizures in patients 12 years of age and older.

Warnings

Some people taking Fycompa have had serious psychotic effects, especially when starting this medicine or changing doses. Stay alert to changes in your mood or symptoms.

Call your doctor right away if you have any changes in mood or behavior changes, personality changes, thoughts about suicide, or thoughts about hurting others. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Before taking this medicine

You should not use Fycompa if you are allergic to perampanel.

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

• depression, a mood disorder, or other mental health problems;
• thoughts of hurting yourself or others;
• liver or kidney disease;
• drug addiction; or
• if you drink alcohol.

Some people taking Fycompa have had serious psychotic effects such as anger, aggression, feeling hostile or irritable, and thoughts about hurting others. These effects may be more likely to occur when you first start taking Fycompa, or whenever your dose is changed. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

Fycompa can make some birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

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

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

How should I take Fycompa?

Fycompa is usually taken at bedtime. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Perampanel may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

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

Do not stop using Fycompa suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor’s instructions about tapering your dose.

Store at room temperature away from moisture and heat. Do not freeze.

Throw away any leftover liquid medicine 90 days after you first opened the bottle.

Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Dosing information

Usual Adult Dose of Fycompa for Seizures:

In the absence of enzyme inducing AEDs:
Initial dose: 2 mg orally once daily at bedtime. Dosage may be increased by 2 mg orally daily in increments no more frequently than every week.
Maintenance dose: 4 to 12 mg orally once daily at bedtime
Maximum dose: 12 mg orally once daily at bedtime

In the presence of enzyme inducing AEDs (including phenytoin, carbamazepine, and oxcarbazepine):
Initial dose: 4 mg orally once daily at bedtime. Patients should be monitored closely for response. Studies revealed a substantially reduced effect on seizure rates in these patients. When these enzyme-inducing AEDs are introduced or withdrawn from a treatment regimen, the patient should be monitored for clinical response and tolerability. Dose adjustment of perampanel may be necessary.
Maximum dose: 12 mg orally once daily at bedtime

Approved indication: Adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.

Usual Pediatric Dose of Fycompa for Seizures:

Greater than or equal to 12 years of age:

In the absence of enzyme inducing AEDs: Initial dose: 2 mg orally once daily at bedtime. Dosage may be increased by 2 mg orally daily in increments no more frequently than every week. Maintenance dose: 4 to 12 mg orally once daily at bedtime Maximum dose: 12 mg orally once daily at bedtime

In the presence of enzyme inducing AEDs (including phenytoin, carbamazepine, and oxcarbazepine): Initial dose: 4 mg orally once daily at bedtime. Patients should be monitored closely for response. Studies revealed a substantially reduced effect on seizure rates in these patients. When these enzyme-inducing AEDs are introduced or withdrawn from a treatment regimen, the patient should be monitored for clinical response and tolerability. Dose adjustment of perampanel may be necessary.
Maximum dose: 12 mg orally once daily at bedtime

Approved indication: Adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Call your doctor for instructions if you miss your Fycompa dose for more than one day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

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

Drinking alcohol with this medicine can cause side effects.

Fycompa side effects

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

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

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

Call your doctor at once if you have:

• severe dizziness, spinning sensation, feeling like you might pass out;
• trouble walking, loss of balance or coordination;
• feeling very weak or tired;
• an accidental fall; or
• memory problems, confusion, hallucinations.

Accidental falls may occur more often in elderly patients who take Fycompa. Use caution to avoid falling or accidental injury while taking this medicine.

Common Fycompa side effects may include:

• headache, dizziness, drowsiness;
• feeling anxious, tired, or irritable;
• nausea, vomiting, stomach pain;
• bruising;
• weight gain; or
• loss of coordination.

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

What other drugs will affect Fycompa?

Using Fycompa with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

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

Tell your doctor about all your other medicines, especially:

• birth control pills;
• rifampin;
• St. John’s wort;
• other seizure medicine – carbamazepine, oxcarbazepine, phenytoin.