GLYBURIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Bryant Ranch Prepack

INN (International Adı):

GLYBURIDE

Kompozisyon:

GLYBURIDE 5 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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.

Ürün özeti:

Product: 63629-1393 NDC: 63629-1393-1 30 TABLET in a BOTTLE NDC: 63629-1393-2 120 TABLET in a BOTTLE NDC: 63629-1393-3 100 TABLET in a BOTTLE NDC: 63629-1393-4 60 TABLET in a BOTTLE NDC: 63629-1393-5 90 TABLET in a BOTTLE NDC: 63629-1393-6 180 TABLET in a BOTTLE

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

GLYBURIDE- GLYBURIDE TABLET
BRYANT RANCH PREPACK
----------
GLYBURIDE TABLETS USP
1.25, 2.5, AND 5 MG
8342
8343
8344
RX ONLY
DESCRIPTION
Glyburide tablets USP contain glyburide, USP, which is an oral
blood-glucose-lowering drug of the
sulfonylurea class. Glyburide, USP is a white, crystalline compound.
The chemical name for glyburide,
USP is
1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]-sulfonyl]-3-cyclohexylurea.
It has the following
structural formula:
C
H ClN O S M.W. 493.99
Each tablet, for oral administration, contains 1.25 mg, 2.5 mg or 5 mg
of glyburide, USP. In addition,
each tablet contains the following inactive ingredients:
microcrystalline cellulose, pregelatinized corn
starch, sodium starch glycolate, colloidal silicon dioxide, and
magnesium stearate. In addition, the 2.5
MG contains FD&C yellow No. 6 aluminum lake and the 5 MG contains D&C
yellow No. 10 aluminum
lake, and FD&C blue No. 1 aluminum lake.
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,