GLYBURIDE- glyburide tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Mylan Pharmaceuticals Inc.

INN（国际名称）:

GLYBURIDE

组成:

GLYBURIDE 1.5 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Glyburide tablets 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:

產品總結:

Glyburide Tablets, USP (micronized) are available containing 1.5 mg, 3 mg or 6 mg of glyburide, USP. The 1.5 mg tablets are white, oval, scored tablets debossed with M to the left of the score and 113 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1113-01 bottles of 100 tablets The 3 mg tablets are light yellow, oval, scored tablets debossed with M to the left of the score and 125 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1125-01 bottles of 100 tablets NDC 0378-1125-10 bottles of 1000 tablets The 6 mg tablets are green, oval, scored tablets debossed with M to the left of the score and 142 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1142-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The brands listed are trademarks of their respective owners. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 10/2017 GLY:R15

授权状态:

Abbreviated New Drug Application

产品特点

GLYBURIDE- GLYBURIDE TABLET
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Glyburide tablets, USP (micronized) contain glyburide, which is an
oral blood-glucose-lowering drug
of the sulfonylurea class. Glyburide, USP is a white or almost white,
crystalline powder formulated as
glyburide tablets (micronized) of 1.5 mg, 3 mg and 6 mg strengths for
oral administration. Inactive
ingredients: anhydrous lactose, colloidal silicon dioxide,
croscarmellose sodium, magnesium stearate,
pregelatinized starch (corn), and sodium lauryl sulfate. In addition,
the 3 MG tablets contain D&C
Yellow No. 10 Aluminum Lake and the 6 MG tablets contain D&C Yellow
No. 10 Aluminum Lake and
FD&C Blue No. 1 Aluminum Lake. The chemical name for glyburide is
1-[[p-[2-(5-Chloro-_o_-
anisamido) ethyl] phenyl]-sulfonyl]-3-cyclohexylurea and the molecular
weight is 494.01. The
structural formula is represented below:
_Meets USP Dissolution Test 3_.
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 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, glybu