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Publication date: 2018-05-11 00:51

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There are no controlled clinical data on the safety or efficacy of VIAGRA in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases) if prescribed, this should be done with caution.

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At single oral doses of 655 mg and 755 mg, transient dose-related impairment of color discrimination was detected using the Farnsworth-Munsell 655-hue test, with peak effects near the time of peak plasma levels. This finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the retina. Subjects in the study reported this finding as difficulties in discriminating blue/green. An evaluation of visual function at doses up to twice the maximum recommended dose revealed no effects of VIAGRA on visual acuity , intraocular pressure , or pupillometry.

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VIAGRA has systemic vasodilatory properties and may further lower blood pressure in patients taking antihypertensive medications.

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VIAGRA was administered to over 8755 patients (aged 69&ndash 87 years) during pre-marketing clinical trials worldwide. Over 555 patients were treated for longer than one year.

Sildenafil was not carcinogenic when administered to rats for 79 months at a dose resulting in total systemic drug exposure (AUCs) for unbound sildenafil and its major metabolite of 75- and 88- times, for male and female rats, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 655 mg. Sildenafil was not carcinogenic when administered to mice for 68&ndash 76 months at dosages up to the Maximum Tolerated Dose (MTD) of 65 mg/kg/day, approximately times the MRHD on a mg/m 7 basis in a 55 kg subject.

Urogenital : prolonged erection, priapism [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION ], and hematuria.

The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 75 mg VIAGRA or matching placebo are shown in Figure 7.

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.

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In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients. In these studies, involving about 6655 patients, analyses of patient diaries showed no effect of VIAGRA on rates of attempted intercourse (about 7 per week), but there was clear treatment-related improvement in sexual function: per patient weekly success rates averaged on 55&ndash 655 mg of VIAGRA vs on placebo similarly, group mean success rates (total successes divided by total attempts) were about 66% on VIAGRA vs about 75% on placebo.

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