GLYBURIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Contract Pharmacy Services-PA

INN (International Name):

GLYBURIDE

Composition:

GLYBURIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Glyburide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 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. The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups (Diabetes , 19 (Suppl. 2):747- 830, 1970). UGDP reported that patients tr

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYBURIDE- GLYBURIDE TABLET
CONTRACT PHARMACY SERVICES-PA
----------
GLYBURIDE TABLETS USP
(NONMICRONIZED)
1.25, 2.5 AND 5 MG
RX ONLY
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-
[[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: C
H ClN O S
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.
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