GLYBURIDE- glyburide tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Glyburide (UNII: SX6K58TVWC) (Glyburide - UNII:SX6K58TVWC)

Disponível em:

Lake Erie Medical DBA Quality Care Products LLC

DCI (Denominação Comum Internacional):

Glyburide

Composição:

Glyburide 5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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: - Known hypersensitivity or allergy to the drug. - Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin. - Type I diabetes mellitus.

Resumo do produto:

Glyburide tablets USP, 1.25 mg are white, round, bi-convex, compressed tablets engraved with N horizontal bisect 342 on one side and 1.25 on the other side. They are supplied as follows: NDC 0093-8342-01 bottles of 100 Glyburide tablets USP, 2.5 mg are peach-colored, round, bi-convex, compressed tablets engraved with N horizontal bisect 343 on one side and 2.5 on the other side. They are supplied as follows: NDC 0093-8343-98 bottles of 90 NDC 0093-8343-01 bottles of 100 NDC 0093-8343-05 bottles of 500 NDC 0093-8343-10 bottles of 1000 NDC 0093-8343-50 bottles of 5000 Glyburide tablets USP, 5 mg are light-green colored, round, bi-convex, compressed tablets engraved with N horizontal bisect 344 on one side and 5 on the other side. They are supplied as follows: NDC 0093-8344-98 bottles of 90 NDC 0093-8344-01 bottles of 100 NDC 0093-8344-05 bottles of 500 NDC 0093-8344-10 bottles of 1000 NDC 0093-8344-50 bottles of 5000 NDC 0093-8344-93 unit-dose boxes of 100 (10 x 10) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container. Keep container tightly closed. Manufactured In Canada By: NOVOPHARM LIMITED Toronto, Canada M1B 2K9 Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. O 6/2010

Status de autorização:

Abbreviated New Drug Application

Características técnicas

GLYBURIDE- GLYBURIDE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
GLYBURIDE TABLETS, USP
1.25, 2.5, AND 5 MG
8342
8343
8344
RX ONLY
DESCRIPTION
Glyburide tablets USP contain glyburide, which is an oral
blood-glucose-lowering drug of the
sulfonylurea class. Glyburide is a white, crystalline compound. 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. It has the following structural formula:
Molecular formula: C
H ClN O S
Each tablet, for oral administration, contains 1.25 mg, 2.5 mg or 5 mg
of glyburide. In addition, each
tablet contains the following inactive ingredients: microcrystalline
cellulose, pregelatinized starch,
sodium starch glycolate, colloidal silicon dioxide, 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.
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 or more other
sulfonylurea drugs.
In addition to its blood glucose lowering acti