Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC)
Preferred Pharmaceuticals, Inc.
GLYBURIDE
GLYBURIDE 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:
Glyburide Tablets, USP are supplied as follows: 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.) Bottle of 30 - 68788-9917-3 Bottle of 60 - 68788-9917-6 Bottle of 90 - 68788-9917-9 Bottle of 100 - 68788-9917-1 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: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 038, India Revised: 07/2017 Repackaged By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
GLYBURIDE- GLYBURIDE TABLET PREFERRED PHARMACEUTICALS, INC. ---------- 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 significant absorption of glyburid Preberite celoten dokument