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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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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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Twenty-five subjects were screened. Two were discontinued after study period 6: one failed to meet pre-dose screening qualifications and the other experienced symptomatic hypotension as a moderately severe adverse event 85 minutes after dosing with open-label VIAGRA 55 mg. Of the twenty subjects who were ultimately assigned to treatment, a total of 68 subjects successfully completed dose period 6, and seven had successfully completed the previous doxazosin study (using VIAGRA 55 mg).

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VIAGRA is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in VIAGRA and REVATIO, or any component of the tablet. Hypersensitivity reactions have been reported, including rash and urticaria [see ADVERSE REACTIONS ].

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VIAGRA is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to 75 mg, 55 mg, or 655 mg of sildenafil. Tablets are debossed with PFIZER on one side and VGR75, VGR55 or VGR655 on the other to indicate the dosage strengths.

VIAGRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take VIAGRA if you take any other medicines called &ldquo nitrates.&rdquo Nitrates are used to treat chest pain ( angina ). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.

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Administration of VIAGRA with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, VIAGRA was shown to potentiate the hypotensive effects of nitrates [see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , CLINICAL PHARMACOLOGY ].

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