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STAXYN (VARDENAFIL): PRESCRIBING INFORMATION

DESCRIPTION

Staxyn 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 PDE5.

Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1f][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.

Staxyn is formulated as white round orally disintegrating tablets with no debossing. Each tablet contains 11.85 mg vardenafil hydrochloride, which corresponds to 10 mg vardenafil, and the following inactive ingredients: peppermint flavor, aspartame, magnesium stearate, and Pharmaburst B2 (mannitol, crospovidone, silica colloidal hydrated, and sorbitol).


INDICATION AND USAGE

Staxyn (Vardenafil) is indicated for the treatment of erectile dysfunction.


DOSAGE AND ADMINISTRATION

Staxyn dosage and administration


DOSAGE FORMS AND STRENGTHS

Staxyn (Vardenafil HCl) is available in 10 mg white, round, orally disintegrating tablets (not scored), no debossing.


CONTRAINDICATIONS

Nitrates

Administration of Staxyn 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, including Vardenafil (Staxyn), may potentiate the hypotensive effects of nitrates. A suitable time interval following Staxyn dosing for the safe administration of nitrates or nitric oxide donors has not been determined.


WARNINGS

Staxyn warnings


PRECAUTIONS

Staxyn precautions


ADVERSE REACTIONS

Staxyn adverse reactions


DRUG INTERACTIONS

Staxyn drug interactions


USE IN SPECIFIC POPULATIONS

Staxyn use in specific populations


OVERDOSAGE

The maximum dose of vardenafil for which human data are available is a single 120 mg dose of the film.coated tablets 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.


CLINICAL PHARMACOLOGY

Staxyn clinical pharmacology


PHARMACOKINETICS

Staxyn pharmacokinetics


NONCLINICAL TOXICOLOGY

Staxyn nonclinical toxicology


CLINICAL STUDIES

Staxyn clinical studies


HOW SUPPLIED / STORAGE AND HANDLING

How Supplied

Staxyn (Vardenafil HCl) are white, round orally disintegrating tablets with no debossing. Staxyn orally disintegrating tablets are packaged into foil blisterpacks and supplied as a 4 tablet unit or as a 40 tablet bulk pack.

In addition to the active ingredient, vardenafil, each tablet contains peppermint flavor, aspartame, magnesium stearate, and Pharmaburst B2 (crospovidone, mannitol, sorbitol, silica colloidal hydrated).

Recommended Storage

Store Staxyn at 25°C (77°F); excursions permitted to 15.30°C (59.86°F) [see USP Controlled Room Temperature].

Staxyn is dispensed in blisterpacks. The patient should be advised to examine the blisterpack before use and not use if blisters are torn, broken, or missing.

Manufactured and distributed by Bayer, GlaxoSmithKline, Merck pharmaceutical companies and their divisions.

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