国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC)
NuCare Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
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
Glyburide tablets, USP are supplied as follows: Glyburide tablets, USP 5 mg (Blue colored, slightly mottled, capsule shaped, biconvex tablets de-bossed with 'I37 ' on one side and scored on the other side) Bottles of 30 NDC 66267-103-30 Bottles of 60 NDC 66267-103-60 Bottles of 90 NDC 66267-103-90 Bottles of 120 NDC 66267-103-91 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
Abbreviated New Drug Application
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. 完全なドキュメントを読む