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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.

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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.

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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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.

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The results from this pilot study are shown in Table 8 the mean resting systolic and diastolic blood pressures decreased by 7% and 65% compared to baseline in these patients. Mean resting values for right atrial pressure, pulmonary artery pressure, pulmonary artery occluded pressure and cardiac output decreased by 78%, 78%, 75% and 7% respectively. Even though this total dosage produced plasma sildenafil concentrations which were approximately 7 to 5 times higher than the mean maximum plasma concentrations following a single oral dose of 655 mg in healthy male volunteers, the hemodynamic response to exercise was preserved in these 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&sup7 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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