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FDA OKs Once-Daily Cialis
Jan. 11, 2008 -- Men taking the erectile dysfunction drug Cialis may now take a low dose of the drug on a daily basis.
The FDA has approved once-daily use of Cialis in a dose of 5 milligrams or a new 2.5-milligram dose for the treatment of erectile dysfunction (ED).
Once-daily Cialis "may be most appropriate for men with ED who anticipate more frequent sexual activity (e.g. twice weekly)," states a news release from Eli Lilly and Company, which makes Cialis.
"For other men, Cialis taken as needed -- the previously approved dosing regimen -- may be most appropriate," the drug company notes.
The FDA approved the once-daily Cialis dosing plan on based three studies in which 2.5-milligram or 5-milligram daily doses of Cialis trumped a placebo pill. In those studies, men took Cialis every day without regard to the timing of their sexual activity.
The FDA first approved Cialis in 2003 in doses of 5 milligrams, 10 milligrams, and 20 milligrams.
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Indication
Uroxatral® (alfuzosin HCl 10 mg extended-release tablets) is an alpha1-blocker for the treatment of the signs and symptoms of BPH.
Important Safety Information
Do not take UROXATRAL if you have liver problems or if you are taking antifungal drugs like ketoconazole or itraconazole, or HIV drugs like ritonavir.
UROXATRAL can cause a sudden drop in blood pressure, especially when starting treatment. This may lead to fainting, dizziness, and lightheadedness. Do not drive, operate machinery, or do any dangerous activity until you know how UROXATRAL will affect you. This is especially important if you already have a problem with low blood pressure or take medicines to treat high blood pressure. There may be an increased risk of low blood pressure and fainting when taking UROXATRAL in combination with blood pressure medication or nitrates, or erectile dysfunction medication.
If considering cataract surgery (clouding of the eyes), tell your eye surgeon that you are currently taking UROXATRAL or have previously been treated with an alpha-blocker.
Before taking UROXATRAL, tell your doctor if you have kidney problems.
Also, tell your doctor if you or any family member(s) have or take medications for a rare heart condition known as congenital prolongation of the QT interval.
BPH and prostate cancer can cause the same symptoms. However, UROXATRAL is not a treatment for prostate cancer.
The most common side effects with UROXATRAL are dizziness, upper respiratory tract infection, headache, and tiredness.
Please see UROXATRAL full prescribing information.
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