Role of rectal formulations: suppositories.

Mesalazine (5-aminosalicylic acid) suppositories are safe, effective, well tolerated, and well retained in patients with active distal proctitis. The best results are seen in patients with idiopathic ulcerative proctitis. Approximately 85% of these patients are healed within 4 weeks and virtually 100% by 10 weeks, with mucosal healing and complete loss of symptoms. Suppositories cover the last 20 cm of the rectum, as shown by technetium labelling. Maintenance therapy using suppositories alone--in doses varying from 500 mg every second bedtime to 1000 mg per day in divided doses--is at least as effective as oral sulphasalazine. Mesalazine suppositories are also useful in treating patients with Crohn's disease affecting the rectum, although the response rate is slower and healing is incomplete in half the patients treated. In the rare solitary rectal ulcer syndrome, mesalazine suppositories may be as efficacious as mesalazine enemas. Patient compliance and dramatic response even when conventional therapy has failed make an excellent case for mesalazine suppositories being the treatment of choice for distal ulcerative proctocolitis.