formoterol inhalation powder-oral (cont.)
SIDE EFFECTS: Trembling, nervousness, headache, dizziness, dry mouth, nausea, tiredness, or trouble sleeping may occur, but should subside as your body adjusts to this medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these serious side effects occur: fast/pounding/irregular heartbeat. Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, fast breathing, muscle weakness or cramping. In the unlikely event that you have an allergic reaction to this drug, seek medical attention immediately. Symptoms of an allergic reaction include: swelling, severe 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: Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., abnormal heart rhythms, QTc prolongation, ischemic heart disease, coronary insufficiency), high blood pressure, an overactive thyroid gland, seizure disorders (e.g., epilepsy), diabetes, metabolic abnormalities (e.g., ketoacidosis, hypokalemia), any allergies. Use caution engaging in activities requiring alertness such as driving or using machinery until you know how this drug affects you. 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 -- including glaucoma eye drops (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" or diuretics (e.g., hydrochlorothiazide, furosemide), tricyclic antidepressants (e.g., amitriptyline), MAO inhibitors (e.g., furazolidone, linezolid, moclobemide, phenelzine procarbazine, selegiline, isocarboxazid, tranylcypromine). Other drugs besides formoterol which may affect the heart rhythm (QTc prolongation in the EKG) include dofetilide, pimozide, quinidine, sotalol, procainamide, and sparfloxacin among others. QTc prolongation can infrequently result in serious, rarely fatal, irregular heartbeats. Consult your doctor or pharmacist for details. Ask for instructions about whether you need to stop any other QTc-prolonging drugs you may be using in order to minimize the risk of this effect. 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.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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