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Hex(?1-4)[Hex(?1-6)]Hex(?1-4)Hex

PubChem CID
4471484
Structure
Hex(?1-4)[Hex(?1-6)]Hex(?1-4)Hex_small.png
Molecular Formula
Synonyms
  • GLYCOGEN
  • 9005-79-2
  • ICODEXTRIN
  • SCHEMBL21797158
  • DTXSID70864156
Molecular Weight
666.6 g/mol
Computed by PubChem 2.1 (PubChem release 2021.05.07)
Dates
  • Create:
    2005-09-15
  • Modify:
    2025-01-18
Description
Icodextrin is an iso-osmotic peritoneal dialysis solution containing glucose polymers. It is used primarily for ambulatory peritoneal dialysis (CAPD) of diabetic patients and automated peritoneal dialysis (APD) for patients with end-stage renal disease. It is injected as a solution into the peritoneal cavity. The drug is absorbed via convective transport via peritoneal lymphatic pathways.
Glycogen is a metabolite found in or produced by Escherichia coli (strain K12, MG1655).

1 Structures

1.1 2D Structure

Chemical Structure Depiction
Hex(?1-4)[Hex(?1-6)]Hex(?1-4)Hex.png

1.2 3D Status

Conformer generation is disallowed since too many undefined stereo centers

2 Biologic Description

1 of 2
SVG Image
SVG Image
IUPAC Condensed
Hex(?1-4)[Hex(?1-6)]Hex(?1-4)Hex
LINUCS
[][Hexp]{[(4+1)][Hexp]{[(4+1)][Hexp]{}[(6+1)][Hexp]{}}}
IUPAC
hexopyranosyl-(1->4)-[hexopyranosyl-(1->6)]-hexopyranosyl-(1->4)-hexopyranose
2 of 2
Permethylated Mass
Monosaccharide Composition

3 Names and Identifiers

3.1 Computed Descriptors

3.1.1 IUPAC Name

2-[[4,5-dihydroxy-3-[3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]-6-(hydroxymethyl)oxane-3,4,5-triol
Computed by LexiChem 2.6.6 (PubChem release 2019.06.18)

3.1.2 InChI

InChI=1S/C24H42O21/c25-1-5-9(28)11(30)16(35)22(41-5)39-4-8-20(45-23-17(36)12(31)10(29)6(2-26)42-23)14(33)18(37)24(43-8)44-19-7(3-27)40-21(38)15(34)13(19)32/h5-38H,1-4H2
Computed by InChI 1.0.5 (PubChem release 2019.06.18)

3.1.3 InChIKey

BYSGBSNPRWKUQH-UHFFFAOYSA-N
Computed by InChI 1.0.5 (PubChem release 2019.06.18)

3.1.4 SMILES

C(C1C(C(C(C(O1)OCC2C(C(C(C(O2)OC3C(OC(C(C3O)O)O)CO)O)O)OC4C(C(C(C(O4)CO)O)O)O)O)O)O)O
Computed by OEChem 2.3.0 (PubChem release 2024.12.12)

3.2 Molecular Formula

C24H42O21
Computed by PubChem 2.1 (PubChem release 2019.06.18)

