GLYBURIDE- glyburide tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Par Pharmaceutical

INN (mednarodno ime):

GLYBURIDE

Sestava:

GLYBURIDE 1.5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Glyburide tablets USP (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. - Concomitant administration of bosentan. SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were random

Povzetek izdelek:

Glyburide Tablets, USP (micronized) 1.5 mg-  are white oval shaped tablet, bisected on one side, debossed with "M03" and "1.5", and with "MOVA" on the other side; and supplied as follows: Glyburide Tablets, USP (micronized) 3mg- is a light blue oval shaped tablet, bisected on one side, debossed with "M04" and "3.0", and with "MOVA" on the other side; and supplied as follows: Glyburide Tablets, USP (micronized) 6 mg- is a light yellow oval shaped tablet, bisected on one side, debossed with "M07" and "6.0", and with "MOVA" on the other side; and supplied as follows: The tablet 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. Rx only 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, with a child-resistant closure. Keep container tightly closed. Trademarks are the property of their respective owners. Manufactured For: DAVA Pharmaceuticals, Inc. a subsidiary of QUALITEST PHARMACEUTICALS, Huntsville, AL 35811 By: Patheon Puerto Rico, Inc. Manati, Puerto Rico 00674, USA Item#: 672534600815 Rev. 08/15

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

GLYBURIDE- GLYBURIDE TABLET
PAR PHARMACEUTICAL
----------
GLYBURIDE TABLETS, USP (MICRONIZED)
RX ONLY
_For Oral Use_
DESCRIPTION
Glyburide tablets, USP (micronized) contain micronized (smaller
particle size) glyburide, which is an
oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide
is a white, crystalline
compound, formulated as glyburide tablets (micronized) of 1.5 mg, 3
mg, or 6 mg strengths for oral
administration. Inactive ingredients: Colloidal Silicon Dioxide,
Lactose Monohydrate, Magnesium
Stearate, Pregelatinized Corn Starch. In addition, the 3 MG strength
contains FD&C Blue No. 1
Aluminum Lake; and the 6 MG tablet contains D&C Yellow No. 10 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 494.00. The structural formula is represented
below:
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, glyburide produces
a mild diuresis by enhancement of
rena