RHODACINE - SUP 100MG SUPPOSITORY

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

INDOMETHACIN

Mevcut itibaren:

RHOXALPHARMA INC

ATC kodu:

C01EB03

INN (International Adı):

INDOMETACIN

Doz:

100MG

Farmasötik formu:

SUPPOSITORY

Kompozisyon:

INDOMETHACIN 100MG

Uygulama yolu:

RECTAL

Paketteki üniteler:

10/30

Reçete türü:

Prescription

Terapötik alanı:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2004-08-12

Ürün özellikleri

PRODUCT MONOGRAPH
RHODACINE
INDOMETHACIN SUPPOSITORIES USP
100 MG
NONSTEROIDAL ANTI-INFLAMMATORY ANALGESIC AGENT
RHOXALPHARMA INC.
4600 THIMENS BOULEVARD
MONTREAL, QUEBEC
H4R 2B2
CONTROL #: 093319
DATE OF PREPARATION
:
AUGUST 12, 2004
Page 2
PRODUCT MONOGRAPH
RHODACINE
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.
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
Page 3
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 exists in the plasma as the parent