GLYBURIDE tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Zydus Pharmaceuticals (USA) Inc.

INN (Nama Antarabangsa):

GLYBURIDE

Komposisi:

GLYBURIDE 1.25 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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.

Ringkasan produk:

Glyburide Tablets USP, 1.25 mg are white to off-white colored, round shaped, biconvex, uncoated tablets debossed with '656' on one side and breakline on the other side and are supplied as follows: NDC 68382-656-06 in bottles of 30 tablets NDC 68382-656-16 in bottles of 90 tablets NDC 68382-656-01 in bottles of 100 tablets NDC 68382-656-05 in bottles of 500 tablets NDC 68382-656-10 in bottles of 1000 tablets NDC 68382-656-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Glyburide Tablets USP, 2.5 mg are light yellow to yellow colored, may be spotted, round shaped, biconvex, uncoated tablets, debossed with "657" on one side and breakline on the other side and are supplied as follows: NDC 68382-657-06 in bottles of 30 tablets NDC 68382-657-16 in bottles of 90 tablets NDC 68382-657-01 in bottles of 100 tablets NDC 68382-657-05 in bottles of 500 tablets NDC 68382-657-10 in bottles of 1000 tablets NDC 68382-657-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Glyburide Tablets USP, 5 mg are light green colored, may be spotted, round shaped, biconvex, uncoated tablets, debossed with "658" on one side and breakline on the other side and are supplied as follows: NDC 68382-658-06 in bottles of 30 tablets NDC 68382-658-16 in bottles of 90 tablets NDC 68382-658-01 in bottles of 100 tablets NDC 68382-658-05 in bottles of 500 tablets NDC 68382-658-10 in bottles of 1000 tablets NDC 68382-658-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].   Dispense in a tight container (USP). KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Call  your  doctor  for  medical  advice  about  side  effects.  You  may  report  side  effects  to  FDA  at  1-800-FDA-1088. Manufactured  by: Cadila Healthcare Ltd. Baddi, India Distributed  by: Zydus  Pharmaceuticals  USA  Inc. Pennington, NJ 08534 Rev.: 05/16 Revision Date: 02/05/2016

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

GLYBURIDE - GLYBURIDE TABLET
ZYDUS PHARMACEUTICALS (USA) INC.
----------
GLYBURIDE TABLETS, USP
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 or almost
white, crystalline
powder. 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. 494.0
Each glyburide tablet, USP intended for oral administration contains
1.25 mg or 2.5 mg
or 5 mg of Glyburide, USP. In addition, each tablet contains the
following inactive
ingredients: calcium carbonate, dibasic calcium phosphate dihydrate,
magnesium
stearate, microcrystalline cellulose, povidone, pregelatinized starch
and sodium starch
glycolate. Additionally each 2.5 mg tablet contains D&C yellow # 10
aluminum lake and
FD & C yellow # 6 aluminum lake; each 5 mg tablet contains D&C yellow
# 10 aluminum
lake and FD & C blue # 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
unresponsi