GLIPIZIDE XL- glipizide tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

glipizide (UNII: X7WDT95N5C) (glipizide - UNII:X7WDT95N5C)

Available from:

Cardinal Health

INN (International Name):

glipizide

Composition:

glipizide 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Glipizide XL (glipizide) extended-release tablets are supplied as 2.5 mg, 5 mg, and 10 mg round, biconvex tablets and imprinted with black ink as follows: 2.5 mg tablets Blue and imprinted with "GLIPIZIDE XL 2.5" on one side  OR Blue and imprinted with "GXL 2.5" on one side Bottles of 30: NDC 59762-5031-1 Bottles of 30: NDC 59762-0540-1   5 mg tablets White and imprinted with "GLIPIZIDE XL 5" on one side  OR White and imprinted with "GXL 5" on one side Bottles of 100: NDC 59762-5032-1 Bottles of 100: NDC 59762-0541-1 Bottles of 500: NDC 59762-5032-2 Bottles of 500: NDC 59762-0541-2   10 mg tablets White and imprinted with "GLIPIZIDE XL 10" on one side  OR White and imprinted with "GXL 10" on one side Bottles of 100: NDC 59762-5033-1 Bottles of 100: NDC 59762-0542-1 Bottles of 500: NDC 59762-5033-2 Bottles of 500: NDC 59762-0542-2 The tablets should be protected from moisture and humidity and stored at controlled room temperature, 59° to 86°F (15° to 30°C).

Authorization status:

New Drug Application

Summary of Product characteristics

GLIPIZIDE XL- GLIPIZIDE TABLET, EXTENDED RELEASE
CARDINAL HEALTH
----------
GLIPIZIDE XL
(GLIPIZIDE)
EXTENDED-RELEASE TABLETS
_FOR ORAL USE_
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 XL is the Greenstone brand
name for glipizide GITS. Glipizide GITS (Gastrointestinal Therapeutic
System) is formulated as a
once-a-day controlled release tablet for oral use and is designed to
deliver 2.5, 5, or 10 mg of
glipizide.
Inert ingredients in the 2.5 mg, 5 mg and 10 mg formulations are:
polyethylene oxide, hypromellose,
magnesium stearate, sodium chloride, red ferric oxide, cellulose
acetate, polyethylene glycol, Opadry
blue (OY-LS-20921)(2.5 mg tablets), Opadry
white (YS-2-7063)(5 mg and 10 mg tablet) and black ink
(S-1-8106).
SYSTEM COMPONENTS AND PERFORMANCE
Glipizide XL extended-release tablet is similar in appearance to a
conventional tablet. It consists,
however, of an osmotically active drug core surrounded by a
semipermeable membrane. The core itself
is divided into two layers: an "active" layer containing the drug, and
a "push" layer containing
pharmacologically inert (but osmotically active) components. The
membrane surrounding the tablet is
permeable to water but not to drug or osmotic excipients. As water
from the gastrointestinal tract enters
the tablet, pressure increases in the osmotic layer and "pushes"
against the drug layer, resulting in the
release of drug through a small, laser-drilled orifice in the membrane
on the drug side of the tablet.
The Glipizide XL extended-release tablet is designed to provide a
controlled rate of delivery of
glipizide into the