Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance

Fluticasone-salmeterol 250/50 mcg: 1 inhalation orally twice a day, approximately 12 hours apart

Comments:

• If shortness of breath occurs in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.
• Fluticasone 250 mcg-salmeterol 50 mcg is the only approved dosage for the treatment of COPD; higher doses are not recommended, as advantage of the higher strength has not been demonstrated.

Uses: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema; to reduce exacerbations of COPD in patients with a history of exacerbations

Usual Adult Dose for Asthma - Maintenance

Inhalation Powder:

• Fluticasone-salmeterol 100/50 mcg, 250/50 mcg, or 500/50 mcg: 1 inhalation orally twice a day
• Maximum dose: Fluticasone 500 mcg-salmeterol 50 mcg orally twice a day

Inhalation Aerosol:

• Fluticasone-salmeterol 45/21 mcg, 115/21 mcg, or 230/21 mcg: 2 inhalations orally twice a day
• Maximum dose: Fluticasone 230 mcg-salmeterol 31 mcg orally twice a day

Comments:

• Inhalations should be administered approximately 12 hours apart.
• Initial dose should be based on the patient's asthma severity.
• If shortness of breath occurs in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.
• Improvement in asthma control occurs within 30 minutes of beginning treatment; maximum benefit can take 1 week or longer.
• The inhalation dose can be increased if response does not improve after 2 weeks of therapy.
• If previously effective dose fails to improve asthma control, reevaluate treatment and consider additional therapies (e.g., adding additional inhaled or oral corticosteroid).

Uses: Treatment of asthma in patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA

Usual Pediatric Dose for Asthma - Maintenance

Inhalation Powder:
Less than 4 years: Not recommended.

4 years to 11 years:

• Fluticasone-salmeterol 100/50 mcg: 1 inhalation orally twice a day

12 years or older:

• Fluticasone-salmeterol 100/50 mcg, 250/50 mcg, or 500/50 mcg: 1 inhalation orally twice a day
• Maximum dose: Fluticasone 500 mcg-salmeterol 50 mcg orally twice a day

Inhalation Aerosol:
Less than 12 years: Use is not approved.

12 years and older:

• Fluticasone-salmeterol 45/21 mcg, 115/21 mcg, or 230/21 mcg: 2 inhalations orally twice a day

Comments:

• Inhalations should be administered approximately 12 hours apart.
• Initial dose should be based on the patient's asthma severity.
• If shortness of breath occurs in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.
• Improvement in asthma control occurs within 30 minutes of beginning treatment; maximum benefit can take 1 week or longer.
• The dose can be increased if response does not improve after 2 weeks of therapy.
• If previously effective dose fails to improve asthma control, reevaluate treatment and consider additional therapies (e.g., adding additional inhaled or oral corticosteroid).

Uses: Treatment of asthma in patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Use with caution.

Dose Adjustments

• Titrate to the lowest dose that maintains symptoms control.
• Once control of asthma is achieved and maintained, assess the patient regularly and step down therapy (e.g., 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.
• If asthma remains poorly controlled the total daily dose of the inhaled corticosteroid can be increased by administering a higher strength of this combination product.
• No adjustment is needed in geriatric patients.

Precautions

Inhalation Powder: Safety and efficacy have not been established in patients younger than 4 years.

Inhalation Aerosol: Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Rinse mouth with water without swallowing after each inhalation to reduce the risk of oropharyngeal candidiasis.
• Increasing the recommended dose can increase the risk of adverse effects with higher doses of salmeterol.
• This drug should not be used with other products containing LABA.
• Prime the inhalation aerosol before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. If the inhaler has not been used for more than 4 weeks or when it has been dropped, prime the inhaler again by releasing 2 sprays into the air away from the face, shaking well for 5 seconds before each spray.

General:

• Limitation of Use: This drug is not indicated for the relief of acute bronchospasm.
• This drug should not be used to relieve of acute symptoms; the use of short acting inhaled bronchodilator is recommended for these situations.
• Only the inhalation powder fluticasone 250 mcg-salmeterol 50 mcg is indicated for the treatment of COPD.

Monitoring:

• Ocular: Changes in vision, intraocular pressure, glaucoma, cataracts
• Pediatric: Growth
• Respiratory: Lung function tests, bronchospasm, signs and symptoms of pneumonia

Patient advice:

• This drug is not indicated relieve acute asthma symptoms or exacerbations of COPD and extra doses should not be used for that purpose.
• Patients should seek medical attention immediately if they experience decreasing effectiveness of inhaled, short-acting beta2-agonists; need for more inhalations than usual dose of inhaled, short-acting beta2-agonists; significant decrease in lung function.
• Therapy with this drug should not be discontinued without medical advice as symptoms may recur after discontinuation.
• Patients should consider regular eye exam.

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