BNF for Children 2011-2012

52 1.5.1 Aminosalicylates BNFC 2011–20121 Gastro-intestinal systemChild 6–18 years and body-weight over 40 kg 1.5–3 gonce daily (preferably in the morning) or 0.5–1 g 3 timesdailyMaintenance of remission. By mouthChild 6–18 years and body-weight under 40 kg 5–10 mg/kg 3 times daily; total daily dose may alternativelybe given in 2 divided dosesChild 6–18 years and body-weight over 40 kg 500 mg3 times dailyAdministration Granules should be placed on tongue andwashed down with water without chewingNote Preparations that lower stool pH (e.g. lactulose) mayprevent release of mesalazineSuppositories, mesalazine 500 mg. Net price 30-suppos pack = £14.81. Counselling, blood disordersymptoms (see recommendation above)DoseAcute attack. By rectumChild 12–18 years 0.5–1 g 2–3 times daily adjustedaccording to responseEnema, mesalazine 2 g in 59-mL pack. Net price 7enemas = £29.92. Counselling, blood disorder symptoms(see recommendation above)DoseAcute attack or maintenance. By rectumChild 12–18 years 2 g once daily at bedtimeRectal foam, mesalazine 1 g/metered application, netprice 14-application canister with disposable applicatorsand plastic bags = £30.17. Counselling, blooddisorder symptoms (see recommendation above)Excipients include cetostearyl alcohol, disodium edetate, polysorbate60, propylene glycol, sodium metabisulphiteDoseMild ulcerative colitis affecting sigmoid colon andrectum. By rectumChild 12–18 years 2 metered applications (mesalazine2 g) into the rectum at bedtime or in 2 divided dosesOLSALAZINE SODIUMCautions see notes above; interactions: Appendix 1(aminosalicylates)Blood disorders see recommendation aboveContra-indications see notes aboveRenal impairment use with caution; manufactureradvises avoid in significant impairmentPregnancy manufacturer advises avoid unless potentialbenefit outweighs riskBreast-feeding monitor infant for diarrhoeaSide-effects see notes above; watery diarrhoea common;also reported, tachycardia, palpitation, pyrexia,blurred vision, and photosensitivityLicensed use not licensed for use in children under12 yearsIndication and doseTreatment of acute attack of mild ulcerativecolitis. By mouthChild 2–18 years 500 mg twice daily after foodincreased if necessary over 1 week to max. 1 g 3times dailyMaintenance of remission of mild ulcerativecolitis. By mouthChild 2–18 years 250–500 mg twice daily afterfoodAdministration Capsules can be opened and contentssprinkled on foodDipentum c (UCB Pharma) ACapsules, brown, olsalazine sodium 250 mg. Netprice 112-cap pack = £19.77. Label: 21, counselling,blood disorder symptoms (see recommendationabove)Tablets, yellow, scored, olsalazine sodium 500 mg.Net price 60-tab pack = £21.18. Label: 21, counselling,blood disorder symptoms (see recommendationabove)SULFASALAZINE(Sulphasalazine)Cautions see notes above; also history of allergy orasthma; G6PD deficiency (section 9.1.5); slow acetylatorstatus; risk of haematological and hepatic toxicity(differential white cell, red cell, and plateletcounts initially and at monthly intervals for first 3months; liver function tests at monthly intervals forfirst 3 months); maintain adequate fluid intake; uppergastro-intestinal side-effects common with doses over4 g daily; acute porphyria (section 9.8.2); interactions:Appendix 1 (aminosalicylates)Blood disorders see recommendation aboveContra-indications see notes above; also sulfonamidehypersensitivity; child under 2 years of ageHepatic impairment use with cautionRenal impairment risk of toxicity, including crystalluria,in moderate impairment—ensure high fluidintake; avoid in severe impairmentPregnancy theoretical risk of neonatal haemolysis inthird trimester; adequate folate supplements shouldbe given to motherBreast-feeding small amount in milk (1 report ofbloody diarrhoea); theoretical risk of neonatal haemolysisespecially in G6PD-deficient infantsSide-effects see notes above; also cough, insomnia,dizziness, fever, blood disorders (including Heinzbody anaemia, megaloblastic anaemia), proteinuria,tinnitus, stomatitis, taste disturbances, and pruritus;less commonly dyspnoea, depression, convulsions,vasculitis, and alopecia; also reported loss of appetite,hypersensitivity reactions (including exfoliativedermatitis, epidermal necrolysis, photosensitivity,anaphylaxis, serum sickness), ataxia, hallucinations,aseptic meningitis, oligospermia, crystalluria, disturbancesof smell, and parotitis; yellow-orange discolorationof skin, urine, and other body fluids; some softcontact lenses may be stainedIndication and doseTreatment of acute attack of mild to moderateand severe ulcerative colitis, active Crohn’sdisease. By mouthChild 2–12 years 10–15 mg/kg (max. 1 g) 4–6times daily until remission occurs; increased tomax. 60 mg/kg daily in divided doses, if necessaryChild 12–18 years 1–2 g 4 times daily untilremission occurs