GLYBURIDE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Dispensing Solutions, Inc.

INN (Tarptautinis Pavadinimas):

GLYBURIDE

Sudėtis:

GLYBURIDE 6 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Glyburide tablets (micronized) are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide tablets (micronized) 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.

Produkto santrauka:

Glyburide tablets (micronized), USP are supplied as follows: Glyburide tablets (micronized), USP 1.5 mg are white, oval-shaped, flat face, beveled-edge, compressed tablets, debossed with 1.5 | 034 on one side and stylized N on the reverse. They are supplied as follows: NDC 0093-8034-01 bottles of 100 Glyburide tablets (micronized), USP 3 mg are pale-blue colored, oval-shaped, flat face, beveled-edge, compressed tablets, debossed with 3 | 035 on one side and stylized N on the reverse. They are supplied as follows: NDC 0093-8035-01 bottles of 100 NDC 0093-8035-05 bottles of 500 NDC 0093-8035-50 bottles of 5000 Glyburide tablets (micronized), USP 6 mg are dark-blue colored, oval-shaped, flat face, beveled-edge, compressed tablets, debossed with 6 | 036 on one side and stylized N on the reverse. They are supplied as follows: NDC 0093-8036-01 bottles of 100 The glyburide tablet (micronized), USP can be easily divided in half for a more flexible dosing regimen. Press gently on the score and the tablet will split in even halves. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with safety closure. Keep container tightly closed. Manufactured In Canada By: TEVA CANADA LIMITED Toronto, Canada M1B 2K9 Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. J 7/2012

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

GLYBURIDE- GLYBURIDE TABLET
DISPENSING SOLUTIONS, INC.
----------
GLYBURIDE TABLETS (MICRONIZED), USP
RX ONLY
DESCRIPTION
Glyburide tablets (micronized), USP contain smaller particle size.
Glyburide is an oral blood-glucose-
lowering drug of the sulfonylurea class. Glyburide is a white,
crystalline compound. Each tablet, for
oral administration, contains 1.5 mg, 3 mg, or 6 mg of glyburide.
Inactive ingredients: microcrystalline
cellulose, pregelatinized starch, sodium starch glycolate, colloidal
silicon dioxide, magnesium stearate.
In addition, the 3 mg, and 6 mg strengths contain FD&C Blue No. 1
Aluminum Lake and FD&C Blue No.
2 Aluminum Lake. The chemical name for glyburide is
1-[[_p_-[2-(5-Chloro-_o_-
anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea. The molecular
formula is C
H ClN O S, and
the molecular weight is 494.01. The structural formula is represented
below:
Glyburide tablets (micronized), USP meets USP _Dissolution Test 2._
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 lo