SPL Set ID: d6557691-7910-4006-9268-410583e437d1
1 drug(s) with this SPL Set ID
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 alpha1A-adrenoceptors in the prostate). Each dutasteride and tamsulosin hydrochloride capsule contains the following: One dutasteride opaque white colored, oblong shaped soft gelatin capsules containing clear colorless to slightly yellowish oily liquid, containing 0.5 mg dutasteride and the inactive ingredients: butylated hydroxy toluene, gelatin, glycerin, methylparaben, mono and diglycerides of capric acid, propylparaben and titanium dioxide. Tamsulosin hydrochloride white to off-white pellets, containing 0.4 mg tamsulosin hydrochloride and the inactive ingredients: microcrystalline cellulose, methacrylic acid copolymer dispersion, talc and triacetin. The above components are encapsulated in a hard-shell capsule made with the inactive ingredients: carrageenan, hypromellose, iron oxide yellow, potassium chloride, titanium dioxide, and imprinted with black pharmaceutical ink which contains butyl alcohol, ferrosoferic oxide, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, shellac and strong ammonia solution. Dutasteride: Dutasteride, USP 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 molecular 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, USP is white to off-white colored powder. It is soluble in absolute ethanol and methanol and insoluble in water. Tamsulosin: Tamsulosin hydrochloride, USP is a synthetic compound chemically designated as (-)-( R )-5-[2-[[2-( o -Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. The molecular 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, USP is white crystalline powder, odorless or practically odorless. It is slightly soluble in water and anhydrous ethanol, sparingly soluble in methanol, freely soluble in dimethyl sulfoxide and formic acid, practically soluble in ether. Dutasteride and tamsulosin hydrochloride capsules Dutasteride and tamsulosin hydrochloride capsules