EXTRANEAL- icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ICODEXTRIN (UNII: 2NX48Z0A9G) (ICODEXTRIN - UNII:2NX48Z0A9G), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

Baxter Healthcare Corporation

INN (International Name):

ICODEXTRIN

Composition:

ICODEXTRIN 7.5 g in 100 mL

Administration route:

INTRAPERITONEAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of end-stage renal disease. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical Studies (14)]. EXTRANEAL is contraindicated in patients with a known allergy to cornstarch or icodextrin. EXTRANEAL is contraindicated in patients with maltose or isomaltose intolerance and in patients with glycogen storage disease. EXTRANEAL is contraindicated in patients with severe lactic acidosis. EXTRANEAL contains lactate which may contribute to worsening acidosis if conversion to bicarbonate is impaired and may be associated with hyperventilation, lethargy, hypot

Product summary:

EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is available in the following containers and fill volumes: Container Fill Volume NDC ULTRABAG 2 L NDC 0941-0679-52 2.5 L NDC 0941-0679-53 AMBU-FLEX II / Plastic Container with Pull Ring Cap 2 L NDC 0941-0679-06 2.5 L NDC 0941-0679-05 Each 100 mL of EXTRANEAL contains 7.5 grams of icodextrin in an electrolyte solution with 40 mEq/L lactate. Store at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature]. Protect from freezing. Store in moisture barrier overwrap and in carton until ready to use.

Authorization status:

New Drug Application

Patient Information leaflet

EXTRANEAL- ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM
CHLORIDE, MAGNESIUM
CHLORIDE INJECTION, SOLUTION
Baxter Healthcare Corporation
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MEDICATION GUIDE
EXTRANEAL (X-tra-neel)
(icodextrin)
Peritoneal Dialysis Solution
Read the Medication Guide that comes with EXTRANEAL before you begin
treatment and each time you
receive a carton of EXTRANEAL. There may be new information. This
information does not take the
place of talking with your doctor about your medical condition or your
treatment.
What is the most important information I should know about EXTRANEAL?
EXTRANEAL (icodextrin) contains maltose, which can react with certain
blood glucose (blood sugar)
monitors and test strips.
•
Using EXTRANEAL may cause a false (incorrect) high blood sugar reading
or may hide a blood
sugar reading that is actually very low. This can happen if you use a
glucose monitor or test strips
with glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ)
glucose-dye-oxidoreductase
(GDO), or glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD)
at any time during
treatment or within approximately 2 weeks (14 days) after you stop
treatment with EXTRANEAL.
This kind of false reading means that your blood sugar may really be
too low even though the test
says that it is normal or high. This can lead to dangerous side
effects.
•
You could accidentally wait too long to treat your low blood sugar if
you have low blood sugar and
do not use the right kind of monitor and test strips.
•
You could accidentally take too much insulin if you have a false high
blood sugar reading.
•
Taking too much insulin or waiting too long to treat low blood sugar
can cause you to have serious
reactions including: loss of consciousness (passing out), coma,
permanent neurological problems, or
death.
•
If you have high blood sugar or diabetes and monitor your blood
glucose, you must use a specific
glucose monitor and test strips during treatment with EXTRANEAL and up
to 2 weeks after
stopping EXTRANEAL.
•
Do not use blood glucose monito

Summary of Product characteristics

EXTRANEAL- ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM
CHLORIDE,
MAGNESIUM CHLORIDE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EXTRANEAL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EXTRANEAL.
EXTRANEAL (ICODEXTRIN) PERITONEAL DIALYSIS SOLUTION
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
•
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DOSAGE AND ADMINISTRATION
For intraperitoneal administration only. Not for intravenous or
intra-arterial administration. Administer as a
single daily peritoneal dialysis (PD) exchange for the long dwell.
Dosage should be individualized by the
prescribing physician experienced in the treatment of end-stage renal
disease with PD. (2.1)
DOSAGE FORMS AND STRENGTHS
7.5% icodextrin (75 grams icodextrin per 1000 milliliters) in an
electrolyte solution containing 40 mEq/L
lactate (3)
•
•
CONTRAINDICATIONS
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse reaction (incidence > 5%) was rash. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAXTER HEALTHCARE
CORPORATION AT 1-
866-888-2472 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 9/2020
For a single daily exchange for the long (8- to 16- hour) dwell during
continuous ambulatory peritoneal
dialysis (CAPD) or automated peritoneal dialysis (APD) for the
management of end-stage renal
disease. (1)
To improve (compared to 4.25% dextrose) long-dwell ultrafiltration and
clearance of creatinine and
urea nitrogen in patients with high average or greater transport
characteristics, as defined using the
peritoneal equilibration test (PET). (1)
2 L and 2.5 L APD containers
2 L and 2.5 L CAPD containers
Known allergy to cornstarch or icodextrin (4.1)
Maltose or isomaltose intolerance (4.2)
Glycogen storage disease (4.2)
Pre-existing severe lactic acidosis (4.3)
Use glucose-specific glucose monitoring systems when measuring b