Application Nr Approved Date Route Status External Links
NDA021321 2002-12-20 Intraperitoneal RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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 End-Stage Renal Disease. 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)]. Extraneal 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 End-Stage Renal Disease. (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)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 5 Total)

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