Glyburide tablet

Description

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-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. It has the following structural formula:



IMAGE OF FORMULA


Molecular formula: C 23H 28ClN 3O 5S

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: microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate. In addition, the 2.5 mgcontains FD and C yellow No. 6 and the 5 mgcontains D and C yellow No. 10, and FD and C blue No. 1.

Indications and usage

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

Pediatric use


Safety and effectiveness in pediatric patients have not been established.

Geriatric use


Elderly patients are particularly susceptible to the hypoglycemic action of glucose lowering drugs. Hypoglycemia may be difficult to recognize in the elderly (see PRECAUTIONS). The initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (see DOSAGE AND ADMINISTRATION).

Elderly patients are prone to develop renal insufficiency, which may put them at risk of hypoglycemia. Dose selection should include assessment of renal function.

Adverse reactions


Hypoglycemia:See PRECAUTIONSand OVERDOSAGEsections.

Gastrointestinal Reactions:Cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; Glyburide Tablets USP 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.

How supplied



Glyburide tablets USP, 1.25 mg are white, round, bi-convex, compressed tablets engraved with Nhorizontal bisect 342on one side and 1.25on the other side. They are supplied as follows:

NDC0093-8342-01 bottles of 100

Glyburide tablets USP, 2.5 mg are peach-colored, round, bi-convex, compressed tablets engraved with Nhorizontal bisect 343on one side and 2.5on the other side. They are supplied as follows:

NDC0093-8343-98 bottles of 90

NDC0093-8343-01 bottles of 100

NDC0093-8343-05 bottles of 500

NDC0093-8343-10 bottles of 1000

NDC0093-8343-50 bottles of 5000

Glyburide tablets USP, 5 mg are light-green colored, round, bi-convex, compressed tablets engraved with Nhorizontal bisect 344on one side and 5on the other side. They are supplied as follows:

NDC0093-8344-98 bottles of 90

NDC0093-8344-01 bottles of 100

NDC0093-8344-05 bottles of 500

NDC0093-8344-10 bottles of 1000

NDC0093-8344-50 bottles of 5000

NDC0093-8344-93 unit-dose boxes of 100 (10 x 10)

Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].

Dispense in tight, light-resistant container. Keep container tightly closed.

Manufactured In Canada By:

NOVOPHARM LIMITED

Toronto, Canada M1B 2K9

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. O 6/2010

Ingredients and appearance - Product information

Glyburide tablet- Glyburide

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 49349-037
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Glyburide ( UNII: SX6K58TVWC)( Glyburide - UNII: SX6K58TVWC ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Magnesium stearate ( UNII: 70097M6I30)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)

Product Characteristics

Color green Score 2
Shape ROUND (TABLET) Imprint Code N;344;5
Size 8 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 49349-037-02 30 in 1 BLISTER PACK 2010/10/11

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA074388 USA 2010/10/11

Labeler - REMEDYREPACK INC.( 829572556)