2024年6月3日发(作者：)

EXTRANEAL- icodextrin, sodium chloride, sodium lactate, calcium chloride and magnesium

chloride injection, solution

Baxter Healthcare Corporation

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EXTRANEAL

(icodextrin) Peritoneal Dialysis Solution

Dangerous Drug-Device Interaction

Only use glucose-specific monitors and test strips to measure blood glucose levels in patients

using EXTRANEAL (icodextrin) Peritoneal Dialysis Solution. Blood glucose monitoring

devices using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-

oxidoreductase (GDO)-based methods must not be used. In addition, some blood glucose

monitoring systems using glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD)-based

methods must not be used. Use of GDH-PQQ, GDO, and GDH-FAD-based glucose monitors and

test strips has resulted in falsely elevated glucose readings (due to the presence of maltose, see

PRECAUTIONS/Drug/Laboratory Test Interactions). Falsely elevated glucose readings have led

patients or health care providers to withhold treatment of hypoglycemia or to administer insulin

inappropriately. Both of these situations have resulted in unrecognized hypoglycemia, which has

led to loss of consciousness, coma, permanent neurological damage, and death. Plasma levels of

EXTRANEAL (icodextrin) and its metabolites return to baseline within approximately 14 days

following cessation of EXTRANEAL (icodextrin) administration. Therefore falsely elevated

glucose levels may be measured up to two weeks following cessation of EXTRANEAL

(icodextrin) therapy when GDH-PQQ, GDO, and GDH-FAD-based blood glucose monitors and

test strips are used.

Because GDH-PQQ, GDO, and GDH-FAD-based blood glucose monitors may be used in

hospital settings, it is important that the health care providers of peritoneal dialysis patients using

EXTRANEAL (icodextrin) carefully review the product information of the blood glucose testing

system, including that of test strips, to determine if the system is appropriate for use with

EXTRANEAL (icodextrin).

To avoid improper insulin administration, educate patients to alert health care providers of this

interaction whenever they are admitted to the hospital.

The manufacturer(s) of the monitor and test strips should be contacted to determine if icodextrin

or maltose causes interference or falsely elevated glucose readings. For a list of toll free

numbers for glucose monitor and test strip manufacturers, please contact the Baxter Renal Clinical

Help Line 1-888-RENAL-HELP or visit .

DESCRIPTION

EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a peritoneal dialysis solution containing the

colloid osmotic agent icodextrin. Icodextrin is a starch-derived, water-soluble glucose polymer linked

by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight

between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500

Daltons. The representative structural formula of icodextrin is:

Each 100 mL of EXTRANEAL contains:

Icodextrin

Sodium Chloride, USP

Sodium Lactate

Calcium Chloride, USP

Magnesium Chloride, USP

Electrolyte content per liter:

Sodium

Calcium

Magnesium

Chloride

Lactate

Water for Injection, USP qs

HCl/NaOH may have been used to adjust pH.

EXTRANEAL contains no bacteriostatic or antimicrobial agents.

Calculated osmolarity: 282–286 mOsm/L; pH=5.0-6.0

EXTRANEAL is available for intraperitoneal administration only as a sterile, nonpyrogenic, clear

solution in AMBU-FLEX II, AMBU-FLEX III and ULTRABAG containers. The container systems are

composed of polyvinyl chloride.

Solutions in contact with the plastic container can leach out certain of its chemical components in very

small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per

million; however, the safety of the plastic has been confirmed in tests in animals according to USP

biological tests for plastic containers as well as by tissue culture toxicity studies.

CLINICAL PHARMACOLOGY

Mechanism of Action

EXTRANEAL is an isosmotic peritoneal dialysis solution containing glucose polymers (icodextrin) as

the primary osmotic agent. Icodextrin functions as a colloid osmotic agent to achieve ultrafiltration

during long peritoneal dialysis dwells. Icodextrin acts in the peritoneal cavity by exerting osmotic

pressure across small intercellular pores resulting in transcapillary ultrafiltration throughout the dwell.

132 mEq/L

3.5 mEq/L

0.5 mEq/L

96 mEq/L

40 mEq/L

7.5 g

535 mg

448 mg

25.7 mg

5.08 mg