DESCRIPTION
id: a8bc38ef-e5ac-46a0-99e9-f0b466316633
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Glyburide tablets USP contain glyburide, USP, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide, USP is a white or almost white, crystalline powder. The chemical name for Glyburide, USP is 1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]-sulfonyl]-3-cyclohexylurea. It has the following structural formula:
C23H28ClN3O5S M.W. 494.0
Each glyburide tablet, USP intended for oral administration contains 1.25 mg or 2.5 mg or 5 mg of Glyburide, USP. In addition, each tablet contains the following inactive ingredients: calcium carbonate, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and sodium starch glycolate. Additionally each 2.5 mg tablet contains D&C yellow # 10 aluminum lake and FD & C yellow # 6 aluminum lake; each 5 mg tablet contains D&C yellow # 10 aluminum lake and FD & C blue # 1 aluminum lake.
INDICATIONS AND USAGE
id: 4b699379-41a2-46fd-be1c-2bd735382bca
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
id: 618cb11e-c905-4548-b609-ff3780da8b28
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.
- Concomitant administration of bosentan.
PRECAUTIONS
id: 73f5b8f8-48a7-4b48-9b4c-b9b36a432244
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.
ADVERSE REACTIONS
id: fa2e873e-58f8-44e4-a2c9-ff9d90e8f674
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Hypoglycemia: See
PRECAUTIONS
and
OVERDOSAGE
.
Gastrointestinal Reactions: Cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; glyburide tablets should be discontinued if this occurs.
Liver function abnormalities, including isolated transaminase elevations, have been reported.
Gastrointestinal disturbances, e.g., nausea, epigastric fullness, and heartburn are the most common reactions, having occurred in 1.8% of treated patients during clinical trials. They tend to be dose related and may disappear when dosage is reduced.
Dermatologic Reactions: Allergic skin reactions, e.g., pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions occurred in 1.5% of treated patients during clinical trials. These may be transient and may disappear despite continued use of glyburide; if skin reactions persist, the drug should be discontinued.
Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas.
Hematologic Reactions: Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia (see
PRECAUTIONS
), aplastic anemia, and pancytopenia have been reported with sulfonylureas.
Metabolic Reactions: Hepatic porphyria and disulfiram-like reactions have been reported with sulfonylureas; however, hepatic porphyria has not been reported with glyburide and disulfiram-like reactions have been reported very rarely.
Cases of hyponatremia have been reported with glyburide and all other sulfonylureas, most often in patients who are on other medications or have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone. The syndrome of inappropriate antidiuretic hormone (SIADH) secretion has been reported with certain other sulfonylureas, and it has been suggested that these sulfonylureas may augment the peripheral (antidiuretic) action of ADH and/or increase release of ADH.
Other Reactions: Changes in accommodation and/or blurred vision have been reported with glyburide and other sulfonylureas. These are thought to be related to fluctuation in glucose levels.
In addition to dermatologic reactions, allergic reactions such as angioedema, arthralgia, myalgia and vasculitis have been reported.
OVERDOSAGE
id: 8f4ee3b4-5dcb-4676-a31c-afa815e9532d
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: 0c7a7d50-4b4b-48bc-9826-ae9b67d344a9
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
id: 934f44b7-005c-4743-a0fe-33c991bb3aac
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Glyburide Tablets USP, 1.25 mg are white to off-white colored, round shaped, biconvex, uncoated tablets debossed with ‘656’ on one side and breakline on the other side and are supplied as follows:
NDC 65841-832-06 in bottles of 30 tablets
NDC 65841-832-16 in bottles of 90 tablets
NDC 65841-832-01 in bottles of 100 tablets
NDC 65841-832-05 in bottles of 500 tablets
NDC 65841-832-10 in bottles of 1000 tablets
NDC 65841-832-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets
Glyburide Tablets USP, 2.5 mg are light yellow to yellow colored, may be spotted, round shaped, biconvex, uncoated tablets, debossed with “657” on one side and breakline on the other side and are supplied as follows:
NDC 65841-833-06 in bottles of 30 tablets
NDC 65841-833-16 in bottles of 90 tablets
NDC 65841-833-01 in bottles of 100 tablets
NDC 65841-833-05 in bottles of 500 tablets
NDC 65841-833-10 in bottles of 1000 tablets
NDC 65841-833-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets
Glyburide Tablets USP, 5 mg are light green colored, may be spotted, round shaped, biconvex, uncoated tablets, debossed with “658” on one side and breakline on the other side and are supplied as follows:
NDC 65841-834-06 in bottles of 30 tablets
NDC 65841-834-16 in bottles of 90 tablets
NDC 65841-834-01 in bottles of 100 tablets
NDC 65841-834-05 in bottles of 500 tablets
NDC 65841-834-10 in bottles of 1000 tablets
NDC 65841-834-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets
Storage
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight container (USP).
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Manufactured by:
Cadila Healthcare Ltd.
Baddi, India
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
id: 9e1c852f-f7b9-478e-a8b3-57c13d7b81e6
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 65841-832-01 in bottles of 100 tablets
Glyburide Tablets USP, 1.25 mg
100 Tablets
Zydus
Rx only
NDC 65841-833-01 in bottles of 100 tablets
Glyburide Tablets USP, 2.5 mg
100 Tablets
Zydus
Rx only
NDC 65841-834-01 in bottles of 100 tablets
Glyburide Tablets USP, 5 mg
100 Tablets
Zydus
Rx only
