SULFINPYRAZONE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SULFINPYRAZONE

Available from:

AA PHARMA INC

ATC code:

M04AB02

INN (International Name):

SULFINPYRAZONE

Dosage:

200MG

Pharmaceutical form:

TABLET

Composition:

SULFINPYRAZONE 200MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

URICOSURIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0106089002; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-05-26

Summary of Product characteristics

0
PRODUCT MONOGRAPH
SULFINPYRAZONE
SULFINPYRAZONE TABLETS USP
200 MG
A) PLATELET INHIBITORY AGENT
B) URICOSURIC AGENT
AA PHARMA INC.
DATE OF PREPARATION:
100 KING STREET WEST, SUITE 5700
May 27, 2010
TORONTO, ONTARIO
M5X 1C7
Control#: 138859
1
PRODUCT MONOGRAPH
SULFINPYRAZONE
Sulfinpyrazone Tablets USP
200 mg
THERAPEUTIC CLASSIFICATION
Platelet Inhibitory Agent
Uricosuric Agent
ACTIONS AND CLINICAL PHARMACOLOGY
i)
In vitro experiments with SULFINPYRAZONE in human volunteers have
demonstrated
possible effectiveness in clinical states associated with abnormal
platelet aggregation.
ii)
Reduces serum urate level, prevents formation of new tophi, promotes
resorption of existing
tophi by increasing clearance of uric acid and water through the
kidneys.
INDICATIONS AND CLINICAL USE
i)
Inhibition of thrombotic and embolic processes associated with
platelet adhesion,
aggregation and reduced platelet survival time.
ii)
Chronic phases of gout, both the intercritical or silent stage and the
gouty arthritis stage.
2
CONTRAINDICATIONS
The safe use of sulfinpyrazone in pregnancy has not been established.
It should not be used
during pregnancy unless, in the opinion of the treating physician, the
expected benefits outweigh
the potential risks.
Active Peptic Ulcer.
Known hypersensitivity to sulfinpyrazone and other pyrazolone
derivatives.
Severe hepatic or renal disease, unless due to platelet aggregates.
WARNINGS
Avoid salicylate therapy, unless administered under careful
supervision:
i)
Salicylates and citrates antagonize the uricosuric action of
sulfinpyrazone and may therefore
interfere with uric acid excretion.
ii)
Salicylates may cause unpredictable, and, at times, serious
prolongation of the bleeding
time, and in combination with sulfinpyrazone, may cause bleeding
episodes. If, during
sulfinpyrazone therapy, aspirin or another chemically-related drug
must be used, patients
should be urged to report immediately any undue bleeding episode.
It should be administered with care to patients with a history of
healed peptic ulcer.