Could rectal administration of prednisolone (PredClysma or prednisolone ex tempore 20 mg rectally a

Fråga: Could rectal administration of prednisolone (PredClysma or prednisolone ex tempore 20 mg rectally administrated) or mesalazine (Mesasal) cause itching, stitches, palpitations, thirst, general sense of numbness and swollen throat? The question concerns a 45-year-old man with ulcerative colitis and hiatus hernia. A few hours after rectal administration of prednisolone or mesalazine the patient woke up in the night with the above-mentioned symptoms, which disappeared a few hours later. If the patient continued with the treatment for some days the symptoms decreased, but where still present. When the patient stopped the treatment for each preparation the symptoms vanished and reappeared at re-exposition. In connection with one of the nightly episodes the patient sought advice at the emergency ward. A coloscopy was performed later, but nothing pathological was found upon examination. Psychogenic reaction was considered by the questioner, but excluded. The patient was also treated with lansoprazole.

Sammanfattning: Despite the allergic potential of mesalazine and prednisolones it is impossible to judge whether the preparations mentioned in the present case caused the symptoms. A possible explanation could be a vasovagal reaction due to the route of administration. A physiological saline solution administered rectally in the same volume can be employed to test this hypothesis.

Svar: After a search in relevant pharmacological databases and literature we have found little information concerning the described symptoms and the drugs the patient was using.

Mesalazine (5-aminosalicylic acid, 5-ASA) is a rectally administered drug with low systemic exposure. Approximately 20 % of the drug is recovered in the urine mainly as the metabolite N-acetyl-mesalazine and to a smaller part as 5-ASA. After a rectally administered dose of two grams of mesalazine, 1.3 ug/mL of mesalazine and 2.3 ug/mL of N-acetyl-mesalazine could be found in the plasma (1). Mesalazine preparations include metabisulfite that might cause allergic reactions, including anaphylactic symptoms and bronchospasm (1). According to (2) mesalazine is poorly absorbed and the adverse effects that are reported is mainly due to the form of drug instillation. However, retrosternal pain, pleuropericarditis and myalgia have been reported (3) after mesalazine treatment.

Pred-Clysma includes prednisolone-sodium-phosphate and nicotinamide. There are reports about contact allergy to corticosteroids (4). Monk and Skipper described a patient with inflammatory bowel syndrome, treated with oral mesalazine and prednisolone metasulphobenzoate sodium rectally, who improved when the patient withdraw the prednisolone preparation. An allergic test relieved that he had a positive reaction to budenoside. At follow up three months later the patient remained free of symptoms (5).

According to the Swedish Adverse Drug Reactions Register (6) faintness is reported in one case for mesalazine and dizziness in 3 cases for mesalazine and in 2 cases for prednisolone.

None of the constituents of the preparations in the present case could be linked to the clinical findings.

Even if contact allergy has been reported for prednisolone and allergic reactions after administration of mesalazine preparations it is impossible to judge whether these compounds caused the symptoms. A possible explanation could be a vasovagal reaction due to the route of administration of the drugs.