icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

FDA Drug Profile — EXTRANEAL

Drug Details

Generic Name
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Brand Names
EXTRANEAL
Application Number
NDA021321
Sponsor
Vantive US Healthcare LLC
NDC Codes
6
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAPERITONEAL
Active Ingredients
CALCIUM CHLORIDE, ICODEXTRIN, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE

Indications and Usage

1 INDICATIONS AND USAGE 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 kidney failure in patients requiring long-term kidney replacement therapy. 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 )]. • 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 kidney failure in patients requiring long-term kidney replacement therapy. ( 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 )