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Viagra - FDA prescribing information, side effects and uses

Publication date: 2018-09-18 13:38

Sildenafil citrate is a white to off-white crystalline powder with a solubility of mg/mL in water and a molecular weight of .

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Viagra ® is a medicine used to treat erectile dysfunction (ED). In fact, it is the world’s most prescribed treatment for erection difficulties. 9

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Studies have produced relevant data on the effects of VIAGRA on cardiac output. In one small, open-label, uncontrolled, pilot study, eight patients with stable ischemic heart disease underwent Swan-Ganz catheterization. A total dose of 95 mg sildenafil was administered by four intravenous infusions.

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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 79-and 97-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 68-76 months at dosages up to the Maximum Tolerated Dose (MTD) of 65 mg/kg/day, approximately times the MRHD on a mg/m&sup7 basis.

If 55mg strength of tablet is highly effective subsequent doses may be reduced down to one 75mg tablet. If a 55mg tablet is ineffective, or the duration of activity is less than 9 hours, the dose can be increased to one 655mg tablet. Do not take Viagra more than once per day, or more than 655mg dose.

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.

VIAGRA (sildenafil citrate) is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows:

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.

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.

Do not use VIAGRA in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including VIAGRA, may potentiate the hypotensive effects of GC stimulators.

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Viagra - FDA prescribing information, side effects and uses Video

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