Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
Code ATC: B05DA
Icodextrin is a starch-derived glucose polymer which acts as an osmotic agent when administered intraperitoneally for continuous ambulatory peritoneal dialysis. A 7.5% solution is approximately iso-osmolar to serum but produces sustained ultrafiltration over a period up to 12 hours in CAPD. There is a reduction in calorie load compared to hyperosmolar glucose solutions.
The volume of ultrafiltrate produced is comparable to that with 3.86% glucose when used in CAPD. Blood glucose and insulin levels remain unaffected.
Ultrafiltration is maintained during episodes of peritonitis.
The recommended posology is limited to a single exchange in each 24 hour-period, as part of a CAPD or APD regimen.
Carbohydrate polymer levels in blood reach steady state after about 7-10 days when used on a daily basis for overnight dialysis. The polymer is hydrolysed by amylase to smaller fragments which are cleared by peritoneal dialysis. Steady state plasma levels of 1.8 mg/ml have been measured for oligomers of glucose units greater than 9 (G9) and there is a rise in serum maltose (G2) to 1.1 mg/ml but there is no significant change in serum osmolality. When used for the long day time dwell in APD maltose levels of 1.4 mg/ml have been measured but with no significant change in serum osmolality.
The long-term effects of raised plasma levels of maltose and glucose polymer are unknown, but there is no reason to suppose these to be harmful.
Acute i.v. and i.p. studies in mice and rats have demonstrated no effects at doses up to 2000mg/kg.
Twice daily i.p. administration of 20% Icodextrin solution for 28 days to rats and dogs revealed no target organ or tissue toxicity. The major effect was upon the dynamics of fluid balance.
In vitro and in vivo studies on mutagenicity gave negative results. Carcinogenicity studies with the product are not feasible but carcinogenic effects are unlikely given the chemical nature of the molecule, its lack of pharmacological effect, lack of target organ toxicity and negative results in mutagenicity studies.
A reproduction toxicity study in rats demonstrated no effect on fertility or embryofetal development.
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