LEVITRA® is indicated for the treatment of erectile dysfunction.

General Dose Information

For most patients, the recommended starting dose of LEVITRA is 10 mg, taken orally, as needed, 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. Sexual stimulation is required for a response to treatment.

Use with Food

LEVITRA can be taken with or without food.

Use In Specific Populations

Geriatrics

A starting dose of 5 mg LEVITRA should be considered in patients ≥ 65 years of age [see Use In Specific Populations].

Hepatic Impairment

For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg LEVITRA is recommended. The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg.

Do not use LEVITRA in patients with severe hepatic impairment (Child-Pugh C) [see WARNINGS AND PRECAUTIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY].

Renal Impairment

Do not use LEVITRA in patients on renal dialysis [see WARNINGS AND PRECAUTIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY].

Concomitant Medications

Nitrates

Concomitant use with nitrates and nitric oxide donors in any form is contraindicated [see CONTRAINDICATIONS].

CYP3A4 Inhibitors

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 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.

Alpha-Blockers

In those patients who are stable on alpha-blocker therapy, phosphodiesterase type 5 (PDE5) inhibitors should be initiated at the lowest recommended starting dose. 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 WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS.]

Dosage Forms And Strengths

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

Storage And Handling

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.

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

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470. Manufactured in Germany. Distributed by: GlaxoSmithKline Research Triangle Park NC 27709. Revision Date: 11/2011

Last reviewed on RxList: 12/19/2011
This monograph has been modified to include the generic and brand name in many instances.