Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
CHLORPROPAMIDE
APOTEX INC
A10BB02
CHLORPROPAMIDE
250MG
TABLET
CHLORPROPAMIDE 250MG
ORAL
100/1000
Prescription
SULFONYLUREAS
Active ingredient group (AIG) number: 0103626002; AHFS:
MARKETED
1974-12-31
PRESCRIBING INFORMATION APO-CHLORPROPAMIDE CHLORPROPAMIDE TABLETS USP 100 MG AND 250 MG ORAL HYPOGLYCEMIC APOTEX INC. DATE OF REVISION: 150 SIGNET DRIVE NOVEMBER 20, 2009 WESTON, ONTARIO M9L 1T9 CONTROL NO. 131776 1 PRESCRIBING INFORMATION APO-CHLORPROPAMIDE Chlorpropamide Tablets USP 100 mg and 250 mg THERAPEUTIC CLASSIFICATION Oral Hypogylcemic ACTIONS AND CLINICAL PHARMACOLOGY Chlorpropamide is an orally active hypoglycemic agent which reduces blood sugar concentration without affecting glucose tolerance. It probably acts by stimulating insulin secretion in the presence of functioning pancreatic islet tissue. Chlorpropamide is absorbed readily from the gastrointestinal tract and is bound to plasma proteins. Within 1 hour after a single dose, it is detectable in the blood, and the level reaches a maximum within 2 to 4 hours. It is slowly excreted by the kidneys as unchanged chlorpropamide, 2-hydroxy-chlorpropamide, p-chlorbenzene-sulfonylurea, and other metabolites. The biological half-life of a single dose of chlorpropamide averages about 36 hours. Within 96 hours, 80 to 90% of a single oral dose is excreted in the urine. When the drug is administered daily in the appropriate therapeutic dose, it accumulates in the body until a steady state of equilibrium develops between the amount administered (daily) and the amount eliminated (daily) through metabolism and excretion. This equilibrium is usually reached in about 5 to 7 days and no further accumulation occurs thereafter unless the dosage is excessive. Chlorpropamide exerts a hypoglycemic effect in normal humans within 1 hour, becoming maximal at 3 to 6 hours and persisting for at least 24 hours. 2 INDICATIONS AND CLINICAL USE In mild, stable diabetes mellitus of the maturity-onset (or adult) variety to control hyperglycemia responsive to the drug. It should not be used in those patients who are prone to ketosis or who can be controlled by dietary management and exercise alone or for whom insulin therapy is more appropriate. CONTRAINDICATIONS • Known hyperse Baca dokumen lengkapnya