METHENAMINE HIPPURATE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

County Line Pharmaceuticals, LLC

INN (Kansainvälinen yleisnimi):

METHENAMINE HIPPURATE

Koostumus:

METHENAMINE HIPPURATE 1 g

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 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 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. Methenamine Hippurate Tablets are contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. It should not be used

Tuoteyhteenveto:

Methenamine Hippurate Tablets are capsule-shaped, scored, white, imprinted “VP” on one side and “UREX” on the other. Each tablet contains methenamine hippurate 1 g. Bottles of 100 tablets (NDC 43199-020-01). Store at controlled room temperature 15°-30°C (59°-86°F).

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

METHENAMINE HIPPURATE- METHENAMINE HIPPURATE TABLET
COUNTY LINE PHARMACEUTICALS, LLC
----------
METHENAMINE HIPPURATE TABLETS 1 G
PI -CLP020A
02/10
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 are a urinary tract antiseptic drug.
Each white, scored tablet contains
methenamine hippurate 1g (see HOW SUPPLIED). Methenamine Hippurate
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
Molecular Weight 319.37
CLINICAL PHARMACOLOGY
Methenamine hippurate 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 a Methenamine
Hippurate Tablet, antibacterial activity is
demonstrable in the urine. Urine shows continuous antibacterial
activity when Methenamine Hippurate
Tablets are 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.
15
21
5
3
MICROBIOLOGY: Methenamine hippurate 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 concen