Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

FORMOTEROL - ORAL INHALATION POWDER

(for-MOW-ter-all)

COMMON BRAND NAME(S): Foradil

Uses

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 exercise-induced breathing difficulties (e.g. exercise-induced bronchospasm, EIB). This medication is not to be used for an acute asthma attack, nor is it a substitute for inhaled or oral corticosteroids (e.g., beclomethasone, fluticasone, prednisone). In fact, it is generally used in combination with another controller-type asthma medication (such as inhaled corticosteroids).

How To Use

Formoterol is inhaled by mouth, usually one capsule via the inhaler device twice daily (morning and evening), or as directed. Formoterol must always be used with its own special inhaler device. Always discard your old inhaler device when you refill your formoterol prescription. Formoterol capsules should never be swallowed, nor should a "spacer" device be used with the inhaler. Leave the capsule sealed in the foil packet until just before use. Be sure to inhale rapidly and deeply through the mouthpiece when using this drug. Learn the proper use of formoterol, and carefully read the patient instruction sheet that comes with the product. Consult your pharmacist for more details. When formoterol is being used to prevent exercise-induced breathing problems (EIB), it should be used at least 15 minutes before exercising. Do not use additional doses of formoterol for the next 12 hours. If you are already using formoterol twice daily, do not use additional doses for EIB. Make sure that you understand when to use this medication in relation to other asthma medications you may be using. For example, acute asthma attacks should still be treated with short- acting bronchodilators such as albuterol. Your asthma must be stable (i.e., not acutely worsening) before starting treatment with formoterol; consult your doctor. Excessive use of formoterol may result in a decrease in drug effectiveness and an increase in serious side effects. Do not exceed the recommended dosage. Do not stop or decrease the dose of other asthma medications (e.g., inhaled corticosteroids such as beclomethasone) without your doctor's approval. Short-acting bronchodilators you are using on a regular schedule every day (such as every six hours) should be stopped while using this drug. Seek immediate medical attention if your asthma worsens. Signs of worsening asthma include: usual doses of your asthma medications no longer control symptoms; the short-acting (quick-relief) inhaler is less effective; you need to use the short-acting inhaler more often than usual (e.g., use of 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.

Side Effects

Trembling, nervousness, headache, dizziness, dry mouth, nausea, tiredness, trouble sleeping, may occur. If these symptoms persist or worsen, inform your doctor promptly. Tell your doctor immediately if you have any of these unlikely but serious side effects: chest pain, fast breathing, muscle weakness or cramping. Tell your doctor immediately if you have any of these highly unlikely but very serious side effects: fainting, fast/irregular heartbeat. In the unlikely event that you have an allergic reaction to this drug, seek medical attention immediately. Symptoms of an allergic reaction include: swelling, dizziness, rash, itching, trouble breathing. Rarely, Formoterol can cause a worsening of breathing problems (e.g. paradoxical bronchospasm) that may be life threatening. If this occurs, immediately seek medical attention. To relieve dry mouth, suck on (sugarless) hard candy or ice chips; chew (sugarless) gum, drink water or use saliva substitute. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history, especially of: heart disease, high blood pressure, an overactive thyroid gland, seizure disorders (e.g. epilepsy), diabetes, metabolic abnormalities (e.g. ketoacidosis, hypokalemia), any allergies. This medication should be used only when clearly needed during pregnancy. 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.

Drug Interactions

Tell your doctor of all prescription and nonprescription medication you may use, especially of: beta- blockers (e.g. propranolol, labetalol, timolol), adrenaline-like drugs (e.g., sympathomimetics such as pseudoephedrine), other drugs used for asthma (e.g. corticosteroids, theophylline), "water pills" (e.g. hydrochlorothiazide, furosemide), tricyclic antidepressants (e.g., amitriptyline), MAO inhibitors (e.g., furazolidone, linezolid, phenelzine, selegiline, tranylcypromine). Report other drugs which affect the heart rhythm (QTc prolongation), such as: dofetilide, pimozide, quinidine, sotalol, procainamide, sparfloxacin. Ask your doctor or pharmacist for more details. 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 the safe use of those products. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include chest pain, fast or irregular heartbeat, severe nervousness, severe dizziness, fainting, seizures, and severe muscle cramps.

Notes

Do not share this medication with others. Learn to use a peak flow meter, use it daily, and promptly report worsening asthma (such as readings in the yellow or red range, or increased use of quick-relief inhalers).

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 68 and 77 degrees F (between 20 and 25 degrees C) away from heat and moisture.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).