3.3 Other Identifiers

3.3.1 CAS

9005-79-2

3.3.2 European Community (EC) Number

3.3.3 DrugBank ID

3.3.4 DSSTox Substance ID

3.3.5 Metabolomics Workbench ID

3.3.6 NCI Thesaurus Code

3.3.7 RXCUI

3.3.8 Wikidata

3.4 Synonyms

3.4.1 MeSH Entry Terms

Glycogen

3.4.2 Depositor-Supplied Synonyms

4 Chemical and Physical Properties

4.1 Computed Properties

Property Name
Molecular Weight
Property Value
666.6 g/mol
Reference
Computed by PubChem 2.1 (PubChem release 2021.05.07)
Property Name
XLogP3-AA
Property Value
-8.5
Reference
Computed by XLogP3 3.0 (PubChem release 2019.06.18)
Property Name
Hydrogen Bond Donor Count
Property Value
14
Reference
Computed by Cactvs 3.4.6.11 (PubChem release 2019.06.18)
Property Name
Hydrogen Bond Acceptor Count
Property Value
21
Reference
Computed by Cactvs 3.4.6.11 (PubChem release 2019.06.18)
Property Name
Rotatable Bond Count
Property Value
10
Reference
Computed by Cactvs 3.4.6.11 (PubChem release 2019.06.18)
Property Name
Exact Mass
Property Value
666.22185834 Da
Reference
Computed by PubChem 2.1 (PubChem release 2021.05.07)
Property Name
Monoisotopic Mass
Property Value
666.22185834 Da
Reference
Computed by PubChem 2.1 (PubChem release 2021.05.07)
Property Name
Topological Polar Surface Area
Property Value
348 Ų
Reference
Computed by Cactvs 3.4.6.11 (PubChem release 2019.06.18)
Property Name
Heavy Atom Count
Property Value
45
Reference
Computed by PubChem
Property Name
Formal Charge
Property Value
0
Reference
Computed by PubChem
Property Name
Complexity
Property Value
918
Reference
Computed by Cactvs 3.4.6.11 (PubChem release 2019.06.18)
Property Name
Isotope Atom Count
Property Value
0
Reference
Computed by PubChem
Property Name
Defined Atom Stereocenter Count
Property Value
0
Reference
Computed by PubChem
Property Name
Undefined Atom Stereocenter Count
Property Value
20
Reference
Computed by PubChem
Property Name
Defined Bond Stereocenter Count
Property Value
0
Reference
Computed by PubChem
Property Name
Undefined Bond Stereocenter Count
Property Value
0
Reference
Computed by PubChem
Property Name
Covalently-Bonded Unit Count
Property Value
1
Reference
Computed by PubChem
Property Name
Compound Is Canonicalized
Property Value
Yes
Reference
Computed by PubChem (release 2019.01.04)

4.2 Experimental Properties

4.2.1 Physical Description

White solid; [Merck Index] Beige crystalline solid; [Sigma-Aldrich MSDS]

4.2.2 Solubility

80 mg/mL

4.2.3 Other Experimental Properties

A starch-derived, water soluble glucose polymer linked by alpha (1-4) and alpha (1-6) glycosidic bonds
Wishart DS et al; DrugBank: a knowledgebase for drugs, drug actions and drug targets. Nucleic Acids Res. 2008 Jan;36(Database issue):D901-6. Available from, as of Oct 5, 2010: https://www.drugbank.ca

4.3 Chemical Classes

4.3.1 Drugs

4.3.1.1 Human Drugs
Human drug -> Active ingredient (ICODEXTRIN)

4.3.2 Cosmetics

Humectant; Skin conditioning
S13 | EUCOSMETICS | Combined Inventory of Ingredients Employed in Cosmetic Products (2000) and Revised Inventory (2006) | DOI:10.5281/zenodo.2624118

4.3.3 Polymers

Biological Agents -> Polysaccharides

6 Chemical Vendors

7 Drug and Medication Information

7.1 Drug Indication

Used for continuous ambulatory peritoneal dialysis (CAPD) of diabetic patients or automated peritoneal dialysis (APD) for the management of end-stage renal disease.

7.2 FDA Approved Drugs

7.3 FDA Orange Book

7.4 FDA National Drug Code Directory

7.5 Drug Labels

Active ingredient and drug

7.6 Clinical Trials

7.6.1 ClinicalTrials.gov

7.6.2 EU Clinical Trials Register

7.6.3 NIPH Clinical Trials Search of Japan

7.7 Therapeutic Uses

Glucans; Dialysis Solutions
National Library of Medicine's Medical Subject Headings online file (MeSH, 2009)
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. 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). /Included in US product label/
US Natl Inst Health; DailyMed. Current Medication Information for EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection, solution (December 2009). Available from, as of October 1, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13874&CFID=19428124&CFTOKEN=2ec4a39687173f01-3AADFE4D-C860-EA92-9A8781A36C5F6935&jsessionid=ca307addf9d0787b4b2e

