GLIPIZIDE ER- glipizide tablet, film coated, extended release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Dispensing Solutions, Inc.

INN (International Name):

GLIPIZIDE

Sammensætning:

GLIPIZIDE 5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide extended-release tablets are contraindicated in patients with: - Known hypersensitivity to glipizide or any excipients in the tablets. Known hypersensitivity to glipizide or any excipients in the tablets. - Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin. Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

Produkt oversigt:

Glipizide Extended-Release Tablets are supplied as 2.5 mg, 5 mg, and 10 mg round, film-coated tablets and are printed with black ink as follows: 2.5 mg tablets are light orange and printed with WPI and 900 , and are supplied in bottles of 30, 100 and 1000. 5 mg tablets are orange and printed with WPI and 844 , and are supplied in bottles of 100 and 1000 and blister packages of 30. 10 mg tablets are white to off-white and printed with WPI and 845 , and are supplied in bottles of 100 and 1000 and blister packages of 30. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and humidity. Mfd. for: Watson Laboratories, Inc. Corona, CA 92880 USA Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA Revised: January 2009

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

GLIPIZIDE ER- GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE
DISPENSING SOLUTIONS, INC.
----------
GLIPIZIDE
EXTENDED-RELEASE TABLETS
RX ONLY
DESCRIPTION
Glipizide 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 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 extended-release tablets are formulated as a polymer matrix
based once-a-day controlled
release tablet for oral use and is designed to deliver 2.5 mg, 5 mg or
10 mg of glipizide. Each tablet
contains the following inactive ingredients: acetyltributyl citrate,
edible black ink, hydroxyethyl
cellulose, hydroxypropyl cellulose, lactose monohydrate, magnesium
stearate, methacrylic acid
copolymer type A and polyethylene glycol.
The 2.5 mg and 5 mg tablets also contain FD&C Yellow #6.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Glipizide appears to lower blood glucose acutely by stimulating the
release of insulin from the
pancreas, an effect dependent upon functioning beta cells in the
pancreatic islets. Extrapancreatic effects
also may play a part in the mechanism of action of oral sulfonylurea
hypoglycemic drugs. Two
extrapancreatic effects shown to be important in the action of
glipizide are an increase in insulin
sensitivity and a decrease in hepatic glucose production. However, the
mechanism by which glipizide
lowers blood glucose during long-term administration has not been
clearly established. Stimulation of
insulin secretion by glipizide in response to a meal is of major
importance. The insulinotropic response
to a meal is enhanced with glipizide administration in diabetic
patients. The postprandial insulin and C-
peptide responses continue to be enhanced after at least 6 months of