AVA-GLYBURIDE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

GLYBURIDE

Dostępny od:

AVANSTRA INC

Kod ATC:

A10BB01

INN (International Nazwa):

GLIBENCLAMIDE

Dawkowanie:

2.5MG

Forma farmaceutyczna:

TABLET

Skład:

GLYBURIDE 2.5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

SULFONYLUREAS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0108708002; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2014-08-21

Charakterystyka produktu

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PRODUCT MONOGRAPH
AVA-GLYBURIDE
GLYBURIDE TABLETS
MANUFACTURER’S STANDARD
2.5 AND 5 MG
ORAL HYPOGLYCEMIC
AVANSTRA INC.
DATE OF PREPARATION:
10761 – 25TH NE, SUITE 110, BUILDING “B”
FEBRUARY 14, 2011
CALGARY, ALBERTA
T2C 3C2
CONTROL # 144970
1
1
PRODUCT MONOGRAPH
AVA-GLYBURIDE
Glyburide Tablets
Manufacturer’s Standard
2.5 and 5 mg
THERAPEUTIC CLASSIFICATION
Oral hypoglycemic agent
ACTIONS AND CLINICAL PHARMACOLOGY
The principal action of glyburide results in an increased insulin
release from the beta cells of the
pancreas. Other mechanisms leading to a reduction of blood glucose are
also believed to be
influenced by glyburide. The insertion of an alkylene chain on the
benzene nucleus results in a
product of very high potency.
Schulz and Schmidt indicated that the presence of a sulfonamide
(sulphaphenazoIe) decreased
the distribution volume of glyburide without influence on the
half-life of the oral hypoglycemic
agent. As a result, insulin and serum concentrations of glyburide were
higher and hypoglycemic
attacks could he expected.
Hirn and Konigstein have observed hypoglycemia when phenylbutazone and
oxyphenbutazone
were added to glyburide. Schulz and Schmidt confirmed that
phenylbutazone has an enhancing
effect on the blood-sugar-Iowering effect of glyburide and found
higher insulin levels. The plasma
haIf-life of glyburide did not change with phenylbutazone
administration. However, a significant
decrease in the renal excretion of the main metabolite of glyburide
was observed, suggesting that
the elimination in the bile may compensate for the amount not excreted
in the urine.
2
2
Glyburide is highly bound to plasma proteins after absorption from the
gastrointestinal tract. It is
completely metabolized by hydroxylation of the cyclohexyl ring into 3
cis and 4 trans derivatives in
the liver and the kidneys play only a minor role in their
biotransformation and elimination from
plasma. The metabolites have no essential hypoglycemic effect and they
are not stored in the
body, but they are eliminated via t