GLYBURIDE- glyburide tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

REMEDYREPACK INC.

ІПН (Міжнародна Ім'я):

GLYBURIDE

Склад:

GLYBURIDE 2.5 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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.

Огляд продуктів:

Glyburide tablets USP, 1.25 mg are white, round, bi-convex, compressed tablets engraved with N horizontal bisect 342 on one side and 1.25 on the other side. They are supplied as follows: NDC 0093-8342-01 bottles of 100 Glyburide tablets USP, 2.5 mg are peach-colored, round, bi-convex, compressed tablets engraved with N horizontal bisect 343 on one side and 2.5 on the other side. They are supplied as follows: NDC 0093-8343-98 bottles of 90 NDC 0093-8343-01 bottles of 100 NDC 0093-8343-05 bottles of 500 NDC 0093-8343-10 bottles of 1000 Glyburide tablets USP, 5 mg are light-green colored, round, bi-convex, compressed tablets engraved with N horizontal bisect 344 on one side and 5 on the other side. They are supplied as follows: NDC 0093-8344-98 bottles of 90 NDC 0093-8344-01 bottles of 100 NDC 0093-8344-05 bottles of 500 NDC 0093-8344-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. W 5/2015

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

GLYBURIDE- GLYBURIDE TABLET
REMEDYREPACK INC.
----------
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.
23
28
3
5
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 a