Extraneal

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.



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