Levitra Indications and Dosage
- erectile dysfunction (ED)
Levitra Indications and Dosage
For the treatment of erectile dysfunction (ED) including ED associated with diabetes or after radical prostatectomy:
Oral dosage:
Adult males: The recommended starting dose for patients not taking certain CYP3A4 inhibitors (e.g., ritonavir, indinavir, ketoconazole, itraconazole, erythromycin) or an alpha-blocker is 10 mg PO 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. If coadministering with an alpha-blocker, patients should be stable on alpha blocker therapy before starting vardenafil, and the initial vardenafil dose should be reduced to 5 mg. Single doses ranging from 5 to 40 mg PO have been evaluated in clinical studies of men with mild-to-severe ED for at least 6 months and diabetic men. Doses of 10 mg PO and 20 mg PO were the most effective. The 40 mg PO dose was no more effective than the 20 mg dose. Adult males taking ritonavir: A single dose of 2.5 mg PO should not be exceeded in a 72-hour period.
Adult males taking indinavir, ketoconazole 400 mg qd, or itraconazole 400 mg qd: A single dose of 2.5 mg PO should not be exceeded in a 24-hour period.
Adult males taking erythromycin, ketoconazole 200 mg qd, or itraconazole 200 mg qd: A single dose of 5 mg PO should not be exceeded in a 24-hour period. If the patient is also taking an alpha-blocker, the initial dose should be 2.5 mg PO.
Elderly males: Initially, consider a starting dose of 5 mg PO approximately 60 minutes before sexual activity. The maximum recommended dosing frequency is once per day.
Maximum Dosage Limits:
- Adults: 20 mg/day PO.
- Elderly: 20 mg/day PO; elderly patients should be started at lower doses initially.
- Adolescents: Safe and effective use has not been established.
- Children: Safe and effective use has not been established.
Patients with hepatic impairment:
For patients with mild hepatic impairment (Child-Pugh class A), no dose adjustment is required. Vardenafil clearance is reduced in patients with moderate hepatic impairment (Child-Pugh class B) and a starting dose of 5 mg/day PO is recommended; the maximum dose should not exceed 10 mg/day PO. Vardenafil has not been studied in patients with severe hepatic impairment (Child-Pugh class C).
Patients with renal impairment:
CrCl > 80 ml/min: No dosage adjustments are needed.
CrCl <= 80 ml/min: No dosage adjustments are needed. The pharmacokinetics of vardenafil have not been studied in patients requiring dialysis.
[ Last revised: 5/18/2005 5:21:00 PM ]
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