METHENAMINE HIPPURATE- 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:

Micro Labs Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

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

Product summary:

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. Bottles of 100                                                                 NDC 42571-332-01 Carton of 80 (8 x10) Unit-dose Tablets                          NDC 42571-332-23 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]. Dispense in well-closed, light-resistant container with child-resistant closure. Manufactured by: Micro Labs Limited Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Rev.10/2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHENAMINE HIPPURATE - METHENAMINE HIPPURATE TABLET
MICRO LABS LIMITED
----------
METHENAMINE HIPPURATE TABLETS, USP
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF METHENAMINE HIPPURATE 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
BACTERIA.
DESCRIPTION
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.
ACTIONS
MICROBIOLOGY: Methenamine hippurate 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.
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, 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