{"id":"icodextrin","rwe":[{"pmid":"41754763","year":"2026","title":"A Novel Peritoneal Dialysis Fluid Based on Succinylated Gelatin and Citrate: A Preliminary Investigation of Efficacy, Safety, and Biocompatibility.","finding":"","journal":"Pharmaceuticals (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41553819","year":"2026","title":"Impact of peritoneal dialysis fluid composition and infusion timing on 18F-fluoro-2-deoxy-2-d-glucose positron emission tomography-computed tomography interpretability in peritoneal dialysis patients.","finding":"","journal":"Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis","studyType":"Clinical Study"},{"pmid":"41540866","year":"2026","title":"[Nephrology : what's new in 2025].","finding":"","journal":"Revue medicale suisse","studyType":"Clinical Study"},{"pmid":"41526848","year":"2026","title":"Clinical rationale behind glucose-sparing strategies in peritoneal dialysis: a narrative review.","finding":"","journal":"BMC nephrology","studyType":"Clinical Study"},{"pmid":"41490178","year":"2026","title":"Stability and Compatibility of Levofloxacin, Clindamycin Phosphate, and Fluconazole in Various Peritoneal Solutions.","finding":"","journal":"Blood purification","studyType":"Clinical Study"}],"_fda":{"id":"348e2829-a0c9-3ee6-e063-6294a90a585d","set_id":"2b327b13-a0e9-4b2c-9875-4470998e2e30","openfda":{"unii":["02F3473H9O","2NX48Z0A9G","TU7HW0W0QT","451W47IQ8X","M4I0D6VV5M"],"route":["INTRAPERITONEAL"],"rxcui":["1100742","1100746"],"spl_id":["348e2829-a0c9-3ee6-e063-6294a90a585d"],"brand_name":["EXTRANEAL"],"spl_set_id":["2b327b13-a0e9-4b2c-9875-4470998e2e30"],"package_ndc":["0941-0681-02","0941-0681-08","0941-0719-01","0941-0719-05"],"product_ndc":["0941-0681","0941-0719"],"generic_name":["ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["CALCIUM CHLORIDE","ICODEXTRIN","MAGNESIUM CHLORIDE","SODIUM CHLORIDE","SODIUM LACTATE"],"manufacturer_name":["Vantive US Healthcare LLC"],"is_original_packager":[true]},"version":"6","effective_time":"20250507","spl_product_data_elements":["EXTRANEAL icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride ICODEXTRIN ICODEXTRIN SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION EXTRANEAL icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride ICODEXTRIN ICODEXTRIN SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION"],"health_care_provider_letter":["Health Care Provider Letter Extraneal DHCP Letter-1 Extraneal DHCP Letter-2 Extraneal DHCP Letter-3 Extraneal DHCP Letter-4 Extraneal DHCP Letter-5 Extraneal DHCP Letter-6 Extraneal DHCP Letter-7 Extraneal DHCP Letter-8 Extraneal DHCP Letter-9"],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Lot EXP B4938R 2000 ml Baxter EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution UK: Baxter Healthcare Ltd Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom IE and MT: Baxter Holding B.V., Kobaltweg 49, 3542CE, Utrecht, Netherlands PL 00116/0266 PA 2299/017/001 MA 1277/01101 POM Symbol Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-605 EXTRANEAL FPB4938RC 2000 ml x 5 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion Keep out of the sight and reach of children UK: Baxter Healthcare Limited Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom IE and MT: Baxter Holding B.V. Kobaltweg 49, 3542CE, Utrecht, Netherlands 88-46-13-193 Lot: EXP Do not store below 4°C Single bag with Luer connector MA 1277/01101 PA 2299/017/001 PL 00116/0266 POM Symbol Barcode (01)55413760441875(17)201200(10)88C88C88B2 EXTRANEAL FPB4938RC 2000 ml x 5 Lot: EXP Lot EXP B4938R 2000 ml Vantive EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom PL 58711/0005 POM Symbol CB-35-05-248 EXTRANEAL FPB4938RC 2000 ml x 5 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion Keep out of the sight and reach of children Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom 88-46-14-004 Lot: EXP UK Only Do not store below 4°C Single bag with Luer connector PL 58711/0005 POM Symbol Barcode (01)57332414202786(17)201200(10)88C88C88B2 EXTRANEAL FPB4938RC 2000 ml x 5 Lot: EXP Lot EXP B4945R 2500 ml Baxter EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution UK: Baxter Healthcare Ltd Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom IE and MT: Baxter Holding B.V., Kobaltweg 49, 3542CE, Utrecht, Netherlands PL 00116/0266 PA 2299/017/001 MA 1277/01101 POM Symbol Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-606 EXTRANEAL FPB4945R 2500 ml x 4 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion Keep out of the sight and reach of children UK: Baxter Healthcare Limited Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom IE and MT: Baxter Holding B.V. Kobaltweg 49, 3542CE, Utrecht, Netherlands 88-46-13-194 Lot: EXP Do not store below 4°C Single bag with Luer connector MA 1277/01101 PA 2299/017/001 PL 00116/0266 POM Symbol Barcode (01)50085412574368(17)201200(10)88C88C88B2 EXTRANEAL FPB4945R 2500 ml x 4 Lot: EXP Lot EXP B4945R 2500 ml Vantive EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom PL 58711/0005 POM Symbol CB-35-05-249 EXTRANEAL FPB4945R 2500 ml x 4 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion Keep out of the sight and reach of children Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom 88-46-14-005 Lot: EXP UK Only Do not store below 4°C Single bag with Luer connector PL 58711/0005 POM Symbol Barcode (01)57332414203240(17)201200(10)88C88C88B2 EXTRANEAL FPB4945R 2500 ml x 4 Lot: EXP Representative Extraneal Container Label