displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Glipizide Tablets USP are oral blood-glucose-lowering drugs of the sulfonylurea class.
The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine- carboxamido)ethyl]phenyl]sulfonyl]urea and has the following structural formula:
C21H27N5O4S M.W. 445.55
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 for oral use are available in 5 and 10 mg strengths.
Each tablet contains the following inactive ingredients: lactose monohydrate; microcrystalline cellulose; pregelatinized starch; silicon dioxide; stearic acid.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Glipizide Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Glipizide tablets are contraindicated in patients with:
- Known hypersensitivity to the drug.
- Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
In U.S. and foreign controlled studies, the frequency of serious adverse reactions reported was very low. Of 702 patients, 11.8% reported adverse reactions and in only 1.5% was glipizide discontinued.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
There is no well documented experience with glipizide overdosage. The acute oral toxicity was extremely low in all species tested (LD50 greater than 4 g/kg).
Overdosage of sulfonylureas, including glipizide, can produce hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dL. Patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycemia may recur after apparent clinical recovery. Clearance of glipizide from plasma would be prolonged in persons with liver disease. Because of the extensive protein binding of glipizide, dialysis is unlikely to be of benefit.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
There is no fixed dosage regimen for the management of diabetes mellitus with glipizide or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient’s blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood-glucose-lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient’s response to therapy.
Short-term administration of glipizide may be sufficient during periods of transient loss of control in patients usually controlled well on diet.
In general, glipizide should be given approximately 30 minutes before a meal to achieve the greatest reduction in postprandial hyperglycemia.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Glipizide Tablets USP, 5 mg are available as white to off-white, round, flat-faced, beveled-edge tablets, bisected and debossed on one side with “9201” above bisect and debossed with “TEVA” on the other side, containing 5 mg of glipizide, packaged in bottles of 100 and 500 tablets and unit-dose boxes of 100 tablets.
Glipizide Tablets USP, 10 mg are available as white to off-white, round, flat-faced, beveled-edge tablets, bisected and debossed on one side with “9200” above bisect and debossed with “TEVA” on the other side, containing 10 mg of glipizide, packaged in bottles of 100 and 500 tablets and unit-dose boxes of 100 tablets.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured In Croatia By:
PLIVA HRVATSKA d.o.o.
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. E 2/2011
PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4