GLIPIZIDE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C)

Saatavilla:

Mylan Pharmaceuticals Inc.

INN (Kansainvälinen yleisnimi):

GLIPIZIDE

Koostumus:

GLIPIZIDE 5 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide tablets are contraindicated in patients with:

Tuoteyhteenveto:

Glipizide Tablets, USP are available containing 5 mg or 10 mg of glipizide, USP. The 5 mg tablets are white, round, scored tablets debossed with MYLAN above the score and G1 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1105-01 bottles of 100 tablets NDC 0378-1105-05 bottles of 500 tablets The 10 mg tablets are white, round, scored tablets debossed with MYLAN above the score and G2 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1110-01 bottles of 100 tablets NDC 0378-1110-05 bottles of 500 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: 9/2016 GLIP:R13

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

GLIPIZIDE - GLIPIZIDE TABLET
MYLAN PHARMACEUTICALS INC.
----------
DESCRIPTION
Glipizide tablets, USP is an oral blood-glucose-lowering drug of the
sulfonylurea class.
The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-
methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea. The molecular
formula is
C
H
N O S; the molecular weight is 445.55; the structural formula is shown
below:
Glipizide, USP is a whitish, odorless powder with a pKa of 5.9. It is
insoluble in water and
alcohols, but soluble in 0.1 _N_ NaOH; it is freely soluble in
dimethylformamide. Glipizide
tablets for oral use are available in 5 mg and 10 mg strengths.
Inert ingredients are: colloidal silicon dioxide, lactose (anhydrous),
microcrystalline
cellulose, pregelatinized starch (corn) and stearic acid.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The primary mode of action of glipizide tablets in experimental
animals appears to be the
stimulation of insulin secretion from the beta cells of pancreatic
islet tissue and is thus
dependent on functioning beta cells in the pancreatic islets. In
humans, glipizide tablets
appear 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 glipizide tablets lower blood glucose during
long-term
administration has not been clearly established. In man, stimulation
of insulin secretion
by glipizide tablets in response to a meal is undoubtedly of major
importance. Fasting
insulin levels are not elevated even on long-term glipizide tablets
administration, but the
postprandial insulin response continues to be enhanced after at least
6 months of
treatment. The insulinotropic response to a meal occurs within 30
minutes after an oral
dose of glipizide tablets in diabetic patients, but elevated insulin
levels do not persist
beyond the time of the meal challenge. Extrapancreatic effects may
play a part in the
mechanism of action of oral sulfonylurea hypoglycemic drugs.
Blood sugar