GLIPIZIDE TABLETS, USP

/GLIPIZIDE TABLETS, USP
GLIPIZIDE TABLETS, USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

GLIPIZIDE TABLETS, USP

ID:

792a3d71-8cb9-4c4c-84e8-9e1376787005

Code:

34391-3

DESCRIPTION


id: c8851674-8657-49a0-923e-88870a276b6c
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-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea. Its structural formula is: M.W. 445.55
C21H27N5O4S
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. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide, USP. Inactive ingredients are: colloidal silicon dioxide, lactose (anhydrous), microcrystalline cellulose, pregelatinized starch and stearic acid.

INDICATIONS AND USAGE


id: 9bf29a36-9d9e-4033-9f86-611b3ee6a7bf
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Glipizide tablets are indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with non-insulin-dependent diabetes mellitus (NIDDM; type II), formerly known as maturity-onset diabetes, after an adequate trial of dietary therapy has proved unsatisfactory. In initiating treatment for non-insulin-dependent diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified, and corrective measures taken where possible. If this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea or insulin should be considered. Use of glipizide must be viewed by both the physician and patient as a treatment in addition to diet, and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone also may be transient, thus requiring only short-term administration of glipizide. During maintenance programs, glipizide should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgements should be based on regular clinical and laboratory evaluations. In considering the use of glipizide in asymptomatic patients, it should be recognized that controlling blood glucose in non-insulin-dependent diabetes has not been definitely established to be effective in preventing the long-term cardiovascular or neural complications of diabetes.

CONTRAINDICATIONS


id: 1f937517-3837-43bb-8d61-00d1eb5cabe5
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Glipizide tablets are contraindicated in patients with: Known hypersensitivity to the drug.
Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

ADVERSE REACTIONS


id: 010df6d0-4f62-4a6a-b50f-8c1b09a59960
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: 62ce1739-107b-4394-a637-1a6ee1e66435
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: f7d709f6-f8a3-42ca-b4fc-9aa867f31904
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.

HOW SUPPLIED


id: 5f7f6c28-e603-484e-8a15-e041922370d2
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Glipizide Tablets, USP are available containing 5 mg or 10 mg of glipizide, USP. The 5 mg tablets are white, round, scored tablets debossed with MYLAN above the score and G1 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0615-3595-39
blistercards of 30 tablets
NDC 0615-3595-05
blistercards of 15 tablets
The 10 mg tablets are white, round, scored tablets debossed with MYLAN above the score and G2 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0615-3596-39
blistercards of 30 tablets
NDC 0615-3596-31
blistercards of 31 tablets

PACKAGE LABEL PRINCIPAL DISPLAY PANEL


id: 6540c7a7-7375-4d0b-8415-d01b910ec2b6
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Glipizide Tablets USP 5mg

PRINCIPAL LABEL PRINCIPAL DISPLAY PANEL


id: dd8c1e7f-db43-4bae-9c11-39e142bc94ad
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Glipizide Tablets, USP 10mg