Beclomethasone Dipropionate

What it is and how it works

Mechanism of Action Beclomethasone dipropionate is a corticosteroid demonstrating potent anti-inflammatory activity. The precise mechanism of corticosteroid action on asthma is not known. Corticosteroids have been shown to have multiple anti-inflammatory effects, inhibiting both inflammatory cells (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and release of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines). These anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma.

Indications

Beclomethasone dipropionate HFA inhalation aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important Limitations of Use: Beclomethasone dipropionate HFA inhalation aerosol is NOT indicated for the relief of acute bronchospasm. Beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid indicated for: Maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important Limitations: Not indicated for the relief of acute bronchospasm.

Dosage and administration (summary)

For oral inhalation only. Starting dosage is based on prior asthma therapy and disease severity. Treatment of asthma in patients 12 years and older: 40 mcg, 80 mcg, 160 mcg, or 320 mcg twice daily. Treatment of asthma in patients 5 to 11 years of age: 40 or 80 mcg twice daily. Discard beclomethasone dipropionate HFA inhalation aerosol inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first. Administration Information Administer beclomethasone dipropionate HFA inhalation aerosol by the orally inhaled route in patients 5 years of age and older. Beclomethasone dipropionate HFA inhalation aerosol does not require shaking prior to use.

Contraindications

Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to any of the ingredients of beclomethasone dipropionate HFA inhalation aerosol. Status Asthmaticus Beclomethasone dipropionate HFA inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

Warnings and precautions

Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth with water without swallowing after inhalation. Deterioration of asthma and acute episodes: Do not use beclomethasone dipropionate HFA inhalation aerosol for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids.

Pregnancy

Pregnancy Risk Summary There are no adequate and well-controlled studies with beclomethasone dipropionate HFA inhalation aerosol or beclomethasone dipropionate in pregnant women. There are clinical considerations with the use of inhaled corticosteroids (ICS), including beclomethasone dipropionate, in pregnant women .

Storage and supply

How Supplied Beclomethasone dipropionate HFA inhalation aerosol is supplied in 2 strengths: Beclomethasone dipropionate HFA inhalation aerosol 40 mcg is available in a box of one 8.7 g canister containing 120 actuations with a beige plastic actuator with a dose counter and light blue dust cap, and Patient Information and Instructions for Use.

Source: Beclomethasone Dipropionate (Beclomethasone Dipropionate) — US FDA prescribing information, 2020-07-31, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.