GLYBURIDE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

NuCare Pharmceuticals,Inc.

INN (Medzinárodný Name):

GLYBURIDE

Zloženie:

GLYBURIDE 2.5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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: 1.  With known hypersensitivity to the drug or any of its excipients. 2.  With type 1 diabetes mellitus or diabetic ketoacidosis, with or without coma.      These conditions should be treated with insulin. 3.  Treated with bosentan.

Prehľad produktov:

2.5 mg (pink colored, capsule-shaped, scored tablets, debossed with C on the left side of the score and P on the right side of the score on one side and 291 on the other side). NDC 68071-4142-3 Bottles of 30 NDC 68071-4142-6 Bottles of 60 NDC 68071-4142-9 Bottles of 90 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers with child-resistant closure. LB# 811-01 Rev. February, 2017 Manufactured for and Distributed by: CorePharma, LLC Middlesex, NJ 08846

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

GLYBURIDE- GLYBURIDE TABLET
NUCARE PHARMCEUTICALS,INC.
----------
GLYBURIDE TABLETS, USP
1.25 MG, 2.5 MG AND 5 MG
RX ONLY
DESCRIPTION
Glyburide Tablets, USP are an oral blood-glucose-lowering drug of the
sulfonylurea class.
It is a white, crystalline compound, formulated as tablets of 1.25 mg,
2.5 mg, and 5 mg
strengths for oral administration. Glyburide Tablets, USP contain the
active ingredient
glyburide and the following inactive ingredients: dibasic calcium
phosphate anhydrous
USP, dibasic calcium phosphate dihydrate USP, magnesium stearate NF,
microcrystalline
cellulose NF, sodium alginate NF, talc USP. Glyburide Tablets USP,
1.25 mg also contain
FD&C Yellow #6 Aluminum Lake. Glyburide Tablets USP, 2.5 mg also
contain D&C Red
#27 Aluminum Lake. Glyburide Tablets USP, 5 mg also contain FD&C Blue
#1 Aluminum
Lake. Chemically, glyburide is identified as 1-[[p-[2-(5-Chloro-o-
anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea.
The CAS Registry Number is 10238-21-8.
The structural formula is:
The molecular weight is 493.99. The aqueous solubility of glyburide
increases with pH as
a result of salt formation.
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 play a part in the mechanism of action of
oral sulfonylurea
hypoglycemic drugs.
In addition to its blood glucose lowering actions, glyburide produces
a mild diuresis by
enhancement of renal free water clearance. Clinical experience to date
indicates an
extremely low incidence of disulfiram-like reactions in patients while
taking glyburide
tablets.
PHARMACOKINETICS
Single-dose studies with glyb