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Urex™
(methenamine hippurate)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of UREX
tablets and other antibacterial drugs, UREX tablets should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
UREX (methenamine hippurate) is a urinary tract antiseptic drug. Each white, scored UREX
tablet contains methenamine hippurate 1 g (see HOW SUPPLIED). UREX tablets also contain:
magnesium stearate, povidone and saccharin sodium. Chemically, methenamine hippurate is the
hippuric acid salt of methenamine (hexamethylenetetramine).
Structural formula:
C H N O
15 21 5 3
Molecular Weight 319.37
CLINICAL PHARMACOLOGY
UREX is readily absorbed from the GI tract. Methenamine distributes widely into body fluids,
but very little is hydrolyzed prior to excretion in the kidney and thus has minimal systemic toxic
potential.
Within one-half hour after a single 1 g dose of UREX, anti-bacterial activity is demonstrable in
the urine. Urine shows continuous antibacterial activity when UREX is administered at the
recommended dosage schedule of 1 g twice daily. Over 90% of the methenamine moiety is
excreted in the urine within twenty-four hours after administration of a single 1 g dose.
Similarly, the hippurate moiety is rapidly absorbed and excreted, and it reaches the urine by both
tubular secretion and glomerular filtration. This may be of importance in older patients or those
with some degree of renal impairment.
Methenamine is placentally transferred to the fetus during pregnancy.
1
Microbiology. UREX exerts its activity because the methenamine component is hydrolyzed to
formaldehyde in acid urine. Hippuric acid, the other component, acts to keep the urine acid. The
minimal inhibitory concentrations are significantly lower in more acidic media; therefore, the
efficacy of UR
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