Introduction

Synthetic corticosteroid; minimal mineralocorticoid activity.

Uses for Beclomethasone (Systemic, Oral Inhalation)

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)^{† [off-label]} 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^{† [off-label]} (e.g., inflammatory bowel disease^{† [off-label]}, eosinophilic gastroenteritis^{† [off-label]}). However, the role of beclomethasone dipropionate in the management of inflammatory conditions of the GI tract remains to be established.

Beclomethasone (Systemic, Oral Inhalation) 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• Death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly.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 not 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.

Contraindications

• Primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids) are required.

• Known hypersensitivity to the drug or any ingredient in the formulation.

Warnings/Precautions

Warnings

Withdrawal Of Systemic Corticosteroid Therapy

Possible corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression); acute adrenal insufficiency; life-threatening exacerbation of asthma; pulmonary infiltrates with eosinophilia; or symptomatic exacerbation of allergic conditions if prolonged systemic corticosteroid therapy is replaced with oral inhalation corticosteroid therapy. Such symptoms may be observed especially in patients maintained on ≥20 mg of prednisone (or its equivalent) daily and particularly during the later part of the transfer.

In general, the greater the dosage and duration of systemic corticosteroid therapy, the greater the time required for withdrawal of systemic corticosteroids and replacement by orally inhaled corticosteroids.

Taper the dosage of the systemic corticosteroid, and carefully monitor patients during dosage reduction for objective signs of adrenal insufficiency (e.g., hypotension, weight loss).

Immunosuppressed Patients

Increased susceptibility to infections in patients who are taking immunosuppressant drugs compared with healthy individuals. Certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients, particularly in children.

Exposure to varicella and measles should be avoided in previously unexposed patients. If exposure to varicella (chickenpox) or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or immune globulin (IG), respectively. Consider treatment with an antiviral agent if varicella develops.

Concomitant Therapy

Use with caution in patients receiving systemic prednisone for any disease. Concomitant use with prednisone in an alternate-day or daily dosing regimen could increase the likelihood of HPA-axis suppression compared with therapeutic dosages of either drug alone.

Resume systemic corticosteroids during periods of stress (e.g., infection, trauma, surgery) or a severe asthma exacerbation in patients who were attempting a switch from systemic to orally inhaled corticosteroid therapy.

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

Avoid higher than recommended dosages of the drug, since suppression of HPA function may occur. If higher than recommended dosages are used, carefully consider the relative risks of adrenal suppression and potential therapeutic benefits. Recommended dosages of orally inhaled drug provide less than normal physiologic amounts of glucocorticoid systemically and do not provide mineralocorticoid activity. Orally inhaled drug will not compensate for insufficient endogenous cortisol production caused by previous systemic corticosteroid therapy.

Respiratory Effects

Bronchospasm, cough, and/or wheezing may occur, especially in asthmatic patients with hyperactive airways.

If bronchospasm occurs, treat immediately with a short-acting bronchodilator, and discontinue treatment with beclomethasone dipropionate and institute alternative therapy.

Infection

Use with caution, if at all, in patients with clinical tuberculosis or latent M. tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, or parasitic infections; or ocular herpes simplex or untreated, systemic viral infections.

Sensitivity Reactions

Immediate or delayed hypersensitivity reactions, including bronchospasm, anaphylactic/anaphylactoid reactions, urticaria, angioedema, and rash reported rarely.

General Precautions

Systemic Corticosteroid Effects

Possible signs and symptoms of Cushing’s syndrome (e.g., hypertension, glucose intolerance, cushingoid features) in patients who are particularly sensitive to corticosteroid effects or when usual dosages of the drug are exceeded.

Carefully monitor neonates exposed to prenatal corticosteroids for manifestations of hypoadrenalism.

Ocular Effects

Glaucoma, increased intraocular pressure, and cataracts reported rarely.

Other Effects

Unknown long-term, systemic, and local effects of the drug in humans, particularly developmental or immunologic processes in the mouth, pharynx, trachea, and lung.

Specific Populations

Pregnancy

Category C. (See Systemic Corticosteroid Effects under Cautions.)

Lactation

Distributed into milk. Discontinue nursing or the drug.

Pediatric Use

Safety and efficacy not established in children <5 years of age. No overall differences in the pattern, severity, or frequency of adverse events in children 5–12 years of age compared with those in adults. Monitor periodically children receiving prolonged therapy for possible adverse effects on growth and development.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.

Use caution due to the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in geriatric patients. (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Headache, pharyngitis, upper respiratory tract infection, rhinitis.

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 not 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.

Metabolized by CYP3A4.

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP3A4: potential pharmacokinetic interaction (increased plasma beclomethasone dipropionate concentrations).

Inducers of CYP3A4: potential pharmacokinetic interaction (decreased plasma beclomethasone dipropionate concentrations).

Specific Drugs