Uroka Description

Each soft gelatin capsule contains dutasteride 0.5 mg.
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 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- and di-glycerides and butylhydroxytoluene.
Excipients/Inactive Ingredients: The inactive excipients in the capsule shell are gelatin [lime bovine 160 bloom (DGF)], glycerin, iron oxide yellow, titanium dioxide and purified water.