Foradil 12 mcg 30 caps. & inhaler

Foradil

Dry powder in capsules for inhalation

Composition:

Formoterol fumarate dihydrate

Inactive ingredients:

Lactose monohydrate, gelatin 

Properties:

Inhaled formoterol works like other β2 agonists, causing bronchodilation by relaxing the smooth muscle in the airway so as to treat the exacerbation of asthma.

Indications:

Formoterol is indicated in various formulations for the treatment of asthma and COPD.

Dosage and administration:

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. The two doses should be about 12 hours apart. 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. Open the inhaler after use. Check that the capsule is empty. If it is not empty, close the inhaler and repeat. Do not exhale into the inhaler.

Side effects:

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, inform your doctor immediately.

Get medical help right away if you have any very serious side effects, including: chest pain, fast/irregular heartbeat, severe dizziness, fainting.

Contraindications:

• Formoterol: Contraindicated for treatment of asthma without concomitant use of long-term asthma controller therapy (e.g., inhaled corticosteroids) because of risk of asthma-related death and hospitalization.
• Formoterol/budesonide and formoterol/mometasone: Contraindicated as primary treatment of status asthmaticus or other acute episodes of asthma or COPD when intensive measures required.
• Formoterol/glycopyrrolate: Not indicated for treatment of asthma.
• Formoterol alone or in fixed combination with budesonide, glycopyrrolate, or mometasone: Known hypersensitivity to formoterol or any ingredient in the formulation.

Warnings and precautions:

• Before taking formoterol, tell your doctor or pharmacist if you are allergic to it; or to similar bronchodilators (such as albuterol, arformoterol, metaproterenol, salmeterol); or to sympathomimetic drugs (such as epinephrine, pseudoephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems.
• Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (such as irregular heartbeat, angina), high blood pressure, overactive thyroid (hyperthyroidism), seizures, diabetes, metabolism problems (such as ketoacidosis), swelling of an artery (aneurysm), a certain tumor of the adrenal gland (pheochromocytoma).
• Formoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
• The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using formoterol, tell your doctor or pharmacist of all the drugs you take and 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.
• 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.

Storage:

Store at a temperature not exceeding 25°C away from heat or moisture.

Package:

Carton box holds 1 inhaler, 30 capsules and paper instructions.