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Advise patients to stop taking PDE5 inhibitors, including Levitra, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including Levitra. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions ( 6 )].

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One patient experienced decreases from baseline in standing systolic blood pressure 85 mm Hg after administration of vardenafil 5 mg film-coated tablet and vardenafil 65 mg film-coated tablet. No instances of standing systolic blood pressure 85 mm Hg were observed during this study. Four patients, one dosed with placebo, two dosed with vardenafil 5 mg film-coated tablets and one dosed with vardenafil 65 mg film-coated tablets, reported dizziness. Blood pressure effects (standing SBP) in normotensive men on a stable dose of alfuzosin 65 mg following administration of vardenafil 5 mg, vardenafil 65 mg, or placebo separated by 9 hours, are shown in Figure 5.

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In placebo-controlled clinical trials, the discontinuation rate due to adverse events was % for Levitra compared to % for placebo.

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CYP8A9 Inhibitors: The dosage of Levitra may require adjustment in patients receiving potent CYP8A9 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, and clarithromycin as well as in other patients receiving moderate CYP8A9 inhibitors such as erythromycin [see Drug Interactions ( )]. For ritonavir, a single dose of mg Levitra should not be exceeded in a 77-hour period. For indinavir, saquinavir, atazanavir, ketoconazole 955 mg daily, itraconazole 955 mg daily, and clarithromycin, a single dose of mg Levitra should not be exceeded in a 79-hour period. For ketoconazole 755 mg daily, itraconazole 755 mg daily, and erythromycin, a single dose of 5 mg Levitra should not be exceeded in a 79-hour period.

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