PMS-KETOPROFEN SUPPOSITORY

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

KETOPROFEN

Available from:

PHARMASCIENCE INC

ATC code:

M01AE03

INN (International Name):

KETOPROFEN

Dosage:

100MG

Pharmaceutical form:

SUPPOSITORY

Composition:

KETOPROFEN 100MG

Administration route:

RECTAL

Units in package:

10/30

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0110497002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2021-04-27

Summary of Product characteristics

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_pms-KETOPROFEN Product Monograph_
_Page 1 of 21 _
PRODUCT MONOGRAPH
PMS-KETOPROFEN
(Ketoprofen Suppositories)
50mg and 100 mg
NON-STEROIDAL, ANTI-INFLAMMATORY, ANALGESIC AGENT
PHARMASCIENCE INC.
6111 Royalmount Suite 100
Montreal Quebec
H4P 2T4
www.pharmascience.com
Submission Control No: 139180
Date of Revision:
June 8, 2010
_ _
_pms-KETOPROFEN Product Monograph_
_Page 2 of 21 _
PRODUCT MONOGRAPH
pms-KETOPROFEN
50mg and 100 mg
(Ketoprofen Suppositories)
THERAPEUTIC CLASSIFICATION
Non-steroidal anti-inflammatory analgesic agent.
ACTION AND CLINICAL PHARMACOLOGY
Ketoprofen has been shown to possess anti-inflammatory, analgesic, and
antipyretic properties in
animal pharmacological studies. The anti-inflammatory action is not
mediated through the
pituitary adrenal axis.
The therapeutic effectiveness of Ketoprofen has been demonstrated by;
a reduction in joint
swelling, pain and duration of morning stiffness, and by; increased
grip strength and an
improvement in functional capacity. The drug is also effective in the
relief of post-partum and
post-operative pains.
Like other non-steroidal anti-inflammatory drugs, Ketoprofen is an
inhibitor of prostaglandin
synthesis. Its potency in this regard is 8 times that of Indomethacin.
Ketoprofen at 200 mg daily was found to be comparable to Naproxen at
750 mg daily in the
effective treatment of rheumatoid arthritis. At 300 mg/day Ketoprofen
is comparable to
phenylbutazone at 600 mg/day. It is comparable to pirprofen in the
effective treatment of
osteoarthritis, ankylosing spondylitis, extra-articular rheumatism and
radicular neuralgia. The
anti-inflammatory and analgesic properties of Ketoprofen are superior
to those of Ibuprofen.
This property of the drug was also demonstrated against placebo.
Clinical trials in rheumatoid arthritis have demonstrated that the
anti-arthritic activity of
Ketoprofen at 200 mg/day was similar to that of acetylsalicylic acid
at 3.6 g/day.
At 200 mg/day, there was less gastrointestinal bleeding with
Ketoprofen than with acetylsalicylic
acid at