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