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Drug Description
DESCRIPTION
Budesonide, the active ingredient of RHINOCORT AQUA ª Nasal Spray, is an anti-inflammatory synthetic corticosteroid. It is designated chemically as (RS)-11-beta, 16-alpha, 17, 21-tetrahydrox-ypregna-1, 4-diene-3,20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide is provided as the mixture of two epimers (22R and 22S). The empirical formula of budesonide is C 25 H 34 O 6 and its molecular weight is 430.5. Text Continues Below
Budesonide is a white to off-white, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 5 is 1.6 x 10 3 . RHINOCORT AQUA is an unscented, metered-dose, manual-pump spray formulation containing a micronized suspension of budesonide in an aqueous medium. Microcrystalline cellulose and carboxymethyl cellulose sodium, dextrose anhydrous, polysorbate 80, disodium edetate, potas-sium sorbate and purified water are contained in this medium; hydrochloric acid is added to adjust the pH to a target of 4.5. RHINOCORT AQUA Nasal Spray delivers 32 mcg of budesonide per spray. Each bottle of RHINOCORT AQUA Nasal Spray 32 mcg contains 120 metered sprays after initial priming. Prior to initial use, the container must be shaken gently and the pump must be primed by actuating eight times. If used daily, the pump does not need to be reprimed. If not used for two consecutive days, reprime with one spray or until a fine spray appears. If not used for more than 14 days, rinse the applicator and reprime with two sprays or until a fine spray appears.
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