SPL Set ID: 8c6031b3-b6a8-4ec7-b0d3-286f50d29353

Dutasteride and tamsulosin hydrochloride capsules contain dutasteride (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 and tamsulosin (an antagonist of alpha 1A -adrenoceptors in the prostate). Each dutasteride and tamsulosin hydrochloride capsule contains the following: One dutasteride oblong, opaque, yellow gelatin capsule, containing 0.5 mg of dutasteride dissolved in a mixture of butylated hydroxytoluene and mono-and di-glycerides of caprylic/capric acid. The inactive ingredients in the soft-gelatin capsule shell are ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, titanium dioxide, lecithin, medium chain triglycerides, propylene glycol, iron oxide black, polyvinyl acetate phthalate, macrogol, and ammonium hydroxide. Tamsulosin hydrochloride white to off-white pellets, containing 0.4 mg tamsulosin hydrochloride and the inactive ingredients: methacrylic acid copolymer, sugar sphere, ethylcellulose, polyethylene glycol, triethyl citrate and talc. The above components are encapsulated in a hard-shell capsule made with the inactive ingredients of hypromellose, FD&C Blue #1, titanium dioxide, shellac, iron oxide black, propylene glycol, FD&C blue #2, FD&C red #40, D&C yellow #10. Blue opaque cap imprinted with “C280” and white opaque body imprinted with “0.5/0.4” in black ink containing white to off white spherical shaped pellets and one oblong, opaque yellow softgel capsule printed with “C300” in black ink. Dutasteride: Dutasteride is a synthetic 4-azasteroid compound 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. Tamsulosin: Tamsulosin hydrochloride is a synthetic compound chemically designated as (-)-( R )-5-[2-[[2-( o -Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. The empirical formula of tamsulosin hydrochloride is C 20 H 28 N 2 O 5 S•HCl. The molecular weight of tamsulosin hydrochloride is 444.97. Its structural formula is: Tamsulosin hydrochloride is a white or almost white crystalline powder that melts with decomposition at approximately 234°C. It is sparingly soluble in water and slightly soluble in methanol, ethanol, acetone, and ethyl acetate. Dutasteride-Structural-Formula.jpg Tamsulosin-Structural-Formula.jpg