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LEVITRA (VARDENAFIL): PRESCRIBING INFORMATION

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-7propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride.

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 crospovidone, microcrystalline cellulose, colloidal silicon dioxide, hypromellose, magnesium stearate, polyethylene glycol, yellow ferric oxide, titanium dioxide, 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 phosphodiesterase type 5 (PDE5); therefore, the inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.

In vitro studies have shown that Levitra (Vardenafil) is a selective inhibitor of PDE5. The inhibitory effect of vardenafil is more selective on PDE5 than for other known phosphodiesterases ( > 15fold relative to PDE6, > 130-fold relative to PDE1, > 300-fold relative to PDE11, and > 1,000fold relative to PDE2, 3, 4, 7, 8, 9, and 10).


PHARMACOKINETICS

Levitra pharmacokinetics


PHARMACODYNAMICS

Levitra pharmacodynamics


CLINICAL STUDIES

Levitra clinical studies


INDICATIONS AND USAGE

Levitra (Vardenafil Hydrochloride) tablets are indicated for the treatment of erectile dysfunction.


CONTRAINDICATIONS

Nitrates

Administration of Levitra with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated. 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 Vardenafil HCl (Levitra) dosing for the safe administration of nitrates or nitric oxide donors has not been determined.

Hypersensitivity

Vardenafil HCl (Levitra) tablets are contraindicated for patients with a known hypersensitivity to any component of the tablet.


WARNINGS

Levitra warnings


PRECAUTIONS

Levitra precautions


DRUG INTERACTIONS

Levitra drug interactions


USE IN SPECIAL POPULATIONS

Levitra use in special populations


ADVERSE REACTIONS

Levitra adverse reactions


OVERDOSAGE

The maximum dose of Levitra (Vardenafil HCl) for which human data are available is a single 120 mg dose administered to eight healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or "abnormal vision."

In cases of overdose, standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance because vardenafil is highly bound to plasma proteins and is not significantly eliminated in the urine.


DOSAGE AND ADMINISTRATION

Levitra dosage and administration


HOW SUPPLIED

Levitra (Vardenafil HCl) is formulated as orange, film-coated round tablets with debossed "BAYER" cross on one side and "2.5", "5", "10", and "20" on the other side equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively.

Recommended Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Manufactured and distributed by Bayer, GlaxoSmithKline, Schering-Plough pharmaceutical companies and their divisions.

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