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Uses

Asthma

Used for the long-term prevention of bronchospasm in patients with asthma.

Should not be used in the treatment of nonasthmatic bronchitis.

Chronic Obstructive Pulmonary Disease

Efficacy in patients with chronic obstructive pulmonary disease (e.g., bronchitis)† who are stabilized with oral corticosteroids or whose disease is corticosteroid responsive remains to be fully evaluated.

Inflammatory Conditions of the GI Tract

Has been used as an oral solution or rectal suspension (these dosage forms not commercially available in the US) in the management of inflammatory diseases of the GI tract† (e.g., inflammatory bowel disease†, eosinophilic gastroenteritis†). However, the role of beclomethasone dipropionate in the management of inflammatory conditions of the GI tract remains to be established.

Dosage and Administration

General

• Adjust dosage carefully according to individual requirements and response.
• After a satisfactory response is obtained, decrease dosage gradually to the lowest dosage that maintains an adequate clinical response. Achieve the lowest effective dosage, particularly in children, since inhaled corticosteroids have the potential to affect growth. (See Pediatric Use under Cautions.)

Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids

• When switching from systemic corticosteroids to orally inhaled beclomethasone dipropionate, asthma should be reasonably stable before initiating treatment with the oral inhalation.
• Initially, administer the aerosol concurrently with the maintenance dosage of the systemic corticosteroid. After about 1 week, gradually withdraw the systemic corticosteroid.
• Death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly. (See Withdrawal of Systemic Corticosteroid Therapy under Warnings.)
• If exacerbations of asthma occur after transfer to oral inhalation therapy, administer short courses of systemic corticosteroids, then taper dosage as symptoms subside.

Administration

Oral Inhalation

Administer by oral inhalation using an oral aerosol inhaler.

Test-spray inhalation aerosol (2 times) before first use or whenever the aerosol has not been used for prolonged periods (>10 days).

Oral inhalation aerosol is formulated as a solution, which does not require shaking.

Exhale slowly and completely and place the mouthpiece of the inhaler well into the mouth with the lips closed firmly around it; keep the tongue below the mouthpiece. Inhale slowly and deeply through the mouth while actuating the inhaler. Hold the breath for as long as possible (about 5–10 seconds), withdraw the mouthpiece, and exhale gently. If additional inhalations are required, repeat the procedure.

Rinse the mouth thoroughly with water to remove drug deposited in the oropharyngeal area.

Clean the mouthpiece weekly using a clean, dry tissue or cloth. Do not wash or place any part of the inhaler canister in water.

Dosage

Available as beclomethasone dipropionate; dosage expressed in terms of the salt.

Oral inhalation aerosol releases 50 or 100 mcg of beclomethasone dipropionate, and delivers 40 or 80 mcg, respectively, from the actuator (mouthpiece) per metered spray.

Pediatric Patients

Asthma

Oral Inhalation

Children 5–11 years of age receiving bronchodilators alone or inhaled corticosteroids previously: Initially, 40 mcg twice daily. If required, dosage may be increased to a maximum 80 mcg twice daily.

Children ≥12 years of age receiving bronchodilators alone previously: Initially, 40–80 mcg twice daily. If required, dosage may be increased to a maximum 320 mcg twice daily.

Children ≥12 years of age receiving inhaled corticosteroids previously: Initially, 40–160 mcg twice daily. If required, dosage may be increased to a maximum 320 mcg twice daily.

Adults

Asthma

Oral Inhalation

In adults receiving bronchodilators alone previously: Initially, 40–80 mcg twice daily. If required, dosage may be increased to a maximum 320 mcg twice daily.

Adults receiving inhaled corticosteroids: Initially, 40–160 mcg twice daily. If required, dosage may be increased to a maximum of 320 mcg twice daily.

Prescribing Limits

Pediatric Patients

Asthma

Oral Inhalation

Children 5–11 years of age: Maximum 80 mcg twice daily.

Children ≥12 years of age: Maximum 320 mcg twice daily.

Adults

Asthma

Oral Inhalation

Maximum 320 mcg twice daily.

Special Populations

Geriatric Patients

Consider initial dosages at the lower end of the usual range due to possible age-related decrease in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.