Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC)
AvKARE
GLYBURIDE
GLYBURIDE 2.5 mg
ORAL
PRESCRIPTION DRUG
Glyburide tablets USP 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. - Concomitant administration of bosentan.
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: 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 42291-316-50 bottles of 500 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 42291-317-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. V 10/13 AV 09/14 (P)
Abbreviated New Drug Application
GLYBURIDE- GLYBURIDE TABLET AVKARE ---------- GLYBURIDE TABLETS, USP 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. The chemical name for glyburide, USP is 1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]- sulfonyl]-3-cyclohexylurea. It has the following structural formula: C H ClN O S M.W. 493.99 Each tablet, for oral administration, contains 1.25 mg, 2.5 mg or 5 mg of glyburide, USP. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized corn starch, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate. In addition, the 2.5 MG contains FD&C yellow No. 6 aluminum lake and the 5 MG contains D&C yellow No. 10 aluminum lake, and FD&C blue No. 1 aluminum lake. 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. 23 28 3 5 In addition to its blood glucose lowering actions, glyburide produces a mild diuresis by enhanc Đọc toàn bộ tài liệu