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LEVITRA (VARDENAFIL): DOSAGE AND ADMINISTRATION

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 (Vardenafil HCl) tablets 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.

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 Vardenafil (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).

Renal Impairment

For patients with mild (CLcr = 50-80 ml/min), moderate (CLcr = 30-50 ml/min), or severe (CLcr < 30 ml/min) renal impairment, no dose adjustment is required.

Levitra has not been evaluated in patients on renal dialysis.

Concomitant Medications

The dosage of Vardenafil (Levitra) tablets may require adjustment in patients receiving potent CYP3A4 inhibitors such as itraconazole, ketoconazole, ritonavir, saquinavir, indinavir, atazanavir, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin. For ritonavir, a single dose of 2.5 mg Levitra should not be exceeded in a 72-hour period. For saquinavir, indinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, and clarithromycin, a single dose of 2.5 mg Levitra (Vardenafil Hydrochloride) 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 (Vardenafil Hydrochloride) tablets, 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 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).

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