RHODIS SUPPOSITORY

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

KETOPROFEN

Tersedia dari:

SANOFI-AVENTIS CANADA INC

Kode ATC:

M01AE03

INN (Nama Internasional):

KETOPROFEN

Dosis:

100MG

Bentuk farmasi:

SUPPOSITORY

Komposisi:

KETOPROFEN 100MG

Rute administrasi :

RECTAL

Unit dalam paket:

30

Jenis Resep:

Prescription

Area terapi:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2006-05-25

Karakteristik produk

PRODUCT MONOGRAPH
RHODIS
®
(Ketoprofen)
100 mg Suppositories
RHODIS
®
EC
50 mg, 100 mg Enteric-Coated Tablets
Anti-Inflammatory Analgesic Agent
sanofi-aventis Canada Inc.
Date of Preparation:
2150 St. Elzear Blvd. West
June 2, 2006
Laval, Quebec H7L 4A8
Submission Control No. 106123
s-a Version 1.0 dated
2
NAME OF DRUG
RHODIS
®
(Ketoprofen)
100 mg Suppositories
RHODIS
®
EC
50 mg, 100 mg Enteric-Coated Tablets
THERAPEUTIC CLASSIFICATION
Anti-inflammatory analgesic agent.
ACTIONS AND CLINICAL PHARMACOLOGY
Animal pharmacological studies have shown that ketoprofen is a
non-steroidal anti-inflammatory drug that
possesses anti-inflammatory, analgesic and antipyretic properties. The
anti-inflammatory action is not
mediated through the pituitary adrenal axis.
Its therapeutic effectiveness 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.
Clinical trials in rheumatoid arthritis have shown that the
anti-arthritic activity of RHODIS (ketoprofen)
200 mg/day was similar to that of acetylsalicylic acid 3.6 g/day.
RHODIS
®
200 mg daily induced less gastrointestinal bleeding than
acetylsalicylic acid 4 g daily.
The effectiveness of RHODIS
®
as a general purpose analgesic has been studied in standard pain
models
which have shown the effectiveness of doses of 25 to 150 mg. Doses of
25 mg were superior to placebo.
Larger doses than 25 mg generally could not be shown significantly
more effective but there was a tendency
toward faster onset and greater duration of action with 50 mg and, in
the case of dysmenorrhea, a significantly
greater effect overall with 75 mg. Doses greater than 50 to 75 mg did
not have increased analgesic effect.
Pharmacokinetics properties:
In man, RHODIS
®
(ketoprofen) is rapidly and almost completely absorbed from the
gastrointestinal tract.
Maximum plasma levels are reached within 1/2 to 2 hours after
administration of capsules or suppositories;
however, peak plasma levels are delay