methenamine hippurate

FDA Drug Profile — METHENAMINE HIPPURATE

Drug Details

Generic Name
methenamine hippurate
Brand Names
METHENAMINE HIPPURATE
Application Number
ANDA210068
Sponsor
Golden State Medical Supply, Inc.
NDC Codes
2
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
METHENAMINE HIPPURATE

Indications and Usage

INDICATIONS Methenamine hippurate tablets, USP 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. To reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate tablets, USP and other antibacterial drugs, methenamine hippurate tablets, USP 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.

Warnings

WARNING Large doses of methenamine (8 grams daily for 3 to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.