SURGAM SR CAPSULE (SUSTAINED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TIAPROFENIC ACID

Available from:

SANOFI-AVENTIS CANADA INC

ATC code:

M01AE11

INN (International Name):

TIAPROFENIC ACID

Dosage:

300MG

Pharmaceutical form:

CAPSULE (SUSTAINED-RELEASE)

Composition:

TIAPROFENIC ACID 300MG

Administration route:

ORAL

Units in package:

60

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0115902002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2007-07-31

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
SURGAM
®
(Tiaprofenic Acid Tablets, 300 mg)
Pr
SURGAM
®
SR
(Tiaprofenic Acid Sustained Release Capsules, 300 mg)
Anti-inflammatory, analgesic agent
sanofi-aventis Canada Inc.
Date of Preparation:
2150 St. Elzear Blvd. West
May 31, 2006
Laval, Quebec H7L 4A8
Submission Control No.
106130
s-a Version 1.0 dated
2
PRODUCT MONOGRAPH
NAME OF DRUG
Pr
SURGAM
®
(Tiaprofenic Acid Tablets, 300 mg)
Pr
SURGAM
®
SR
(Tiaprofenic Acid Sustained Release Capsules, 300 mg)
PHARMACOLOGICAL/THERAPEUTIC CLASSIFICATION
Anti-inflammatory, analgesic agent
ACTIONS AND CLINICAL PHARMACOLOGY
SURGAM (tiaprofenic acid), a propionic acid derivative, is a
nonsteroidal anti-inflammatory
agent with analgesic and antipyretic properties. Its mechanism of
action, as with other
nonsteroidal anti-inflammatory agents, is not yet completely known.
Tiaprofenic acid is an
inhibitor of prostaglandin synthetase enzymes which are known to be
associated with
inflammation and pain. The therapeutic effect of SURGAM does not
result from pituitary-
adrenal stimulation.
In vitro and ex vivo studies in different experimental models with
cartilage and cultures of human
chondrocytes obtained from biopsy specimens have shown that exposure
to tiaprofenic acid did
not depress the biosynthesis of proteoglycans nor alter the
differentiation of proteoglycans
secreted. The degradation of proteoglycan aggregates was inhibited. In
vivo data in
osteoarthritis patients showed a significant reduction in stromelysin
(proteoglycanase) activity
further to pre-treatment with tiaprofenic acid. These results support
tiaprofenic acid as an
effective inhibitor of stromelysin and also suggest a positive effect
on the joint cartilage under
experimental conditions in patients receiving therapeutic doses. The
clinical significance of
these findings is under further investigation.
Pharmacokinetics
SURGAM (tiaprofenic acid) given orally is rapidly absorbed at the
gastric and duodenal levels.
Peak serum levels are achieved in 30-90 minutes. It is extensively
plasma pro