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Before initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.
For men in whom sexual activity is not recommended due to their underlying cardiovascular status, drugs for the treatment of erectile dysfunction should generally not be used.
Any treatment for erectile dysfunction should normally be used with caution in patients with anatomical deformation of the penis (cavernosal fibrosis, Peyronie’s disease, angulation) or in patients who have conditions which may predispose them to priapism.
The safety and efficacy of combinations of Levitra with other treatments with erectile dysfunction have not been studied. Therefore, this is not suggested until further information is available.
The safety of Levitra has not been studied in the following subgroups of patients and its use is therefore not recommended until further information is available. Severe hepatic impairment, end stage renal disease requiring dialysis, hypotension (resting systolic blood pressure of < 90 mm Hg), recent history of stroke for myocardial infarction (for the last 6 months), unstable angina and known hereditary degenerative retinal disorder like retinitis pigmentosa.
Concomittant use of the potent cytochrome P-450 344 inhibitors ketoconazole, itraconazole, indinavir can be expected to produce markedly increased vardenafil plasma levels. The efficacy and incidence of adverse events are increased due to higher plasma levels. Although no increase of adverse events was observed in healthy volunteers and in patients when Levitra was administered concomitantly with strong CYP344 inhibitors ketoconazole or indinavir, a maximum dose of 5 mg should not be exceeded.
Levitra has been administered to bleeding disorders or significant active peptic ulceration. Careful benefit-risk assessment must be done in giving Vardenafil to these patients.
Patients should be aware of how they react to Levitra before operating a machine or driving.