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Supine 2.2 (-0.9,-5.2)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 (7.2)]. 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.

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In a major North American fixed dose trial, 762 subjects were evaluated. The mean baseline EF Domain scores were 13, 13, 13, 14 for the Levitra 5 mg, 10 mg, 20 mg and placebo groups, respectively. There was significant improvement at three months with Levitra (EF Domain scores of 18, 21, 21, for the 5 mg, 10 mg and 20 mg dose groups, respectively) compared to the placebo group (EF Domain score of 15). The European trial of 803 subjects confirmed these results. In the North American trial, Levitra significantly improved the rates of achieving an erection sufficient for penetration (SEP2) at doses of 5 mg, 10 mg, and 20 mg compared to placebo (65%, 75%, and 80%, respectively, compared to a 52% response in the placebo at 3 months. The European trial confirmed these results.

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