SPL Set ID: ccd3aaec-4892-40d0-ad60-3e570178fbe1

The active component of QVAR REDIHALER 40 mcg Inhalation Aerosol and QVAR REDIHALER 80 mcg Inhalation Aerosol is beclomethasone dipropionate, USP, a corticosteroid having the chemical name 9-chloro-11ß,17,21-trihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. Beclomethasone dipropionate is a diester of beclomethasone, a synthetic corticosteroid chemically related to dexamethasone. Beclomethasone differs from dexamethasone in having a chlorine at the 9‑alpha carbon in place of a fluorine, and in having a 16‑beta-methyl group instead of a 16‑alpha-methyl group. Beclomethasone dipropionate is a white to creamy white, odorless powder with a molecular formula of C 28 H 37 ClO 7 and a molecular weight of 521.1. Its chemical structure is: Chemical Structure QVAR REDIHALER is a pressurized, breath‑actuated, metered‑dose aerosol with a dose counter intended for oral inhalation only. Each unit consists of a sealed breath‑actuated inhaler device enclosing a canister containing a solution of beclomethasone dipropionate in propellant HFA‑134a (1,1,1,2 tetrafluoroethane) and ethanol (0.85 g). QVAR REDIHALER 40 mcg delivers 40 mcg of beclomethasone dipropionate from the actuator mouthpiece and 50 mcg from the canister valve. QVAR REDIHALER 80 mcg delivers 80 mcg of beclomethasone dipropionate from the actuator mouthpiece and 100 mcg from the canister valve. Both products deliver 50 microliters (59 milligrams) of solution formulation as an aerosol from the canister valve with each actuation. The 40‑mcg canisters and the 80‑mcg canisters provide 120 inhalations each. Since the QVAR REDIHALER canister is fitted with a primeless valve, no priming actuations are required before use. For both products, an actuation was always triggered by a 20 L/min inspiratory flow rate. structure