Representative Extraneal Carton Label Vantive Representative Extraneal Container Label Vantive Representative Extraneal Carton Label Representative Extraneal Container Label Representative Extraneal Carton Label Vantive Representative Extraneal Container Label Vantive Representative Extraneal Carton Label"],"package_label_principal_display_panel_table":["<table width=\"467.9pt\" styleCode=\"Noautorules\"><col width=\"35%\"/><col width=\"28%\"/><col width=\"13%\"/><col width=\"23%\"/><tbody><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Formula 1000 ml</content></paragraph></td><td align=\"right\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">mmol/l</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Icodextrin</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">75 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Na+</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">133</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium Chloride</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5,4 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Ca++</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">1,75</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium (S)-lactate</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">4,5 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Mg++</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,25</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Calcium Chloride 2H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,257 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Cl&#x2C9;</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">96</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Magnesium Chloride 6H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,051 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>C <sub>3</sub>H <sub>5</sub>0 <sub>3</sub>&#x2C9; </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">40</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Water for Injections</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Osmolarity</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">284</content>mOsm/l </paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Hydrochloric acid or sodium hydroxide (for pH adjustment)</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>pH</paragraph></td><td align=\"right\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5,0 &#x2013; 6,0</content></paragraph></td></tr></tbody></table>","<table width=\"299.85pt\" styleCode=\"Noautorules\"><col width=\"35%\"/><col width=\"28%\"/><tbody><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">1000 ml</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Icodextrin</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">75 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium Chloride</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5,4 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium (S)-lactate</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">4,5 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Calcium Chloride 2H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,257 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Magnesium Chloride 6H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,051 g</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Water for injections to 1000 ml</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Sodium hydroxide or hydrochloric acid (for pH adjustment)</paragraph></td></tr></tbody></table>","<table width=\"467.9pt\" styleCode=\"Noautorules\"><col width=\"35%\"/><col width=\"28%\"/><col width=\"13%\"/><col width=\"23%\"/><tbody><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Formula 1000 ml</content></paragraph></td><td align=\"right\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">mmol/l</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Icodextrin</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">75 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Na+</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">133</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium Chloride</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5,4 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Ca++</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">1,75</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium (S)-lactate</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">4,5 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Mg++</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,25</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Calcium Chloride 2H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,257 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Cl&#x2C9;</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">96</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Magnesium Chloride 6H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,051 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>C <sub>3</sub>H <sub>5</sub>0 <sub>3</sub>&#x2C9; </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">40</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Water for Injections</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Osmolarity</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">284</content>mOsm/l </paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Hydrochloric acid or sodium hydroxide (for pH adjustment)</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>pH</paragraph></td><td