SPL Set ID: c4bc56a1-e31c-44fb-bfb5-f77425ff1ea1

1 drug(s) with this SPL Set ID

Open DailyMed details

Dutasteride DUTASTERIDE
0.5 mg Capsule
MARKSANS PHARMA LIMITED 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 and di-glycerides of caprylic/capric acid and butylated hydroxytoluene. The inactive excipients in the capsule shell are colour iron oxide yellow, gelatin, glycerin, non crystallizing Sorbitol solution, titanium dioxide and purified water. The soft gelatin capsules are printed with edible black ink Opacode Black (S-1-17823).(Containing- Isopropyl alcohol, Shellac Glaze, Black iron oxide, N-butyl alcohol, Propylene glycol, and Ammonium hydroxide). dutasteride-str

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