7.8 Drug Warnings

/BOXED WARNING/ WARNING: UNRECOGNIZED HYPOGLYCEMIA RESULTING FROM DRUG-DEVICE INTERACTION. Only use glucose-specific monitors and test strips to measure blood glucose levels in patients using Extraneal (icodextrin). Peritoneal Dialysis Solution. Blood glucose monitoring devices using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase (GDO)-based methods must not be used. In addition, some blood glucose monitoring systems using glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD)-based methods must not be used. Use of GDH-PQQ, GDO, and GDH-FAD-based glucose monitors and test strips has resulted in falsely elevated glucose readings (due to the presence of maltose). Falsely elevated glucose readings have led patients or health care providers to withhold treatment of hypoglycemia or to administer insulin inappropriately. Both of these situations have resulted in unrecognized hypoglycemia, which has led to loss of consciousness, coma, permanent neurological damage, and death. Plasma levels of Extraneal (icodextrin) and its metabolites return to baseline within approximately 14 days following cessation of Extraneal (icodextrin) administration. Therefore falsely elevated glucose levels may be measured up to two weeks following cessation of Extraneal (icodextrin) therapy when GDH-PQQ, GDO, and GDH-FAD-based blood glucose monitors and test strips are used. To avoid improper insulin administration, educate all patients to alert health care providers of this interaction particularly in hospital settings. The manufacturer(s) of the monitor and test strips should be contacted to determine if icodextrin or maltose causes interference or falsely elevated glucose readings. Because of the risk of unrecognized hypoglycemia that could result from a drug-device interaction, Extraneal is available only through a restricted program
US Natl Inst Health; DailyMed. Current Medication Information for EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection, solution (Updated: December 2014). Available from, as of April 24, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5b85158-b0d6-4855-9d07-8d1b3ad9ab71
EXTRANEAL (icodextrin) is contraindicated in patients with a known allergy to cornstarch or icodextrin, in patients with maltose or isomaltose intolerance, in patients with glycogen storage disease, and in patients with pre-existing severe lactic acidosis.
US Natl Inst Health; DailyMed. Current Medication Information for EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection, solution (December 2009). Available from, as of October 1, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13874&CFID=19428124&CFTOKEN=2ec4a39687173f01-3AADFE4D-C860-EA92-9A8781A36C5F6935&jsessionid=ca307addf9d0787b4b2e
Encapsulating peritoneal sclerosis (EPS) is a known, rare complication of peritoneal dialysis therapy. EPS has been reported in patients using peritoneal dialysis solutions including EXTRANEAL (icodextrin). Infrequent but fatal outcomes have been reported.
US Natl Inst Health; DailyMed. Current Medication Information for EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection, solution (December 2009). Available from, as of October 1, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13874&CFID=19428124&CFTOKEN=2ec4a39687173f01-3AADFE4D-C860-EA92-9A8781A36C5F6935&jsessionid=ca307addf9d0787b4b2e
If peritonitis occurs, the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organism(s) when possible. Prior to the identification of the involved organism(s), broad-spectrum antibiotics may be indicated.
US Natl Inst Health; DailyMed. Current Medication Information for EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection, solution (December 2009). Available from, as of October 1, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13874&CFID=19428124&CFTOKEN=2ec4a39687173f01-3AADFE4D-C860-EA92-9A8781A36C5F6935&jsessionid=ca307addf9d0787b4b2e
For more Drug Warnings (Complete) data for Icodextrin (20 total), please visit the HSDB record page.

8 Pharmacology and Biochemistry

8.1 Pharmacodynamics

Icodextrin is an iso-osmotic peritoneal dialysis solution containing glucose polymers. It is used primarily for ambulatory peritoneal dialysis (CAPD) of diabetic patients and automated peritoneal dialysis (APD) for patients with end-stage renal disease. It is injected as a solution into the peritoneal cavity. The drug is absorbed via convective transport via peritoneal lymphatic pathways.

8.2 Absorption, Distribution and Excretion

Absorption
40% of instilled icodextrin was absorbed from the peritoneal solution during a 12-hour dwell.
Absorption of icodextrin from the peritoneal cavity follows zero-order kinetics consistent with convective transport via peritoneal lymphatic pathways. In a single-dose pharmacokinetic study using EXTRANEAL (icodextrin), a median of 40% (60 g) of the instilled icodextrin was absorbed from the peritoneal solution during a 12-hour dwell. Plasma levels of icodextrin rose during the dwell and declined after the dwell was drained. Peak plasma levels of icodextrin plus its metabolites (median Cpeak 2.2g/L) were observed at the end of the long dwell exchange (median Tmax = 13 hours).
US Natl Inst Health; DailyMed. Current Medication Information for EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection, solution (December 2009). Available from, as of October 1, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13874&CFID=19428124&CFTOKEN=2ec4a39687173f01-3AADFE4D-C860-EA92-9A8781A36C5F6935&jsessionid=ca307addf9d0787b4b2e
At steady-state, the mean plasma level of icodextrin plus its metabolites was about 5 g/L. In multidose studies, steady-state levels of icodextrin were achieved within one week. Plasma levels of icodextrin and metabolites return to baseline values within approximately two weeks following cessation of icodextrin administration.
US Natl Inst Health; DailyMed. Current Medication Information for EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection, solution (December 2009). Available from, as of October 1, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13874&CFID=19428124&CFTOKEN=2ec4a39687173f01-3AADFE4D-C860-EA92-9A8781A36C5F6935&jsessionid=ca307addf9d0787b4b2e
Steady-state plasma levels of icodextrin metabolites were achieved within one week and stable plasma levels were observed during long-term administration.
US Natl Inst Health; DailyMed. Current Medication Information for EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection, solution (December 2009). Available from, as of October 1, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13874&CFID=19428124&CFTOKEN=2ec4a39687173f01-3AADFE4D-C860-EA92-9A8781A36C5F6935&jsessionid=ca307addf9d0787b4b2e
Icodextrin undergoes renal elimination in direct proportion to the level of residual renal function. Diffusion of the smaller icodextrin metabolites from plasma into the peritoneal cavity is also possible after systemic absorption and metabolism of icodextrin.
US Natl Inst Health; DailyMed. Current Medication Information for EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection, solution (December 2009). Available from, as of October 1, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13874&CFID=19428124&CFTOKEN=2ec4a39687173f01-3AADFE4D-C860-EA92-9A8781A36C5F6935&jsessionid=ca307addf9d0787b4b2e
For more Absorption, Distribution and Excretion (Complete) data for Icodextrin (6 total), please visit the HSDB record page.

