GLYBURIDE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Aidarex Pharmaceuticals LLC

INN (Mezinárodní Name):

GLYBURIDE

Složení:

GLYBURIDE 2.5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

Glyburide tablets are supplied as follows: 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 30 NDC 33261-0813-30 Bottles of 60 NDC 33261-0813-60 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 30 NDC 33261-0209-30 Bottles of 60 NDC 33261-0209-60 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. Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 11/13

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

GLYBURIDE- GLYBURIDE TABLET
AIDAREX PHARMACEUTICALS LLC
----------
GLYBURIDE TABLETS, USP
1.25 MG, 2.5 MG AND 5 MG
FOR ORAL USE
DESCRIPTION
Glyburide tablets 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 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
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, a