align=\"right\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5,0 &#x2013; 6,0</content></paragraph></td></tr></tbody></table>","<table width=\"299.85pt\" styleCode=\"Noautorules\"><col width=\"35%\"/><col width=\"28%\"/><tbody><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">1000 ml</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Icodextrin</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">75 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium Chloride</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5,4 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium (S)-lactate</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">4,5 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Calcium Chloride 2H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,257 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Magnesium Chloride 6H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,051 g</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Water for injections to 1000 ml</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Sodium hydroxide or hydrochloric acid (for pH adjustment)</paragraph></td></tr></tbody></table>","<table width=\"467.9pt\" styleCode=\"Noautorules\"><col width=\"35%\"/><col width=\"28%\"/><col width=\"13%\"/><col width=\"23%\"/><tbody><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Formula 1000 ml</content></paragraph></td><td align=\"right\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">mmol/l</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Icodextrin</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">75 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Na+</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">133</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium Chloride</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5,4 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Ca++</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">1,75</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium (S)-lactate</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">4,5 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Mg++</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,25</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Calcium Chloride 2H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,257 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Cl&#x2C9;</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">96</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Magnesium Chloride 6H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,051 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>C <sub>3</sub>H <sub>5</sub>0 <sub>3</sub>&#x2C9; </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">40</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Water for Injections</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Osmolarity</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">284</content>mOsm/l </paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Hydrochloric acid or sodium hydroxide (for pH adjustment)</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>pH</paragraph></td><td align=\"right\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5,0 &#x2013; 6,0</content></paragraph></td></tr></tbody></table>","<table width=\"299.85pt\" styleCode=\"Noautorules\"><col width=\"35%\"/><col width=\"28%\"/><tbody><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">1000 ml</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Icodextrin</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">75 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium Chloride</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5,4 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium (S)-lactate</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">4,5 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Calcium Chloride 2H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,257 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Magnesium Chloride 6H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,051 g</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Water for injections to 1000 ml</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Sodium hydroxide or hydrochloric acid (for pH adjustment)</paragraph></td></tr></tbody></table>","<table width=\"467.9pt\" styleCode=\"Noautorules\"><col width=\"35%\"/><col width=\"28%\"/><col width=\"13%\"/><col width=\"23%\"/><tbody><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Formula 1000 ml</content></paragraph></td><td align=\"right\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">mmol/l</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Icodextrin</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">75 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Na+</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">133</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium Chloride</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5,4 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Ca++</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">1,75</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium (S)-lactate</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">4,5 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Mg++</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,25</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Calcium Chloride 