Country: United States
Language: English
Source: NLM (National Library of Medicine)
VARDENAFIL HYDROCHLORIDE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H)
APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
VARDENAFIL HYDROCHLORIDE
VARDENAFIL HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
LEVITRA is indicated for the treatment of erectile dysfunction. Nitrates: Administration of LEVITRA with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated (see CLINICAL PHARMACOLOGY , Pharmacodynamics , Effects on Blood Pressure and Heart Rate when LEVITRA is Combined with Nitrates ). Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates. A suitable time interval following LEVITRA dosing for the safe administration of nitrates or nitric oxide donors has not been determined. Hypersensitivity: LEVITRA is contraindicated for patients with a known hypersensitivity to any component of the tablet.
LEVITRA (vardenafil HCl) is formulated as orange, film-coated round tablets with debossed “BAYER” cross on one side and "5" on the other side equivalent to 5 mg of vardenafil. Vardenafil HCl (Levitra) 5mg tablets are supplied in bottles of 2 or 6 tablets per bottle. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Manufactured by: Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470 Made in Germany Marketed By GlaxoSmithKline Research Triangle Park NC 27709 Distributed and Marketed By: Schering-Plough Schering Corporation Kenilworth, NJ 07033 LEVITRA is a registered trademark of Bayer Aktiengesellschaft and is used under license by GlaxoSmithKline and Schering Corporation. Rx Only 08918646IP, R.7 12/08 14272 ©2008 Bayer HealthCare Pharmaceuticals Inc. Printed in U.S.A. Repackaged by: APHENA PHARMA SOLUTIONS - TN Cookeville, TN 38506 20111026AW
New Drug Application
LEVITRA- VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED APHENA PHARMA SOLUTIONS - TENNESSEE, INC. ---------- VARDENAFIL HCL (LEVITRA ) 5MG TABLETS RX ONLY DESCRIPTION LEVITRA is an oral therapy 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 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 and has the following structural formula: Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “2.5”, “5”, “10”, and “20” on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum. Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection. The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs). The most abundant PDE in the human corpus cavernosum is the cGMP- Read the complete document