RHODIS EC TABLET (ENTERIC-COATED)

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

KETOPROFEN

から入手可能:

SANOFI-AVENTIS CANADA INC

ATCコード:

M01AE03

INN（国際名）:

KETOPROFEN

投薬量:

50MG

医薬品形態:

TABLET (ENTERIC-COATED)

構図:

KETOPROFEN 50MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

製品概要:

Active ingredient group (AIG) number: 0110497001; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2006-07-28

製品の特徴

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