Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Casen Recordati, S.L., AutovÃa de Logroño, Km 13,300, 50180 UTEBO, Zaragoza (Spain)
Pharmacotherapeutic group: Drugs for constipation. Osmotically acting laxatives
ATC code: A06AD15
High molecular weight (4000) macrogols are long linear polymers which retain water molecules by means of hydrogen bonds. When administered by the oral route, they lead to an increase in volume of intestinal fluids. This is why an adequate hydration is important during the treatment.
The volume of unabsorbed intestinal fluid accounts for the laxative properties of the solution.
The pharmacokinetic data confirm that macrogol 4000 undergoes neither gastrointestinal resorption nor biotransformation following oral ingestion.
Toxicological studies conducted in different animal species did not reveal any sign of systemic or local gastrointestinal toxicity. Macrogol 4000 had no teratogenic or mutagenic effect.
No carcinogenicity studies have been performed.
Macrogol 4000 was not teratogenic in rats or rabbits.
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