Application Nr Approved Date Route Status External Links
NDA021321 None Intraperitoneal None 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 )]. • 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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