Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC)
Contract Pharmacy Services-PA
GLYBURIDE
GLYBURIDE 5 mg
ORAL
PRESCRIPTION DRUG
Glyburide tablets 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, as sole therapy. 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 treatment groups (Diabetes , 19 (Suppl. 2):747- 830, 1970). UGDP reported that patients tr
Glyburide tablets are supplied as follows: Glyburide tablets 5 mg (light green, round compressed tablets debossed “cor” above the bisect and “125” below the bisect and other side is plain). Blister of 30 (NDC 67046-240-30) Blister of 60 (NDC 67046-240-60) Store at controlled room temperature 15° - 30°C (59° - 86°F) (see USP). Dispense in tight, light-resistant container. Keep container tightly closed. Rev. 10-2009 MF #746 Manufactured by Corepharma LLC Middlesex, NJ 08846 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--04/2010--NJW
Abbreviated New Drug Application
GLYBURIDE- GLYBURIDE TABLET CONTRACT PHARMACY SERVICES-PA ---------- GLYBURIDE TABLETS USP (NONMICRONIZED) 1.25, 2.5 AND 5 MG RX ONLY DESCRIPTION Glyburide tablets USP contain glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound. The chemical name for glyburide is 1- [[ρ-[2-(5-chloro-ο-anisamido)- ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. It has the following structural formula: Molecular formula: C H ClN O S Each tablet, for oral administration, contains 1.25 mg, 2.5 mg or 5 mg of glyburide. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate. In addition, the 2.5 mg contains D&C yellow No. 10 Aluminum Lake and the 5 mg contains FD&C Blue No. 1 Aluminum Lake and D&C Yellow No. 10 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. In addition to its blood Pročitajte cijeli dokument