Identification

Summary

Icodextrin is an iso-osmotic solution used for continuous peritoneal dialysis or automated peritoneal dialysis.

Brand Names
Extraneal
Generic Name
Icodextrin
DrugBank Accession Number
DB00702
Background

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.

Type
Small Molecule
Groups
Approved, Investigational
Synonyms
  • Icodextrin
  • Icodextrina
  • Icodextrine
  • Icodextrinum

Pharmacology

Indication

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

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Associated Therapies
Contraindications & Blackbox Warnings
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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.

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.

Absorption

40% of instilled icodextrin was absorbed from the peritoneal solution during a 12-hour dwell.

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism

Icodextrin is metabolized by alpha-amylase into oligosaccharides with a lower degree of polymerization), including maltose, maltotriose, maltotetraose, and higher molecular weight species.

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Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
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Toxicity

Not Available

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
No interactions found.
Food Interactions
No interactions found.

Products

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International/Other Brands
Adept (Baxter) / Dextrin, Caloreen (Baxter) / Icodial
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
EXTRANEALIcodextrin (7.5 g) + Calcium chloride dihydrate (0.0257 g) + Sodium lactate (0.45 g) + Magnesium chloride hexahydrate (0.0051 g) + Sodium chloride (0.54 g)SolutionIntraperitonealBAXTER S.A. DE C.V.2007-05-11Not applicableColombia flag
ExtranealIcodextrin (75 g / L) + Calcium chloride (257 mg / L) + Sodium lactate (4.48 g / L) + Magnesium chloride (51 mg / L) + Sodium chloride (5.35 g / L)SolutionHemodialysisBaxter Laboratories2000-01-20Not applicableCanada flag
ExtranealIcodextrin (7.5 g/100mL) + Calcium chloride dihydrate (25.7 mg/100mL) + Sodium lactate (448 mg/100mL) + Magnesium chloride hexahydrate (5.08 mg/100mL) + Sodium chloride (535 mg/100mL)Injection, solutionIntraperitonealBaxter Healthcare Corporation2002-12-20Not applicableUS flag
EXTRANEAL PERITON DIYALIZ COZELTISI (2000 ML CIFTLI TORBA, MINI KAPAKLI)Icodextrin (75 g/L) + Calcium chloride (0.257 g/L) + Sodium lactate (4.5 g/L) + Magnesium chloride hexahydrate (0.051 g/L) + Sodium chloride (5.4 g/L)SolutionIntraperitonealBAXTER TURKEY RENAL HİZMETLER A.Ş.2020-08-14Not applicableTurkey flag
EXTRANEAL PERITON DIYALIZ ÇÖZELTİSİ, ÇIFTLI TORBA MINI KAPAKLI 2500 MLIcodextrin (75 g/L) + Calcium chloride (0.257 g/L) + Sodium lactate (4.5 g/L) + Magnesium chloride hexahydrate (0.051 g/L) + Sodium chloride (5.4 g/L)SolutionIntraperitonealBAXTER TURKEY RENAL HİZMETLER A.Ş.2020-08-14Not applicableTurkey flag
EXTRANEAL PERITON DIYALIZ ÇÖZELTİSİ, TEKLI TORBA 2000 MLIcodextrin (75 g/L) + Calcium chloride (0.257 g/L) + Sodium lactate (4.5 g/L) + Magnesium chloride hexahydrate (0.051 g/L) + Sodium chloride (5.4 g/L)SolutionIntraperitonealBAXTER TURKEY RENAL HİZMETLER A.Ş.2020-08-14Not applicableTurkey flag
EXTRANEAL PERİTON DİYALİZ ÇÖZELTİSİ, TEKLI TORBA 2500 MLIcodextrin (75 g/L) + Calcium chloride (0.257 g/L) + Sodium lactate (4.5 g/L) + Magnesium chloride hexahydrate (0.051 g/L) + Sodium chloride (5.4 g/L)SolutionIntraperitonealBAXTER TURKEY RENAL HİZMETLER A.Ş.2020-08-14Not applicableTurkey flag
EXTRANEAL PERITONEAL DIALYSIS SOLUTION 75 g/lIcodextrin (75 g/l) + Calcium chloride dihydrate (257 mg/l) + Sodium lactate (4.48 g/l) + Magnesium chloride (50.8 mg/l) + Sodium chloride (5.38 g/l)SolutionIntraperitonealBAXTER HEALTHCARE (ASIA) PTE LTD1999-11-09Not applicable
EXTRANEFROL PERİTON DİYALİZ ÇÖZELTİSİ, 2000 ML ÇİFTLİIcodextrin (7.5 g/100mL) + Calcium chloride dihydrate (0.0257 g/100mL) + Sodium lactate (0.45 g/100mL) + Magnesium chloride hexahydrate (0.0051 g/100mL) + Sodium chloride (0.54 g/100mL)SolutionIntraperitonealPOLİFARMA İLAÇ SAN. VE TİC. A.Ş.2020-08-14Not applicableTurkey flag
EXTRANEFROL PERİTON DİYALİZ ÇÖZELTİSİ, 2000 ML TEKLİIcodextrin (7.5 g/100mL) + Calcium chloride dihydrate (0.0257 g/100mL) + Sodium lactate (0.45 g/100mL) + Magnesium chloride hexahydrate (0.0051 g/100mL) + Sodium chloride (0.54 g/100mL)SolutionIntraperitonealPOLİFARMA İLAÇ SAN. VE TİC. A.Ş.2020-08-14Not applicableTurkey flag

