GLYBURIDE- glyburide tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC)

Disponible des:

A-S Medication Solutions

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Glyburide tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide tablets are contraindicated in patients with: - Known hypersensitivity or allergy to the drug. - Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin. - Type I diabetes mellitus. - Concomitant administration of bosentan.

Resumen del producto:

Product: 50090-3012 NDC: 50090-3012-1 100 TABLET in a BOTTLE NDC: 50090-3012-9 90 TABLET in a BOTTLE

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

GLYBURIDE- GLYBURIDE TABLET
A-S MEDICATION SOLUTIONS
----------
GLYBURIDE TABLETS, USP
RX ONLY
DESCRIPTION
Glyburide tablets USP contain glyburide, USP, which is an oral
blood-glucose-lowering drug of the
sulfonylurea class. Glyburide, USP is a white or almost white,
crystalline powder. The chemical name
for Glyburide, USP is
1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]-sulfonyl]-3-cyclohexylurea.
It has
the following structural formula:
C
H ClN O S M.W. 494.0
Each glyburide tablet, USP intended for oral administration contains
1.25 mg or 2.5 mg or 5 mg of
Glyburide, USP. In addition, each tablet contains the following
inactive ingredients: calcium carbonate,
dibasic calcium phosphate dihydrate, magnesium stearate,
microcrystalline cellulose, povidone,
pregelatinized starch and sodium starch glycolate. Additionally each
2.5 mg tablet contains D&C yellow
# 10 aluminum lake and FD & C yellow # 6 aluminum lake; each 5 mg
tablet contains D&C yellow # 10
aluminum lake and FD & C blue # 1 aluminum lake.
CLINICAL PHARMACOLOGY
ACTIONS
Glyburide appears to lower the blood glucose acutely by stimulating
the release of insulin from the
pancreas, an effect dependent upon functioning beta cells in the
pancreatic islets. The mechanism by
which glyburide lowers blood glucose during long-term administration
has not been clearly
established. With chronic administration in Type II diabetic patients,
the blood glucose lowering effect
persists despite a gradual decline in the insulin secretory response
to the drug. Extrapancreatic effects
may be involved in the mechanism of action of oral sulfonylurea
hypoglycemic drugs. The combination
of glyburide and metformin may have a synergistic effect, since both
agents act to improve glucose
tolerance by different but complementary mechanisms.
Some patients who are initially responsive to oral hypoglycemic drugs,
including glyburide, may
become unresponsive or poorly responsive over time. Alternatively,
glyburide tablets may be effective
in some patients who have become unresponsive to one