Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Fildena 50. If your doctor tells you to stop taking Fildena 25, or the tablets have passed their expiry date, ask your pharmacist what to do with any left over.
Concomitant Use with Drugs Which Lower Blood Pressure. 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. 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. 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.
Pharmacokinetic data from patients in clinical trials showed no effect on sildenafil 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. Fildena (50 mg) did not potentiate the increase in bleeding time caused by aspirin (150 mg). Fildena 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.
The effect on one of the major end points, maintenance of erections after penetration, is shown in Figure 6, for the pooled results of 5 fixed-dose, dose-response studies of greater than one month duration, showing response according to baseline function. Figure 6: Effect of Fildena and Placebo on Maintenance of Erection by Baseline Score. Sixty-three percent, 74%, and 82% of the patients on 25 mg, 50 mg and 100 mg of Fildena, respectively, reported an improvement in their erections, compared to 24% on placebo.
In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients. At the end of the long-term study, 88% of patients reported that Fildena improved their erections. One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268).
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. Diary data indicated that on Fildena, 48% of intercourse attempts were successful versus 12% on placebo. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of Fildena.
Diary data indicated that on Fildena, 59% of attempts at sexual intercourse were successful compared to 13% on placebo. Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of Fildena patients reported improvement in erections compared with 26% of placebo. Fildena was effective in a broad range of ED patients, including those with a history of coronary artery disease , hypertension , other cardiac disease, peripheral vascular disease , diabetes mellitus, depression, coronary artery bypass graft ( CABG ), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants /antipsychotics and anti-hypertensives/diuretics.
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