Rectal irritation and damage

Long term rectal application of drugs has been reported to produce irritation, rectal bleeding pain and even ulceration. Ergotamine tartrate suppositories used at a dose range of 1.5 to 9 mg over a period of between 1 and 8 years can produce rectal damage, probably due to mucosal ischaemia produced by the alkaloid145.

Rectal ulceration and stenoses have also been reported in patients using suppositories containing dextropropoxyphene146, paracetamol, aspirin, caffeine, carbromal, bromisoval and codeine phosphate147. Rectal damage only appears to occur after long term daily suppository use and aspirin, ergotamine and paracetamol appear to cause the most common problems.

Local irritation can be elicited by rectal application of various drug in humans, for example oxprenolol solution, diazepam preparations, promethazine suppositories and carbamazepine suspension, hence tolerability represents an important consideration in the development of rectal formulations. Interestingly, epithelial cell loss and local inflammatory reactions have been observed after administration of plain suppository bases, e.g. Suppocire AP, Witepsol H12, H15 and H19, and polyethylene glycols in rats148 149. However, since these materials are well accepted in clinical practice, the occurrence of mucosal damage does not necessarily preclude their use in humans, if the damage is reversible.

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