Geriatrics: Healthy elderly volunteers (65 years or over) had a reduced clearance of Filagra, resulting in approximately 84% and 107% higher plasma AUC values of Filagra and its active N-desmethyl metabolite, respectively, compared to those seen in health

Geriatrics: Healthy elderly volunteers (65 years or over) had a reduced clearance of Filagra, resulting in approximately 84% and 107% higher plasma AUC values of Filagra and its active N-desmethyl metabolite, respectively, compared to those seen in health

After either oral or intravenous administration, Filagra 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 Filagra, so that the metabolite accounts for about 20% of Filagra's pharmacologic effects. This metabolite has a PDE selectivity profile similar to Filagra and an in vitro potency for PDE5 approximately 50% of the parent drug.

 

Figure 5: Mean Filagra Plasma Concentrations in Healthy Male Volunteers. Both Filagra and the metabolite have terminal half lives of about 4 hours. The pharmacokinetics of Filagra are dose-proportional over the recommended dose range.

 

The mean times (adjusted for baseline) to onset of limiting angina were 423.6 and 403.7 seconds for Filagra (N=70) and placebo, respectively. A total dose of 40 mg Filagra was administered by four intravenous infusions. Single oral doses of Filagra up to 100 mg produced no clinically relevant changes in the ECGs of normal male volunteers.

 

Effects of FILDENA on Cardiac Parameters. fildena vs viagra were taking FILDENA 100 mg, and all three reported mild adverse events at the time of reductions in standing SBP, including vasodilation and lightheadedness. Figure 4: Mean Standing Systolic Blood Pressure Change from Baseline.

 

In dose period 1, subjects were administered open-label doxazosin and a single dose of FILDENA 50 mg simultaneously, after at least 14 consecutive days of doxazosin. There were no severe adverse events potentially related to blood pressure and no episodes of syncope reported in this study. In these two subjects, hypotension was reported as a moderately severe adverse event, beginning at approximately 1 hour after administration of FILDENA 50 mg and resolving after approximately 7.5 hours.

 

Figure 3: Mean Standing Systolic Blood Pressure Change from Baseline. For these four subjects, the placebo-subtracted mean maximum decreases from baseline in supine and standing systolic blood pressures were 14.8 mmHg and 21.5 mmHg, respectively. Figure 2: Mean Standing Systolic Blood Pressure Change from Baseline.

 

Placebo-subtracted mean maximum decrease in systolic blood pressure (mm Hg) Following a review of the data from these first 4 subjects (details provided below), the FILDENA dose was reduced to 25 mg. Thereafter, 17 subjects were treated with FILDENA 25 mg or matching placebo in combination with doxazosin 4 mg (15 subjects) or doxazosin 8 mg (2 subjects). Following at least 14 consecutive daily doses of doxazosin, FILDENA 100 mg or matching placebo was administered simultaneously with doxazosin.

 

Larger effects were recorded among patients receiving concomitant nitrates see CONTRAINDICATIONS. The time course of effect was examined in one study, showing an effect for up to 4 hours but the response was diminished compared to 2 hours.

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