METHENAMINE HIPPURATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHENAMINE HIPPURATE (UNII: M329791L57) (METHENAMINE - UNII:J50OIX95QV)

Available from:

Ingenus Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methenamine hippurate tablets 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 tablets 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. Methenamine hippurate tablets are contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. Methenamine preparations should n

Product summary:

Peach colored, capsule shaped, biconvex tablets debossed with "I" and "7"on one side and scoreline on two sides, free from mottled surface in bottles of 100 (NDC 50742- 142-01). Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Dispense in well-closed, light-resistant container with child-resistant closure. Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32811 Rx Only 553502 Revised: 01/2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHENAMINE HIPPURATE- METHENAMINE HIPPURATE TABLET
INGENUS PHARMACEUTICALS, LLC
----------
METHENAMINE HIPPURATE TABLETS, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
methenamine hippurate tablets and other antibacterial drugs,
methenamine hippurate
tablets should be used only to treat or prevent infections that are
proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Methenamine Hippurate Tablets, USP is a urinary tract antiseptic drug.
Each peach color,
capsule-shaped bi-convex tablet contains 1 g methenamine hippurate
which is the
hippuric acid salt of methenamine (hexamethylene tetramine). The
tablet also contains
inactive ingredients: FD&C Yellow No. 6, Magnesium Stearate, Colloidal
Silicon Dioxide,
Povidone, and Saccharin Sodium.
STRUCTURAL FORMULA:
ACTIONS
MICROBIOLOGY
Methenamine hippurate tablets have antibacterial activity because the
methenamine
component is hydrolyzed to formaldehyde in acid urine. Hippuric acid,
the other
component, has some antibacterial activity and also acts to keep the
urine acid. The
drug is generally active against _E. coli_, enterococci and
staphylococci. _Enterobacter_
_aerogenes _is generally resistant. The urine must be kept
sufficiently acid for urea-
splitting organisms such as _Proteus _and _Pseudomonas _to be
inhibited.
_SUSCEPTIBILITY TESTING_
_FOR SPECIFIC INFORMATION REGARDING SUSCEPTIBILITY TEST INTERPRETIVE
CRITERIA_
_AND ASSOCIATED TEST METHODS AND QUALITY CONTROL STANDARDS RECOGNIZED
BY_
_FDA FOR THIS DRUG, PLEASE SEE: HTTPS://WWW.FDA.GOV/STIC_
HUMAN PHARMACOLOGY
Within 1/2 hour after ingestion of a single 1-gram dose of methenamine
hippurate
tablets antibacterial activity is demonstrable in the urine. Urine has
continuous
antibacterial activity when methenamine hippurate tablets are
administered at the
recommended dosage schedule of 1 gram twice daily. Over 90% of
methenamine moiety
is excreted in the urine within 24 hours after administration of a
single 1-gram dose.
Similarly, the hippurate moiety is