Categories

Drug Categories
Classification
Not classified
Affected organisms
  • Humans and other mammals

Chemical Identifiers

UNII
2NX48Z0A9G
CAS number
337376-15-5
InChI Key
Not Available
InChI
Not Available
IUPAC Name
Not Available
SMILES
Not Available

References

General References
  1. Frampton JE, Plosker GL: Icodextrin: a review of its use in peritoneal dialysis. Drugs. 2003;63(19):2079-105. [Article]
PubChem Substance
46508585
RxNav
140480
ChEMBL
CHEMBL1201472
PharmGKB
PA164743096
RxList
RxList Drug Page
Wikipedia
Icodextrin
FDA label
Download (243 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedTreatmentAPD / Continuous ambulatory peritoneal dialysis therapy / Diabetes / ESRD1
4CompletedTreatmentChronic Kidney Disease (CKD) / Peritoneal dialysis therapy1
4CompletedTreatmentImpaired Renal Function1
4CompletedTreatmentPeritonitis1
4WithdrawnTreatmentHypertriglyceridemias / Peritoneal dialysis therapy1
3CompletedTreatmentContinuous ambulatory peritoneal dialysis therapy / Diabetes / End Stage Renal Disease (ESRD)1
3CompletedTreatmentDiabetes / ESRD1
3TerminatedTreatmentCongestive Heart Failure (CHF)1
2CompletedTreatmentEnd Stage Renal Disease (ESRD)1
2Not Yet RecruitingTreatmentEnd Stage Renal Disease (ESRD)1

Pharmacoeconomics

Manufacturers
  • Baxter healthcare corp
Packagers
  • Baxter International Inc.
Dosage Forms
FormRouteStrength
Injection, solutionIntraperitoneal
SolutionHemodialysis
SolutionIntraperitoneal
SolutionIntraperitoneal257 mg/l
Prices
Unit descriptionCostUnit
Extraneal icodextrin dial soln0.05USD ml
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)Region
US4761237No1988-08-022009-08-09US flag
US6077836No2000-06-202017-06-20US flag
US6248726No2001-06-192018-06-19US flag

Properties

State
Solid
Experimental Properties
PropertyValueSource
water solubility80 mg/mLNot Available
Predicted Properties
Not Available
Predicted ADMET Features
Not Available

Spectra

Mass Spec (NIST)
Not Available
Spectra
Not Available

Enzymes

Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Substrate
General Function
Chloride ion binding
Specific Function
Not Available
Gene Name
AMY2A
Uniprot ID
P04746
Uniprot Name
Pancreatic alpha-amylase
Molecular Weight
57706.51 Da
References
  1. Flore KM, Delanghe JR: Analytical interferences in point-of-care testing glucometers by icodextrin and its metabolites: an overview. Perit Dial Int. 2009 Jul-Aug;29(4):377-83. [Article]
  2. Garcia-Lopez E, Lindholm B: Icodextrin metabolites in peritoneal dialysis. Perit Dial Int. 2009 Jul-Aug;29(4):370-6. [Article]

Drug created at June 13, 2005 13:24 / Updated at January 02, 2022 11:50