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:

b61ab462-de4d-4ec4-b0b1-5e6863d9279e

Code:

34391-3

DESCRIPTION


id: 2240a10f-7e20-431f-bf32-9088ee935355
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


id: f380d561-ddbc-400d-af4b-2de77f612080
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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

CONTRAINDICATIONS


id: 2c542e00-0889-41f5-83f3-b356e85a75c9
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Glyburide tablets 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, as sole therapy.

PRECAUTIONS


id: 4a72583d-acb5-4e44-b400-81bac4608bf0
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9

Bioavailability studies have demonstrated that micronized glyburide tablets 3 mg provide serum glyburide concentrations that are not bioequivalent to those from nonmicronized glyburide tablets 5 mg. Therefore, patients should be retitrated when transferred from micronized glyburide tablets or other oral hypoglycemic agents.

OVERDOSAGE


id: 559f763f-c490-49e1-b2bd-92fd7cee64c2
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


id: c45862c5-ed0a-4a19-b108-f3fe206606a6
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Patients should be retitrated when transferred from nonmicronized glyburide 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 may be sufficient during periods of transient loss of control in patients usually controlled well on diet.

HOW SUPPLIED


id: 9481b842-7974-437f-af1f-fcdd102f3f92
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Glyburide tablets are supplied as follows: Glyburide tablets 5 mg (light green, round compressed tablets debossed “cor” above the bisect and “125” below the bisect and other side is plain).
Blister of 30 (NDC 67046-240-30)
Blister of 60 (NDC 67046-240-60)
Store at controlled room temperature 15° – 30°C (59° – 86°F) (see USP). Dispense in tight, light-resistant container. Keep container tightly closed. Rev. 10-2009
MF #746
Manufactured by
Corepharma LLC

Middlesex, NJ 08846 Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA Original–04/2010–NJW