METHENAMINE HIPPURATE- methenamine hippurate tablet
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
21-09-2018
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Active ingredient:
Methenamine Hippurate (UNII: M329791L57) (Methenamine - UNII:J50OIX95QV)
Available from:
Winthrop U.S.
INN (International Name):
Methenamine Hippurate
Composition:
Methenamine Hippurate 1 g
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Methenamine hippurate 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 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. Methenamine hippurate tablets USP is contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. Methenamine preparations should not be given to
Product summary:
1-gram scored, capsule-shaped yellow tablets debossed W 1037 in bottles of 100 (NDC 0955-1037-10). Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].
Authorization status:
New Drug Application
Summary of Product characteristics
METHENAMINE HIPPURATE- METHENAMINE HIPPURATE TABLET
WINTHROP U.S.
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METHENAMINE HIPPURATE TABLETS, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of methenamine
hippurate tablets USP 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 bacteria.
DESCRIPTION
Each yellow capsule-shaped 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. 5 (tartrazine, see PRECAUTIONS), Magnesium Stearate, Povidone, and
Saccharin Sodium.
ACTIONS
MICROBIOLOGY
methenamine hippurate tablets USP has 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.
HUMAN PHARMACOLOGY
Within 1/2 hour after ingestion of a single 1-gram dose of methenamine
hippurate, antibacterial activity
is demonstrable in the urine. Urine has continuous antibacterial
activity when methenamine hippurate is
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 rapidly absorbed and excreted, and it reaches
the urine by both tubular secretion
and glomerular filtration. This action may be important in older
patients or in those with some degree of
renal impairment.
INDICATIONS
Methenamine hippurate is indicated for prophylactic or suppressive
treatment of frequently recurring
urinary tract infections when long-term therapy is cons
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