GLIPIZIDE ER- glipizide tablet, film coated, extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Rebel Distributors Corp

INN (mednarodno ime):

GLIPIZIDE

Sestava:

GLIPIZIDE 2.5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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:

Povzetek izdelek:

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. 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 Repackaged by : Rebel Distributors Corp Thousand Oaks, CA 91320

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

GLIPIZIDE ER- GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE
REBEL DISTRIBUTORS CORP
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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
tr