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Publication date: 2018-05-02 21:17

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In a double-blind study, 699 patients with erectile dysfunction and chronic stable angina limited by exercise, not receiving chronic oral nitrates, were randomized to a single dose of placebo or Viagra 655 mg 6 hour prior to exercise testing. The primary endpoint was time to limiting angina in the evaluable cohort. The mean times (adjusted for baseline) to onset of limiting angina were and seconds for sildenafil (N=75) and placebo, respectively. These results demonstrated that the effect of Viagra on the primary endpoint was statistically non-inferior to placebo.

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When Viagra was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took Viagra at least once weekly, and the following adverse reactions were reported:

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Physicians should discuss with patients the contraindication of VIAGRA with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [see CONTRAINDICATIONS ].

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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.

Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex.

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

Digestive: vomiting, glossitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, dry mouth, liver function tests abnormal, rectal hemorrhage, gingivitis.

In eight double-blind, placebo-controlled crossover studies of patients with either organic or psychogenic erectile dysfunction, sexual stimulation resulted in improved erections, as assessed by an objective measurement of hardness and duration of erections (RigiScan® ), after VIAGRA administration compared with placebo. Most studies assessed the efficacy of VIAGRA approximately 65 minutes post dose. The erectile response, as assessed by RigiScan® , generally increased with increasing sildenafil dose and plasma concentration. The time course of effect was examined in one study, showing an effect for up to 9 hours but the response was diminished compared to 7 hours.

There are no controlled clinical data on the safety or efficacy of Viagra in the following groups if prescribed, this should be done with caution.

Viagra works by blocking an enzyme that acts as an inhibitor of blood flow. In men, this can cause penile tissue to swell. When a man takes Viagra, there is an increase in blood flow to the genital areas, which thus helps to treat erectile dysfunction or impotence in men.

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