METHENAMINE HIPPURATE TABLETS USP 1 g Rx only

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 bacteria.

Methenamine hippurate tablets, USP are available as 1 g oval shaped, scored and peach colored tablets. Chemically, methenamine hippurate is Hexamethylene-tetramine monohippurate. The molecular formula of methenamine hippurate is C H N O and molecular weight is 319.36. Its structural formula is: _{15 21 5 3}

Each methenamine hippurate tablets, USP intended for oral administration contains 1 g of methenamine hippurate. In addition, it also contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, povidone K29/32, saccharin sodium and FD&C Yellow #6 Aluminum Lake as a color additive.

Meets USP Dissolution Test 2.

Methenamine hippurate tablets, USP has antibacterial activity because the methenamine component is hydrolyzed to formaldehyde in acid urine. Hippuric acid, the other component, has some antibacterial activity and also acts to keep the urine acid. The drug is generally active against , enterococci and staphylococci. is generally resistant. The urine must be kept sufficiently acid for urea-splitting organisms such as and to be inhibited. Microbiology: E. coli Enterobacter aerogenes Proteus Pseudomonas

Methenamine hippurate tablets, USP 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 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.

Methenamine hippurate tablets, USP are contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. Methenamine preparations should not be given to patients taking sulfonamides because some sulfonamides may form an insoluble precipitate with formaldehyde in the urine.

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

Prescribing methenamine hippurate tablets, USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

1.  Care should be taken to maintain an acid pH of the urine, especially when treating infections due to urea-splitting organisms such as and strains of .          Proteus
Pseudomonas

2.  In a few instances in one study, the serum transaminase levels were slightly elevated during treatment but returned to normal while      the patients were still taking methenamine hippurate tablets, USP. Because of this report, it is recommended that liver function studies      be performed periodically on patients taking the drug, especially those with liver dysfunction.

3.  Use in Pregnancy: In early pregnancy the safe use of methenamine hippurate tablets, USP is not established. In the last trimester,      safety is suggested, but not definitely proved. No adverse effects on the fetus were seen in studies in pregnant rats and rabbits.           Methenamine hippurate tablets, USP taken during pregnancy can interfere with laboratory tests of urine estriol (resulting in       unmeasurably low values) when acid hydrolysis is used in the laboratory procedure. This interference is due to the presence in        the urine of methenamine and/or formaldehyde. Enzymatic hydrolysis, in place of acid hydrolysis, will circumvent this problem.

Minor adverse reactions have been reported in less than 3.5% of patients treated. These reactions have included nausea, upset stomach, dysuria, and rash.

1 tablet (1 g) twice daily (morning and night) for adults and pediatric patients over 12 years of age. 1/2 to 1 tablet (0.5 to 1 g) twice daily (morning and night) for pediatric patients 6 to 12 years of age. Since the antibacterial activity of methenamine hippurate tablets, USP is greater in acid urine, restriction of alkalinizing foods and medications is desirable. If necessary, as indicated by urinary pH and clinical response, supplemental acidification of the urine should be instituted. The efficacy of therapy should be monitored by repeated urine cultures.

NDC:68151-0984-1 in a PACKAGE of 1 TABLETS

Store at  20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in well-closed, light-resistant containers with child-resistant closures. Manufactured by: CorePharma LLC Middlesex, NJ 08846 LB# 745-02                              Rev.  December, 2010

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