NULYTELY Powder for oral solution Ref.[50755] Active ingredients: Macrogol Potassium chloride Sodium bicarbonate Sodium chloride

Source: FDA, National Drug Code (US)  Revision Year: 2022 

12.1. Mechanism of Action

The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces a watery stool.

12.2. Pharmacodynamics

NuLYTELY induces as diarrhea which rapidly cleanses the bowel, usually within four hours.

12.3. Pharmacokinetics

The pharmacokinetics of PEG3350 following administration of NuLYTELY were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been performed to evaluate carcinogenic potential of NuLYTELY. Studies to evaluate the possible impairment of fertility or mutagenic potential of NuLYTELY have not been performed.

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