GLYBURIDE- glyburide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC)

Available from:

Hikma Pharmaceutical

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Glyburide Tablets, USP (micronized) 1.5 mg: is available as white, scored, capsule shape tablets, imprinted “G1” Bottles of 100 Bottles of 500 Glyburide Tablets, USP (micronized) 3 mg: is available as blue, scored, capsule shape tablets, imprinted “G2” Bottles of 100 Bottles of 500 Bottles of 1000 Glyburide Tablets, USP (micronized) 6 mg: is available as yellow, scored, capsule shape tablets, imprinted “H5” Bottles of 100 Bottles of 500 Bottles of 1000 Glyburide Tablets, USP (micronized) can be easily divided in half for a more flexible dosing regimen. Press gently on the score and the tablet will split in even halves. Rx Only Store at 20º to 25ºC (68º to77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistance closure. Keep container tightly closed. Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724 - USA Manufactured by: HIKMA Pharmaceuticals P.O. Box 182400 Amman 11118 – Jordan Revised June 2013

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYBURIDE- GLYBURIDE TABLET
HIKMA PHARMACEUTICAL
----------
GLYBURIDE TABLETS, USP
(MICRONIZED)
REV. 06/13
RX ONLY
_FOR ORAL USE_
DESCRIPTION:
Glyburide Tablets, USP (micronized) contain micronized (smaller
particle size) glyburide, which is an
oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide
is a white, crystalline
compound, formulated as Glyburide Tablets USP (micronized) tablets of
1.5, 3, and 6 mg strengths for
oral administration. Inactive ingredients: colloidal silicon dioxide,
pregelatinized maize starch, lactose
monohydrate, magnesium stearate. In addition, the 3 MG strength
contains FD&C Blue No. 1 Aluminum
Lake, and the 6 MG tablet contains D&C Yellow No. 10 Aluminum Lake.
The chemical name for
glyburide is 1-[[_p_-[2-(5-chloro-o-anisamido)
ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the
molecular weight is 494.00. The structural formula is represented
below:
Glyburide Tablets meet USP Dissolution Test 5.
CLINICAL PHARMACOLOGY:
ACTIONS :
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 be involved in the mechanism of action of oral sulfonylurea
hypoglycemic drugs. The combination
of glyburide and metformin may have a synergistic effect, since both
agents act to improve glucose
tolerance by different but complementary mechanisms.
Some patients who are initially responsive to oral hypoglycemic drugs,
including glyburide, may
become unresponsive or poorly responsive over time. Alternatively,
glyburide tablets may be effective
in some patients who have become unresponsive to one or more other
sulfonylurea drugs.
In addition to its blood