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Extraneal

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Extraneal

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 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 manufacturers) 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 www.glucosesafety.com.

DRUG 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:

XTRANEAL
  (icodextrin) Structural Formula Illustration

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 (icodextrin peritoneal dialysis solution) contains no bacteriostatic or antimicrobial agents.

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

Extraneal (icodextrin peritoneal dialysis solution) is available for intraperitoneal administration only as a sterile, nonpyrogenic, clear solution in AMBU-FLEXII, AMBU-FLEX III and ULTRABAG containers. The container systems are composed of poly vinyl 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.

What are the possible side effects of icodextrin (LVP solution) (Extraneal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using icodextrin and call your doctor at once if you have a serious side effect such as:

  • fever, stomach pain, redness, or cloudy drained fluid;
  • flu symptoms;
  • chest pain;
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or
  • severe skin reaction -- fever, sore...

Read All Potential Side Effects and See Pictures of Extraneal »

Last reviewed on RxList: 4/29/2011
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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