8.3 Metabolism / Metabolites

Icodextrin is metabolized by alpha-amylase into oligosaccharides with a lower degree of polymerization), including maltose, maltotriose, maltotetraose, and higher molecular weight species.
Icodextrin is metabolized by alpha-amylase into oligosaccharides with a lower degree of polymerization (DP), including maltose (DP2), maltotriose (DP3), maltotetraose (DP4), and higher molecular weight species. In a single dose study, DP2, DP3 and DP4 showed a progressive rise in plasma concentrations with a profile similar to that for total icodextrin, with peak values reached by the end of the dwell and declining thereafter.
US Natl Inst Health; DailyMed. Current Medication Information for EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection, solution (December 2009). Available from, as of October 1, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13874&CFID=19428124&CFTOKEN=2ec4a39687173f01-3AADFE4D-C860-EA92-9A8781A36C5F6935&jsessionid=ca307addf9d0787b4b2e
Male Wistar rats with implanted peritoneal catheters were infused twice daily for 3 weeks with 20 mL 7.5% icodextrin-based peritoneal dialysis fluid (IPDF; ICO group, n = 12) or 3.86% glucose-based peritoneal dialysis fluid (GLU group, n = 11). A 4-hour dwell study using 30 mL IPDF was performed on day 10 (D1) and day 21 (D2) in both the ICO and the GLU groups. Radiolabeled serum albumin (RISA) was used as a macromolecular volume marker. Dialysate samples were collected at 3, 15, 30, 60, 90, 120, and 240 minutes. Blood samples were drawn before the start and at the end of the dwell. During all dwell studies, the dialysate concentrations of total icodextrin decreased due to decrease in high molecular weight (MW) fractions, whereas there was a marked increase in icodextrin low MW metabolites. alpha-Amylase activity increased in dialysate and decreased in plasma. About 60% of the total icodextrin was absorbed from the peritoneal cavity during the 4-hour dwells. Low MW icodextrin metabolites were present in the dialysate already at 3 minutes, and maltose (G2), maltotriose (G3), maltotetraose (G4), and maltopentaose (G5) increased progressively, reaching maximum concentrations at 60 minutes. Maltohexaose (G6) and maltoheptaose (G7) were also detected already at 3 minutes but did not change significantly during the dwells. During the two 4-hour dwell studies (D1 and D2), the concentrations of total icodextrin and icodextrin metabolites and alpha-amylase activity in dialysate did not differ between the ICO and GLU groups, during either D1 or D2. No icodextrin metabolites were detected in plasma at the end of the dwells. alpha-Amylase activity in the dialysate increased six- to eightfold whereas plasma alpha-amylase activity decreased by 21% - 26% during the two 4-hour dwells in both the ICO and the GLU groups; there were no significant differences between the ICO and the GLU groups during either D1 or D2. alpha-Amylase activity in the dialysate correlated strongly with the disappearance rate of icodextrin from the peritoneal cavity during the 4-hour dwells, and with the concentrations of G2, G3, G6, and G7 in dialysate. The decline in the dialysate concentrations of high MW fractions and the increase in low MW metabolites of icodextrin suggest intraperitoneal alpha-amylase mediated the metabolism of icodextrin and the transport of predominantly the smaller icodextrin metabolites from dialysate. However, no icodextrin could be detected in plasma, suggesting that it was metabolized and excreted by the kidney in these nonuremic rats. ...
Garcia-Lopez E et al; Perit Dial Int 27 (4): 415-23 (2007)

8.4 Biological Half-Life

... Icodextrin had a plasma half-life of 14.73 hours ...
Monerly JB et al; Kidney Int Suppl (81): S23-33 (2002)

