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STAXYN (VARDENAFIL): DOSAGE AND ADMINISTRATION

General

Staxyn (Vardenafil) 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).

Staxyn (Vardenafil) tablets should be taken orally, as needed, approximately 60 minutes before sexual activity. The maximum dosing frequency is one 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.

Use with Food

Vardenafil Hydrochloride (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.

Renal Impairment

Do not use Vardenafil Hydrochloride (Staxyn) tablets in patients on renal dialysis.

Concomitant Medications

Nitrates

Concomitant use with nitrates in any form is contraindicated.

CYP3A4 Inhibitors

Do not use Staxyn with potent or moderate CYP3A4 inhibitors such as ketoconazole, ritonavir, itraconazole, indinavir, atazanavir, saquinavir, clarithromycin and erythromycin.

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 HCl). 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.

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