Country: United States
Language: English
Source: NLM (National Library of Medicine)
GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C)
Aphena Pharma Solutions - Tennessee, LLC
ORAL
PRESCRIPTION DRUG
Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide is contraindicated in patients with: 1. Known hypersensitivity to the drug. 2. Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
Glipizide Tablets, USP are supplied as white to off-white, round, scored tablets, imprinted as follows: 5 mg- “APO” on the side and “GLP” over bisect “5” on the other side; 10 mg- “APO” on one side and “GLP” over bisect “10” on the other side. 5 mg Bottles: 100’s (NDC 60505-0141-0) 500’s (NDC 60505-0141-2) 1,000’s (NDC 60505-0141-1) 18,000’s (NDC 60505-0141-8) 10 mg Bottles: 100’s (NDC 60505-0142-0) 500’s (NDC 60505-0142-2) 1,000’s (NDC 60505-0142-1) 10,000’s (NDC 60505-0142-4)
Abbreviated New Drug Application
GLIPIZIDE- GLIPIZIDE TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- GLIPIZIDE TABLETS, USP 5 MG AND 10 MG 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-methylpyrazine- carboxamido)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 tablets, USP for oral use are available in 5 and 10 mg strengths. Inert ingredients are: anhydrous lactose; colloidal silicon dioxide; magnesium stearate; sodium starch glycolate. Meets USP Dissolution Test 2. CLINICAL PHARMACOLOGY MECHANISM OF ACTION The primary mode of action of glipizide 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, glipizide 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 glipizide lowers blood glucose during long-term administration has not been clearly established. In man, stimulation of insulin secretion by glipizide in response to a meal is undoubtedly of major importance. Fasting insulin levels are not elevated even on long-term glipizide 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 glipizide 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. Blood sugar con Read the complete document