INDICATIONS Methenamine hippurate tablets are 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 and other antibacterial drugs, methenamine hippurate tablets 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 Large doses of methenamine (8 grams daily for 3 to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.

ADVERSE REACTIONS Minor adverse reactions have been reported in less than 3.5% of patients treated.

These reactions have included nausea, upset stomach, dysuria and rash.

To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .