METHENAMINE MANDELATE tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

METHENAMINE MANDELATE (UNII: 695N30CINR) (METHENAMINE - UNII:J50OIX95QV)

Beszerezhető a:

Bryant Ranch Prepack

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Methenamine mandelate, USP is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also those neurologic diseases leading to an infected residual urine. When used as recommended, methenamine mandelate, USP is particularly suitable for long-term therapy because of its safety and because resistance to the nonspecific bactericidal action of formaldehyde does not develop. Pathogens resistant to other antibacterial agents may respond to methenamine mandelate, USP because of the nonspecific effect of formaldehyde formed in an acid urine. To reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine mandelate, USP and other antibacterial drugs, methenamine mandelate, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Prophylactic Use Rationale:  Urine is a good culture medium for many urinary pathogens. Inocul

Termék összefoglaló:

Methenamine Mandelate Tablets, USP 500 mg are blue, oval, film-coated, debossed with “M460”. Supplied in bottles of 100 (NDC 63629-1147-1) Dispense in a tight, light-resistant container as defined in the USP. Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Rx only

Engedélyezési státusz:

unapproved drug other

Termékjellemzők

METHENAMINE MANDELATE- METHENAMINE MANDELATE TABLET, FILM COATED
BRYANT RANCH PREPACK
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
----------
METHENAMINE MANDELATE TABLETS
METHENAMINE MANDELATE TABLETS, USP
DESCRIPTION
Methenamine mandelate, USP, a urinary antibacterial agent, is the
chemical combination
of mandelic acid with methenamine. Methenamine mandelate, USP is
available for oral
use as film-coated tablets.
Methenamine mandelate tablets, USP contain 500 mg methenamine
mandelate and the
following inactive ingredients: microcrystalline cellulose,
croscarmellose sodium, silicon
dioxide, magnesium stearate, FD&C Blue #2, polyethylene glycol,
polyvinyl alcohol, talc,
titanium dioxide.
CLINICAL PHARMACOLOGY
Methenamine mandelate, USP is readily absorbed but remains essentially
inactive until it
is excreted by the kidneys and concentrated in the urine. An acid
urine is essential for
antibacterial action, with maximum efficacy occurring at pH 5.5 or
less. In an acid urine,
mandelic acid exerts its antibacterial action and also contributes to
the acidification of
the urine. Mandelic acid is excreted both by glomerular filtration and
tubular excretion.
The methenamine component is hydrolyzed in acid urine to ammonia and
to the
bactericidal agent formaldehyde.
Proportionally less formaldehyde is released as urinary pH approaches
6.0 and
insufficient quantities are released above this level for therapeutic
response. There is
equally effective antibacterial activity against both gram-positive
and gram-negative
organisms, since the antibacterial action of mandelic acid and
formaldehyde is
nonspecific. There are reports that methenamine mandelate, USP is
ineffective in some
infections with Proteus vulgaris and urea-splitting strains of
Pseudomonas aeruginosa
and A aerogenes. Since urea-splitting strains may raise the pH of the
urine, particular
attention to supplementary acidifica