LEVITRA- vardenafil hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VARDENAFIL HYDROCHLORIDE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H)

Available from:

APHENA PHARMA SOLUTIONS - TENNESSEE, INC.

INN (International Name):

VARDENAFIL HYDROCHLORIDE

Composition:

VARDENAFIL HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

LEVITRA (vardenafil HCl) is formulated as orange, film-coated round tablets with debossed “BAYER” cross on one side and “5”, “10”, and “20” on the other side equivalent to 5 mg, 10 mg, and 20 mg of vardenafil, respectively. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470 Manufactured in Germany Distributed By: GlaxoSmithKline Research Triangle Park NC 27709 LEVITRA is a registered trademark of Bayer AG and is used under license by GlaxoSmithKline. Rx Only 04/11 ©2011 Bayer HealthCare Pharmaceuticals Inc. Printed in U.S.A. Repackaged by: APHENA PHARMA SOLUTIONS - TN Cookeville, TN 38506 20111027AW

Authorization status:

New Drug Application

Summary of Product characteristics

LEVITRA- VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
----------
VARDENAFIL HCL (LEVITRA
) TABLETS
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-specific
pho