METHENAMINE MANDELATE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Seton Pharmaceuticals

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Methenamine mandelate 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 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 because of the nonspecific effect of formaldehyde formed in an acid urine. Prophylactic Use Rationale: Urine is a good culture medium for many urinary pathogens. Inoculation by a few organisms (relapse or reinfection) may lead to bacteriuria in susceptible individuals. Thus, the rationale of management in recurring urinary tract infection (bacteriuria) is to change the urine from a growth-supporting to a growth-inhibiting medium. There is a growing body of evidence that lon

Povzetek izdelek:

Methenamine Mandelate Tablets 1000 mg (1 g) are blue, scored, oblong, film-coated, debossed with "ERTH" on one side and "1000" on the other side. Supplied in bottles of 100 (NDC 13925-107-01) Preserve in well-closed containers Store at 25°C (77°F) excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Rx only Marketed by: Seton Pharmaceuticals Inc. Manasquan, NJ 08736 USA 1-800-510-3401 Iss. 06/11 Part No. 70023501

Status dovoljenje:

unapproved drug other

Lastnosti izdelka

METHENAMINE MANDELATE- METHENAMINE MANDELATE TABLET, FILM COATED
SETON PHARMACEUTICALS
_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._
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METHENAMINE MANDELATE TABLETS (USP)
DESCRIPTION:
Methenamine mandelate, a urinary antibacterial agent, is the chemical
combination of
mandelic acid with methenamine. Methenamine mandelate is available for
oral use as film-
coated tablets.
Methenamine mandelate tablets contain 1000 mg (1 g) methenamine
mandelate and the
following inactive ingredients: croscarmellose sodium, FD&C blue #2
aluminum lake,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
polyvinyl alcohol,
silicon dioxide, talc and tItanium dioxide.
CLINICAL PHARMACOLOGY
Methenamine mandelate 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 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 acidification with
agents suc