Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Methenamine Hippurate Tablets USP , 1 g are white to off-white colored capsule shaped tablets debossed with “E” and “71” on one side and scoreline (functional) on other side. Bottles of 100 NDC 65862-782-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in well-closed, light-resistant container with child-resistant closure. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 10/2024; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1 g (100 Tablets Bottle) NDC 65862-782-01 Rx only Methenamine Hippurate Tablets USP 1 g AUROBINDO 100 Tablets PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1 g (100 Tablets Bottle)
- HOW SUPPLIED Methenamine Hippurate Tablets USP , 1 g are white to off-white colored capsule shaped tablets debossed with “E” and “71” on one side and scoreline (functional) on other side. Bottles of 100 NDC 65862-782-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in well-closed, light-resistant container with child-resistant closure. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 10/2024
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1 g (100 Tablets Bottle) NDC 65862-782-01 Rx only Methenamine Hippurate Tablets USP 1 g AUROBINDO 100 Tablets PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1 g (100 Tablets Bottle)
Overview
Each white to off-white colored capsule shaped tablet contains 1 g Methenamine Hippurate USP which is the Hippuric Acid Salt of Methenamine (hexamethylene tetramine). The tablet also contains inactive ingredients. Magnesium stearate, povidone, and saccharin sodium.
Indications & Usage
INDICATIONS 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.
Dosage & Administration
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 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.
Warnings & Precautions
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.
Contraindications
Methenamine hippurate tablets 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.
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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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