8.5 Mechanism of Action

Icodextrin is a starch-derived, water-soluble glucose polymer linked by alpha (1-4) and alpha (1-6) glycosidic bonds with an average molecular weight between 13,000 and 19,000 daltons. It functions as a colloid osmotic agent to achieve ultrafiltration during long (12-16 hour) peritoneal dialysis dwells. In other words it helps clean waste out of the body when the kidneys are not functioning properly. Icodectrin acts in the peritoneal cavity by exerting osmotic pressure across small intercellular pores resulting in transcapillary ultrafiltration through the dwell. This is due to the fact that the polymer is minimially absorbed across the peritoneal membrane. Icodextrin achieves superior fluid removal compared with glucose-based dialysates.
EXTRANEAL is an isosmotic peritoneal dialysis solution containing glucose polymers (icodextrin) as the primary osmotic agent. Icodextrin functions as a colloid osmotic agent to achieve ultrafiltration during long peritoneal dialysis dwells. Icodextrin acts in the peritoneal cavity by exerting osmotic pressure across small intercellular pores resulting in transcapillary ultrafiltration throughout the dwell. Like other peritoneal dialysis solutions, EXTRANEAL also contains electrolytes to help normalize electrolyte balance and lactate to help normalize acid-base status.
US Natl Inst Health; DailyMed. Current Medication Information for EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection, solution (December 2009). Available from, as of October 1, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13874&CFID=19428124&CFTOKEN=2ec4a39687173f01-3AADFE4D-C860-EA92-9A8781A36C5F6935&jsessionid=ca307addf9d0787b4b2e
Fluids commonly used for peritoneal dialysis hold poor biocompatibility vis a vis the peritoneal membrane, basically due to the presence of osmotic agents. When rat mesothelium was exposed to glucose-enriched dialysis solutions for 2 hr in vivo, an early and short-lived acceleration of cell life cycle was observed, which, after 30 d of exposure, resulted in a depopulated monolayer of senescent cells. These changes appear to result from persistent oxidative stress due to continuous exposure to high concentration of glucose and to substances generated by the Maillard reaction. Long-term exposure (30 d) of the peritoneal mesothelium to 7.5% icodextrin resulted in a depopulated monolayer consisting mostly of senescent cells, which, additionally, showed atypical nuclear changes and atypical mitosis suggesting DNA damage. These changes coincided with substantial lipid peroxidation, starting immediately after the introduction of the icodextrin solution into the rat's abdominal cavity. So far, the currently used osmotic agents in peritoneal dialysis fluids induce substantial oxidative injury to the exposed monolayer in vivo. Use of high concentrations of glucose results in premature senescence of the exposed cell population. The 7.5% icodextrin dialysis fluid induces through lipid peroxidation substantial genomic damage, which, in turn, sets the biological mechanisms leading to protective cellular suicide in motion.
Gotloib L et al; Free Radic Biol Med 34 (4): 419-28 (2003)

9 Use and Manufacturing

9.1 Uses

Sources/Uses
Carbohydrate reserve in animals, insects, and lower plants (fungi and yeast); [Merck Index]
Merck Index - O'Neil MJ, Heckelman PE, Dobbelaar PH, Roman KJ (eds). The Merck Index, An Encyclopedia of Chemicals, Drugs, and Biologicals, 15th Ed. Cambridge, UK: The Royal Society of Chemistry, 2013.
MEDICATION

9.1.1 Use Classification

Human Drugs -> FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) -> Active Ingredients
Cosmetics -> Humectant; Skin conditioning
S13 | EUCOSMETICS | Combined Inventory of Ingredients Employed in Cosmetic Products (2000) and Revised Inventory (2006) | DOI:10.5281/zenodo.2624118

9.1.2 Household Products

Household & Commercial/Institutional Products

Information on 2 consumer products that contain Glycogen in the following categories is provided:

• Personal Care

9.2 Formulations / Preparations

Each 100 mL of EXTRANEAL contains 7.5 grams of icodextrin in an electrolyte solution with 40 mEq/L lactate. EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is available in the following containers and fill volumes: ULTRABAG1.5 L; ULTRABAG2.0 L; ULTRABAG2.5 L; AMBU- FLEX III1.5 L; AMBU- FLEX III2.0 L; AMBU- FLEX III2.5 L; AMBU- FLEX II2.0 L; AMBU- FLEX II2.5 L.
US Natl Inst Health; DailyMed. Current Medication Information for EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection, solution (December 2009). Available from, as of October 1, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13874&CFID=19428124&CFTOKEN=2ec4a39687173f01-3AADFE4D-C860-EA92-9A8781A36C5F6935&jsessionid=ca307addf9d0787b4b2e

9.3 General Manufacturing Information

EPA TSCA Commercial Activity Status
Glycogen: ACTIVE
EPA TSCA Regulatory Flag
XU - indicates a substance exempt from reporting under the Chemical Data Reporting Rule, (40 CFR 711).

10 Safety and Hazards

10.1 Hazards Identification

10.1.1 GHS Classification

Note
This chemical does not meet GHS hazard criteria for 100% (91 of 91) of all reports. Pictograms displayed are for < 0.1% (0 of 91) of reports that indicate hazard statements.
GHS Hazard Statements

Not Classified

Reported as not meeting GHS hazard criteria by 91 of 91 companies. For more detailed information, please visit ECHA C&L website.

