Why is there a limit on the dose and duration of use for carbamazepine suppositories?

· UKMi

This Medicines Q&A addresses why there is a limit on the dose and duration of use for carbamazepine suppositories.

Summary

  • The maximum recommended daily dose for carbamazepine suppositories is 1000mg (250mg four times daily) which is equivalent to 800mg per day orally. This maximum dosage is based on carbamazepine’s pharmacokinetic data.
  • The maximum recommended treatment period for carbamazepine suppositories is 7 days as clinical trials have only been carried out for this length of time.
  • One case involving the rectal administration of carbamazepine suppositories for 10 weeks to an 18 month old child reported the development of erythema and excoriation of the anus after 9 weeks. This was felt to represent a direct effect of the carbamazepine suppositories.

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