Formoterol (for-MOE-ter-ol)

Prevents asthma attacks and exercise-induced bronchospasm (EIB). Also treats breathing problems caused by chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This medicine is a bronchodilator.

Brand Name(s):

Foradil Aerolizer, Perforomist

When This Medicine Should Not Be Used:

How to Use This Medicine:

Powder Under Pressure, Capsule, Liquid

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• You will use the capsule with a special inhaler device called an Aerolizer®. Do not swallow the capsule. Place the capsule into the chamber at the base of the Aerolizer® inhaler. This device opens the capsule and loads the powder medicine from the capsule into the air chamber. You then inhale the powder through the mouthpiece. Your caregiver will show you how to use your inhaler.
• You will use the solution with an inhaler device called a jet nebulizer connected to an air compressor. The nebulizer turns the medicine into a fine mist that you breathe in through your mouth. Do not swallow the solution. Do not mix any other medicines with the solution. To use:
  • Remove the vial from the pouch.
  • Place the inhalation solution in the medicine reservoir or nebulizer cup on the machine.
  • Connect the nebulizer to the face mask or mouthpiece, then connect the nebulizer to the compressor.
  • To inhale the medicine, place the mouthpiece in your mouth, then turn on the compressor. Breathe in deeply and steadily until no more mist is formed in the nebulizer reservoir.
  • Use the nebulizer for about 9 minutes, or until the medicine in the nebulizer cup is gone.
  • Clean the nebulizer after each use.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose or forget to use your medicine, skip the missed dose and return to your regular dosing schedule. Do not take 2 doses at once. Do not use more than 2 vials of Perforomist® per day.
• Capsule: Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze. Keep the inhaler and the capsules dry. With dry hands, remove capsules from the pouch just before use.
• Solution: Store the solution in the refrigerator. You may also keep it at room temperature, away from direct heat or light for up to 3 months. Throw away any unused solution after 3 months.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with similar inhaled medicines, including arformoterol, budesonide/formoterol, indacaterol, salmeterol, or salmeterol/fluticasone.
• Some medicines can affect how formoterol works. Tell your doctor if you are using any of the following:
  • Aminophylline, arsenic trioxide, dofetilide, theophylline
  • Beta-blocker medicine
  • Diuretic (water pill)
  • Medicine to treat depression (including an MAO inhibitor, TCAs)
  • Medicine to treat infection (including azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, sparfloxacin)
  • Steroid medicine

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart or blood vessel disease (including aneurysm), heart rhythm problems, high blood pressure, angina (severe chest pain), adrenal gland problem (including pheochromocytoma), diabetes, epilepsy or seizures, electrolyte imbalance, or thyroid problems.
• This medicine may cause the following problems:
  • Increased risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma who take Perforomist® without an inhaled steroid
  • Paradoxical bronchospasm (trouble breathing right after use), which can be life-threatening
  • High blood pressure
  • Heart rhythm problems
  • High blood sugar levels
• This should not be the first and only medicine you use for asthma or COPD. This medicine will not stop an asthma or COPD attack that has already started. Your doctor may prescribe another medicine for an acute asthma attack or an acute COPD flare-up. If the other medicine does not work as well, tell your doctor right away.
• The powder in the capsule contains trace amounts of milk proteins. Make sure your doctor knows if you have a severe milk protein allergy.
• If any of your asthma medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.
• If you use a corticosteroid medicine to control your asthma, keep using it as instructed by your doctor.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, fast, pounding, or uneven heartbeat
• Dry mouth, muscle cramps, nausea, vomiting
• Increased hunger, thirst, or urination, weight loss
• Increased trouble breathing
• Lightheadedness, dizziness, fainting
• Seizures or tremors

If you notice these less serious side effects, talk with your doctor:

• Fever, headache, stuffy or runny nose, sore throat, sneezing

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088