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Drug Catalog - Product Detail

METHENAMINE MANDELATE, USP TB 1000MG 100

NDC Mfr Size Str Form
13925-0107-01 SETON PHARMACEUTICALS 100 1GM TABLET
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Description
DESCRIPTION: Methenamine mandelate, a urinary antibacterial agent, is the chemical combination of mandelic acid with methenamine. Methenamine mandelate is available for oral use as film-coated tablets. Methenamine mandelate tablets contain 1000 mg (1 g) methenamine mandelate and the following inactive ingredients: croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and tItanium dioxide.
How Supplied
HOW SUPPLIED Methenamine Mandelate Tablets 1000 mg (1 g) are blue, scored, oblong, film-coated, debossed with "ERTH" on one side and "1000" on the other side. Supplied in bottles of 100 (NDC 13925-107-01) Preserve in well-closed containers Store at 25°C (77°F) excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Rx only Marketed by: Seton Pharmaceuticals Inc. Manasquan, NJ 08736 USA 1-800-510-3401 Iss. 06/11 Part No. 70023501
Indications & Usage
INDICATIONS AND USAGE Methenamine mandelate is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also those neurologic diseases leading to an infected residual urine. When used as recommended, methenamine mandelate is particularly suitable for long-term therapy because of its safety and because resistance to the nonspecific bactericidal action of formaldehyde does not develop. Pathogens resistant to other antibacterial agents may respond to methenamine mandelate because of the nonspecific effect of formaldehyde formed in an acid urine. Prophylactic Use Rationale: Urine is a good culture medium for many urinary pathogens. Inoculation by a few organisms (relapse or reinfection) may lead to bacteriuria in susceptible individuals. Thus, the rationale of management in recurring urinary tract infection (bacteriuria) is to change the urine from a growth-supporting to a growth-inhibiting medium. There is a growing body of evidence that long-term administration of methenamine mandelate can prevent the recurrence of bacteriuria in patients with chronic pyelonephritis. Therapeutic Use Rationale: Methenamine mandelate helps to sterilize the urine, and in some situations in which underlying pathologic conditions prevent sterilization by any means, it can help to suppress the bacteriuria. Methenamine mandelate should not be used alone for acute infections with parenchymal involvement causing systemic symptoms such as chills and fever. A thorough diagnostic investigation as a part of the overall management of the urinary tract infection should accompany the use of methenamine mandelate.
Dosage and Administration
DOSAGE AND ADMINISTRATION The average adult dose is 4 g a day given as 1 g tablet after each meal and at bedtime. Children 6 to 12 years of age should receive half the adult dose; one-half tablet 4 times a day.