Rx Item-Glipizide 5Mg Tab 100 By Apotex Corp

GLUCOTROL- glipizide tablet
Roerig


For Oral Use

DESCRIPTION

GLUCOTROL (glipizide) is an oral blood-glucose-lowering drug of the sulfonylurea class.

The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C21 H27 N5 O4 S;
Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. GLUCOTROL tablets for oral use are available in 5 and 10 mg strengths.

Inert ingredients are: colloidal silicon dioxide; lactose; microcrystalline cellulose; starch; stearic acid.

CLINICAL PHARMACOLOGY

Mechanism of Action
The primary mode of action of GLUCOTROL in experimental animals appears to be the stimulation of insulin secretion from the beta cells of pancreatic islet tissue and is thus dependent on functioning beta cells in the pancreatic islets. In humans, GLUCOTROL 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 GLUCOTROL lowers blood glucose during long-term administration has not been clearly established. In man, stimulation of insulin secretion by GLUCOTROL in response to a meal is undoubtedly of major importance. Fasting insulin levels are not elevated even on long-term GLUCOTROL administration, but the postprandial insulin response continues to be enhanced after at least 6 months of treatment. The insulinotropic response to a meal occurs within 30 minutes after an oral dose of GLUCOTROL in diabetic patients, but elevated insulin levels do not persist beyond the time of the meal challenge. Extrapancreatic effects may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs.
Glucotrol Indications and Usage

GLUCOTROL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

RX ITEM-Glipizide 5Mg Tab 100 By Apotex
NDC 60505-0141-00 UPC/GTIN No.3-60505-01410-1 Mfg.Part No.14100

Glipizide 5Mg Tab 100 By Apotex Corp
BRAND: GLIPIZIDE NDC: 60505-0141-00,60505014100 UPC: 3-60505-01410-1,360505014101

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