GLYBURIDE- glyburide tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Preferred Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

GLYBURIDE

Composição:

GLYBURIDE 5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Glyburide  tablets, USP 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:

Resumo do produto:

Glyburide Tablets, USP are supplied as follows: Glyburide Tablets 5 mg (White to off white, round, flat, beveled edge tablets with scoreline in between ‘3’ & ‘1’ on one side and ‘A’ debossed on other side.) Bottle of 30 - 68788-9917-3 Bottle of 60 - 68788-9917-6 Bottle of 90 - 68788-9917-9 Bottle of 100 - 68788-9917-1 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispensed in well closed containers with safety closures. Keep container tightly closed. Distributed by: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 038, India Revised: 07/2017 Repackaged By: Preferred Pharmaceuticals Inc.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

GLYBURIDE- GLYBURIDE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
DESCRIPTION
Glyburide is an oral blood-glucose-lowering drug of the sulfonylurea
class. Glyburide USP is a white,
crystalline compound, formulated as glyburide tablets of 1.25, 2.5,
and 5 mg strengths for oral
administration. Inactive ingredients: dibasic calcium phosphate
dihydrate, magnesium stearate,
microcrystalline cellulose, sodium alginate, and talc. 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, 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 patients treated
with glyburide tablets.
PHARMACOKINETICS
Single dose studies with glyburide tablets in normal subjects
demonstrate significant absorption of
glyburid