Formoterol (patient information)

IMPORTANT WARNING
In a large clinical study, more patients who used an asthma medication similar to formoterol died of asthma problems than patients who did not use the medication. If you have asthma, use of formoterol may increase the chance that you will experience serious or fatal asthma problems. Your doctor will only prescribe formoterol if other medications have not controlled your asthma or if your asthma is so severe that two medications are needed to control it. Formoterol should not be the first or the only medication that you use to treat your asthma.

Do not use formoterol if you have asthma that is quickly getting worse. Tell your doctor if you have had many severe asthma attacks or if you have ever been hospitalized because of asthma symptoms. If you have any of the following signs of worsening asthma, call your doctor immediately:


 * your short-acting inhaler [inhaled medication such as albuterol (Proventil, Ventolin) that is used to treat sudden attacks of asthma symptoms] does not work as well as it did in the past
 * you need to use more puffs than usual of your short-acting inhaler or use it more often
 * you need to use four or more puffs per day of your short-acting inhaler for 2 or more days in a row
 * you use more than one canister (200 inhalations) of your short-acting inhaler during an 8-week period
 * your peak-flow meter (home device used to test breathing) shows your breathing is worsening
 * you need to go to the emergency room for asthma treatment
 * your symptoms do not improve after you use formoterol regularly for one week or your symptoms get worse at any time during your treatment

Talk to your doctor about the risks of using this medication.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with formoterol and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/cder) or the manufacturer's website to obtain the Medication Guide.

Why this medication is prescribed
Formoterol is used to treat wheezing, shortness of breath, and breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD; a group of lung diseases, which includes chronic bronchitis and emphysema). It also is used to prevent breathing difficulties (bronchospasm) during exercise. Formoterol is in a class of medications called long-acting beta agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.

How this medication should be used
Formoterol comes as a powder-filled capsule to inhale by mouth using a special inhaler. If you are using formoterol to treat asthma and COPD, you will probably inhale it twice a day in the morning and the evening. Always inhale your next dose of formoterol 12 hours after you inhaled your last dose and try to inhale formoterol at about the same times every day. If you are using formoterol to prevent breathing difficulties during exercise, you will probably inhale it at least 15 minutes before exercise, but not more often than once in 12 hours. If you are using formoterol twice a day on a regular basis, do not use an additional dose before exercising. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use formoterol exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Talk to your doctor about how you should take your other oral or inhaled medications for asthma during your treatment with formoterol. If you were taking a corticosteroid (a type of medication used to prevent airway swelling in patients with asthma), your doctor will probably tell you to continue taking it just as you did before you began using formoterol. If you were using a short acting beta agonist inhaler such as albuterol (Proventil, Ventolin) on a regular basis, your doctor will probably tell you to stop using it regularly, but to continue to use it to treat sudden attacks of asthma symptoms. Follow these directions carefully. Do not change the way you use any of your medications without talking to your doctor.

Formoterol helps to prevent asthma or COPD attacks but will not stop an attack that has already started. Do not use formoterol during an attack of asthma or COPD. Your doctor will prescribe a short-acting inhaler to use during attacks.

Formoterol controls the symptoms of asthma and other lung diseases but does not cure these conditions. Do not stop using formoterol without talking to your doctor. If you suddenly stop using formoterol, your symptoms may worsen.

Before you use the formoterol inhaler the first time, ask your doctor, pharmacist, or respiratory therapist to show you how to use it. Practice using the inhaler while he or she watches.

To use the inhaler, follow these steps:


 * 1) Before you use a new inhaler for the first time, find the sticker on the box that says "Use by" and has been marked with a date by your pharmacist. Remove this sticker from the box and attach it to the cover of your inhaler to remind you to stop using the inhaler by this date. If the sticker on your box is blank, fill in the expiration date that is stamped on the box or the date that is 4 months after you purchased the inhaler, whichever comes sooner.
 * 2) Open the foil pouch containing a blister card of formoterol and set it aside. Do not remove a capsule until you are ready to inhale your dose.
 * 3) Pull off the inhaler cover and twist the mouthpiece open in the direction shown by the arrow on the mouthpiece. Push the buttons on each side to be sure you can see four pins in the capsule well of the inhaler.
 * 4) Separate one blister from the blister card by tearing along the dotted lines. Remove the capsule from the blister by peeling back the paper backing and pushing the capsule through the foil.
 * 5) Place the capsule in the chamber. Do not place it directly into the mouthpiece. Twist to close.
 * 6) Hold the inhaler upright and press in both side buttons at the same time. Do not press the buttons more than once. You will hear a click as the capsule is punctured. Release the buttons. #If the buttons do not pop out, pull the wings of the buttons to release them.
 * 7) Exhale (breathe out) as completely as possible but not into the mouthpiece.
 * 8) Turn the inhaler on its side so that the blue buttons are on the left and right (not the top and bottom) of the inhaler. Hold the inhaler so that it is level.
 * 9) Tilt your head back slightly, place the mouthpiece in your mouth, and close your lips. Breathe in quickly and deeply. As the medicine is released from the capsule, you'll get a sweet taste and hear a whirring noise. (If you don't, the capsule may be stuck. Tap on the side of the inhaler to loosen the capsule and repeat steps 7–9. Do not press the side buttons again.)
 * 10) Remove the inhaler from your mouth and hold your breath for as long as you comfortably can. #Then exhale.
 * 11) Open the inhaler to see if there is any powder left in the capsule. If there is, repeat steps 7–10.
 * 12) Once the capsule is empty, remove it and throw it away. Do not leave it in the chamber. Close the mouthpiece and replace the cover.

