HIPREX- methenamine hippurate tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Validus Pharmaceuticals LLC

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

HIPREX 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 HIPREX and other antibacterial drugs, HIPREX 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. HIPREX (methenamine hippurate tablets USP) is contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. Methenamine preparations should not be given to patients taking sulfonamides becau

제품 요약:

1-gram scored, capsule-shaped yellow tablets debossed W 1037 in bottles of 100 (NDC 30698-477-01). Store at 68° to 77°F (20° to 25°C); excursions permitted to 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant container with child-resistant closure. Manufactured for and Distributed by: Validus Pharmaceuticals LLC Parsippany, NJ 07054 [e-mail] www.validuspharma.com 1-866-982-5438 Product of India © 2021 Validus Pharmaceuticals LLC 60029-03July 2021

승인 상태:

New Drug Application

제품 특성 요약

HIPREX- METHENAMINE HIPPURATE TABLET
VALIDUS PHARMACEUTICALS LLC
----------
HIPREX TABLETS
HIPREX
(METHENAMINE HIPPURATE TABLETS USP)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
HIPREX (methenamine hippurate tablets USP) and other antibacterial
drugs, HIPREX
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: HIPREX (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
HIPREX, antibacterial activity is demonstrable in the urine. Urine has
continuous
antibacterial activity when HIPREX 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
HIPREX is indicated for prophylactic or suppressive treatment of
frequently recurring
urinary tract infections when long-term therapy is considered
necessa