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HOME >> Pharmaceuticals API List 1 >> Dutasteride >> Drug Description

DRUG DESCRIPTION
Dutasteride

CAS number 164656-23-9

Dutasteride is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5α-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 C27H30F6N2O2, representing a molecular weight of 528.5

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 Soft Gelatin Capsule, administered orally, contains 0.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylated hydroxytoluene. The inactive excipients in the capsule shell are gelatin (from certified BSE-free bovine sources), glycerin, and ferric oxide (yellow). The soft gelatin capsules are printed with edible red ink.

Dutasteride is used to treat an enlarged prostate (benign prostatic hyperplasia, or BPH). Dutasteride is in a class of medications called 5-alpha reductase inhibitors. It works by blocking the production of a natural substance that enlarges the prostate. This shrinks the prostate, relieves symptoms of BPH, such as frequent and difficult urination, and decreases the chance that surgery will be needed to treat this condition.

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