ECHA C&L Notifications Summary

Aggregated GHS information provided per 91 reports by companies from 1 notifications to the ECHA C&L Inventory.

Reported as not meeting GHS hazard criteria per 91 of 91 reports by companies. For more detailed information, please visit ECHA C&L website.

There are 0 notifications provided by 0 of 91 reports by companies with hazard statement code(s).

Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown.

10.1.2 Hazard Classes and Categories

Not Classified

10.1.3 Hazards Summary

May cause irritation; [Sigma-Aldrich MSDS]

10.2 Accidental Release Measures

10.2.1 Disposal Methods

SRP: Expired or waste pharmaceuticals shall carefully take into consideration applicable DEA, EPA, and FDA regulations. It is not appropriate to dispose by flushing the pharmaceutical down the toilet or discarding to trash. If possible return the pharmaceutical to the manufacturer for proper disposal being careful to properly label and securely package the material. Alternatively, the waste pharmaceutical shall be labeled, securely packaged and transported by a state licensed medical waste contractor to dispose by burial in a licensed hazardous or toxic waste landfill or incinerator.

10.3 Regulatory Information

The Australian Inventory of Industrial Chemicals
Chemical: Glycogen
New Zealand EPA Inventory of Chemical Status
Glycogen: Does not have an individual approval but may be used under an appropriate group standard

10.3.1 FDA Requirements

The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription drug products, including icodextrin, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act.
DHHS/FDA; Electronic Orange Book-Approved Drug Products with Therapeutic Equivalence Evaluations. Available from, as of November 11, 2010: https://www.accessdata.fda.gov/scripts/cder/ob/docs/queryai.cfm

10.4 Other Safety Information

Chemical Assessment
IMAP assessments - Glycogen: Environment tier I assessment

11 Toxicity

11.1 Toxicological Information

11.1.1 Antidote and Emergency Treatment

/SRP:/ Immediate first aid: Ensure that adequate decontamination has been carried out. If patient is not breathing, start artificial respiration, preferably with a demand valve resuscitator, bag-valve-mask device, or pocket mask, as trained. Perform CPR if necessary. Immediately flush contaminated eyes with gently flowing water. Do not induce vomiting. If vomiting occurs, lean patient forward or place on the left side (head-down position, if possible) to maintain an open airway and prevent aspiration. Keep patient quiet and maintain normal body temperature. Obtain medical attention. /Poisons A and B/
Currance, P.L. Clements, B., Bronstein, A.C. (Eds).; Emergency Care For Hazardous Materials Exposure. 3Rd edition, Elsevier Mosby, St. Louis, MO 2005, p. 160
/SRP:/ Basic treatment: Establish a patent airway (oropharyngeal or nasopharyngeal airway, if needed). Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if needed. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for pulmonary edema and treat if necessary ... . Monitor for shock and treat if necessary ... . Anticipate seizures and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with 0.9% saline (NS) during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 mL/kg up to 200 mL of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool ... . Cover skin burns with dry sterile dressings after decontamination ... . /Poisons A and B/
Currance, P.L. Clements, B., Bronstein, A.C. (Eds).; Emergency Care For Hazardous Materials Exposure. 3Rd edition, Elsevier Mosby, St. Louis, MO 2005, p. 160
/SRP:/ Advanced treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious, has severe pulmonary edema, or is in severe respiratory distress. Positive-pressure ventilation techniques with a bag valve mask device may be beneficial. Consider drug therapy for pulmonary edema ... . Consider administering a beta agonist such as albuterol for severe bronchospasm ... . Monitor cardiac rhythm and treat arrhythmias as necessary ... . Start IV administration of D5W /SRP: "To keep open", minimal flow rate/. Use 0.9% saline (NS) or lactated Ringer's if signs of hypovolemia are present. For hypotension with signs of hypovolemia, administer fluid cautiously. Watch for signs of fluid overload ... . Treat seizures with diazepam or lorazepam ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Poisons A and B/
Currance, P.L. Clements, B., Bronstein, A.C. (Eds).; Emergency Care For Hazardous Materials Exposure. 3Rd edition, Elsevier Mosby, St. Louis, MO 2005, p. 160-1

