Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED White to off white colored, capsule shaped, biconvex tablets, debossed with "H" and "1" on either side of breakline on one side and other side plain with approximate length 20.00 mm, width 8.00 mm and thickness 7.40 mm. Unit dose packages of 30 (3 x 10) NDC 60687-694-21 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister torn or broken.; Package/Label Display Panel – Carton – 1 g NDC 60687- 694 -21 Methenamine Hippurate Tablets, USP 1 g 30 Tablets (3 x 10) Rx Only Each Tablet Contains: Methenamine Hippurate, USP...................................................... 1 g Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 42571-332, Micro Labs USA, Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 769421 0469421/0824 1 g Methenamine Tablets Carton; Package/Label Display Panel – Blister – 1 g Methenamine Hippurate Tablet, USP 1 g 1 g Methenamine Hippurate Tablet Blister
- HOW SUPPLIED White to off white colored, capsule shaped, biconvex tablets, debossed with "H" and "1" on either side of breakline on one side and other side plain with approximate length 20.00 mm, width 8.00 mm and thickness 7.40 mm. Unit dose packages of 30 (3 x 10) NDC 60687-694-21 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister torn or broken.
- Package/Label Display Panel – Carton – 1 g NDC 60687- 694 -21 Methenamine Hippurate Tablets, USP 1 g 30 Tablets (3 x 10) Rx Only Each Tablet Contains: Methenamine Hippurate, USP...................................................... 1 g Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 42571-332, Micro Labs USA, Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 769421 0469421/0824 1 g Methenamine Tablets Carton
- Package/Label Display Panel – Blister – 1 g Methenamine Hippurate Tablet, USP 1 g 1 g Methenamine Hippurate Tablet Blister
Overview
Each white to off-white 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 Colloidal silicon dioxide, magnesium stearate and povidone K90.
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 and other antibacterial drugs, methenamine hippurate 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 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
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.
Contraindications
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.
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 Micro Labs USA Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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