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. Use of GDH-PQQ or GDO-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) and has 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 or GDO-based blood glucose monitors and test strips are used.

Because GDH-PQQ and GDO-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.

Information regarding glucose monitor and test strip methodology can be obtained from their manufacturers. 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 www.glucosesafety.com.

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  7.5 g 
Sodium Chloride, USP 535 mg
Sodium Lactate 448 mg
Calcium Chloride, USP 25.7 mg
Magnesium Chloride, USP 5.08 mg

Electrolyte content per liter:

Sodium  132 mEq/L 
Calcium 3.5 mEq/L
Magnesium 0.5 mEq/L
Chloride 96 mEq/L
Lactate 40 mEq/L

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-F