Rarely, serious (sometimes fatal) asthma-related breathing problems have occurred with the use of long-acting inhaled beta agonists such as formoterol. Therefore, in patients with asthma, this drug should only be prescribed when one long-term medication (e.g., inhaled corticosteroids) does not control breathing problems or when symptoms are severe enough to clearly require adding a second long-term medication. Do not use formoterol alone without any other medications to control asthma. Consult your doctor or pharmacist for more details.

Formoterol is a long-acting bronchodilator used to open air passages in the lungs to improve breathing. It is used to prevent/minimize breathing problems in persons 5 years and older with breathing difficulties (e.g., asthma, bronchospasm).

This drug is also used to prevent breathing difficulties brought on by exercise (exercise-induced bronchospasm-EIB).

This medication should not be used for a severe/sudden asthma attack. For sudden attacks of asthma, use your quick-relief inhaler as prescribed. This medication is not a substitute for inhaled or oral corticosteroids (e.g., beclomethasone, fluticasone, prednisone). This medication is usually used along with another controller-type asthma medication (such as inhaled corticosteroids).

Learn the proper use of formoterol, and carefully read the Medication Guide that comes with the product. Consult your pharmacist for more details.

Formoterol comes in a capsule. Do not swallow these capsules by mouth. Inhale the contents of the capsule by mouth using the inhaler device, usually one capsule twice daily (morning and evening) or as directed by your doctor. Formoterol must always be used with its own special inhaler device. Use the new inhaler device that you get each time you refill your formoterol prescription. Always discard your old inhaler device. Do not use a "spacer" device with the inhaler.

Leave the capsule sealed in the foil packet until just before use. Wash and completely dry hands before touching the capsules. Be sure to inhale rapidly and deeply through the mouthpiece when using this drug. Inhale 2 times per capsule to make sure you inhale all of the drug. Do not exhale into the inhaler.

If you are using this medication to prevent exercise-induced breathing problems (EIB), it should be used at least 15 minutes before exercising. Do not use any more doses of formoterol for the next 12 hours. If you are already using formoterol twice daily, do not use any more doses for EIB.

Your asthma must be stable (not worsening) before you start treatment with formoterol. Consult your doctor for more details.

Make sure that you understand when to use this medication and when to use any other asthma medications. For example, sudden asthma attacks should still be treated with a quick-relief inhaler (e.g., short-acting bronchodilators such as albuterol). Do not stop using any of your other asthma medications, even if you feel better after starting formoterol.

Using too much formoterol or using it too often may result in a decrease in drug effectiveness and an increase in serious side effects. Do not use more than the recommended dosage or take this drug more often than prescribed. Do not stop or decrease the dose of other asthma medications (e.g., inhaled corticosteroids such as beclomethasone) without your doctor's approval. If you are using short-acting bronchodilators on a regular schedule (such as every six hours), you should stop taking them while using this drug.

Seek immediate medical attention if you notice any of the following signs of worsening asthma: the usual doses of your asthma medications no longer control symptoms, your quick-relief inhaler is less effective, or you need to use the quick-relief inhaler more often than usual (e.g., more than 4 puffs per day or more than 1 inhaler every 8 weeks). Do not increase your dose of formoterol in this situation.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor immediately if this medication stops working well.

Shakiness (tremor), nausea, headache, dizziness, nervousness, dry mouth, stomach upset, tiredness, trouble sleeping, or hoarseness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips; chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast breathing, muscle weakness/cramping, fast/pounding/irregular heartbeat, increased thirst/urination.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, severe dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: dizziness, rash, itching/swelling (especially of the face/tongue/throat), trouble breathing.

Rarely, formoterol can cause a worsening of breathing problems (paradoxical bronchospasm) that may be life-threatening. If this occurs, immediately seek medical attention.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking formoterol, tell your doctor or pharmacist if you are allergic to it; or to similar bronchodilators (e.g., albuterol, metaproterenol, salmeterol); or to sympathomimetic drugs (e.g., epinephrine, pseudoephedrine); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., irregular heartbeat, angina), high blood pressure, overactive thyroid (hyperthyroidism), seizures, diabetes, metabolism problems (e.g., ketoacidosis).

Formoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using formoterol, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using formoterol safely.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious, possibly fatal drug interaction may occur.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this product.

Tell your doctor of all prescription and nonprescription medication you may use, especially of: beta-blockers (e.g., propranolol, labetalol, timolol), other drugs for asthma (e.g., quick-relief inhalers, corticosteroids, theophylline), inhaled anesthetics (e.g., halothane), tricyclic antidepressants (e.g., amitriptyline).

Many drugs besides formoterol may affect the heart rhythm (QT prolongation) including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using formoterol, report all medications you are currently using to your doctor or pharmacist.

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about using those products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

This medication will not work and may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canadian residents should call a provincial local poison control center. Symptoms of overdose may include: chest pain, fast/irregular heartbeat, severe nervousness, severe dizziness, fainting, seizures, severe muscle cramps.

Do not share this medication with others.

Avoid allergens, irritants, smoking, and other factors that make asthma worse.

Laboratory and/or medical tests (e.g., blood pressure, heart rate, EKG, pulmonary function) may be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.

Learn to use a peak flow meter, use it daily, and promptly report worsening asthma (such as readings in the yellow/red range, increased use of quick-relief inhalers).

If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from heat and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised October 2009 Copyright(c) 2009 First DataBank, Inc.