GLYBURIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Glyburide tablets, USP 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 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. 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 to one of four

Product summary:

Glyburide tablets, USP are supplied as follows: Glyburide tablets, USP 2.5 mg (Pink colored, slightly mottled, capsule shaped, biconvex tablets de-bossed with 'I36' on one side and scored on the other side) Bottles of 30 NDC 66267-102-30 Bottles of 60 NDC 66267-102-60 Bottles of 90 NDC 66267-102-90 Rx only Store at 20° to 25°C (68° to 77°F) [see USP controlled room temperature ]. Dispensed in well closed containers with safety closures. Keep container tightly closed. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) Made in India Revised: 06/15

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYBURIDE- GLYBURIDE TABLET
NUCARE PHARMACEUTICALS, INC.
----------
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.