2H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,257 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Cl&#x2C9;</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">96</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Magnesium Chloride 6H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,051 g</content></paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>C <sub>3</sub>H <sub>5</sub>0 <sub>3</sub>&#x2C9; </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">40</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Water for Injections</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>Osmolarity</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">284</content>mOsm/l </paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Hydrochloric acid or sodium hydroxide (for pH adjustment)</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>pH</paragraph></td><td align=\"right\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5,0 &#x2013; 6,0</content></paragraph></td></tr></tbody></table>","<table width=\"299.85pt\" styleCode=\"Noautorules\"><col width=\"35%\"/><col width=\"28%\"/><tbody><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">1000 ml</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Icodextrin</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">75 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium Chloride</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5,4 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Sodium (S)-lactate</paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">4,5 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Calcium Chloride 2H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,257 g</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Magnesium Chloride 6H <sub>2</sub>0 </paragraph></td><td align=\"right\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0,051 g</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Water for injections to 1000 ml</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Sodium hydroxide or hydrochloric acid (for pH adjustment)</paragraph></td></tr></tbody></table>"]},"tags":[{"label":"icodextrin","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Intraperitoneal","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Vantive Us Hlthcare","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Dialysis Solutions","category":"pharmacology"},{"label":"Pharmaceutical Solutions","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"5983 reports"},{"date":"","signal":"PERITONITIS","source":"FDA FAERS","actionTaken":"1843 reports"},{"date":"","signal":"PERITONEAL DIALYSIS COMPLICATION","source":"FDA FAERS","actionTaken":"1459 reports"},{"date":"","signal":"PERITONITIS BACTERIAL","source":"FDA FAERS","actionTaken":"1450 reports"},{"date":"","signal":"HYPOTENSION","source":"FDA FAERS","actionTaken":"1160 reports"},{"date":"","signal":"MYOCARDIAL INFARCTION","source":"FDA FAERS","actionTaken":"968 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"967 reports"},{"date":"","signal":"INFECTION","source":"FDA FAERS","actionTaken":"785 reports"},{"date":"","signal":"SEPSIS","source":"FDA FAERS","actionTaken":"732 reports"},{"date":"","signal":"FLUID OVERLOAD","source":"FDA FAERS","actionTaken":"727 reports"}],"commonSideEffects":[{"effect":"Peritonitis","drugRate":"26%","severity":"common","organSystem":""},{"effect":"Upper respiratory infection","drugRate":"15%","severity":"common","organSystem":""},{"effect":"Hypertension","drugRate":"13%","severity":"common","organSystem":""},{"effect":"Rash","drugRate":"10%","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"9%","severity":"common","organSystem":""},{"effect":"Abdominal Pain","drugRate":"8%","severity":"common","organSystem":""},{"effect":"Flu syndrome","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Cough increase","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Edema","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Accidental injury","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Chest pain","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Dyspepsia","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Hyperglycemia","drugRate":"5%","severity":"common","organSystem":""}],"specialPopulations":{"Pregnancy":"Animal reproduction studies have not been conducted with EXTRANEAL or icodextrin. It is also not known whether EXTRANEAL can cause fetal harm when administered to pregnant woman or can affect reproduction capacity.","Geriatric use":"No formal studies were specifically carried out in the geriatric population. However, 140 of the patients in clinical studies of EXTRANEAL were age 65 or older, with 28 of the patients age 75 or older. No overall differences in safety or effectiveness were observed between these patients and patients under age 65. Although clinical experience has not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."