GLYBURIDE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Blenheim Pharmacal, Inc.

DCI (Denominação Comum Internacional):

GLYBURIDE

Composição:

GLYBURIDE 2.5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Glyburide tablets 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 the drug or any of its excipients. - Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin. - Type I diabetes mellitus. - Concomitant administration of bosentan. WARNINGS 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

Resumo do produto:

Glyburide tablets are supplied as follows: Glyburide tablets 1.25 mg (White to off white colored, capsule shaped, biconvex tablets de-bossed with ‘I35’ on one side and scored on the other side) Bottles of 100 NDC 23155-056-01 Bottles of 1000 NDC 23155-056-10 Glyburide tablets 2.5 mg (Pink colored, slightly mottled, capsule shaped, biconvex tablets de-bossed with ‘I36’ on one side and scored on the other side) Bottles of 100 NDC 23155-057-01 Bottles of 1000 NDC 23155-057-10 Glyburide tablets 5 mg (Blue colored, slightly mottled, capsule shaped, biconvex tablets de-bossed with ‘I37 ’ on one side and scored on the other side) Bottles of 100 NDC 23155-058-01 Bottles of 1000 NDC 23155-058-10 Rx only Store at 20° to 25°C (68° to 77°F) [see USP controlled room temperature ]. Dispense in well closed containers with safety closures. Keep container tightly closed. Manufactured for : Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) Made in India. 11/13

Status de autorização:

Abbreviated New Drug Application

Características técnicas

GLYBURIDE- GLYBURIDE TABLET
BLENHEIM PHARMACAL, INC.
----------
GLYBURIDE TABLETS, USP
1.25 MG, 2.5 MG AND 5 MG
FOR ORAL USE
CLINICAL PHARMACOLOGY
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.
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 patients
treated with glyburide tablets.
PHARMACOKINETICS
Single dose studies with glyburide tablets in normal subjects
demonstrate significant absorption within
one hour, peak drug levels at about four hours, and low but detectable
levels at twenty-four hours. Mean
serum levels of glyburide, as reflected by areas under the serum
concentration-time curve, increase in
proportion to corresponding increases in dose. Multiple dose studies
with glyburide tablets in diabetic
patients demonstrate drug level concentration-time curves similar to
single dose studies, indicating no
buildup of drug in tissue depots. The decrease of glyburide in the
serum of normal healthy individuals
is biphasic; the terminal half-life is about 10 hours. In single dose
studies in fasting normal subjects, the
degree and duration of blood glucose lowering is proportional to the
dose administered and to the area
under the drug level concentration-time curve. The blood gluco