País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC)
Citron Pharma LLC
GLYBURIDE
GLYBURIDE 1.25 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 are supplied as follows: Glyburide Tablets 1.25 mg (White to off white, round, flat, beveled edge tablets with scoreline in between ‘2’ & ‘9’ on one side and ‘A’ debossed on other side.) Bottles of 50 NDC 57237-020-50 (Child Resistant Closure) Bottles of 100 NDC 57237-020-01 (Child Resistant Closure) Glyburide Tablets 2.5 mg (White to off white, round, flat, beveled edge tablets with scoreline in between ‘3’ & ‘0’ on one side and ‘A’ debossed on other side.) Bottles of 100 NDC 57237-021-01 (Child Resistant Closure) Bottles of 500 NDC 57237-021-05 (Non Child Resistant Closure) Bottles of 1000 NDC 57237-021-99 (Non Child Resistant Closure) Glyburide Tablets 5 mg (White to off white, round, flat, beveled edge tablets with scoreline in between ‘3’ & ‘1’ on one side and ‘A’ debossed on other side.) Bottles of 100 NDC 57237-022-01 (Child Resistant Closure) Bottles of 500 NDC 57237-022-05 (Non Child Resistant Closure) Bottles of 1000 NDC 57237-022-99 (Non Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispensed in well closed containers with safety closures. Keep container tightly closed. Distributed by: Citron Pharma LLC Suite - 1101 2 Tower Center Blvd East Brunswick NJ 08816 Code No.: DRUGS/AP/19/1993 Made in India Revised: 07/2015
Abbreviated New Drug Application
GLYBURIDE - GLYBURIDE TABLET CITRON PHARMA LLC ---------- GLYBURIDE TABLETS, USP (NONMICRONIZED) RX ONLY DESCRIPTION Glyburide is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide USP is a white, crystalline compound, formulated as glyburide tablets of 1.25, 2.5, and 5 mg strengths for oral administration. Inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium alginate, and talc. 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, 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. PHARMACOKINETICS Single dose studies with glyburide tablets in normal subjects demonstrate Leer el documento completo