Usual Adult Dose for Bronchospasm Prophylaxis

Prevention of Exercise-Induced Bronchospasm (EIB):
Formoterol inhalation capsule:

• 12 mcg (1 inhalation) orally using the aerolizer inhaler at least 15 minutes before exercise as needed.

• Protection may last up to 12 hours when used intermittently as needed for prevention.
• Additional doses should not be taken for 12 hours.
• Regular, twice-daily dosing has not been studied in preventing EIB.
• Patients receiving a twice daily dose for treatment of asthma should not use additional doses for prevention of EIB; a short-acting bronchodilator may be required.

• 6 mcg or 12 mcg before exercise
• Maximum dose: 48 mcg within a 24-hour period

• Acute prevention of EIB when administered on an occasional, as-needed basis.
• Use as a single agent for the prevention of EIB in patients who do not have persistent asthma.
• For the prevention of EIB in patients with persistent asthma on a long-term asthma control medication treatment, such as an inhaled corticosteroid.

Usual Adult Dose for Asthma - Maintenance

Formoterol 12 mcg inhalation capsule:

• 12 mcg (1 inhalation) orally every 12 hours using the aerolizer inhaler
• Maximum dose: 24 mcg daily

• 6 mcg or 12 mcg inhaled orally every 12 hours
• Maximum dose: 24 mcg twice a day (total of 48 mcg daily)

• More frequent administration or administration of a larger number of inhalations is not recommended.
• If symptoms arise between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.
• The inhalation powder is available in two strengths, 6 mcg or 12 mcg per inhalation. Use the higher strength when doses of 12 mcg or more, twice daily, are required.

• Treatment of asthma
• Prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in patients with reversible obstructive airways disease, including symptoms of nocturnal asthma.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance

Formoterol 12 mcg inhalation capsule:

• 12 mcg (1 inhalation) orally every 12 hours using the aerolizer inhaler
• Maximum daily dosage: 24 mcg

• One 20 microgram/2 mL unit dose vial orally via jet nebulizer with a facemask or mouthpiece twice a day.

• The twice daily dose should be administered in the morning and evening.
• The efficacy and safety of the inhalation solution when mixed with other drugs in a nebulizer have not been established.
• Seek medical advice if the recommended maintenance treatment regimen fails to provide the usual response, as this is often a sign of destabilization of COPD. Re-evaluate current treatment and consider additional therapeutic options.

• Long-term maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Usual Pediatric Dose for Bronchospasm Prophylaxis

Prevention of Exercise-Induced Bronchospasm (EIB):
Formoterol 12 mcg inhalation capsule:
Less than 5 years: Not approved.
5 years or older:

• 12 mcg (1 inhalation) orally using the aerolizer inhaler at least 15 minutes before exercise as needed.

• Protection may last up to 12 hours when used intermittently as needed for prevention.
• Additional doses should not be taken for 12 hours.
• Regular, twice-daily dosing has not been studied in preventing EIB.
• Patients receiving a twice daily dose for treatment of asthma should not use additional doses for prevention of EIB and may require a short-acting bronchodilator.

• 6 mcg or 12 mcg inhaled orally before exercise
• Maximum dose: 24 mcg within a 24-hour period

• Acute prevention of EIB when administered on an occasional, as-needed basis.
• Use as a single agent for the prevention EIB in patients who do not have persistent asthma.
• For the prevention of EIB in patients with persistent asthma on a long-term asthma control medication treatment, such as an inhaled corticosteroid.

Usual Pediatric Dose for Asthma - Maintenance

Formoterol 12 mcg inhalation capsule:
Less than 5 years: Not approved.
5 years or older:

• 12 mcg (1 inhalation) orally every 12 hours using the aerolizer inhaler
• Maximum dose: 24 mcg daily

• 6 mcg or 12 mcg inhaled orally every 12 hours
• Maximum dose: 12 mcg twice a day (total of 24 mcg daily)

• 6 mcg or 12 mcg inhaled orally every 12 hours
• Maximum dose: 24 mcg twice a day (total of 48 mcg daily)

• For patients with asthma less than 18 years of age requiring addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should be used to ensure adherence with both drugs.
• If the use of a separate long-term asthma control medication (e.g., inhaled corticosteroid) and LABA is clinically indicated, take appropriate steps to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and LABA is recommended.
• The inhalation powder is available in two strengths, 6 mcg or 12 mcg per inhalation. Use the higher strength when doses of 12 mcg or more, twice daily, are required.

• Treatment of asthma
• Prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in patients with reversible obstructive airways disease, including symptoms of nocturnal asthma.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Use of a long-acting beta-2 (LABA) agonist without an inhaled corticosteroid (ICS) in asthma patients; this drug is not indicated for asthma treatment

Dialysis

Data not available

Other Comments

Administration advice:

• For oral inhalation only.
• If a dose is missed, skip that dose and take the next dose at the usual time.
• Consult the manufacturer product information for instructions on how to use the aerolizer inhaler, turbuhaler device, and/or the nebulizer.

• Administer only using the aerolizer inhaler; capsules should not be swallowed.
• Store in the blister and only removed immediately before use.
• Capsules should be handled with dry hands.

• The turbuhaler device delivers the drug to the lungs as the patient inhales; the patient should breathe in forcefully and deeply through the mouthpiece.
• The patient may not taste or feel any medication when using this device due to the small amount of drug dispensed.
• Avoid exhaling into the device and always replace the cover after using this device.

• Administer via standard jet nebulizer connected to an air compressor with an adequate airflow and equipped with a facemask or mouthpiece.
• Vial should always be stored in the foil pouch and only removed immediately before use.
• Content of the vial should not be taken by mouth.
• Contents of any partially used container should be discarded.
• Throw the plastic dispensing container away immediately after use.
• The safety and efficacy of the inhalation solution delivered from non-compressor based nebulizer systems have not been established.

• Avoid exposing the inhalation capsules to moisture.
• The inhalation capsule is less likely to shatter when pierced if: Storage conditions are strictly followed, capsules are removed from the blister immediately before use, and the capsules are only pierced once.

• This drug should only be used with a long-term asthma control medicine, such as an inhaled corticosteroid; it should not be used as the only asthma medicine.
• Patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids should not use this drug.

• This drug is not indicated for the relief of acute bronchospasm and to treat acute deteriorations of chronic obstructive pulmonary disease (COPD).
• The safety and effectiveness of the inhalation solution in asthma have not been established and it is not indicated to treat asthma.

• Cardiac monitoring is recommended in cases of overdosage.

• Patients should seek immediate attention if their condition deteriorates.
• Dose or frequency should not be increased without consulting the prescribing physician.
• Concomitant asthma therapy should not be stopped or reduced without medical advice.
• Other LABA should not be used when using this drug.