Formoterol Fumarate

 What does formoterol inhalation powder do? FORMOTEROL (Foradil(R)) is a slow-acting bronchodilator, a medicine that opens up air passages and makes breathing easier. Formoterol is for regular use to help prevent asthma attacks or to treat the symptoms of chronic lung disease like emphysema or chronic bronchitis. This drug is not for use in an acute asthma attack. In some people, formoterol can be used to prevent exercise-induced asthma when taken at least 15 minutes before exercise is started. You must have a quick-acting bronchodilator (such as albuterol) available for use in a sudden asthma attack. A generic formoterol inhalation powder is not yet available.

 What should my health care professional know before I use formoterol?

They need to know if you have any of the following conditions: diabetes, heart disease, or irregular heartbeat, high blood pressure, overactive thyroid, pheochromocytoma, seizures (convulsions), an unusual or allergic reaction to formoterol, other medicines, food, dyes, or preservatives, pregnant or trying to get pregnant, breast-feeding

 How should I use this medicine?The powder in the gelatin capsules are only for inhalation using the Aerolizer(TM) inhaler device. Do not swallow the capsules! Each capsule for inhalation contains 12 µg of formoterol. Follow the directions on the prescription label. Do not use a spacer device with this inhaler.Prepare the inhaler prior to each use. Never place a capsule directly in the inhaler's mouthpiece. Twist open the Aerolizer(TM) mouthpiece. Push the buttons to be sure the 4 pins are visible in the capsule chamber. Place one capsule in the chamber in the base of the Aerolizer(TM). Twist the mouthpiece closed. With the mouthpiece up, push both buttons on the Aerolizer(TM) at once. You should hear a click. Release the buttons. If the buttons stick, do not depress the buttons a second time as this may shatter the capsule. Instead, grab the wings on the buttons and pull them out before inhaling. If the capsule should shatter, the screen in the Aerolizer(TM) should catch the pieces. If tiny pieces of gelatin should reach your mouth and be swallowed it is not harmful. The capsule is less likely to shatter if the capsule is removed from the packet just before using and is only pierced once. Before you begin using the Aerolizer(TM), exhale fully. Do not exhale into the mouthpiece. Tilt your head back slightly. Inhale from the mouthpiece as deeply as you can. Remove the inhaler from your mouth. Hold your breath as long as you comfortably can. Then exhale. Open the inhaler to check to see if any powder is still in the capsule. If powder is in the capsule, repeat the inhalation again to remove all of the powder from the capsule. After use, open the inhaler and remove and discard the empty capsule. Do not use this medicine more often than directed. Do not wash the Aerolizer(TM). Keep it dry. Your pharmacist will give you an instruction sheet for the Aerolizer(TM) along with your prescription. Be sure to read this information each time you get your medication refilled. Ask your pharmacist or prescriber if you have any questions about use of your inhaler. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. Foradil(R) Aerolizer(TM) has been used in children as young as 5 years of age.

 What if I miss a dose?

If you miss a dose, just take your next scheduled dose when it is due. Do not use double or extra doses.

 What other medicines can interact with formoterol?

        •  beta-blockers, often used for high blood pressure or heart problems

        •  medicines for colds and breathing difficulties

        •  medicines for high blood pressure

        •  medicines for mental depression

Tell your prescriber or health care professional about all other medicines that you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

 What side effects may I notice from using formoterol?

Side effects that you should report to your prescriber or health care professional as soon as possible:

        •  difficulty breathing, wheezing

        •  dizziness

        •  fast heartbeat, palpitations, chest pain

        •  skin rash, hives

        •  swelling of the face

        •  nausea/vomiting

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

        •  cough

        •  tremor

        •  headache

        •  muscle cramps

        •  agitation

        •  nervousness

        •  tiredness

        •  difficulties with sleeping

        •  throat or mouth irritation

 What do I need to watch for while I use formoterol?

Check with your prescriber or health care professional if your symptoms do not improve with formoterol inhalation powder, or if they get worse. You may need a change of therapy. Make sure you are using your inhaler properly. Do not use extra or more frequent inhalations; they will not improve your condition.

Do not use formoterol for sudden asthma symptoms. These symptoms may include severe onset or worsening of cough, wheezing, chest tightness and/or shortness of breath. Always keep a short-acting asthma medication such as albuterol on hand for asthma attacks.

Do not treat yourself for coughs, colds or allergies without checking with your pharmacist or prescriber. Non-prescription medicines may contain ingredients that will increase the effects of your medicine.

If you are going to have surgery tell your prescriber or health care professional that you are using formoterol.

 Where can I keep my medicine?

Keep out of the reach of children.

Store at room temperature, 20 to 25 degrees C (68 to 77 degrees F). Protect from heat and moisture. Throw away any unused medicine after the expiration date. Only remove capsules from the blister pack immediately before use. After the "use by" date has expired on the outside of your formoterol box, discard both the inhaler and the capsules and get a fresh supply.

 NOTE: This information is not intended to cover all possible uses, precautions, interactions, or adverse effects for this drug. If you have questions about the drug(s) you are taking, check with your health care professional.