Glyburide Tablets, USP, (nonmicronized), 1.25, 2.5 and 5 mg, Rx only

/Glyburide Tablets, USP, (nonmicronized), 1.25, 2.5 and 5 mg, Rx only
Glyburide Tablets, USP, (nonmicronized), 1.25, 2.5 and 5 mg, Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

Glyburide Tablets, USP, (nonmicronized), 1.25, 2.5 and 5 mg, Rx only

ID:

49f0ce6f-5305-41c2-8afe-eed1870459b8

Code:

34391-3

DESCRIPTION


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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Glyburide tablets, USP contain glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound. The chemical name for glyburide is 1-[[ρ-[2-(5-chloro-ο-anisamido)- ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. It has the following structural formula: Molecular formula: C23H28ClN3O5S Each tablet, for oral administration, contains 1.25 mg, 2.5 mg or 5 mg of glyburide.  In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate. In addition, the 2.5 mg contains D&C yellow No. 10 Aluminum Lake and the 5 mg contains FD&C Blue No. 1 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake.

INDICATIONS AND USAGE


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

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

CONTRAINDICATIONS


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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Glyburide tablets, USP are contraindicated in patients with: Known hypersensitivity or allergy to the drug.
Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
Type I diabetes mellitus.

OVERDOSAGE


id: f1f70437-6c97-4fa6-8da1-f5ede21a0385
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Overdosage of sulfonylureas, including glyburide tablets can produce hypoglycemia. Mild hypoglycemic symptoms, without loss of consciousness or neurological 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 which 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.

DOSAGE AND ADMINISTRATION


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displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Patients should be retitrated when transferred from glyburide (micronized) tablets or other oral hypoglycemic agents (see PRECAUTIONS). There is no fixed dosage regimen for the management of diabetes mellitus with glyburide tablets 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 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 glyburide tablets may be sufficient during periods of transient loss of control in patients usually controlled well on diet.

HOW SUPPLIED


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displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Glyburide tablets, USP are supplied as follows: Glyburide tablets, USP 1.25 mg (white, round compressed tablets debossed “cor” above the bisect and “123” below the bisect and other side is plain).

Bottles of 30 NDC 54868-3426-1
Bottles of 100 NDC 54868-3426-0
Glyburide tablets, USP 2.5 mg (light yellow, round compressed tablets debossed “cor” above the bisect and “124” below the bisect and other side is plain).
Bottles of 30 NDC 54868-3266-2
Bottles of 60 NDC 54868-3266-4
Bottles of 90 NDC 54868-3266-3
Bottles of 100 NDC 54868-3266-1
Glyburide tablets, USP 5 mg (light green, round compressed tablets debossed “cor” above the bisect and “125” below the bisect and other side is plain).
Bottles of 10 NDC 54868-3265-5
Bottles of 30 NDC 54868-3265-1
Bottles of 60 NDC 54868-3265-3
Bottles of 90 NDC 54868-3265-4
Bottles of 100 NDC 54868-3265-0
Bottles of 360 NDC 54868-3265-6
Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container. Keep container tightly closed. Rev. January, 2011
LB#  746-03
Manufactured by
CorePharma, LLC
Middlesex, NJ 08846

Relabeling and Repackaging by:

Physicians Total Care, Inc.
Tulsa, Oklahoma       74146

Principal Display Panel


id: 5a1d7c54-ef22-4af2-b1e0-61a878118976
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4