GLIPIZIDEER ER- glipizide tablet, film coated, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Aidarex Pharmaceuticals LLC

INN (Medzinárodný Name):

GLIPIZIDE

Zloženie:

GLIPIZIDE 5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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.

Prehľad produktov:

Glipizide Extended-Release Tablets are supplied as 5 mg, and 10 mg round, film-coated tablets and are printed with black ink as follows: 5 mg tablets are orange and printed with WPI and 844 , and are supplied in bottles of 30. 10 mg tablets are white to off-white and printed with WPI and 845 , and are supplied in bottles 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 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Revised: January 2013

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

GLIPIZIDEER ER- GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE
AIDAREX PHARMACEUTICALS LLC
----------
GLIPIZIDE EXTENDED-RELEASE TABLETS
REVISED: JANUARY 2013
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