GLIPIZIDE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

MedVantx, Inc.

INN (nume internaţional):

GLIPIZIDE

Compoziție:

GLIPIZIDE 10 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Glipizide Tablets USP 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: - Known hypersensitivity to the drug. - Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

Rezumat produs:

Glipizide Tablets USP, 5 mg are available as white to off-white, round, flat-faced, beveled-edge tablets, bisected and debossed on one side with “9201” above bisect and debossed with “TEVA” on the other side, containing 5 mg of glipizide, packaged in bottles of 100 and 500 tablets and unit-dose boxes of 100 tablets. Glipizide Tablets USP, 10 mg are available as white to off-white, round, flat-faced, beveled-edge tablets, bisected and debossed on one side with “9200” above bisect and debossed with “TEVA” on the other side, containing 10 mg of glipizide, packaged in bottles of 100 and 500 tablets and unit-dose boxes of 100 tablets. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. E 2/2011

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

GLIPIZIDE- GLIPIZIDE TABLET
MEDVANTX, INC.
----------
GLIPIZIDE TABLETS USP
FOR ORAL USE
RX ONLY
DESCRIPTION
Glipizide Tablets USP are oral blood-glucose-lowering drugs of the
sulfonylurea class.
The Chemical Abstracts name of glipizide is
1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-
carboxamido)ethyl]phenyl]sulfonyl]urea and has the following
structural formula:
C
H N O S M.W. 445.55
Glipizide 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 and 10 mg strengths.
Each tablet contains the following inactive ingredients: lactose
monohydrate; microcrystalline
cellulose; pregelatinized starch; silicon dioxide; stearic acid.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The primary mode of action of glipizide 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 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 glipizide lowers blood glucose during
long-term administration has not
been clearly established. In man, stimulation of insulin secretion by
glipizide in response to a meal is
undoubtedly of major importance. Fasting insulin levels are not
elevated even on long-term glipizide
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
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 control persists in some patients for up to 24 hours a