The inhaler is made to pierce the capsule so that the powder can be released. However, it is possible that the capsule may break into small pieces inside the inhaler. If this happens, a screen in the inhaler should stop the pieces of capsule from reaching your mouth as you inhale the medication. Very tiny pieces of the capsule may reach your mouth or throat, but this will not hurt you. The capsule is less likely to break if you are careful to store the capsules properly, to keep the capsules in the foil package until you are ready to use them, and to press the buttons on the inhaler only once.

Formoterol capsules should only be used with the special inhaler and should not be taken by mouth. Store capsules in the package and remove them immediately before use. Avoid exposing the capsules to moisture, and handle them with dry hands.

Do not use the dry powder inhaler with a spacer. Do not exhale into the device. Keep the inhaler dry; do not wash it. Always use the new inhaler that comes with a refill of your medication. Do not use the inhaler to inhale any other type of capsules.

Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions
Before using formoterol:


 * tell your doctor and pharmacist if you are allergic to formoterol, any other medications, or milk proteins.
 * tell your doctor if you use another LABA such as fluticasone and salmeterol combination (Advair) or salmeterol (Serevent). These medications should not be used with formoterol. Your doctor will tell you which medication you should use and which medication you should stop using.
 * tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aminophylline (Truphylline); amiodarone (Cordarone); antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), propranolol (Inderal), and sotalol (Betapace, Betapace AF); cisapride (Propulsid) (not available in the United States); clonidine (Catapres); diet pills; disopyramide (Norpace); diuretics ('water pills'); dofetilide (Tikosyn); dyphylline (Dilor, Lufyllin); erythromycin (E.E.S., E-Mycin, Erythrocin); guanabenz; medications for colds; monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil) seligiline (Eldepryl), and tranylcypromine (Parnate); midodrine (Orvaten); moxifloxacin (Avelox); oral steroids such as dexamethasone (Decadron, Dexone), methyldopa (Aldomet); methylprednisolone (Medrol), and prednisone (Deltasone); pimozide (Orap); procainamide (Procanbid, Pronestyl); quinidine (Quinidex); sparfloxacin (Zagam); theophylline (Theo-Chron, Theolair); and thioridazine (Mellaril). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
 * tell your doctor if you have or have ever had an irregular heartbeat, high blood pressure, seizures, diabetes, or heart or thyroid disease.
 * tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using formoterol, call your doctor.

Special dietary instructions
Talk to your doctor about drinking beverages that contain caffeine while using this medicine.

What to do if you forget a dose
Skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

Minor side effects
Formoterol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:


 * nervousness
 * headache
 * uncontrollable shaking of a part of the body
 * dry mouth
 * muscle cramps
 * back pain
 * nausea
 * heartburn
 * stomach pain
 * extreme tiredness
 * dizziness
 * difficulty falling asleep or staying asleep
 * stuffed or runny nose
 * sore throat

Severe side effets
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:


 * swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
 * hoarseness
 * difficulty swallowing or breathing
 * hives
 * rash
 * fast, pounding, or irregular heartbeat
 * chest pain
 * lightheadedness
 * fainting

Formoterol may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Storage conditions needed for this medication
Keep sealed in their blister cards until you are ready to use them. Keep this medication out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed, and throw away your old inhaler each time you refill your prescription. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:


 * chest pain
 * fainting
 * fast, pounding, or irregular heartbeat
 * nervousness
 * headache
 * uncontrollable shaking of a part of the body
 * seizures
 * muscle cramps
 * dry mouth
 * nausea
 * dizziness
 * excessive tiredness
 * difficulty falling asleep or staying asleep
 * thirst
 * dry mouth
 * trouble breathing

Other information
Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

 * Foradil® Aerolizer® Inhaler