TRIMETHOPRIM TABLETS

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

TRIMETHOPRIM

Saatavilla:

AA PHARMA INC

ATC-koodi:

J01EA01

INN (Kansainvälinen yleisnimi):

TRIMETHOPRIM

Annos:

200MG

Lääkemuoto:

TABLET

Koostumus:

TRIMETHOPRIM 200MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

URINARY ANTI-INFECTIVES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0114346002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2010-06-17

Valmisteyhteenveto

PRODUCT MONOGRAPH
TRIMETHOPRIM
TRIMETHOPRIM TABLETS USP
100 MG AND 200 MG
ANTIBACTERIAL AGENT
AA PHARMA INC.
DATE OF REVISION:
1165 CREDITSTONE ROAD, UNIT #1
MAY 14, 2014
VAUGHAN, ON
L4K 4N7
CONTROL #: 172985
- 1 -
PRODUCT MONOGRAPH
TRIMETHOPRIM
Trimethoprim Tablets USP
100 mg and 200 mg
THERAPEUTIC CLASSIFICATION
Antibacterial agent
ACTIONS AND CLINICAL PHARMACOLOGY
Trimethoprim blocks the production of tetrahydrofolic acid from
dihydrofolic acid by binding to
and reversibly inhibiting the enzyme dihydrofolate reductase. This
binding is very much
stronger for the bacterial enzyme than for the corresponding mammalian
enzyme; thus,
trimethoprim selectively interferes with bacterial biosynthesis of
nucleic acids and proteins by
causing a deficiency of endogenously produced thymine. The effect is
usually bactericidal in
the absence of an adequate external supply by thymine or thymidine
(see MICROBIOLOGY).
Trimethoprim is rapidly absorbed following oral administration. It
exists in the blood as
unbound, protein-bound and metabolized forms. Ten to 20% of
trimethoprim is metabolized,
primarily in the liver; the remainder is excreted unchanged in the
urine. The principal
metabolites of trimethoprim are the 1- and 3-oxides and the 3 - and 4
-hydroxy derivatives. The
free form is considered to be the therapeutically active form.
Approximately 44% of
trimethoprim is bound to plasma proteins.
Mean peak serum concentrations of approximately 1.0 µg/mL occur 1 to
4 hours after oral
administration of a single 100 mg dose. A single 200 mg dose will
result in serum levels
approximately twice as high. The half-life of trimethoprim ranges from
8 to 10 hours. However,
patients with severely impaired renal function exhibit an increase in
the half-life of trimethoprim,
which requires either dosage regimen adjustment or not using the drug
in such patients (see
DOSAGE AND ADMINISTRATION). During a 13-week study of trimethoprim
administered at a
daily dosage of 200 mg (50 mg q.i.d.), the mean minimum steady-state
concentration of the
dr