BNF for Children 2011-2012

BNFC 2011–2012 13.5.3 Drugs affecting the immune response 573month (discontinue if response still insufficientafter 6 weeks); initial dose of 2.5 mg/kg twice dailyjustified if condition requires rapid improvementImportant For preparations and counselling and foradvice on conversion between the preparations, seesection 8.2.2Refractory ulcerative colitis section 1.5.3Transplantation and graft-versus-host diseasesection 8.2.2PreparationsSection 8.2.2METHOTREXATECautions see section 8.1.3, also photosensitivity—psoriasis lesions aggravated by UV radiation (skinulceration reported)Contra-indications section 8.1.3Hepatic impairment avoid—dose-related toxicityRenal impairment section 8.1.3Pregnancy section 8.1.3Breast-feeding section 8.1.3Side-effects section 8.1.3Licensed use not licensed for use in children withpsoriasisIndication and doseSevere uncontrolled psoriasis unresponsive toconventional therapy (specialist use only). By mouthChild 2–18 years initially 200 micrograms/kg(max. 10 mg) once weekly increased according toresponse to 400 micrograms/kg (max. 25 mg)once weeklySafe PracticeNote that the above dose is a weekly dose. To avoiderror with low-dose methotrexate, it is recommendedthat:. the child or their carer is carefully advised of the dose andfrequency and the reason for taking methotrexate and anyother prescribed medicine (e.g. folic acid);. only one strength of methotrexate tablet (usually 2.5 mg) isprescribed and dispensed;. the prescription and the dispensing label clearly show thedose and frequency of methotrexate administration;. the child or their carer is warned to report immediately theonset of any feature of blood disorders (e.g. sore throat,bruising, and mouth ulcers), liver toxicity (e.g. nausea,vomiting, abdominal discomfort, and dark urine), and respiratoryeffects (e.g. shortness of breath).Malignant disease section 8.1.3Rheumatoid arthritis section 10.1.3Severe Crohn’s disease section 1.5.3PreparationsSection 10.1.3PIMECROLIMUSCautions UV light (avoid excessive exposure to sunlightand sunlamps), avoid other topical treatmentsexcept emollients at treatment site; alcohol consumption(risk of facial flushing and skin irritation)Contra-indications contact with eyes and mucousmembranes, application under occlusion, infection attreatment site; congenital epidermal barrier defects;generalised erythroderma; immunodeficiency; concomitantuse with drugs that cause immunosuppression(may be prescribed in exceptional circumstancesby specialists); application to malignant or potentiallymalignant skin lesionsSide-effects burning sensation, pruritus, erythema,skin infections (including folliculitis and less commonlyimpetigo, herpes simplex and zoster, molluscumcontagiosum); rarely papilloma, skin discoloration,local reactions including pain, paraesthesia,peeling, dryness, oedema, and worsening of eczema;skin malignancy reportedIndication and doseShort-term treatment of mild to moderate atopiceczema (including flares) when topical corticosteroidscannot be used; see also notesaboveChild 2–18 years apply twice daily until symptomsresolve (stop treatment if eczema worsens orno response after 6 weeks)Elidel c (Novartis) ACream, pimecrolimus 1%, net price 30 g = £19.69,60 g = £37.41, 100 g = £59.07. Label: 4, 28Excipients include benzyl alcohol, cetyl alcohol, propylene glycol,stearyl alcoholTACROLIMUSCautions infection at treatment site, UV light (avoidexcessive exposure to sunlight and sunlamps); alcoholconsumption (risk of facial flushing and skin irritation)Contra-indications hypersensitivity to macrolides;congenital epidermal barrier defects; generalisederythroderma; immunodeficiency; concomitant usewith drugs that cause immunosuppression (may beprescribed in exceptional circumstances by specialists);application to malignant or potentially malignantskin lesions; application under occlusion; avoidcontact with eyes and mucous membranesPregnancy manufacturer advises avoid unless essential;toxicity in animal studies following systemicadministrationBreast-feeding manufacturer advises avoid—presentin milk following systemic administrationSide-effects application-site reactions including rash,irritation, pain, and paraesthesia; herpes simplexinfection, Kaposi’s varicelliform eruption; applicationsiteinfections; less commonly acne; rosacea, and skinmalignancy also reportedIndication and doseShort-term treatment of moderate to severeatopic eczema (including flares) either unresponsiveto, or in children intolerant of conventionaltherapy; see also notes aboveChild 2–16 years initially apply 0.03% ointmentthinly twice daily for up to 3 weeks (consider othertreatment if eczema worsens or if no improvementafter 2 weeks) then reduce to once daily untillesion clearsChild 16–18 years initially apply 0.1% ointmentthinly twice daily until lesion clears (consider other13 Skin