Vardenafildosage

2 DOSAGE & ADMINISTRATION Vardenafil orally disintegrating tablet is not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). Vardenafil orally disintegrating tablet provides higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA). Vardenafil orally disintegrating tablet is taken as needed, orally, approximately 60 minutes before sexual activity. The maximum recommended dosing frequency is one tablet per day. Vardenafil orally disintegrating tablet should be placed on the tongue where it will disintegrate. It should be taken without liquid. Vardenafil orally disintegrating tablet may be taken with or without food.

2.1 General

Vardenafil is available in 10 mg orally disintegrating tablets. Vardenafil orally disintegrating tablet is not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). Vardenafil orally disintegrating tablet provides higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA). Vardenafil orally disintegrating tablet should be taken orally, as needed, approximately 60 minutes before sexual activity. The maximum dosing frequency is one Vardenafil orally disintegrating tablet per day. Sexual stimulation is required for a response to treatment. Vardenafil orally disintegrating tablet 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.

2.2 Use with

Food Vardenafil orally disintegrating tablet can be taken with or without food.

2.3 Use in Special

Populations Hepatic Impairment: Do not use vardenafil orally disintegrating tablet in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment.

Renal Impairment: Do not use vardenafil orally disintegrating tablet in patients on renal dialysis.

2.4 Concomitant

Medications Nitrates: Concomitant use with nitrates in any form is contraindicated. Guanylate Cyclase (GC) Stimulators, such as riociguat: Concomitant use is contraindicated.

CYP3A4 Inhibitors: Do not use vardenafil orally disintegrating tablet with strong or moderate CYP3A4 inhibitors such as cobicistat,ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, 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. 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 vardenafil orally disintegrating tablet. 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 vardenafil orally disintegrating tablet at the advice of their healthcare provider. A time interval between dosing should be considered when vardenafil orally disintegrating tablet is prescribed concomitantly with alpha-blocker therapy.