GLYBURIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

TYA Pharmaceuticals

INN (International Name):

GLYBURIDE

Composition:

GLYBURIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Glyburide tablets is 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 the drug or any of its excipients. - Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin. - Type I diabetes mellitus. - Concomitant administration of bosentan. WARNINGS SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned

Product summary:

NDC:64725-0058-1 in a BOTTLE of 100 TABLETS

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYBURIDE - GLYBURIDE TABLET
TYA PHARMACEUTICALS
----------
GLYBURIDE TABLETS, USP
1.25 MG, 2.5 MG AND 5 MG
FOR ORAL USE
DESCRIPTION
Glyburide tablets contain micronized (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 of 1.25, 2.5, and 5 mg strengths for oral
administration.
Inactive ingredients: lactose monohydrate, microcrystalline cellulose,
magnesium stearate. In addition,
the contains FD&C Red No.40 and the 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. 2.5 MG5 MG
CLINICAL PHARMACOLOGY
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.
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.
PHARMACOKINETICS
Single dose studies with glyburide tablets in normal subjects
demonstrate significant absorption within
one hour, peak drug levels at about four hours, and low but detectable
levels at twenty-four hours. Mean
serum levels of glyburide, as reflec