DRUGS FOR INFLAMMATORY BOWEL DISEASE AMINOSALICYLATES (5-ASA) Included in this group of drugs are : Sulphasalazine, Mesalazine, Olsalazine and Balsalazide. Comment of mode of action is required ? Route of administration : Oral as tablets, granules and suspensions (sulphasalazine only). Rectally as suppositories or enemas. Cautions / Contraindications : Sulphasalazine : Glucose 6 phosphate dehydrogenase deficiency – may cause haemolysis. Pregnancy / breast feeding : Sulphasalazine may be associated with transient reversible oligospermia in men of child bearing potential. Folic acid supplements should be prescribed to those trying to conceive and during pregnancy. Small amounts of the drug are excreted in breast milk although this is not thought to be a risk to healthy infants. Contraindicated in patients with hypersensitivity to sulphonamides / co-trimoxazole. All 5-ASA’s Use with caution in patients with renal impairment – and discuss with Nephrology team & monitor renal function regularly whilst on treatment. Avoid in patients with severe renal failure. There is a possible increased risk of haematological toxicity (leucopenia, unexplained bleeding / bruising and purpura) when patients are taking azathioprine or 6 – Mercaptopurine – monitor blood tests more frequently. British Society of Gastroenterology (BSG) recommended monitoring schedule : BSG Guidelines : Pre-treatment assessment Monitoring FBC, U&E, Creatinine, LFT’s FBC & LFT’s at 1 month FBC, U&E, Creatinine, LFT’s at 3 months If results stable repeat above blood tests about once yearly Following dose changes Consider repeating bloods 1 month after increase Actions to be taken : Nausea, dizziness, headache, worsening diarrhoea Severe abdominal pain If troublesome, reduce or stop treatment and consider alternative Monitor carefully – if WBC continues to fall, withhold until discussed with Gastroenterology specialist team Monitor carefully – if neutrophil count continues to fall, withhold until discussed with Gastroenterology specialist team Monitor carefully – if platelet count continues to fall, withhold until discussed with Gastroenterology specialist team Check amylase level; consider ultrasound or CT scanning > 2 fold rise above upper limit of normal reference range for ALT / AST Withold until discussed with specialist team; Ultrasound liver. Rise of creatinine level above the normal range (or rise of > 20% compared to baseline) Withold until discussed with specialist team; Urinalysis for proteinuria etc; renal ultrasound; nephrology opinion. Check FBC immediately and withhold until result available. discuss with Gastroenterology specialist team Withold; seek urgent specialist (preferably Dermatological) advice WBC < 4.0 x 109/l Neutrophils < 2.0 x 109/l Platelets < 150 fl Abnormal bruising or severe sore throat Unexplained acute widespread rash 1. Ransford RA, Langman MJ. Sulphasalazine and mesalazine : serious adverse reactions re-evaluated on the basis of suspected adverse reaction reports to the Committee on Safety of Medicines. Gut 2002; 51 : 536-9. 2. Van Staa TP, Travis S, Leufkens HG, Logan RF. 5-aminosalicylic acids and the risk of renal disease : a large British epidemiological study. Gastroenterology 2004; 126 : 1733 – 9. 3. Muller AF, Stevens P, McIntyre AS, Ellison H, Logan RF. Experience of 5aminosalicylate nephrotoxicity in the United Kingdom. Aliment. Pharmacol. Ther. 2005; 21 : 1217 – 1224.