GLYBURIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Unit Dose Services

INN (International Name):

GLYBURIDE

Composition:

GLYBURIDE 2.5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYBURIDE- GLYBURIDE TABLET
UNIT DOSE SERVICES
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FOR ORAL USE
DESCRIPTION
Glyburide tablets, USP contain a smaller particle size glyburide,
which is an oral blood-glucose-
lowering drug of the sulfonylurea class. Glyburide is a white,
crystalline compound, formulated as
glyburide tablets, USP of 1.25, 2.5, and 5 mg strengths for oral
administration. Inactive ingredients:
lactose monohydrate, microcrystalline cellulose, magnesium stearate.
In addition, the 2.5 MG contains
FD&C Red No.40 and the 5 MG contains FD&C Blue No.1. The chemical name
for glyburide is 1-[[p-
[2-(5-chloro-o-anisamido)-ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and
the molecular weight is
493.99. The structural formula is represented below.
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 tablets,
may become unresponsive or poorly responsive over time. Alternatively,
glyburide tablets may be
effective in some patients who have become unresponsive to one or more
other sulfonylurea drugs.
In addition to its blood glucose lowering actions, glyburide produces
a mild diuresis by enhancement of
renal free water clearance. Disulfiram-like reactions have very rarely
been reported in patients treated
with glyburide tablets.
PHARMACOK