BNF for Children 2011-2012

54 1.5.3 Drugs affecting the immune response BNFC 2011–20121 Gastro-intestinal systemPREDNISOLONECautions section 6.3.2; systemic absorption mayoccur; prolonged use should be avoidedContra-indications section 6.3.2; intestinal obstruction,bowel perforation, recent intestinal anastomoses,extensive fistulas; untreated infectionHepatic impairment section 6.3.2Renal impairment section 6.3.2Pregnancy section 6.3.2Breast-feeding section 6.3.2Side-effects section 6.3.2Licensed use Predfoam c , Predsol c retentionenema not licensed for use in children (age rangenot specified by manufacturer)Indication and doseUlcerative colitis, Crohn’s disease see also underpreparations, below. By mouthChild 2–18 years 2 mg/kg (max. 60 mg) oncedaily until remission occurs, followed by reducingdoses. By rectumSee under preparationsOther indications section 6.3.2Oral preparationsSection 6.3.2Rectal preparationsPredenema c (Chemidex) ARetention enema, prednisolone 20 mg (as sodiummetasulphobenzoate) in 100-mL single-dose disposablepack. Net price 1 (standard tube) = 71p, 1 (longtube) = £1.21DoseUlcerative colitis. By rectumChild 12–18 years initially 20 mg at bedtime for 2–4weeks, continued if good responsePredfoam c (Forest) AFoam in aerosol pack, prednisolone 20 mg (as metasulphobenzoatesodium)/metered application, netprice 14-application cannister with disposable applicators= £6.32Excipients include cetostearyl alcohol, disodium edetate, polysorbate20, sorbic acidDoseProctitis and distal ulcerative colitis. By rectumChild 12–18 years 1 metered application (20 mg prednisolone)inserted into the rectum once or twice daily for2 weeks, continued for further 2 weeks if good responsePredsol c (UCB Pharma) ASuppositories, prednisolone 5 mg (as sodium phosphate).Net price 10 = £1.35DoseProctitis and rectal complications of Crohn’s disease. By rectumChild 2–18 years 5 mg inserted night and morning aftera bowel movement1.5.3 Drugs affecting theimmune responseAzathioprine, mercaptopurine, or once weeklymethotrexate are used to induce remission in unresponsiveor chronically active Crohn’s disease. Azathioprineor mercaptopurine may also be helpful for retainingremission in frequently relapsing inflammatorybowel disease; once weekly methotrexate is used inCrohn’s disease when azathioprine or mercaptopurineare ineffective or not tolerated. Response to azathioprineor mercaptopurine may not become apparent forseveral months. Folic acid (section 9.1.2) should begiven to reduce the possibility of methotrexate toxicity.Folic acid can be given at a dose of 5 mg weekly;alternative regimens may be used in some settings.Ciclosporin (cyclosporin) is a potent immunosuppressantand is markedly nephrotoxic. In children withsevere ulcerative colitis unresponsive to other treatment,ciclosporin may reduce the need for urgent colorectalsurgery.AZATHIOPRINECautions section 8.2.1; interactions: Appendix 1(azathioprine)Contra-indications section 8.2.1Hepatic impairment section 8.2.1Renal impairment section 8.2.1Pregnancy section 8.2.1Breast-feeding section 8.2.1Side-effects section 8.2.1Licensed use not licensed for use in ulcerative colitisor Crohn’s diseaseIndication and doseSevere ulcerative colitis and Crohn’s disease. By mouthChild 2–18 years initially 2 mg/kg once daily,then increased if necessary up to 2.5 mg/kg oncedailyTransplantation rejection section 8.2.1Rheumatic diseases section 10.1.3PreparationsSection 8.2.1CICLOSPORINCautions section 8.2.2; interactions: Appendix 1(ciclosporin)Hepatic impairment section 8.2.2Renal impairment section 8.2.2Pregnancy section 8.2.2Breast-feeding section 8.2.2Side-effects section 8.2.2Licensed use not licensed for use in ulcerative colitis