In the U.S.—

In Canada—

• Bronchodilator, adrenergic (inhalation)

Formoterol (for–MOE–tur–all ) belongs to the family of medicines known as β ₂-agonists. It is used to help prevent the symptoms of asthma. When used regularly every day, inhaled formoterol decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Inhaled formoterol works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.

This medicine should be taken with other asthma medicines known as corticosteroids

Formoterol is also used for patients with COPD (Chronic Obstructive Pulmonary Disease). These are diseases such as chronic bronchitis and emphysema.

This medicine is available only with your doctor's prescription, in the following dosage form:

Inhalation
• Capsule for inhalation (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For formoterol, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to formoterol or inhaled lactose. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Formoterol has not been studied in pregnant women. However, animal studies have shown an increase in the number of birth defects and other negative effects on the fetus

Breast-feeding—It is not known if inhaled formoterol is distributed in human breast milk. However, it is distributed in rat milk. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine been done only in patients 5 years of age and older, and there is no specific information comparing use of formoterol in children less than 5 years of age with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking formoterol, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Antidepressants, tricyclic (amitriptyline [e.g. Elavil], amoxapine [e.g. Asendin], clomipramine [e.g. Anafranil], desipramine [e.g. Norpramin], doxepin [e.g. Adapin, Sinequan, or Zonalon], imipramine [e.g., Tofranil], nortriptyline [e.g. Aventyl or Pamelor], protriptyline [e.g. Vivactil]) or
• Disopyramide (e.g. Norpace) or
• Monoamine oxidase inhibitors (furazolidine [e.g., Furoxone], isocarboxazid [e.g. Marplan], phenelzine [e.g. Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g. Parnate]) or
• Phenothiazines (chlorpromazine [e.g. Thorazine], haloperidol [e.g. Haldol], methdilazine [e.g. Tacaryl], prochlorperazine [e.g. Compazine], promethazine [e.g. Phenergan], trimeprazine [e.g. Temaril]) or
• Procainamide (e.g. Procan SR, Procanbid, or Pronestyl) or
• Quinidine (e.g. Quinaglute) or

• Beta-receptor blocking agents (acebutolol [e.g. Sectral], atenolol [e.g. Tenormin], betoxolol [e.g. Frisium], bisoprolol [e.g. Zebeta], carteolol [e.g. Cartrol or Ocupress], carvedilol [e.g. Coreg], esmolol [e.g. Brevibloc], labetalol [e.g. Normodyne or Trandate], metoprolol [e.g. Lopressor or Toprol XL], nadolol [e.g. Corgard], oxprenolol [e.g. Trasicor], penbutolol [e.g. Levatol], pindolol [e.g. Visken], propranolol [e.g. Inderal], sotalol [e.g. Betapace], or timolol [e.g. Blocadren or Timoptic]

• Acutely deteriorating asthma

• Blocked heart or
• High blood pressure or
• Irregular heartbeat or
• Structural problems with the heart or
• Weak heart, unable to circulate blood effectively—Risk of increased side effects

• Diabetes—Risk of increased side effects

• Overactive thyroid
• Seizures or
• Strong response to this kind of medicine—Risk of increased side effects

Dosing—

Inhaled formoterol is used to prevent asthma attacks. It is not used to relieve an attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your health care professional.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

Inhaled formoterol is used with a special inhaler and usually comes with patient directions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your health care professional to show you what to do. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.

Do not wash and reuse your inhaler. Use a new inhaler with each refill of your medicine.

Do not use a spacer with this medicine.

Do not exhale into your inhaler.

Do not use the inhaler for this medicine with any other medicine.

Dry your hands before handling this medicine.

The dose of formoterol will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of formoterol. If your dose is different, do not change it unless your doctor tells you to do so.

The number of inhaled doses that you take depends on the strength of the medicine.

• For inhalation:
  • Adults and children 5 years of age and older— 12 mcg by oral inhalation every 12 hours
  • Children younger than 6 years of age—use and dose must be determined by your doctor

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any blood or heart problems that may be caused by this medicine.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

You may also be taking an anti-inflammatory medicine along with this medicine.Do not stop taking the anti-inflammatory medicine even if your asthma seems better, unless you are told to do so by your doctor

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• More Common
  • Chills;  cold or flu-like symptoms;  cough or hoarseness;  fever;  sneezing ;  sore throat 
  
  

• Less Common
  • Body aches or pain;  chest pain or discomfort ;  congestion;  cough producing mucous;  difficulty breathing;  dry throat;  headache;  labored breathing;  pain or tenderness around eyes and cheekbones ;  runny nose;  shortness of breath;  tender, swollen glands in neck;  tightness in chest;  trauma;  trouble swallowing;  voice changes;  wheezing 
  
  

• Rare
  • Convulsions;  decreased urine;  dry mouth;  fainting;  fast pounding, or irregular heartbeat or pulse palpitations;  increased thirst;  irregular heartbeat ;  loss of appetite ;  noisy breathing 
  
  

• Symptoms of Overdose

  Get emergency help immediately if any of the following symptoms of overdose occur

  • Arm, back or jaw pain;  blurred vision ;  chest tightness or heaviness;  convulsions;  decreased urine;  dizziness or light-headedness;  dry mouth;  fainting;  fast or irregular heartbeat ;  fatigue;  general feeling or discomfort or illness;  headache;  increased hunger or thirst;  increased urination;  loss of appetite;  mood changes;  muscle pain or cramps;  muscle spasm or jerking of all extremities;  nausea;  nervousness;  no blood pressure or pulse;  numbness or tingling in hands, feet or lips;  palpitations or pounding in the ears;  pounding or racing heartbeat or pulse;  shortness of breath;  sleeplessness;  slow heartbeat;  stopping of heart;  sudden loss of consciousness;  sweating ;  troubled breathing;  trouble sleeping;  unable to sleep;  unconsciousness;  unusual tiredness or weakness;  vomiting 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Headache 
  
  

• Less Common
  • Agitation;  anxiety;  back pain;  cramps;  dizziness ;  hives or welts ;  increased mucous in throat and lungs;  itching;  redness of skin;  restlessness;  shakiness in legs, arms, hands, feet;  skin rash;  sleeplessness;  trembling or shaking of hands or feet;  trouble sleeping ;  unable to sleep