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Basic Drug Info
Drug Name:Methenamine Hippurate
Manufacturer:Rising Pharmaceuticals, Inc.
Other Info:

Store at controlled room temperature 15°-30°C (59°-86°F) (see USP). Meets USP Dissolution Test 2. Dispense in well-closed, light-resistant containers with child-resistant closures. Manufactured by: CorePharma LLC Middlesex, NJ 08846 Distributed by: Rising Pharmaceuticals, Inc.

Allendale, NJ 07401 MF # 285-03 November 2005



Clinical Trials:


Indications and Usage

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.
Urinary tract infection -- Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.

Communicable Diseases -- broad class of diseases whose causative agents may be passed between individuals in many different ways.

Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

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.
Renal Insufficiency -- Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE. The most severe form is KIDNEY FAILURE. Renal function may deteriorate slowly (RENAL INSUFFICIENCY, CHRONIC) or precipitously (RENAL INSUFFICIENCY, ACUTE).

Hepatic Insufficiency -- Conditions in which the LIVER functions fall below the normal ranges. Severe hepatic insufficiency may cause LIVER FAILURE or DEATH. Treatment may include LIVER TRANSPLANTATION.

Dehydration -- The condition that results from excessive loss of water from a living organism.

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.
Branded Drugs
The following US Branded drugs contain Methenamine Hippurate


HIPREX -- SANOFI AVENTIS US LLC

UREX -- VATRING PHARMACEUTICALS LP


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