APO CHLORPROPAMIDE TAB 250MG TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

CHLORPROPAMIDE

Dostupné z:

APOTEX INC

ATC kód:

A10BB02

INN (Medzinárodný Name):

CHLORPROPAMIDE

Dávkovanie:

250MG

Forma lieku:

TABLET

Zloženie:

CHLORPROPAMIDE 250MG

Spôsob podávania:

ORAL

Počet v balení:

100/1000

Typ predpisu:

Prescription

Terapeutické oblasti:

SULFONYLUREAS

Prehľad produktov:

Active ingredient group (AIG) number: 0103626002; AHFS:

Stav Autorizácia:

MARKETED

Dátum Autorizácia:

1974-12-31

Súhrn charakteristických

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