SPL Set ID: e593ab58-70a4-4095-8091-16a4b6d49e4d

Vardenafil hydrochloride, USP is administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl, USP is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride trihydrate and has the following structural formula: C 23 H 32 N 6 O 4 S•HCl•3H 2 O M.W. 579.1 Vardenafil HCl, USP is a nearly colorless, solid substance. It is sparingly soluble in N, N Dimethyl formamide and very slightly soluble in water. Vardenafil hydrochloride tablets are round, standard convex, film-coated tablets with “TV” debossed on one side and "1V", "2V", "4V", and “7V” on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. The 5 mg, 10 mg, and 20 mg tablets are tan. The 2.5 mg tablets are beige to light-peach. In addition to the active ingredient, vardenafil HCl, USP, each tablet contains colloidal silicon dioxide, crospovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, tartaric acid, and titanium dioxide. Structural formula for vardenafil hydrochloride