DESCRIPTION
id: 458e3589-6ad8-4396-baa7-cedc2f07f6a5
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Glyburide is an oral blood-glucose-lowering drug of the sulfonylurea class. It is a white, crystalline compound, formulated as tablets of 1.25 mg, 2.5 mg, and 5 mg strengths for oral administration. Glyburide tablets USP contain the active ingredient glyburide and the following inactive ingredients: dibasic calcium phosphate USP, magnesium stearate NF, microcrystalline cellulose NF, sodium alginate NF, talc USP. Glyburide 2.5 mg tablets USP also contain FD&C Red #40 Aluminum Lake. Glyburide 5 mg tablets USP also contain FD&C Blue #1 Aluminum Lake. Chemically, Glyburide is identified as 1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea.
The CAS Registry Number is 10238-21-8.
The structural formula is:
The molecular weight is 493.99. The aqueous solubility of Glyburide increases with pH as a result of salt formation.
CLINICAL PHARMACOLOGY
id: f75aaa42-322f-449b-83b7-134b953b340f
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Glyburide appears to lower the blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. The mechanism by which Glyburide lowers blood glucose during long-term administration has not been clearly established.
With chronic administration in Type II diabetic patients, the blood glucose lowering effect persists despite a gradual decline in the insulin secretory response to the drug. Extrapancreatic effects may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs.
In addition to its blood glucose lowering actions, Glyburide produces a mild diuresis by enhancement of renal free water clearance. Clinical experience to date indicates an extremely low incidence of disulfiram-like reactions in patients while taking Glyburide.
INDICATIONS AND USAGE
id: cc6cf529-f9a0-4bae-bb8a-81f2be262a4f
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Glyburide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
CONTRAINDICATIONS
id: a458f0c8-634d-4207-9b11-fde4417eafc7
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Glyburide is contraindicated in patients:
- With known hypersensitivity to the drug or any of its excipients.
- With type 1 diabetes mellitus or diabetic ketoacidosis, with or without coma.
These conditions should be treated with insulin.
- Treated with bosentan.
OVERDOSAGE
id: 9b156937-00a5-4606-97f7-d6773ccdc7b8
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Overdosage of sulfonylureas, including Glyburide, 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.
DOSAGE AND ADMINISTRATION
id: 47e501d0-3d49-4d1e-a057-500ea516ebda
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
There is no fixed dosage regimen for the management of diabetes mellitus with Glyburide or any other hypoglycemic agent. The patient’s fasting blood glucose must be measured 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. Periodic glycosylated hemoglobin determinations should be performed.
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: 63b67089-03fc-480a-9a48-5a189aab9213
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Glyburide tablets USP are available in the following strengths and package sizes:
1.25 mg (white to off-white, capsule-shaped, flat faced, beveled edge tablet debossed “GLYBUR” on one side and a score line on the other side).
Bottles of 50 (NDC 0093-9477-53)
2.5 mg (pink, capsule-shaped, flat faced, beveled edge tablet debossed “GLYBUR” on one side and a score line on the other side).
Bottles of 100 (NDC 0093-9433-01)
Bottles of 500 (NDC 0093-9433-05)
5 mg (blue, capsule-shaped, flat faced, beveled edge tablet debossed “GLYBUR” on one side and a score line on the other side).
Bottles of 100 (NDC 0093-9364-01)
Bottles of 500 (NDC 0093-9364-05)
Bottles of 1000 (NDC 0093-9364-10)
PRINCIPAL DISPLAY PANEL – 1.25 mg Tablet Bottle Label
id: 759b1dec-16ca-42e8-9acd-b51a1abcd57f
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 0093-9477-53
Glyburide
Tablets USP
1.25 mg
Rx only
50 TABLETS
TEVA
PRINCIPAL DISPLAY PANEL – 2.5 mg Tablet Bottle Label
id: d50bbbdb-70ac-4f3e-b984-06ef7f35d872
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 0093-9433-01
Glyburide
Tablets USP
2.5 mg
Rx only
100 TABLETS
TEVA
PRINCIPAL DISPLAY PANEL – 5 mg Tablet Bottle Label
id: 3c5dca3a-e499-4b83-b2e4-ac107516f1f9
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 0093-9364-01
Glyburide
Tablets USP
5 mg
Rx only
100 TABLETS
TEVA
