Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Methenamine Hippurate Tablets USP, 1 g are white to off-white capsule shaped tablet, debossed with “L” and “59” on one side and break line (functional) on other side. Bottle pack of 20 tablets with Child Resistant Closure, NDC 59746-797-65 Bottle pack of 100 tablets with Child Resistant Closure, NDC 59746-797-01 Store at 68° to 77°F (20° to 25°C); excursions permitted to 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant container with child-resistant closure. Rx Only Distributed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Manufactured by: Unichem Laboratories Limited, Plot No. 10 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa - 403511, India (IND) Revision 01/2024; PRINCIPAL DISPLAY PANEL NDC 59746-797-65 Methenamine Hippurate Tablets, USP 1 gram CADISTA 20 Tablets Rx Only Each Tablet contains: Methenamine Hippurate USP 1g. Usual Dosage: see package insert for dosage information. Warning: Keep out of the reach of children. Pharmacist: Dispense in well closed, light-resistant container with child-resistant closure. Store at 68° to 77°F (20° to 25°C); excursions permitted to 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Code: G0/DRUGS/321 Distributed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Made in India 13015249 NDC 59746-797-01 100 Tablets 13015250
- HOW SUPPLIED Methenamine Hippurate Tablets USP, 1 g are white to off-white capsule shaped tablet, debossed with “L” and “59” on one side and break line (functional) on other side. Bottle pack of 20 tablets with Child Resistant Closure, NDC 59746-797-65 Bottle pack of 100 tablets with Child Resistant Closure, NDC 59746-797-01 Store at 68° to 77°F (20° to 25°C); excursions permitted to 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant container with child-resistant closure. Rx Only Distributed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Manufactured by: Unichem Laboratories Limited, Plot No. 10 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa - 403511, India (IND) Revision 01/2024
- PRINCIPAL DISPLAY PANEL NDC 59746-797-65 Methenamine Hippurate Tablets, USP 1 gram CADISTA 20 Tablets Rx Only Each Tablet contains: Methenamine Hippurate USP 1g. Usual Dosage: see package insert for dosage information. Warning: Keep out of the reach of children. Pharmacist: Dispense in well closed, light-resistant container with child-resistant closure. Store at 68° to 77°F (20° to 25°C); excursions permitted to 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Code: G0/DRUGS/321 Distributed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Made in India 13015249 NDC 59746-797-01 100 Tablets 13015250
Overview
Each white to off-white capsule shaped tablet contains 1g Methenamine Hippurate, USP which is the Hippuric Acid Salt of Methenamine (hexamethylene tetramine). The tablet also contains inactive ingredients colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, povidone and sodium starch glycolate.
Indications & 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.
Dosage & Administration
1 tablet (1.0 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.
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 Jubilant Cadista Pharmaceuticals Inc. at 1-800-313-4623 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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