Usual Adult Dose for Asthma - Maintenance

50 mcg (1 inhalation) orally twice a day, approximately 12 hours apart.

Comments:

• Reevaluate the therapeutic regimen if a previously effective dosage fails to provide the usual response, as this is often a sign of destabilization of asthma.
• If symptoms arise in the period between doses, an inhaled, short-acting beta2-­agonist should be taken for immediate relief.

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

Usual Adult Dose for Bronchospasm Prophylaxis

Prevention of Exercise Induced Bronchospasm (EIB):

• 50 mcg (1 inhalation) orally at least 30 minutes before exercise

• Protection may last up to 9 hours when used intermittently as needed for prevention.
• Additional doses should not be taken for 12 hours.
• Patients receiving twice daily doses for the treatment of asthma should not use additional doses for the prevention of EIB.

• For the prevention of EIB, as a single agent, in patients with no persistent asthma.
• In patients with persistent asthma use of this drug for the prevention of EIB may be clinically indicated, but the treatment of asthma should include a long-term asthma control medication, such as an inhaled corticosteroid.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance

50 mcg (1 inhalation) orally twice daily, approximately 12 hours apart

Use: Long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis

Usual Pediatric Dose for Asthma - Maintenance

Less than 4 years: Not approved.

4 years or older: 50 mcg (1 inhalation) orally twice a day, approximately 12 hours apart

Comments:

• 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.

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

Usual Pediatric Dose for Bronchospasm Prophylaxis

Prevention of Exercise Induced Bronchospasm:

• Less than 4 years: Not approved.
• 4 years or older: 50 mcg (1 inhalation) orally at least 30 minutes before exercise

• Protection may last up to 9 hours in adolescents and up to 12 hours in pediatrics aged 4 to 11 years, when used intermittently as needed for prevention.
• Additional doses should not be used for 12 hours.
• Patients receiving twice daily doses for the treatment of asthma should not use additional doses for the prevention of EIB.

• For the prevention of EIB, as a single agent in patients with no persistent asthma
• In patients with persistent asthma use of this drug for the prevention of EIB may be clinically indicated, but the treatment of asthma should include a long-term asthma control medication, such as an inhaled corticosteroid.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Use with caution.

Precautions

US BOXED WARNINGS:
ASTHMA-RELATED DEATH:

• Long-acting beta2-adrenergic agonists (LABA), such as this drug, as monotherapy without an inhaled corticosteroid (ICS) increase the risk of asthma-related death.
• A U.S. trial showed an increase in asthma-related deaths in subjects receiving this drug (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 out of 13,179 subjects on placebo); background ICS use was not required in this study.
• Large clinical trials se of LABA in fixed-dose combination with ICS do not show significant increases in serious asthma-related events compared with ICS monotherapy. -Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA.
• This drug should be prescribed only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., gradually discontinue this drug) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. -Do not use this drug for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.
• Available data from controlled clinical trials suggest that LABA monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients.
• Pediatric and adolescent asthma patients who require a LABA in addition to an ICS, fixed-dose combination ICS and LABA products ensure adherence to both medications; take steps to ensure adherence with both components. If adherence is not assured, a fixed- dose combination ICS and LABA product is recommended.

• Treatment of asthma without concomitant use of an inhaled corticosteroid
• Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures
• Severe hypersensitivity to milk proteins

Dialysis

Data not available

Other Comments

Administration advice:

• For oral inhalation only.
• This drug should not be used more often or at doses higher than recommended.
• If a dose is missed, skip that dose and take the next dose at the usual time. Do not take 2

• Consult the manufacturer product information for instructions on how to use the inhaler.

• Store in a dry place away from direct heat or sunlight.
• Store inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use.

• 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.

• 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.
• Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
• Concomitant asthma therapy should not be stopped or reduced without medical advice.
• Other LABA should not be used when using this drug.