FDA Approves Cialis Tadalafil for Erectile Dysfunction
U.S. Food and Drug Administration (FDA) has approved generic Cialis, a new oral PDE5 inhibitor, for the treatment of sexual dysfunction (ED). Cialis was shown to improve sexual dysfunction compared to placebo up to 36 hours following dosing. In laboratory studies, the ability to have sexual intercourse was improved in some patients at 30 minutes after taking a dose.
Thus, tadalafil joins Sildenafil and Vardenafil as alternative oral pills, all 3 now approved by the U.S. FDA, for ED.
Tadalafil is not for everyone. Men taking any form of nitrates (often used to control anginal chest pain) should never take tadalafil, as the combination may cause an unsafe drop in blood pressure. Men taking pills called “alpha blockers” (sometimes prescribed for prostate problems or high blood pressure) should never take tadalafil. This combination may also cause a significant drop in blood pressure.
The safety and efficacy of Cialis was analyzed in twenty two clinical trials in more than 4,000 patients. Tadalafil was found to be effective in treating ED in patients 27 to 87 years old, including patients with other underlying medical conditions. In two of these clinical trials, men had ED along with diabetes or following radical prostatectomy for prostate cancer.
In lab trials, the most common side effects with generic cialis were headache, upset stomach, backache, and muscle ache. Most men were not bothered by the side effects enough to stop taking tadalafil. In placebo controlled Phase three lab trials, discontinuation rates in patients treated with tadalafil 10 mg or 20 mg was 3.1%, compared to 1.4% in placebo treated patients. Apcalis is not recommended in patients who have suffered a heart attack or stroke within the last six months, or patients who have significantly low blood pressure, uncontrolled high blood pressure, unstable angina, severe liver impairment, or retinitis pigmentosa (a rare eye disorder). Men should discuss their health status with their family physicians to ensure that tadalafil is right for them and that they are fit enough to engage in sexual activity. tadalafil does not protect a man or his partner from sexually transmitted diseases, including HIV.
