The incidence of retinal hemorrhage with sildenafil tablets 20 mg three times a day was 1.4% versus 0% placebo and for all sildenafil tablets doses studied was 1.9% versus 0% placebo. Patients were predominantly World Health Organization (WHO) functional classes II–III. Patients were randomized to placebo or sildenafil tablets (in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day) and all patients continued intravenous epoprostenol therapy.At baseline patients had PPH (80%) or PAH secondary to CTD (20%);WHO functional class I (1%), II (26%), III (67%), or IV (6%); and the mean age was 48 years, 80% were female, and 79% were Caucasian.There was a statistically significant greater increase from baseline in 6-minute walk distance at Week 16 (primary endpoint) for the sildenafil tablets group compared with the placebo group. An evaluation of visual function at doses up to 200 mg revealed no effects of sildenafil tablets on visual acuity, intraocular pressure, or pupillometry.Sildenafil tablets is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (25–63%). Patients had to have a mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg and a pulmonary capillary wedge pressure (PCWP) less than or equal to 15 mmHg at rest via right heart catheterization within 21 days before randomization, and a baseline 6-minute walk test distance greater than or equal to 100 meters and less than or equal to 450 meters (mean 349 meters). To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Placebo-corrected mean increases in walk distance of 45–50 meters were observed with all doses of sildenafil tablets. Kaplan-Meier estimates and a stratified log-rank test demonstrated that placebo-treated patients were 3 times more likely to experience a clinical worsening event than the sildenafil tablets-treated patients and that sildenafil tablets-treated patients experienced a significant delay in time to clinical worsening versus placebo-treated patients (p = 0.0074). This information does not take the place of talking with your doctor about your medical condition or treatment. The mean change from baseline at Week 16 (last observation carried forward) was 30 meters for the sildenafil tablets group compared with 4 meters for the placebo group giving an adjusted treatment difference of 26 meters (95% CI: 10.8, 41.2) (p = 0.0009).Patients on sildenafil tablets achieved a statistically significant reduction in mPAP compared to those on placebo. In patients with PAH, however, the ratio of the metabolite to sildenafil is higher. The inhibition of PDE-5 in these tissues by sildenafil may be the basis for the enhanced platelet anti-aggregatory activity of nitric oxide observed in vitro, and the mild peripheral arterial-venous dilatation in vivo.Patients on all sildenafil tablets doses achieved a statistically significant reduction in mean pulmonary arterial pressure (mPAP) compared to those on placebo in a study with no background vasodilators [mPAP = mean pulmonary arterial pressure; PVR= pulmonary vascular resistance; SVR = systemic vascular resistance; RAP = right atrial pressure; CO = cardiac output; HR = heart rate*The number of patients per treatment group varied slightly for each parameter due to missing assessments.In another study evaluating lower doses of sildenafil 1 mg, 5 mg and 20 mg Single oral doses of sildenafil 100 mg administered to healthy volunteers produced decreases in supine blood pressure (mean maximum decrease in systolic/diastolic blood pressure of 8/5 mmHg). Similar effects on blood pressure were noted with 25 mg, 50 mg and 100 mg doses of sildenafil, therefore the effects are not related to dose or plasma levels within this dosage range.

Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in Study 1: Mean (95% Confidence Interval)Figure 10. The improvement in walk distance was apparent after 4 weeks of treatment and was maintained at week 8 and week 12.A randomized, double-blind, placebo controlled study (Study 2) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol. Sildenafil exposure at a dose of 80 mg three times a day without concomitant medication is shown to be 5-fold the exposure at a dose of 20 mg three times a day. Sildenafil Mylan è un farmaco a base del principio attivo Sildenafil Citrato, appartenente alla categoria degli Antipertensivi, Disfunzione erettile e nello specifico Farmaci usati nella disfunzione dell'erezione.E' commercializzato in Italia dall'azienda Mylan S.p.A.. Sildenafil Mylan può essere prescritto con Ricetta RR - medicinali soggetti a prescrizione medica.
Copy the URL below and paste it into your RSS Reader application.DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. If you would like more information about sildenafil tablets talk with your doctor. Your heart has to work hard to pump blood into your lungs. 42543-005-90 Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms.

The primary efficacy endpoint was the change from baseline at Week 12 in 6MWD. Others were reported to have occurred hours to days after use concurrent with sexual activity. These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. The approximately 4,000-fold selectivity for PDE-5 versus PDE3 is important because PDE3 is involved in control of cardiac contractility. Sildenafil is only about 10-fold as potent for PDE-5 compared to PDE6, an enzyme found in the retina and involved in the phototransduction pathway of the retina.