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This article is from the WebMD News Archive
Viagra Rival Levitra Approved
Aug. 20, 2003 -- Levitra has just won FDA approval -- a move toward challenging the groundbreaking erectile dysfunction drug Viagra. But what does Levitra have to offer that the little blue pill doesn't?
The news will hopefully bring more men to their doctors, opening up more conversations about this still-secret subject, says Natan Bar-Chama, MD, urologist and director of male reproductive surgery at Mt. Sinai Medical Center in New York City.
"We'll hopefully encourage more patients, and also physicians, to be more proactive in addressing this problem," he tells WebMD. Bar-Chama, who was not associated with the studies, agreed to comment on the announcement.
The Drugs
Viagra, the first pill for erectile dysfunction, was developed by Pfizer, Inc. and put on the market in 1998.
Levitra, co-developed by Bayer Pharmaceuticals and GlaxoSmithKline, takes effect a bit quicker than Viagra -- in less than 20 minutes for some men. Also, it keeps acting for about five hours, compared with Viagra's four hours, the company says. GlaxoSmithKline is a WebMD sponsor. Bayer and Glaxo say Levitra will be available in September.
Cialis, another erectile dysfunction drug in the pipeline, is expected to get FDA approval later this year. Cialis takes effect quickly (in 30 minutes or less), and its effects last about 36 hours. Also, its effectiveness is not affected by food, which has been a problem with Viagra, says Cialis maker Eli Lilly and Company, a WebMD sponsor.
The Mechanics
Levitra has been studied in more than 50 clinical trials involving 5,700 men. In Europe, it has been available since March 2003, and has shown to be effective and safe in treating erectile dysfunction.
Like Viagra, Levitra acts by relaxing muscles and blood vessels in the penis, allowing increased blood flow into the penis, which produces an erection.
With Levitra, onset of action occurs within 16 minutes for some men, between 30 to 60 minutes for others. Viagra starts acting 45 to 90 minutes after taking the pill. "On a practical level, it doesn't make a big difference. Both time-frames are adequate to engage in satisfactory relations," says Bar-Chama.
Also, Levitra works well when taken either before or after a low-fat meal, Bar-Chama tells WebMD, but a high-fat meal will decrease its aborption, making it less effective. High-fat meals also hinder Viagra.
For difficult-to-treat men who have diabetes and or have had prostate surgery, both Levitra and Viagra work equally well in solving erectile dysfunction, he adds. However, like Viagra, Levitra is not advised for men taking nitrate drugs (such as nitroglycerin tablets or patches) or alpha-blockers (drugs used to treat benign prostate hyperplasia and/or high blood pressure).
Cialis takes effect in 16 to 30 minutes, and stays active in the body for about 36 hours. Also, absorption of Cialis is not affected by either high-fat or low-fat meals, according to Carole Copeland, a Lilly spokeswoman.
Wide-Scale Problem
More than 50% of men over age 40 will experience erectile dysfunction at some time," says Bar-Chama.
"And yet, nine out of 10 are currently not being treated. This is a medical problem that significantly affects quality of life, and yet, for the vast majority, there is still a barrier to discussing and getting effective medical therapy. Hopefully, this news will awaken more men, get them to talk to their doctors."
SOURCE: FDA Talk Paper. Natan Bar-Chama, MD, urologist; director of male reproductive surgery, Mt. Sinai Medical Center, New York City. Bayer Pharmaceuticals Corp. GlaxoSmithKline. Carole Copeland, spokeswoman, Eli Lilly and Company.
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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.
