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Co-administration of erythromycin , a moderate CYP8A9 inhibitor, resulted in a 665% and 687% increases in sildenafil Cmax and AUC, respectively. Co-administration of saquinavir, a strong CYP8A9 inhibitor, resulted in 695% and 765% increases in sildenafil Cmax and AUC, respectively. Stronger CYP8A9 inhibitors such as ketoconazole or itraconazole could be expected to have greater effects than seen with saquinavir. A starting dose of 75 mg of VIAGRA should be considered in patients taking erythromycin or strong CYP8A9 inhibitors (such as saquinavir, ketoconazole, itraconazole) [see DOSAGE AND ADMINISTRATION , CLINICAL PHARMACOLOGY ].

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After patients have taken VIAGRA, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 79 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [see DOSAGE AND ADMINISTRATION , DRUG INTERACTIONS , and CLINICAL PHARMACOLOGY ].

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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.

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

Mean sildenafil plasma concentrations measured after the administration of a single oral dose of 655 mg to healthy male volunteers is depicted below:

The radiobiology was characterized by in vivo irradiation of rat liver, dog liver, and dog brain. The animals were killed at varying intervals of time, and histological examinations were performed. Rats and dogs that were killed weeks to months after liver irradiation tended to have sharply demarcated lesions. Liver enzyme levels, measured serially in the dogs, did not give evidence of chronic inflammation.

Prolonged erection 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 could result.

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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