GLYBURIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cadila Pharmaceuticals Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Glyburide tablets 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: 1. Known hypersensitivity or allergy to the drug. 2. Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin. 3. Type I diabetes mellitus. 4. Concomitant administration of bosentan.

Product summary:

Glyburide tablets, USP are supplied as follows: Glyburide tablets USP, 1.25 mg are white to off-white, round, bi-convex, compressed tablets engraved with "C 13" on one side and horizontal bisect on other side. They are supplied as follows: NDC 71209-009-05 bottles of 100 NDC 71209-009-11 bottles of 1,000 Glyburide tablets USP, 2.5 mg are peach to light-peach colored, round, bi-convex, compressed tablets engraved with "C 12" on one side and horizontal bisect on other side. They are supplied as follows: NDC 71209-010-05 bottles of 100 NDC 71209-010-10 bottles of 500 NDC 71209-010-11 bottles of 1,000   Glyburide tablets USP, 5 mg are green to light-green colored, round, bi-convex, compressed tablets engraved with "C 11" on one side and horizontal bisect on other side. They are supplied as follows: NDC 71209-011-05 bottles of 100 NDC 71209-011-10 bottles of 500 NDC 71209-011-11 bottles of 1,000 The scoring on Glyburide Tablets, USP is functional. Rx only Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature.]. Dispensed in well closed containers with safety closures. Keep container tightly closed.   Manufactured By: Cadila Pharmaceuticals Limited 1389 Trasad Road  Dholka - 382225 District - Ahmedabad, Gujarat, INDIA Revised - January, 2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYBURIDE - GLYBURIDE TABLET
CADILA PHARMACEUTICALS LIMITED
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GLYBURIDE TABLETS, USP
_FOR ORAL USE_
1.25, 2.5, AND 5 MG
DESCRIPTION
Glyburide tablets, USP contain glyburide, USP, which is an oral
blood-glucose-lowering
drug of the sulfonylurea class. Glyburide, USP is a white, crystalline
compound,
formulated as Glyburide tablets, USP of 1.25, 2.5, and 5 mg strengths
for oral
administration. Inactive ingredients: microcrystalline cellulose,
pregelatinized starch (corn
starch), sodium starch glycolate (type A potato) and magnesium
stearate. In addition,
the 2.5 MG contains FD&C yellow No. 6 and the 5 MG contains D&C yellow
No. 10, and
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 w