TOILAX MICRO ENEMA Rectal suspension Ref.[50433] Active ingredients: Bisacodyl

Hydrolysis of bisacodyl by enzymes of the enteric mucosa forms desacetylbisacodyl which is absorbed and excreted partly via urine and bile as glucuronide. By bacterial cleavage the active form, the free diphenol, is formed in the colon. Formulations of bisacodyl which are resistant to gastric and small intestinal juice reach the colon without any appreciable absorption and therefore avoid enterohepatic circulation. Consequently, orally administered formulations have an onset of action from between 6-12 hours. Micro enema formulations of bisacodyl have a short onset of action within 15-30 minutes, although in some cases it may be prolonged to 15-60 minutes. The onset of action is determined by the release of the active substance from the preparation.

There is no relationship between the laxative effect and plasma levels of the active diphenol.

Testing in rats and mice showed no carcinogenic effect. Bisacodyl has shown no mutagenic or genotoxic potential.

No teratogenic effect could be found in rats dosed with 10-15 mg bisacodyl per kilogram per day.

The safety of bisacodyl has not been studied in descriptive animal toxicity tests. Induction of cell proliferation in intestinal epithelia has been described in animal experiments after chronic bisacodyl treatment. Dietary supplements with 0.3% bisacodyl for 32 weeks was found to induce both calculi and epithelial proliferative lesions in the urinary bladder of rats.