Foradil Aerolizer inhalation

Formoterol inhalation is a long-acting bronchodilator. It relaxes muscles in the airways to improve breathing.

The Foradil brand of formoterol is used to prevent asthma attacks or exercise-induced bronchospasm in adults and children who are at least 5 years old.

The Foradil and Perforomist brands of formoterol are used to prevent bronchospasm in adults with chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis.

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

Follow all directions on your prescription label. Use only the prescribed dose of this medicine, and do not use it for longer than your doctor recommends.

If you use formoterol for asthma, you must use it together with another long-term asthma control medication. Use all medications as directed by your doctor. Do not change your doses or medication schedule without your doctor's advice.

For asthma or COPD, formoterol is usually given 2 times a day, about 12 hours apart. To prevent exercise-induced asthma, use the medicine 15 minutes before exercising and allow 12 hours to pass before using the medicine again. Follow your doctor's dosing instructions very carefully.

Formoterol is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack. Use only a fast acting inhalation medicine for an attack. Tell your doctor if any of your medicines seem to stop working as well in controlling your asthma or COPD.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Any child using formoterol inhalation should be supervised by an adult while using this medicine.

Formoterol capsules are for use only in the Foradil Aerolizer device provided. Do not take the capsule by mouth. Use only one capsule at a time. Use dry hands when handling the capsule. Never place a capsule in the mouthpiece of the inhaler.

The Foradil Aerolizer inhalation device is not to be used with a spacer.

Perforomist solution is for use only with a standard jet nebulizer machine connected to an air compressor. Do not mix formoterol with other medicines in the nebulizer. Do not take this medicine by mouth or swallow it while inhaling.

To use the Perforomist solution with a nebulizer:

• Open the foil pouch and single-use vial. Squeeze all of the medicine out into the chamber of the nebulizer. Attach the mouthpiece or face mask to the drug chamber. Then, attach the chamber to the compressor.

• Sit upright in a comfortable position. Place the mouthpiece into your mouth or put the face mask on, covering your nose and mouth. Turn on the compressor.

• Breathe in slowly and evenly until you have inhaled all of the medicine (usually 5 to 10 minutes). The treatment is complete when no more mist is formed by the nebulizer and the drug chamber is empty.

• Clean the nebulizer after each use. Follow the cleaning directions that came with your nebulizer.

Use formoterol inhalation regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Seek medical attention if you think your asthma medications are not working as well. An increased need for medication could be an early sign of a serious asthma attack.

Store this medicine at room temperature away from moisture and heat. Keep all capsules and vials in their original packaging until you are ready to use a dose. Throw away any Perforomist solution vials that have not been used within 3 months.

Do not try to clean or take apart the Aerolizer device. Throw it away when your capsules run out. Always use the new device provided with the medication when you get your prescription refilled.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Formoterol is a long-acting bronchodilator used as a long-term (maintenance) treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). It should only be used long-term if your asthma symptoms are not controlled by your other asthma medications (such as inhaled corticosteroids). Formoterol must not be used alone to treat asthma. (See also Warning section.) It works in the airways by relaxing muscles and opening air passages to improve breathing. Controlling symptoms of breathing problems can decrease time lost from work or school.

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 should be used along with another controller-type asthma medication (such as inhaled corticosteroids). However, it should not be used with other long-acting beta-agonist inhalers (such as arformoterol, salmeterol) because doing so may increase your risk for side effects.

It is recommended that children and teenagers, who need to use formoterol to treat their asthma, should use a combination formoterol/budesonide product. Check with your child's doctor to see if this product is the right product for your child.

How to use Foradil Capsule, With Inhalation Device

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. 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.

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.

If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication.

Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

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 right away if this medication stops working well.

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 (e.g., epinephrine, pseudoephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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), 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.

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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

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.

See also Uses section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.