GLIPIZIDE TABLETS, USP 5 mg, Rx Only

/GLIPIZIDE TABLETS, USP 5 mg, Rx Only
GLIPIZIDE TABLETS, USP 5 mg, Rx Only2018-09-06T09:12:40+00:00

Prescription Drug Name:

GLIPIZIDE TABLETS, USP 5 mg, Rx Only

ID:

3994a267-ddc8-4886-9daa-9adb2ddd0ca3

Code:

34391-3

DESCRIPTION


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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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 C21H27N5O4S; 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.

INDICATIONS AND USAGE


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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

CONTRAINDICATIONS


id: 3eef7559-a15f-47c0-aaf8-eb1c90f8e5d0
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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.

WARNINGS


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displayName: WARNINGS SECTION
FDA Article Code: 34071-1

SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY  The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups (Diabetes, 19, supp. 2: 747-830, 1970). UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 21/2 times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of glipizide and of alternative modes of therapy.   Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.

ADVERSE REACTIONS


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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.

OVERDOSAGE


id: 5fe7c67c-bf4b-4d93-97a8-606b50ff2bb3
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


id: ecf6e746-07c9-46b7-9327-bb60795c8ec4
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 tablets should be given approximately 30 minutes before a meal to achieve the greatest reduction in postprandial hyperglycemia.

HOW SUPPLIED


id: 7b24b866-5001-41a4-ae16-474217d06645
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

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:  
30’s (NDC 42708-109-30)

RECOMMENDED STORAGE


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displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

Store at 20˚C to 25˚C (68˚F to 77˚F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. APOTEX INC.

GLIPIZIDE TABLETS, USP

5 mg Manufactured by      Manufactured for

Apotex Inc.                Apotex Corp.
Toronto, Ontario         Weston, Florida
Canada M9L 1T9        USA 33326  Revised: May 2017 Rev. 8

PRINCIPAL DISPLAY PANEL-5 mg


id: 6d752f84-1340-4e38-83c3-43cea3bbd46b
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Representative sample of labeling (see HOW SUPPLIED section for complete listing) QPHARMA NDC 42708-109-30 Glipizide Tablets, USP 5 mg Rx 30 bottle count