Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC)
Zydus Pharmaceuticals (USA) Inc.
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, 1.25 mg are white to off-white colored, round shaped, biconvex, uncoated tablets debossed with '656' on one side and breakline on the other side and are supplied as follows: NDC 68382-656-06 in bottles of 30 tablets NDC 68382-656-16 in bottles of 90 tablets NDC 68382-656-01 in bottles of 100 tablets NDC 68382-656-05 in bottles of 500 tablets NDC 68382-656-10 in bottles of 1000 tablets NDC 68382-656-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Glyburide Tablets USP, 2.5 mg are light yellow to yellow colored, may be spotted, round shaped, biconvex, uncoated tablets, debossed with "657" on one side and breakline on the other side and are supplied as follows: NDC 68382-657-06 in bottles of 30 tablets NDC 68382-657-16 in bottles of 90 tablets NDC 68382-657-01 in bottles of 100 tablets NDC 68382-657-05 in bottles of 500 tablets NDC 68382-657-10 in bottles of 1000 tablets NDC 68382-657-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Glyburide Tablets USP, 5 mg are light green colored, may be spotted, round shaped, biconvex, uncoated tablets, debossed with "658" on one side and breakline on the other side and are supplied as follows: NDC 68382-658-06 in bottles of 30 tablets NDC 68382-658-16 in bottles of 90 tablets NDC 68382-658-01 in bottles of 100 tablets NDC 68382-658-05 in bottles of 500 tablets NDC 68382-658-10 in bottles of 1000 tablets NDC 68382-658-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container (USP). KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured by: Cadila Healthcare Ltd. Baddi, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 Rev.: 05/16 Revision Date: 02/05/2016
Abbreviated New Drug Application
GLYBURIDE - GLYBURIDE TABLET ZYDUS PHARMACEUTICALS (USA) INC. ---------- GLYBURIDE TABLETS, USP RX ONLY DESCRIPTION Glyburide tablets USP contain glyburide, USP, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide, USP is a white or almost white, crystalline powder. The chemical name for Glyburide, USP is 1-[[p-[2-(5-chloro-o- anisamido)ethyl]phenyl]-sulfonyl]-3-cyclohexylurea. It has the following structural formula: C H ClN O S M.W. 494.0 Each glyburide tablet, USP intended for oral administration contains 1.25 mg or 2.5 mg or 5 mg of Glyburide, USP. In addition, each tablet contains the following inactive ingredients: calcium carbonate, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and sodium starch glycolate. Additionally each 2.5 mg tablet contains D&C yellow # 10 aluminum lake and FD & C yellow # 6 aluminum lake; each 5 mg tablet contains D&C yellow # 10 aluminum lake and FD & C blue # 1 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 unresponsi Prečítajte si celý dokument