"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
To reduce the development of drug-resistant bacteria and maintain the effectiveness of UREX (methenamine hippurate) and other antibacterial drugs, UREX (methenamine hippurate) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
UREX (methenamine hippurate) is indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents.
DOSAGE AND ADMINISTRATION
One tablet (1 g) twice daily for adults and children over 12 years of age. One-half tablet or one tablet (0.5 or 1 g) twice daily for children 6 to 12 years of age.
The antibacterial activity of UREX (methenamine hippurate) is greater in acid urine. Therefore, restriction of alkalinizing foods and medications is desirable. If necessary, as indicated by urinary pH and clinical response, supplemental acidification of the urine may be instituted. The efficacy of therapy should be monitored by repeated urine cultures.
UREX (methenamine hippurate) Tablets are capsule-shaped, scored, white, imprinted "VP" on one side, and "UREX" on the other. Each table contains methenamine hippurate 1g.
Bottles of 100 tablets (NDC 65199-1201-1).
Store at controlled room temperature 15°-30°C (59°-86°F).
Distributed by: VATRING PHARMACEUTICALS, INC. Wytheville, Va. 24382. Medical Inquiries: 1-276-223-0800. Other Inquiries: 1-888-968-4726. Manufactured by: DRAXIS Pharma, a division of DRAXIS Specialty Pharmaceuticals Inc. Kirkland, Quebec, Canada. December 2006. FDA Rev date: 3/11/2008
Last reviewed on RxList: 3/28/2008
This monograph has been modified to include the generic and brand name in many instances.
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