LEVITRA is indicated for the treatment of erectile dysfunction.

For most patients, the recommended starting dose of LEVITRA is 10 mg, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. LEVITRA can be taken with or without food. Sexual stimulation is required for a response to treatment.

Geriatrics

A starting dose of 5 mg LEVITRA should be considered in patients ≥ 65 years of age (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations and PRECAUTIONS).

Hepatic Impairment

For patients with mild hepatic impairment (Child-Pugh A), no dose adjustment of LEVITRA is required. Vardenafil clearance is reduced in patients with moderate hepatic impairment (Child-Pugh B), and a starting dose of 5 mg LEVITRA is recommended. The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. LEVITRA has not been evaluated in patients with severe hepatic impairment (Child-Pugh C) (see CLINICAL PHARMACOLOGY, Metabolism and Excretion, WARNINGS and PRECAUTIONS).

Renal Impairment

For patients with mild (CL_cr = 50-80 ml/min), moderate (CL_cr = 30-50 ml/min), or severe (CL_cr < 30 ml/min) renal impairment, no dose adjustment is required. LEVITRA has not been evaluated in patients on renal dialysis (see CLINICAL PHARMACOLOGY, Metabolism and Excretion and PRECAUTIONS).

Concomitant Medications

The dosage of LEVITRA may require adjustment in patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin (see WARNINGS, PRECAUTIONS, DRUG INTERACTIONS). For ritonavir, a single dose of 2.5 mg LEVITRA should not be exceeded in a 72-hour period. For indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, and clarithromycin, a single dose of 2.5 mg LEVITRA should not be exceeded in a 24-hour period. For ketoconazole 200 mg daily, itraconazole 200 mg daily, and erythromycin, a single dose of 5 mg LEVITRA should not be exceeded in a 24-hour period. For alpha-blockers, caution is advised when PDE5 inhibitors, including LEVITRA, are used concomitantly with alpha-blockers because of the potential for an additive effect on blood pressure. In some patients, concomitant use of these two drug classes can lower blood pressure significantly (see PRECAUTIONS, Alpha-blockers and DRUG INTERACTIONS) leading to symptomatic hypotension (e.g., fainting). Concomitant treatment should be initiated only if the patient is stable on his alpha blocker therapy. In those patients who are stable on alpha-blocker therapy, LEVITRA should be initiated at a dose of 5 mg (2.5 mg when used concomitantly with certain CYP3A4 inhibitors - see DRUG INTERACTIONS).

LEVITRA (vardenafil HCl) is formulated as orange, film-coated round tablets with debossed “BAYER” cross on one side and “2.5”, “5”, “10”, and “20” on the other side equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively.

Recommended Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

LEVITRA is a registered trademark of Bayer Aktiengesellschaft and is used under license by GlaxoSmithKline and Schering Corporation.
©2007 Bayer Pharmaceuticals Corporation. FDA rev date: 10/18/2007

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