MANDELAMINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHENAMINE MANDELATE

Available from:

SEARCHLIGHT PHARMA INC

ATC code:

J01XX05

INN (International Name):

METHENAMINE

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

METHENAMINE MANDELATE 500MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Ethical

Therapeutic area:

URINARY ANTI-INFECTIVES

Product summary:

Active ingredient group (AIG) number: 0106960001; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-08-12

Summary of Product characteristics

PRODUCT MONOGRAPH
MANDELAMINE*
METHENAMINE MANDELATE TABLETS U.S.P.
500 MG
URINARY ANTIBACTERIAL
Searchlight Pharma Inc.
1600 Notre-Dame West, suite 312
Montreal, Quebec
H3J 1M1
Submission Control No.: 267641
Date of Preparation:
OCT 24, 2022
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MANDELAMINE*
METHENAMINE MANDELATE TABLETS U.S.P.
500 MG
THERAPEUTIC CLASSIFICATION
Urinary Antibacterial
ACTION AND CLINICAL PHARMACOLOGY
Methenamine mandelate a urinary antibacterial agent, is the chemical
combination of mandelic
acid with methenamine. MANDELAMINE (Methenamine Mandelate Tablets
U.S.P.) is
available for oral use as film-coated tablets.
Methenamine mandelate is readily absorbed but remains essentially
inactive until it is excreted by
the kidney and concentrated in the urine. An acid urine is essential
for antibacterial action, with
maximum efficacy occurring at pH 5.5 or less.
Mechanism of Action
In an acid urine, mandelic acid exerts its antibacterial action and
also contributes to the acidification
of the urine. Mandelic acid is excreted by both glomerular filtration
and tubular excretion.
Pharmacokinetics and Metabolism
The methenamine component, in an acid urine, is hydrolyzed to ammonia
and to the bactericidal
agent formaldehyde. 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 _Aerobacter aerogenes_.
Since urea-splitting strains may raise the pH of the urine, particular
attention to supplementary
acidification, with agents such as ascorbic acid, is required.
However, results in any single case
will depend to a large extent on the underlying pathology and the
overall management.
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INDICATIONS AND USAGE
MANDELAMINE (Methenamine Mandelate Tablets U.S.P.) are indicated for
the suppression or
elimination of bacteriuria associated with pyelonephritis, cystitis
a