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| |  First One-Dose Treatment for Uncomplicated UTIs in Women Now Available NEW YORK, April 30, 1997 -- The 24 million American women who suffer from uncomplicated urinary tract infections each year now have a new option for relief. Monurol(TM) (fosfomycin tromethamine), the only approved one-time, one-dose treatment for bladder infections, is nationally available, according to Forest Laboratories, Inc. Uncomplicated urinary tract infections, also known as acute cystitis or bladder infections, are second only to respiratory infections in prompting doctor visits. A recent survey by the American Medical Association (AMA) found that four out of five women ages 18-49 who had had a bladder infection and were prescribed a five-day or more antibiotic treatment said they would prefer a shorter course of treatment. Commonly prescribed treatments require at least three days and often seven to ten days of medication. Some women abandon their medication after symptoms disappear, which can increase the risk that their infection will recur, and also increase the risk of developing bacterial resistance. Monurol May Improve Patient Compliance "One of the biggest problems in treating acute cystitis is ensuring that a patient will take her full course of therapy to properly treat this infection," says Jerry G. Blaivas, MD, clinical professor of urology at Cornell University Medical Center in New York. "With Monurol, women take the medication once, which should certainly make it much easier to comply with therapy." Monurol begins to work immediately, and symptoms should resolve within two to three days. The symptoms of uncomplicated UTIs are burning, frequent urination and pain or tenderness above the pubic bone. Uncomplicated UTIs are caused by bacteria and are often sexually related. They are not sexually transmitted diseases; rather they occur due to the "mechanics" of sex, which pushes harmful bacteria into the urinary tract causing infection. Use of diaphragms and spermicides also increases the risk for bladder infections. Monurol comes in an educational, "user-friendly" package. The unique package requires the patient to go through several simple steps before she can remove the medicine. With each step, women learn about their infection and what Monurol will do through straight-forward language and pictures. In addition, each package includes a clearly written booklet about bladder infections: what they are, what causes them, steps to help prevent them, how to take Monurol and when to expect relief. "It is our hope the Monurol packaging, the first to provide complete patient education with each treatment, will greatly facilitate patient awareness of the cause and treatment of acute cystitis," says Howard Solomon, president and chief executive officer, Forest Laboratories, Inc. Forest Laboratories also is offering a toll-free number (888-AWAY-UTI) for women and healthcare professionals to obtain information about uncomplicated UTIs. By calling, they can receive a free American Medical Association booklet, "Urinary Tract Infections: A Patient's Guide To Their Treatment." Monurol Track Record Monurol is the first one-dose antibiotic indicated for the treatment of acute cystitis caused by Escherichia coli or Enterococcusfaecalis in women. The first in a new class of antibiotics, Monurol has been available in Europe since 1988 and has been prescribed more than 11 million times. It is a pleasant tasting, orange-flavored, water-soluble powder that is mixed with three to four ounces of room temperature water. Monurol starts destroying bacteria within two to three hours and sustains bactericidal levels for up to 3-1/2 days against the most common type of bacteria (Escherichia coli) that causes acute cystitis. Of 771 females 18 years of age and older, patients given one dose of Monurol had an 82 percent bacterial cure rate and a 70 percent clinical response rate. In a separate evaluation, investigators in the clinical trials judged that 92 percent of patients were cured by Monurol. Monurol was well-tolerated in clinical trials. The most common adverse effect is diarrhea, which occurs in less than one in 10 patients. Other adverse events that occurred in more than one percent of patients were: vaginitis (5.5%), nausea (4.1%), headache (3.9%), dizziness (1.3%), asthenia (1.1%), and dyspepsia (1.1%). Headquartered in New York, Forest Laboratories is an international health care company that develops, manufacturers and distributes prescription and nonprescription pharmaceutical products, especially for women's health.
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