TOLBUTAMIDE TAB 500MG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TOLBUTAMIDE

Available from:

PRO DOC LIMITEE

ATC code:

A10BB03

INN (International Name):

TOLBUTAMIDE

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

TOLBUTAMIDE 500MG

Administration route:

ORAL

Units in package:

100/1000

Prescription type:

Prescription

Therapeutic area:

SULFONYLUREAS

Product summary:

Active ingredient group (AIG) number: 0103268001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2010-07-13

Summary of Product characteristics

PRESCRIBING INFORMATION
TOLBUTAMIDE - 500
TOLBUTAMIDE TABLETS USP
500 MG
ORAL HYPOGLYCEMIC
PRO DOC LTÉE
DATE OF REVISION:
2925, BOUL. INDUSTRIEL
FEBRUARY 02, 2010
LAVAL, QUEBEC
H7L 3W9 CONTROL# 131929
1
PRESCRIBING INFORMATION
TOLBUTAMIDE - 500
Tolbutamide Tablets USP
500 mg
THERAPEUTIC CLASSIFICATION
Oral Hypoglycemic
ACTIONS
Tolbutamide reduces blood sugar by stimulating the islet tissue to
secrete insulin.
Tolbutamide can be detected in the blood within 30 minutes after oral
administration; peak
concentrations are reached within 3 to 5 hours. The drug is bound to
plasma proteins.
Tolbutamide is principally oxidized to form a carboxylated metabolite,
butyl-p-
carboxyphenylsulfonylurea. The carboxylation occurs in the liver and
the kidneys. The
metabolite does not appear to have clinically significant hypoglycemic
effects. The half-life of
tolbutamide is about 5 hours. The metabolism and excretion of
tolbutamide may be slowed in
patients with impaired renal or hepatic function. Tolbutamide is
contraindicated in the presence
of liver disease or renal impairment.
INDICATIONS AND CLINICAL USE
To control hyperglycemia in tolbutamide responsive diabetes mellitus
of stable, mild, nonketosis
prone, maturity onset or adult type which cannot be controlled by
proper dietary management
and exercise or when insulin therapy is not appropriate.
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CONTRAINDICATIONS
•
Known hypersensitivity or allergy to tolbutamide.
•
Unstable and/or insulin dependent diabetes mellitus; ketoacidosis;
coma; during stress
conditions such as severe infections, trauma or surgery; in the
presence of liver disease or
frank jaundice; in the presence of renal impairment; thyrotoxicosis.
•
During pregnancy or breast-feeding.
WARNINGS
Tolbutamide will not prevent the development of complications peculiar
to diabetes mellitus.
Tolbutamide administration must be considered as treatment in addition
to a proper dietary
regimen and not as a substitute for diet.
Over a period of time, patients may become progressively less
responsive to therapy with or