August 29, 2016
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How Supplied


STAXYN® is indicated for the treatment of erectile dysfunction.



STAXYN is available in 10 mg orally disintegrating tablets. STAXYN is not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). STAXYN provides higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA). [See CLINICAL PHARMACOLOGY]

STAXYN should be taken orally, as needed, approximately 60 minutes before sexual activity. The maximum dosing frequency is one STAXYN tablet per day. Sexual stimulation is required for a response to treatment.

STAXYN should be placed on the tongue where it will disintegrate. The tablet should be taken without liquid. It should be taken immediately upon removal from the blister.

Those patients who require a lower or higher dose of vardenafil need to be prescribed vardenafil film-coated tablets [see PATIENT INFORMATION].

Use With Food

STAXYN can be taken with or without food.

Use In Special Populations

Hepatic Impairment

Do not use STAXYN in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Renal Impairment

Do not use STAXYN in patients on renal dialysis [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Concomitant Medications


Concomitant use with nitrates in any form is contraindicated [see CONTRAINDICATIONS].

Guanylate Cyclase (GC) Stimulators, such as riociguat

Concomitant use is contraindicated [see CONTRAINDICATIONS].

CYP3A4 Inhibitors

Do not use STAXYN with potent or moderate CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, clarithromycin and erythromycin [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].


In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including vardenafil. In patients taking alpha-blockers, do not initiate vardenafil therapy with STAXYN. Lower doses of vardenafil film-coated tablets should be used as initial therapy in these patients. Patients taking alpha-blockers who have previously used vardenafil film-coated tablets may change to STAXYN at the advice of their healthcare provider. [See WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS]

A time interval between dosing should be considered when STAXYN is prescribed concomitantly with alpha-blocker therapy [see CLINICAL PHARMACOLOGY].


Dosage Forms And Strengths

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

Storage And Handling

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.

Package Strength NDC Code
1 blister card containing 4 tablets 10 mg 0173-0822-04

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

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 for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981 Manufactured in Germany. Distributed by: GlaxoSmithKline Research Triangle Park NC 27709. Revision Date 09/2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 10/2/2015

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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