देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C)
Dispensing Solutions, Inc.
GLIPIZIDE
GLIPIZIDE 5 mg
ORAL
PRESCRIPTION DRUG
Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide extended-release tablets are contraindicated in patients with: - Known hypersensitivity to glipizide or any excipients in the tablets. Known hypersensitivity to glipizide or any excipients in the tablets. - Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin. Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
Glipizide Extended-Release Tablets are supplied as 2.5 mg, 5 mg, and 10 mg round, film-coated tablets and are printed with black ink as follows: 2.5 mg tablets are light orange and printed with WPI and 900 , and are supplied in bottles of 30, 100 and 1000. 5 mg tablets are orange and printed with WPI and 844 , and are supplied in bottles of 100 and 1000 and blister packages of 30. 10 mg tablets are white to off-white and printed with WPI and 845 , and are supplied in bottles of 100 and 1000 and blister packages of 30. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and humidity. Mfd. for: Watson Laboratories, Inc. Corona, CA 92880 USA Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA Revised: January 2009
Abbreviated New Drug Application
GLIPIZIDE ER- GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE DISPENSING SOLUTIONS, INC. ---------- GLIPIZIDE EXTENDED-RELEASE TABLETS RX ONLY DESCRIPTION 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- methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C H N O S; the molecular weight is 445.55; the structural formula is shown below: 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. Glipizide extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use and is designed to deliver 2.5 mg, 5 mg or 10 mg of glipizide. Each tablet contains the following inactive ingredients: acetyltributyl citrate, edible black ink, hydroxyethyl cellulose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer type A and polyethylene glycol. The 2.5 mg and 5 mg tablets also contain FD&C Yellow #6. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Glipizide 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. Extrapancreatic effects also may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs. Two extrapancreatic effects shown to be important in the action of glipizide are an increase in insulin sensitivity and a decrease in hepatic glucose production. However, the mechanism by which glipizide lowers blood glucose during long-term administration has not been clearly established. Stimulation of insulin secretion by glipizide in response to a meal is of major importance. The insulinotropic response to a meal is enhanced with glipizide administration in diabetic patients. The postprandial insulin and C- peptide responses continue to be enhanced after at least 6 months of पूरा दस्तावेज़ पढ़ें