GLYBURIDE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Teva Pharmaceuticals USA, Inc.

INN (International Nazwa):

GLYBURIDE

Skład:

GLYBURIDE 1.5 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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: - 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.

Podsumowanie produktu:

Glyburide tablets, USP are supplied as follows: Glyburide Tablets USP 1.5 mg are white, oval-shaped, flat faced, bevel-edged, compressed tablets, debossed with 1.5 | 034 on one side and stylized N on the other side. They are supplied as follows: NDC 0093-8034-01 bottles of 100 Glyburide Tablets USP 3 mg are pale-blue colored, oval-shaped, flat faced, bevel-edged, compressed tablets, debossed with 3 | 035 on one side and stylized N on the other side. They are supplied as follows: NDC 0093-8035-01 bottles of 100 NDC 0093-8035-05 bottles of 500 Glyburide Tablets USP 6 mg are dark-blue colored, oval-shaped, flat faced, bevel-edged, compressed tablets, debossed with 6 | 036 on one side and stylized N on the other side. They are supplied as follows: NDC 0093-8036-01 bottles of 100 Glyburide Tablets USP can be 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 Parsippany, NJ 07054 Rev. N 1/2023

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

GLYBURIDE- GLYBURIDE TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
GLYBURIDE TABLETS, USP
RX ONLY
DESCRIPTION
Glyburide tablets, USP contain micronized (smaller particle size)
glyburide, USP which is
an oral blood-glucose-lowering drug of the sulfonylurea class.
Glyburide, USP is a white,
crystalline compound. Each tablet, for oral administration, contains
1.5 mg, 3 mg, or 6
mg of glyburide, USP. Inactive ingredients: microcrystalline
cellulose, pregelatinized corn
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, USP is
1-[[_p_-[2-(5-
Chloro-_o_-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohex-ylurea. The
structural formula is
represented below:
C
H
ClN O S M.W. 494.00
Glyburide Tablets, USP meet 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.
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 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, glyburide produces