Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC)
NuCare Pharmceuticals,Inc.
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: 1. With known hypersensitivity to the drug or any of its excipients. 2. With type 1 diabetes mellitus or diabetic ketoacidosis, with or without coma. These conditions should be treated with insulin. 3. Treated with bosentan.
2.5 mg (pink colored, capsule-shaped, scored tablets, debossed with C on the left side of the score and P on the right side of the score on one side and 291 on the other side). NDC 68071-4142-3 Bottles of 30 NDC 68071-4142-6 Bottles of 60 NDC 68071-4142-9 Bottles of 90 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers with child-resistant closure. LB# 811-01 Rev. February, 2017 Manufactured for and Distributed by: CorePharma, LLC Middlesex, NJ 08846
Abbreviated New Drug Application
GLYBURIDE- GLYBURIDE TABLET NUCARE PHARMCEUTICALS,INC. ---------- GLYBURIDE TABLETS, USP 1.25 MG, 2.5 MG AND 5 MG RX ONLY DESCRIPTION Glyburide Tablets, USP are an oral blood-glucose-lowering drug of the sulfonylurea class. It is a white, crystalline compound, formulated as tablets of 1.25 mg, 2.5 mg, and 5 mg strengths for oral administration. Glyburide Tablets, USP contain the active ingredient glyburide and the following inactive ingredients: dibasic calcium phosphate anhydrous USP, dibasic calcium phosphate dihydrate USP, magnesium stearate NF, microcrystalline cellulose NF, sodium alginate NF, talc USP. Glyburide Tablets USP, 1.25 mg also contain FD&C Yellow #6 Aluminum Lake. Glyburide Tablets USP, 2.5 mg also contain D&C Red #27 Aluminum Lake. Glyburide Tablets USP, 5 mg also contain FD&C Blue #1 Aluminum Lake. Chemically, glyburide is identified as 1-[[p-[2-(5-Chloro-o- anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea. The CAS Registry Number is 10238-21-8. The structural formula is: The molecular weight is 493.99. The aqueous solubility of glyburide increases with pH as a result of salt formation. CLINICAL PHARMACOLOGY 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 play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs. In addition to its blood glucose lowering actions, glyburide produces a mild diuresis by enhancement of renal free water clearance. Clinical experience to date indicates an extremely low incidence of disulfiram-like reactions in patients while taking glyburide tablets. PHARMACOKINETICS Single-dose studies with glyb Aqra d-dokument sħiħ