RATIO-INDOMETHACIN SUPPOSITORY

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

INDOMETHACIN

Beschikbaar vanaf:

TEVA CANADA LIMITED

ATC-code:

M01AB01

INN (Algemene Internationale Benaming):

INDOMETACIN

Dosering:

100MG

farmaceutische vorm:

SUPPOSITORY

Samenstelling:

INDOMETHACIN 100MG

Toedieningsweg:

RECTAL

Eenheden in pakket:

30

Prescription-type:

Prescription

Therapeutisch gebied:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0101832003; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2018-05-02

Productkenmerken

PRODUCT MONOGRAPH
RATIO-
INDOMETHACIN
INDOMETHACIN SUPPOSITORIES USP
100 MG
NONSTEROIDAL ANTI-INFLAMMATORY ANALGESIC AGENT
TEVA CANADA LIMITED.
30 NOVOPHARM COURT
TORONTO, ON
CANADA, M1B 2K9
D-1012-1
CONTROL #: 164013
DATE OF PREPARATION
:
JUNE 21, 2013
Page 2
PRODUCT MONOGRAPH
RATIO-
INDOMETHACIN
INDOMETHACIN SUPPOSITORIES USP
100 MG
NONSTEROIDAL ANTI-INFLAMMATORY ANALGESIC AGENT
PHARMACEUTICAL / THERAPEUTIC CLASSIFICATION
Nonsteroidal anti-inflammatory analgesic agent
ACTION AND CLINICAL PHARMACOLOGY
Indomethacin is a nonsteroidal anti-inflammatory drug with marked
analgesic, and
antipyretic properties. It has a unique chemical structure, which
differentiates it from the
salicylates, corticosteroids, phenylbutazone-like compounds and
colchicine. Unlike
corticosteroids, it has no effect on pituitary or adrenal function.
Page 3
Indomethacin is a potent inhibitor of prostaglandin synthesis _ in
vitro_. Concentrations
are reached during therapy which have been demonstrated to have an _in
vivo_ effect as
well.
Although indomethacin does not alter the course of the underlying
disease, it has been
found effective to relieve pain, reduce fever, swelling and
tenderness, and increase
mobility in patients with rheumatic diseases, including rheumatoid
arthritis, ankylosing
spondylitis, osteoarthritis and gout.
PHARMACOKINETICS:
In man, indomethacin is readily absorbed, attaining peak plasma
concentrations of
about 1 and 2 _µ_g/mL at approximately 2 hours following single oral
doses of 25 and 50
mg, respectively. Ninety percent of the orally administered
indomethacin is absorbed
within 4 hours. The suppository formulation is more rapidly and
completely absorbed
than the oral dose of indomethacin. Thus, C
max
after rectal administration is lower than
after oral dosing. The mean half-life of indomethacin is estimated to
be about 4.5 hours.
With a typical therapeutic regimen of 25 or 50 mg t.i.d., the steady
state plasma
concentrations of indomethacin are on average 1.4 times those
following the first dose.
Indomethacin exist