AT THE SAME TIME, ON-TREATMENT FUNCTION WAS BETTER IN TREATED PATIENTS WHO WERE LESS IMPAIRED AT BASELINE. FIGURE 6 ... review that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo. was administered to more than 3,000 patients aged 19 to 87 years, with ED of various etiologies (organic, psychogenic, mixed) with a mean duration of 5 years. VIAGRA (50 mg) did not potentiate the increase in bleeding time caused by aspirin (150 mg).

Pharmacokinetic data from patients in clinical trials showed no effect on Fildena pharmacokinetics of CYP2C9 inhibitors (such as tolbutamide, warfarin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants ), thiazide and related diuretics, ACE inhibitors, and calcium channel blockers. In healthy male volunteers, there was no evidence of a clinically significant effect of azithromycin (500 mg daily for 3 days) on the systemic exposure of Fildena or its major circulating metabolite. of antacid (magnesium hydroxide/aluminum hydroxide) did not affect the bioavailability of VIAGRA.

VIAGRA had no effect on ritonavir pharmacokinetics see DOSAGE AND ADMINISTRATION and DRUG INTERACTIONS. At 24 hours the plasma levels of Fildena were still approximately 200 ng/mL, compared to approximately 5 ng/mL when Fildena was dosed alone. A starting oral dose of 25 mg should be considered in those patients see DOSAGE AND ADMINISTRATION.

The pharmacokinetics of Fildena in patients with severely impaired hepatic function (Child-Pugh Class C) have not been studied see DOSAGE AND ADMINISTRATION , and Use in Specific Populations. Renal Impairment: In volunteers with mild (CLcr=50-80 mL/min) and moderate (CLcr=30-49 mL/min) renal impairment, the pharmacokinetics of a single oral dose of VIAGRA (50 mg) were not altered. Geriatrics: Healthy elderly volunteers (65 years or over) had a reduced clearance of Fildena, resulting in approximately 84% and 107% higher plasma AUC values of Fildena and its active N-desmethyl metabolite, respectively, compared to those seen in healthy younger volunteers (18-45 years).

After either oral or intravenous administration, Fildena is excreted as metabolites predominantly in the feces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose). Plasma concentrations of this metabolite are approximately 40% of those seen for Fildena, so that the metabolite accounts for about 20% of Fildena’s pharmacologic effects. This metabolite has a PDE selectivity profile similar to Fildena and an in vitro potency for PDE5 approximately 50% of the parent drug.

Figure 5: Mean Fildena Plasma Concentrations in Healthy Male Volunteers. The pharmacokinetics of Fildena are dose-proportional over the recommended dose range. Subjects in the study reported this finding as difficulties in discriminating blue/green. (adjusted for baseline) to onset of limiting angina were 423.6 and 403.7 seconds for Fildena (N=70) and placebo, respectively. A total dose of 40 mg Fildena was administered by four intravenous infusions.