Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC)
Par Pharmaceutical
GLYBURIDE
GLYBURIDE 1.5 mg
ORAL
PRESCRIPTION DRUG
Glyburide tablets USP (micronized) are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide tablets (micronized) 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 random
Glyburide Tablets, USP (micronized) 1.5 mg- are white oval shaped tablet, bisected on one side, debossed with "M03" and "1.5", and with "MOVA" on the other side; and supplied as follows: Glyburide Tablets, USP (micronized) 3mg- is a light blue oval shaped tablet, bisected on one side, debossed with "M04" and "3.0", and with "MOVA" on the other side; and supplied as follows: Glyburide Tablets, USP (micronized) 6 mg- is a light yellow oval shaped tablet, bisected on one side, debossed with "M07" and "6.0", and with "MOVA" on the other side; and supplied as follows: The tablet can be easily divided in half for a more flexible dosing regimen. Press gently on the score and the tablet will split in even halves. Rx only Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure. Keep container tightly closed. Trademarks are the property of their respective owners. Manufactured For: DAVA Pharmaceuticals, Inc. a subsidiary of QUALITEST PHARMACEUTICALS, Huntsville, AL 35811 By: Patheon Puerto Rico, Inc. Manati, Puerto Rico 00674, USA Item#: 672534600815 Rev. 08/15
Abbreviated New Drug Application
GLYBURIDE- GLYBURIDE TABLET PAR PHARMACEUTICAL ---------- GLYBURIDE TABLETS, USP (MICRONIZED) RX ONLY _For Oral Use_ DESCRIPTION Glyburide tablets, USP (micronized) contain micronized (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 (micronized) of 1.5 mg, 3 mg, or 6 mg strengths for oral administration. Inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Pregelatinized Corn Starch. In addition, the 3 MG strength contains FD&C Blue No. 1 Aluminum Lake; and the 6 MG tablet contains D&C Yellow No. 10 Aluminum Lake. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 494.00. 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 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 rena Baca dokumen lengkapnya