VIOXX TAB 25MG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ROFECOXIB

Available from:

MERCK FROSST CANADA & CIE, MERCK FROSST CANADA & CO.

ATC code:

M01AH02

INN (International Name):

ROFECOXIB

Dosage:

25MG

Pharmaceutical form:

TABLET

Composition:

ROFECOXIB 25MG

Administration route:

ORAL

Units in package:

30/100/1000

Prescription type:

Prescription

Therapeutic area:

CYCLOOXYGENASE-2 (COX-2) INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0138801002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2004-09-30

Summary of Product characteristics

PRODUCT MONOGRAPH
VIOXX
®
rofecoxib tablets
12.5, 25 AND 50 MG
VIOXX
®
rofecoxib oral suspension
12.5 MG/5 ML AND 25 MG/5 ML
THERAPEUTIC CLASSIFICATION
Anti-inflammatory Analgesic Agent
MERCK FROSST CANADA & CO.
Initial Date of Preparation:
KIRKLAND, QUEBEC, CANADA
October 20, 1999
Date of Revision:
August 11, 2004
Control #092249
VIOXX
®
is a Registered Trademark of Merck &. Co., Inc.
Used under license.
1
PRODUCT MONOGRAPH
NAME OF DRUG
VIOXX
®
rofecoxib tablets
12.5, 25 AND 50 MG
VIOXX
®
rofecoxib oral suspension
12.5 MG/5 ML AND 25 MG/5 ML
THERAPEUTIC CLASSIFICATION
Anti-inflammatory Analgesic Agent
ACTION AND CLINICAL PHARMACOLOGY
VIOXX
®
(rofecoxib) is a nonsteroidal anti-inflammatory drug (NSAID) that
exhibits anti-
inflammatory, analgesic and antipyretic activities in animal models.
At therapeutic doses,
VIOXX
®
is an orally active cyclooxygenase-2 (COX-2) selective inhibitor. At
therapeutic
concentrations, VIOXX
®
does not inhibit the cyclooxygenase-1 (COX-1) isoenzyme.
Cyclooxygenase is responsible for the generation of prostaglandins,
which are potent
biological mediators involved in diverse physiologic functions as well
as in pathologic
conditions. Two isoforms of cyclooxygenase have been identified:
cyclooxygenase-1
(COX-1) and cyclooxygenase-2 (COX-2). COX-1 is constitutively
expressed and
enzymatically active in various tissues, including the stomach,
intestines, and kidneys,
and in platelets. The prostaglandins produced by COX-1 play key roles
in the
maintenance of physiological functions such as platelet aggregation
and are among the
factors that maintain the GI mucosal barrier. Inhibition of COX-1 has
been associated
with gastric damage. COX-2 is constitutively expressed and plays a
physiological role
in a limited number of tissues, including the brain, kidney and female
reproductive tract.
2
In addition, inhibition of COX-2 reduces the formation of systemic
(and therefore
possibly endothelial) prostacyclin. Both COX-1 and COX-2 are important
for normal
renal function and inhibition of th