For majority of patients, the starting dose of LEVITRA recommended by experts is 10mg, and it should be taken orally approximately an hour before the sexual act. This fixed dosage can either be decreased to 5mg, or can be increased to 20mg based on the side effects and efficacy. But the maximum frequency for consumption of this drug is only once per day. This drug could be taken with or without food.
Hepatic Impairment: For patients under this category i.e. mild hepatic impairment (Child-Pugh A), no adjustment of this dose is required. Vardenafil clearance level is decreased in such patients with moderate hepatic impairment (Child-Pugh B), and for these people, 5mg of LEVITRA is recommended as a starting dose. But for such patients, the maximum dosage should never exceed 10mg. Evaluation of LEVITRA has never been carried out on patients with severe hepatic impairment (Child-Pugh C) (refer CLINICAL PHARMACOLOGY, WARNINGS and PRECAUTIONS, Metabolism and Excretion).
Geriatrics: For patients belonging to the category of age above 65 years, a starting dose of 5 mg LEVITRA are recommended (refer CLINICAL PHARMACOLOGY, PRECAUTIONS and Pharmacokinetics in Special Populations).
Renal Impairment: Patients having severe (CLcr < 30 ml/min), moderate (CLcr = 30-50 ml/min), or mild (CLcr = 50-80 ml/min) renal impairment, no adjustment in dosage is required.
LEVITRA hasn’t been evaluated yet on category of patients belonging to renal dialysis (refer CLINICAL PHARMACOLOGY, PRECAUTIONS, and Metabolism and Excretion).
Concomitant Medications: For patients receiving potent CYP3A4 inhibitors such as itraconazole, ketoconazole, saquinavir, indinavir, clarithromycin, atazanavir and ritonavir, and for patients receiving moderate CYP3A4 inhibitors including erythromycin, the adjustment of LEVITRA dosage may be required. In case of ritonavir, a single dose of about 2.5 mg LEVITRA should never exceed in a span of 72 hours.
For saquinavir, indinavir, ketoconazole 400 mg daily, clarithromycin, itraconazole 400 mg daily, and atazanavir, a single dosage of 2.5 mg LEVITRA must never be exceeded within a time span of 24 hours. For itraconazole 200 mg daily, for ketoconazole 200 mg daily, and erythromycin, a single dosage of 5 mg LEVITRA should never be exceeded in a time span of 24 hours. For alpha-blockers, special care should be taken when PDE5 inhibitors, which even include LEVITRA, are consumed concomitantly with alpha blockers since this can cause an additive effect on the blood pressure levels. Concomitant treatment must be initiated only when a patient is quite stable on his alpha blocker therapy.
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