11.1.2 Human Toxicity Excerpts

/HUMAN EXPOSURE STUDIES/ ... The purpose of this study was to examine the insulin resistance in patients undergoing continuous ambulatory peritoneal dialysis (CAPD) with standard glucose and icodextrin containing solutions. The entire non diabetic CAPD patients of our center were studied: forty-four patients in all who were on CAPD treatment for 36.2 +/- 23.7 months. Twenty-seven of them (11 male and 16 female) with a mean age of 46 +/- 16 years were treated with standard glucose solutions (glucose group). The other 17 patients (10 male and 7 female) with a mean age of 49 +/- 16 years were treated with standard glucose solutions during the day and icodextrin dwell during the night, for a median of 12 +/- 6.3 months (icodextrin group). Morning fasting serum insulin levels were 20.59 +/- 17.86 in the glucose group and 10.15 +/- 6.87 in the icodextrin group (p = 0.0001). Homeostasis Model Assessment Method scores of the glucose group were significantly higher (4.8+/-4.1 vs 2.3+/- 1.7; p = 0.025) than the icodextrin group. A significant positive correlation of HOMA score with insulin, fasting plasma glucose, and triglyceride levels were found in HOMA (IR+) patients. Twenty patients of the icodextrin group (74%) and 15 patients of the glucose group (88%) were hypertensive, but there was no statistically significant difference between the two groups (p = 0.13). The groups showed no significant differences for body mass index and serum levels of glucose, total cholesterol, LDL cholesterol, VLDL cholesterol, HDL cholesterol, triglyceride, intact parathyroid hormone (iPTH), and fibrinogen. In conclusion, the use of icodextrin in the long nighttime dwell can reduce serum insulin levels and increase insulin sensitivity in CAPD patients.
Canbakan M, Sahin GM; Ren Fail 29 (3): 289-93 (2007)
/SIGNS AND SYMPTOMS/ No data are available on experiences of overdosage with EXTRANEAL. Overdosage of EXTRANEAL would be expected to result in higher levels of serum icodextrin and metabolites, but it is not known what signs or symptoms might be caused by exposure in excess of the exposures used in clinical trials. In the event of overdosage with EXTRANEAL, continued peritoneal dialysis with glucose-based solutions should be provided.
US Natl Inst Health; DailyMed. Current Medication Information for EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection, solution (December 2009). Available from, as of October 1, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13874&CFID=19428124&CFTOKEN=2ec4a39687173f01-3AADFE4D-C860-EA92-9A8781A36C5F6935&jsessionid=ca307addf9d0787b4b2e
/CASE REPORTS/ ... A case of severe cutaneous hypersensitivity to icodextrin occurring in a CAPD diabetic patient /is reported/. Icodextrin withdrawal was necessary to achieve cutaneous recovery. Although rare, this adverse event should be kept in mind.
Queffeulou G et al; Clin Nephrol 51 (3): 184-6 (1999)
/CASE REPORTS/ Icodextrin is an 7.5% isoosmotic solution of the glucose polymer maltodextrin, recently frequently used in continuous ambulatory peritoneal dialysis (CAPD). ... Among side effects of icodextrin, skin reactions and sterile peritonitis have been described. The authors present two cases of sterile peritonitis after icodextrin. In these two patients, the adverse events included peritoneal reaction to icodextrin solution. The reaction did not occur immediately after the initial administration of icodextrin, but after 70 (case 1) and 412 days (case 2) of regular use. This reaction to icodextrin solution resembled chemical peritonitis, however, the clinical picture was not absolutely typical of bacterial peritonitis either. Both patients had cloudy dialysate, elevated WBC in dialysate, no microorganisms were isolated, and no signs of allergic reaction could be detected. The clinical course was characterized by rapid remission upon isodextrin withdrawal. One patient received empiric antibiotic therapy, the other did not. Upon switching from icodextrin to glucose-based dialysate, the two patients were not challenged to icodextrin, and were doing well, without any symptoms of peritonitis. ...
Ekart R et al; Acta Med Croatica 56 (4-5): 185-7 (2002)
For more Human Toxicity Excerpts (Complete) data for Icodextrin (11 total), please visit the HSDB record page.

11.1.3 Non-Human Toxicity Excerpts

/LABORATORY ANIMALS: Developmental or Reproductive Toxicity/ A fertility study in rats where males and females were treated for four and two weeks, respectively, prior to mating and until day 17 of gestation at up to 1.5 g/kg/day (1/3 the human exposure on a mg/m2 basis) revealed slightly low epididymal weights in parental males in the high dose group as compared to Control. Toxicological significance of this finding was not evident as no other reproductive organs were affected and all males were of proven fertility. The study demonstrated no effects of treatment with icodextrin on mating performance, fertility, litter response, embryo-fetal survival, or fetal growth and development.
US Natl Inst Health; DailyMed. Current Medication Information for EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection, solution (December 2009). Available from, as of October 1, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13874&CFID=19428124&CFTOKEN=2ec4a39687173f01-3AADFE4D-C860-EA92-9A8781A36C5F6935&jsessionid=ca307addf9d0787b4b2e
/GENOTOXICITY/ Icodextrin did not demonstrate evidence of genotoxicity potential in in vitro bacterial cell reverse mutation assay (Ames test); in vitro mammalian cell chromosomal aberration assay (CHO cell assay); and in the in vivo micronucleus assay in rats. Long-term animal studies to evaluate the carcinogenic potential of EXTRANEAL or icodextrin have not been conducted. Icodextrin is derived from maltodextrin, a common food ingredient.
US Natl Inst Health; DailyMed. Current Medication Information for EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection, solution (December 2009). Available from, as of October 1, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=13874&CFID=19428124&CFTOKEN=2ec4a39687173f01-3AADFE4D-C860-EA92-9A8781A36C5F6935&jsessionid=ca307addf9d0787b4b2e

