BNF for Children 2011-2012

50 1.5.1 Aminosalicylates BNFC 2011–20121 Gastro-intestinal systemsalicylic acid) and olsalazine (a dimer of 5-aminosalicylicacid which cleaves in the lower bowel), the sulfonamide-relatedside-effects of sulfasalazine are avoided,but 5-aminosalicylic acid alone can still cause sideeffectsincluding blood disorders (see recommendationbelow) and lupus-like syndrome also seen with sulfasalazine.Cautions Renal function should be monitored beforestarting an oral aminosalicylate, at 3 months of treatment,and then annually during treatment (more frequentlyin renal impairment). Blood disorders can occurwith aminosalicylates (see recommendation below).Blood disordersChildren receiving aminosalicylates and their carersshould be advised to report any unexplained bleeding,bruising, purpura, sore throat, fever or malaisethat occurs during treatment. A blood count shouldbe performed and the drug stopped immediately ifthere is suspicion of a blood dyscrasia.Contra-indications Aminosalicylates should beavoided in salicylate hypersensitivity.Side-effects Side-effects of the aminosalicylatesinclude diarrhoea, nausea, vomiting, abdominal pain,exacerbation of symptoms of colitis, headache, hypersensitivityreactions (including rash and urticaria); sideeffectsthat occur rarely include acute pancreatitis,hepatitis, myocarditis, pericarditis, lung disorders(including eosinophilia and fibrosing alveolitis), peripheralneuropathy, blood disorders (including agranulocytosis,aplastic anaemia, leucopenia, methaemoglobinaemia,neutropenia, and thrombocytopenia—see alsorecommendation above), renal dysfunction (interstitialnephritis, nephrotic syndrome), myalgia, arthralgia, skinreactions (including lupus erythematosus-likesyndrome, Stevens-Johnson syndrome), alopecia.BALSALAZIDE SODIUMCautions see notes above; also history of asthma;interactions: Appendix 1 (aminosalicylates)Blood disorders see recommendation aboveContra-indications see notes aboveHepatic impairment avoid in severe impairmentRenal impairment manufacturer advises avoid inmoderate to severe impairmentPregnancy manufacturer advises avoidBreast-feeding monitor infant for diarrhoeaSide-effects see notes above; also cholelithiasisLicensed use not licensed for use in children under18 yearsIndication and doseTreatment of mild to moderate ulcerative colitisand maintenance of remission. By mouthChild 12–18 years acute attack, 2.25 g 3 timesdaily until remission occurs or for up to max. 12weeks; maintenance, 1.5 g twice daily, adjustedaccording to response (max. 3 g twice daily)Colazide c (Almirall) ACapsules, beige, balsalazide sodium 750 mg, net price130-cap pack = £30.42. Label: 21, 25, counselling,blood disorder symptoms (see recommendationabove)MESALAZINECautions see notes above; interactions: Appendix 1(aminosalicylates)Blood disorders see recommendation aboveContra-indications see notes above; blood clottingabnormalitiesHepatic impairment avoid in severe impairmentRenal impairment use with caution; avoid if estimatedglomerular filtration rate less than 20 mL/minute/1.73 m 2Pregnancy negligible quantity crosses placentaBreast-feeding diarrhoea reported but negligibleamounts detected in breast milk; monitor infant fordiarrhoeaSide-effects see notes aboveLicensed use Asacol c (all preparations) and Salofalkc enema not licensed for use in children under18 years; Salofalk c suppositories, Pentasa c tabletsand suppositories not licensed for use in childrenunder 15 years; Pentasa c granules not licensed foruse in children under 6 years; Salofalk c rectal foamno dose recommendations for children (age rangenot specified by manufacturer)Indication and doseTreatment of mild to moderate ulcerative colitisand maintenance of remission for dose see underpreparations belowNote The delivery characteristics of oral mesalazinepreparations may vary; these preparations should not beconsidered interchangeableAsacol c (Warner Chilcott) AFoam enema, mesalazine 1 g/metered application,net price 14-application canister with disposableapplicators and plastic bags = £26.72. Counselling,blood disorder symptoms (see recommendationabove)Excipients include disodium edetate, hydroxybenzoates (parabens),polysorbate 20, sodium metabisulphiteDoseAcute attack affecting the rectosigmoid region. By rectumChild 12–18 years 1 metered application (mesalazine1 g) into the rectum daily for 4–6 weeksAcute attack affecting the descending colon. By rectumChild 12–18 years 2 metered applications (mesalazine2 g) once daily for 4–6 weeksSuppositories, mesalazine 250 mg, net price 20-suppospack = £4.82; 500 mg, 10-suppos pack = £4.82.Counselling, blood disorder symptoms (see recommendationabove)DoseTreatment and maintenance of remission of ulcerativecolitis affecting the rectosigmoid region. By rectumChild 12–18 years 250–500 mg 3 times daily, with lastdose at bedtime