Rx Item-Glyburide-Metformin 2.5 500Mg Tab 500 By Actavis Pharma(Teva)

GLUCOVANCE- glyburide and metformin hydrochloride tablet, film coated
Bristol-Myers Squibb Company

1.25 mg/250 mg
2.5 mg/500 mg5 mg/500 mg

DESCRIPTION

GLUCOVANCE� (Glyburide and Metformin HCl) Tablets contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes, glyburide and metformin hydrochloride.

Glyburide is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glyburide is 1-[[p -[2-(5-chloro-o -anisamido)ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide is a white to off-white crystalline compound with a molecular formula of C23 H28 ClN3 O5 S and a molecular weight of 494.01. The glyburide used in GLUCOVANCE has a particle size distribution of 25% undersize value not more than 6 μm, 50% undersize value not more than 7 to 10 μm, and 75% undersize value not more than 21 μm
Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N -dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white to off-white crystalline compound with a molecular formula of C4 H12 ClN5 (monohydrochloride) and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68
CLINICAL PHARMACOLOGY

Mechanism of Action
GLUCOVANCE combines glyburide and metformin hydrochloride, 2 antihyperglycemic agents with complementary mechanisms of action, to improve glycemic control in patients with type 2 diabetes.

Glyburide appears to lower 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 patients with type 2 diabetes, 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.

Metformin hydrochloride is an antihyperglycemic agent that improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

RX ITEM-Glyburide-Metformin 2.5 500Mg Ta
NDC 00228-2752-50 UPC/GTIN No.3-02282-75250-2 Mfg.Part No.275250

Glyburide-Metformin 2.5 500Mg Tab 500 By
BRAND: GLYBURIDE-METFORMIN NDC: 00228-2752-50,228275250 UPC: 3-02282-75250-2,302282752502

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