12 Associated Disorders and Diseases

13 Literature

13.1 Consolidated References

13.2 NLM Curated PubMed Citations

13.3 Chemical Co-Occurrences in Literature

13.4 Chemical-Gene Co-Occurrences in Literature

13.5 Chemical-Disease Co-Occurrences in Literature

14 Patents

14.1 Depositor-Supplied Patent Identifiers

15 Classification

15.1 MeSH Tree

15.2 UN GHS Classification

15.3 NORMAN Suspect List Exchange Classification

15.4 Consumer Product Information Database Classification

15.5 EPA TSCA and CDR Classification

15.6 Glycan Naming and Subsumption Ontology (GNOme)

15.7 MolGenie Organic Chemistry Ontology

16 Information Sources

  1. Australian Industrial Chemicals Introduction Scheme (AICIS)
  2. CAS Common Chemistry
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    https://creativecommons.org/licenses/by-nc/4.0/
    β-D-Mannopyranose, O-α-D-galactopyranosyl-(1→6)-O-[β-D-mannopyranosyl-(1→4)]-O-β-D-mannopyranosyl-(1→4)-
    https://commonchemistry.cas.org/detail?cas_rn=119400-89-4
  3. DrugBank
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  5. European Chemicals Agency (ECHA)
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    https://echa.europa.eu/web/guest/legal-notice
  6. Hazardous Substances Data Bank (HSDB)
  7. New Zealand Environmental Protection Authority (EPA)
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  8. ClinicalTrials.gov
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  9. Comparative Toxicogenomics Database (CTD)
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    http://ctdbase.org/about/legal.jsp
  10. Consumer Product Information Database (CPID)
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    https://www.whatsinproducts.com/contents/view/1/6
    Consumer Products Category Classification
    https://www.whatsinproducts.com/
  11. DailyMed
  12. E. coli Metabolome Database (ECMDB)
    LICENSE
    ECMDB is offered to the public as a freely available resource.
    https://ecmdb.ca/citations
  13. Drugs@FDA
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    https://www.fda.gov/about-fda/about-website/website-policies#linking
  14. EPA DSSTox
    Hexopyranosyl-(1->4)-[hexopyranosyl-(1->6)]hexopyranosyl-(1->4)hexopyranose
    https://comptox.epa.gov/dashboard/DTXSID70864156
  15. EU Clinical Trials Register
  16. FDA Orange Book
    LICENSE
    Unless otherwise noted, the contents of the FDA website (www.fda.gov), both text and graphics, are not copyrighted. They are in the public domain and may be republished, reprinted and otherwise used freely by anyone without the need to obtain permission from FDA. Credit to the U.S. Food and Drug Administration as the source is appreciated but not required.
    https://www.fda.gov/about-fda/about-website/website-policies#linking
  17. NORMAN Suspect List Exchange
    LICENSE
    Data: CC-BY 4.0; Code (hosted by ECI, LCSB): Artistic-2.0
    https://creativecommons.org/licenses/by/4.0/
    NORMAN Suspect List Exchange Classification
    https://www.norman-network.com/nds/SLE/
  18. GlyGen
  19. Haz-Map, Information on Hazardous Chemicals and Occupational Diseases
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    https://haz-map.com/About
  20. Metabolomics Workbench
  21. National Drug Code (NDC) Directory
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    https://www.fda.gov/about-fda/about-website/website-policies#linking
  22. NCI Thesaurus (NCIt)
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    https://www.cancer.gov/policies/copyright-reuse
  23. NIPH Clinical Trials Search of Japan
  24. NLM RxNorm Terminology
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    https://www.nlm.nih.gov/research/umls/rxnorm/docs/termsofservice.html
  25. Wikidata
  26. PubChem
  27. Medical Subject Headings (MeSH)
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    https://www.nlm.nih.gov/copyright.html
  28. GHS Classification (UNECE)
  29. Glycan Naming and Subsumption Ontology (GNOme)
    GNOme
  30. MolGenie
    MolGenie Organic Chemistry Ontology
    https://github.com/MolGenie/ontology/
CONTENTS