SPL Set ID: 947644ea-bc35-41df-8a7a-874360c90192

1 drug(s) with this SPL Set ID

Open DailyMed details

DUTASTERIDE DUTASTERIDE
0.5 mg Capsule
BANYAN PHARMA LLC FDA Rx Only

Dutasteride is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5α,17β)-N-{2,5 bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C 27 H 30 F 6 N 2 O 2 , representing a molecular weight of 528.5 with the following structural formula: Dutasteride is a white to pale yellow powder with a melting point of 242° to 250°C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water. Each dutasteride capsule, administered orally, contains 0.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylhydroxytoluene. The inactive excipients are glycerol, gelatin, titanium dioxide, yellow iron oxide, red iron oxide, mono and di-glycerides, butylhydroxytoluene, lecithin, medium chain triglycerides and black ink. The non-volatile ingredients of the black ink are ammonium hydroxide, black iron oxide, propylene glycol and shellac. Chemical Structure

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