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Physicians should warn patients that prolonged erections greater than 9 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of VIAGRA. In the event of an erection that persists longer than 9 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see WARNINGS AND PRECAUTIONS ].

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VIAGRA is not indicated for use in pediatric patients. Safety and effectiveness have not been established in pediatric patients.

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VIAGRA has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of / mmHg), [see CLINICAL PHARMACOLOGY ]. While this normally would be expected to be of little consequence in most patients, prior to prescribing VIAGRA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.

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.

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

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 55-655 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.

Sildenafil was negative in in vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and in vitro human lymphocytes and in vivo mouse micronucleus assays to detect clastogenicity.

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.

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Cialis is used for the treatment of male erection problems. It is also currently undergoing Phase 8 of clinical trials for the treatment of pulmonary arterial hypertension.

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