GLYBURIDE - glyburide tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Citron Pharma LLC

INN (mednarodno ime):

GLYBURIDE

Sestava:

GLYBURIDE 1.25 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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: - 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.

Povzetek izdelek:

Glyburide Tablets, USP are supplied as follows: Glyburide Tablets 1.25 mg (White to off white, round, flat, beveled edge tablets with scoreline in between ‘2’ & ‘9’ on one side and ‘A’ debossed on other side.)           Bottles of 50                       NDC 57237-020-50 (Child Resistant Closure)          Bottles of 100                     NDC 57237-020-01 (Child Resistant Closure) Glyburide Tablets 2.5 mg (White to off white, round, flat, beveled edge tablets with scoreline in between ‘3’ & ‘0’ on one side and ‘A’ debossed on other side.)                    Bottles of 100                     NDC 57237-021-01 (Child Resistant Closure)          Bottles of 500                     NDC 57237-021-05 (Non Child Resistant Closure)          Bottles of 1000                  NDC 57237-021-99 (Non Child Resistant Closure) 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.)                    Bottles of 100                     NDC 57237-022-01 (Child Resistant Closure)          Bottles of 500                     NDC 57237-022-05 (Non Child Resistant Closure)          Bottles of 1000                  NDC 57237-022-99 (Non Child Resistant Closure) 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: Citron Pharma LLC Suite - 1101 2 Tower Center Blvd East Brunswick NJ 08816 Code No.: DRUGS/AP/19/1993 Made in India Revised: 07/2015

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

GLYBURIDE - GLYBURIDE TABLET
CITRON PHARMA LLC
----------
GLYBURIDE TABLETS, USP
(NONMICRONIZED)
RX ONLY
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