},"seriousAdverseEvents":[{"effect":"Exfoliative dermatitis","drugRate":"0.2%","severity":"serious"},{"effect":"Hyponatremia (serum sodium < 125 mmol/L)","drugRate":"0.8%","severity":"serious"}]},"trials":[],"aliases":[],"company":"Vantive Us Hlthcare","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ICODEXTRIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:10:01.360420+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:10:08.313007+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:09:59.997838+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ICODEXTRIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:10:09.272077+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:09:58.750082+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:09:58.750135+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:10:10.835819+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201472/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:10:09.747422+00:00"}},"allNames":"extraneal","offLabel":[],"synonyms":["icodextrin","extraneal"],"timeline":[{"date":"2002-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from BAXTER HLTHCARE to Vantive Us Hlthcare"},{"date":"2002-12-20","type":"positive","source":"DrugCentral","milestone":"FDA approval (Baxter Hlthcare)"}],"approvals":[{"date":"2002-12-20","orphan":true,"company":"BAXTER HLTHCARE","regulator":"FDA"}],"brandName":"Extraneal","ecosystem":[],"mechanism":{"modality":"Small Molecule","drugClass":"icodextrin","explanation":"","oneSentence":"","technicalDetail":"Extraneal (icodextrin) is a high molecular weight polysaccharide that acts as an osmotic agent, drawing fluid from the peritoneal cavity into the bloodstream through osmosis, thereby reducing fluid accumulation and improving respiratory function."},"commercial":{"launchDate":"2002","_launchSource":"DrugCentral (FDA 2002-12-20, BAXTER HLTHCARE)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4105","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ICODEXTRIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ICODEXTRIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T11:59:48.151328","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:10:11.784384+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"icodextrin","indications":{"approved":[],"offLabel":[],"pipeline":[]},"currentOwner":"Vantive Us Hlthcare","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[{"nctId":"NCT03994471","phase":"PHASE3","title":"Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.","status":"RECRUITING","sponsor":"Iperboreal Pharma Srl","startDate":"2022-12-14","conditions":["End Stage Renal Disease"],"enrollment":170,"completionDate":"2027-04-28"},{"nctId":"NCT07168343","phase":"NA","title":"Effectiveness of Two Icodextrin Exchanges on Fluid Status and Blood Pressure Control Compared to a Single Icodextrin Exchange","status":"NOT_YET_RECRUITING","sponsor":"National University Health System, Singapore","startDate":"2026-02-28","conditions":["Children on Chronic Peritoneal Dialysis"],"enrollment":10,"completionDate":"2028-06-30"},{"nctId":"NCT01219959","phase":"PHASE3","title":"Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients","status":"COMPLETED","sponsor":"Vantive Health LLC","startDate":"2010-10","conditions":["End Stage Renal Disease (ESRD)","Diabetes","CAPD"],"enrollment":71,"completionDate":"2011-07"},{"nctId":"NCT00567489","phase":"PHASE4","title":"IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients","status":"COMPLETED","sponsor":"Vantive Health LLC","startDate":"2008-01","conditions":["ESRD","Diabetes","CAPD","APD"],"enrollment":137,"completionDate":"2011-07"},{"nctId":"NCT00567398","phase":"PHASE3","title":"IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients","status":"COMPLETED","sponsor":"Vantive Health LLC","startDate":"2008-04","conditions":["ESRD","Diabetes"],"enrollment":43,"completionDate":"2011-07"},{"nctId":"NCT00368641","phase":"PHASE2","title":"Heart Failure and Peritoneal Ultrafiltration","status":"TERMINATED","sponsor":"Vantive Health LLC","startDate":"2006-08","conditions":["Congestive Heart Failure"],"enrollment":12,"completionDate":"2008-04"},{"nctId":"NCT01045980","phase":"PHASE2","title":"Assessment of Bioimpedance and Vitamin D and LV Mass in PD Patients (FLUID Study)","status":"COMPLETED","sponsor":"St. Joseph's Healthcare Hamilton","startDate":"2010-08-01","conditions":["Disorders Associated With Peritoneal Dialysis"],"enrollment":74,"completionDate":"2016-11-30"},{"nctId":"NCT05811585","phase":"","title":"PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery","status":"COMPLETED","sponsor":"Baxter Healthcare Corporation","startDate":"2023-06-26","conditions":["Adhesion"],"enrollment":153,"completionDate":"2024-05-31"},{"nctId":"NCT06492031","phase":"","title":"Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients","status":"RECRUITING","sponsor":"Vantive Health LLC","startDate":"2024-06-28","conditions":["Chronic Renal Failure"],"enrollment":889,"completionDate":"2026-03"},{"nctId":"NCT01093547","phase":"PHASE4","title":"Open-label, Randomized Trial to Determine the Effect of Icodextrin Versus Dextrose (Dianeal 2.5%) in HOMA IR","status":"WITHDRAWN","sponsor":"Vantive Health LLC","startDate":"2010-02","conditions":["End Stage Renal Disease","Continuous Ambulatory Peritoneal Dialysis"],"enrollment":0,"completionDate":"2011-12"},{"nctId":"NCT00397358","phase":"PHASE4","title":"Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients","status":"WITHDRAWN","sponsor":"Vantive Health LLC","startDate":"2006-11","conditions":["Peritoneal Dialysis","Hypertriglyceridemia"],"enrollment":0,"completionDate":"2007-06"},{"nctId":"NCT06838819","phase":"","title":"CGM in Icodextrin PD","status":"NOT_YET_RECRUITING","sponsor":"Elaine Chow","startDate":"2025-02-20","conditions":["Diabetes Mellitus (Diagnosis)","End Stage Renal Disease (ESRD)","Dialysis","Continuous Glucose Monitoring"],"enrollment":30,"completionDate":"2026-09-20"},{"nctId":"NCT06777446","phase":"NA","title":"Elective Adhesiolysis vs. a Wait-and-see Policy to Prevent