Levitra Tablets (Luh-VEE-Trah) (vardenafil HCl)
Overdosage, Dosage and Administration
Overdosage
The maximum dose of Levitra for which human data are available is a single 120 mg dose administered to eight healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or “abnormal vision”.
In cases of overdose, standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance because vardenafil is highly bound to plasma proteins and is not significantly eliminated in the urine.
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 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 requires for 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 mild 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 (CLcr= 50-80ml/min), moderate (CLcr= 30-50ml/min), or severe (CLcr<30ml/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 certain CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, and 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, ketoconazole 400mg daily, and itraconazole 400 mg daily, a single dose of 2.5 mg Levitra should not be exceeded in a 24-hout 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.
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