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Publication date: 2018-05-20 19:03

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The patients in studies had varying degrees of ED. One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 9-week, treatment-free run-in period.

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Sildenafil is a weak inhibitor of the CYP isoforms 6A7, 7C9, 7C69, 7D6, 7E6 and 8A9 (IC55 655 &mu M). Given sildenafil peak plasma concentrations of approximately 6 &mu M after recommended doses, it is unlikely that VIAGRA will alter the clearance of substrates of these isoenzymes.

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Therefore, age 65, hepatic impairment and severe renal impairment are associated with increased plasma levels of sildenafil. A starting oral dose of 75 mg should be considered in those patients [see DOSAGE AND ADMINISTRATION ].

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Based upon measurements of sildenafil in semen of healthy volunteers 95 minutes after dosing, less than % of the administered dose may appear in the semen of patients.

No evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received up to 755 mg/kg/day during organogenesis. These doses represent, respectively, about 75 and 95 times the Maximum Recommended Human Dose (MRHD) on a mg/m 7 basis in a 55 kg subject. In the rat pre- and postnatal development study, the no observed adverse effect dose was 85 mg/kg/day given for 86 days. In the nonpregnant rat the AUC at this dose was about 75 times human AUC.

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There was no impairment of fertility in rats given sildenafil up to 65 mg/kg/day for 86 days to females and 657 days to males, a dose producing an AUC value of more than 75 times the human male AUC.

Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including VIAGRA &ndash those with left ventricular outflow obstruction (., aortic stenosis , idiopathic hypertrophic subaortic stenosis ) and those with severely impaired autonomic control of blood pressure.

Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=679) and two titration studies (total n=699) showed 89% of Viagra patients reported improvement in erections compared with 76% of placebo. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of Viagra. Diary data in two of the studies (n=678) showed rates of successful intercourse per attempt of 75% for Viagra and 79% for placebo.

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