GLYBURIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Glyburide tablets, USP is 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. - Concomitant administration of bosentan. SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY 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. UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2½ times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of glyburide tablets and of alternative modes of therapy. Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.

Product summary:

Glyburide tablets, USP are supplied as follows: Glyburide tablets, USP 5 mg (Blue colored, slightly mottled, capsule shaped, biconvex tablets de-bossed with 'I37 ' on one side and scored on the other side) NDC: 70518-1646-00 NDC: 70518-1646-01 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 360 in 1 BOTTLE PLASTIC Rx only Store at 20° to 25°C (68° to 77°F) [see USP controlled room temperature]. Dispensed in well closed containers with safety closures. Keep container tightly closed. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYBURIDE- GLYBURIDE TABLET
REMEDYREPACK INC.
----------
GLYBURIDE TABLETS, USP
1.25, 2.5, AND 5 MG
_FOR ORAL USE_
RX ONLY
DESCRIPTION
Glyburide tablets, USP contain a 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 of
1.25, 2.5, and 5 mg strengths for oral administration. Inactive
ingredients: lactose monohydrate,
microcrystalline cellulose, magnesium stearate. In addition, the 2.5
MG contains FD&C Red No.40 and the 5
MG contains FD&C Blue No.1. 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. The structural formula is
represented below.
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 tablets, 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 glucose lowering actions, glyburide produces
a mild diuresis by enhancement of renal
free water clearance. Disulfiram-like reactions have very rarely been
reported in