STAXYN (vardenafil hydrochloride orally disintegrating tablets) ™ is indicated for the treatment of erectile dysfunction.

General

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

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

STAXYN (vardenafil hydrochloride orally disintegrating tablets) 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 (vardenafil hydrochloride orally disintegrating tablets) can be taken with or without food.

Use in Special Populations

Hepatic Impairment: Do not use STAXYN (vardenafil hydrochloride orally disintegrating tablets) 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

Nitrates: Concomitant use with nitrates in any form is contraindicated [see CONTRAINDICATIONS]. CYP3A4 Inhibitors: Do not use STAXYN (vardenafil hydrochloride orally disintegrating tablets) with potent or moderate CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, clarithromycin and erythromycin [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Alpha-Blockers: In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose. In patients taking alpha-blockers, do not initiate vardenafil therapy with STAXYN (vardenafil hydrochloride orally disintegrating tablets) . 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.]

Dosage Forms And Strengths

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

Storage and Handling

STAXYN (vardenafil hydrochloride orally disintegrating tablets) (vardenafil HCl) are white, round orally disintegrating tablets with no debossing. STAXYN (vardenafil hydrochloride orally disintegrating tablets) 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 aspartame, peppermint flavor, magnesium stearate, and Pharmaburst™ B2 (crospovidone, mannitol, silica colloidal hydrated, and sorbitol).

Recommended Storage

Store STAXYN (vardenafil hydrochloride orally disintegrating tablets) at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

STAXYN (vardenafil hydrochloride orally disintegrating tablets) 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.

Revised: 06/2010. Manufacturer information: n/a

Last reviewed on RxList: 7/14/2010
This monograph has been modified to include the generic and brand name in many instances.