The recommended dose for Fildena, used to treat ED, is 100 mg per day.
Across all trials, Fildena improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo. On a global improvement question, 83% of patients reported improved erections on Fildena versus 12% on placebo. On a global improvement question, 57% of Fildena patients reported improved erections versus 10% on placebo.
There were highly statistically significant improvements on the two principal IIEF questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) on Fildena compared to placebo. At the end of the long-term study, 88% of patients reported that Fildena improved their erections. Effects of Fildena on Other Drugs.
When a single 100 mg dose of Fildena was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg bid for 5 days), there was a 160% increase in sildenafil Cmax and a 182% increase in sildenafil AUC. An evaluation of visual function at doses up to twice the maximum recommended dose revealed no effects of Fildena on visual acuity , intraocular pressure , or pupillometry. At single oral doses of 100 mg and 200 mg, transient dose-related impairment of color discrimination was detected using the Farnsworth-Munsell 100-hue test, with peak effects near the time of peak plasma levels.
Two were discontinued after study period 1: one failed to meet pre-dose screening qualifications and the other experienced symptomatic hypotension as a moderately severe adverse event 30 minutes after dosing with open-label Fildena 50 mg. Of the twenty subjects who were ultimately assigned to treatment, a total of 13 subjects successfully completed dose period 1, and seven had successfully completed the previous doxazosin study (using Fildena 50 mg). The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 50 mg Fildena or matching placebo are shown in Figure 3. For the 19 subjects who received both Fildena and matching placebo, the placebo-subtracted mean maximum decreases from baseline (95% CI) in systolic blood pressure were as follows: http://myfildena.com/
In the second study, a single oral dose of Fildena 50 mg or matching placebo was administered in a 2-period crossover design to 20 generally healthy males with BPH. The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 25 mg Fildena or matching placebo are shown in Figure 2. For the 17 subjects who received Fildena 25 mg and matching placebo, the placebo-subtracted mean maximum decreases from baseline (95% CI) in systolic blood pressure were as follows:
Following at least 14 consecutive daily doses of doxazosin, Fildena 100 mg or matching placebo was administered simultaneously with doxazosin. Effects of Fildena on Blood Pressure When Co-administered with Alpha-Blockers. In the following patients: age > 65 years, hepatic impairment (e.g., cirrhosis ), severe renal impairment (e.g., creatinine clearance < 30 mL/min), and concomitant use of erythromycin or strong CYP3A4 inhibitors, plasma levels of sildenafil at 24 hours post dose have been found to be 3 to 8 times higher than those seen in healthy volunteers.
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