Recurrences After Conservative Treatment of Adhesive Small Bowel Obstruction","status":"NOT_YET_RECRUITING","sponsor":"Radboud University Medical Center","startDate":"2025-02","conditions":["Adhesive Small Bowel Obstruction"],"enrollment":380,"completionDate":"2034-02"},{"nctId":"NCT04086212","phase":"PHASE2","title":"Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine","status":"WITHDRAWN","sponsor":"Iperboreal Pharma Srl","startDate":"2019-10-02","conditions":["End Stage Renal Disease (ESRD)"],"enrollment":0,"completionDate":"2023-04"},{"nctId":"NCT06552546","phase":"NA","title":"Pharmacokinetics of Single- and Double-dose Icodextrin","status":"NOT_YET_RECRUITING","sponsor":"Peking University First Hospital","startDate":"2024-08-15","conditions":["Peritoneal Dialysis"],"enrollment":16,"completionDate":"2025-03-30"},{"nctId":"NCT05721404","phase":"PHASE4","title":"Icodextrin Postpones the Shift of Low Dose to Full Dose Dialysis in the First Year of Incremental Peritoneal Dialysis","status":"RECRUITING","sponsor":"First Affiliated Hospital, Sun Yat-Sen University","startDate":"2023-05-24","conditions":["Peritoneal Dialysis"],"enrollment":194,"completionDate":"2025-12-31"},{"nctId":"NCT05185999","phase":"PHASE1","title":"Icodextrin Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free Solution in PD Patients","status":"COMPLETED","sponsor":"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","startDate":"2022-10-17","conditions":["Chronic Kidney Failure"],"enrollment":10,"completionDate":"2023-10-20"},{"nctId":"NCT06119373","phase":"NA","title":"Incremental PD With Single Icodextrin Exchange","status":"NOT_YET_RECRUITING","sponsor":"RenJi Hospital","startDate":"2023-12-01","conditions":["Peritoneal Dialysis Complication","Residual Kidney Function","Survival","Health-related Quality of Life"],"enrollment":72,"completionDate":"2026-11-30"},{"nctId":"NCT05965934","phase":"PHASE1,PHASE2","title":"Management of Volume Overload HF Patients by Individual DSR Treatment adJustment-a clinicAl inVestigation of InfusatE2.0","status":"UNKNOWN","sponsor":"Sequana Medical N.V.","startDate":"2023-07-07","conditions":["Heart Failure","Volume Overload"],"enrollment":33,"completionDate":"2025-06-30"},{"nctId":"NCT05943470","phase":"PHASE4","title":"The Difference Between Daily and Alternative Day Use of Icodextrin","status":"UNKNOWN","sponsor":"RenJi Hospital","startDate":"2023-08-01","conditions":["Peritoneal Dialysis Solution Adverse Reaction"],"enrollment":74,"completionDate":"2024-12-28"},{"nctId":"NCT05780086","phase":"PHASE1","title":"Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution","status":"UNKNOWN","sponsor":"Instituto Mexicano del Seguro Social","startDate":"2023-02-03","conditions":["Chronic Kidney Diseases"],"enrollment":10,"completionDate":"2023-12-30"},{"nctId":"NCT04001036","phase":"PHASE2","title":"Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD","status":"TERMINATED","sponsor":"Iperboreal Pharma Srl","startDate":"2019-09-01","conditions":["End Stage Renal Disease"],"enrollment":11,"completionDate":"2022-08-30"},{"nctId":"NCT05381051","phase":"","title":"Faster Peritoneal Solute Transfer Rate and Survival in a Pre-APD and Icodextrin Peritoneal Dialysis Cohort","status":"COMPLETED","sponsor":"RenJi Hospital","startDate":"2015-01-01","conditions":["Peritoneal Dialysis"],"enrollment":430,"completionDate":"2020-12-31"},{"nctId":"NCT03685747","phase":"PHASE1","title":"Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis","status":"COMPLETED","sponsor":"Thomas Jefferson University","startDate":"2018-11-15","conditions":["Peritoneal Dialysis-associated Peritonitis"],"enrollment":4,"completionDate":"2020-10-01"},{"nctId":"NCT01228279","phase":"PHASE4","title":"Sympathetic Activity in Patients With End-stage Renal Disease on Peritoneal Dialysis","status":"COMPLETED","sponsor":"Ottawa Hospital Research Institute","startDate":"2007-07","conditions":["End-stage Renal Disease (ESRD)","Kidney Disease"],"enrollment":50,"completionDate":"2018-12"},{"nctId":"NCT01944852","phase":"PHASE4","title":"Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental PD.","status":"COMPLETED","sponsor":"Pr Eric Goffin","startDate":"2013-03","conditions":["Renal Insufficiency"],"enrollment":117,"completionDate":"2020-02-28"},{"nctId":"NCT02318888","phase":"NA","title":"Does Icodextrin Reduce the Risk of Small Bowel Obstruction?","status":"UNKNOWN","sponsor":"Uppsala University","startDate":"2009-12","conditions":["Surgical Adhesions"],"enrollment":1808,"completionDate":"2022-12"},{"nctId":"NCT02708407","phase":"NA","title":"PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease","status":"TERMINATED","sponsor":"University of Nottingham","startDate":"2016-01","conditions":["Heart Failure","Chronic Kidney Disease"],"enrollment":11,"completionDate":"2017-06"},{"nctId":"NCT02212327","phase":"","title":"Testing Tissue Sodium Stores in CAPD Patients-Aims 1 & 2","status":"COMPLETED","sponsor":"Vanderbilt University Medical Center","startDate":"2014-08","conditions":["End Stage Renal Disease"],"enrollment":41,"completionDate":"2016-11-29"},{"nctId":"NCT01124227","phase":"PHASE3","title":"Peritoneal Dialysis in Congestive Heart Failure","status":"TERMINATED","sponsor":"Martini Hospital Groningen","startDate":"2010-04","conditions":["Congestive Heart Failure"],"enrollment":26,"completionDate":"2017-09"},{"nctId":"NCT00755456","phase":"PHASE2","title":"Effect of an 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