BNF for Children 2011-2012

304 5.2.1 Triazole antifungals BNFC 2011–20125 Infections. By intravenous infusionChild 1 month–18 years 2.5 mg/kg (max.200 mg) every 12 hours for 2 days, then 2.5 mg/kg(max. 200 mg) once daily for max. 12 daysHistoplasmosis. By mouthChild 1 month–18 years 5 mg/kg (max. 200 mg)1–2 times dailyMaintenance in HIV-infected patients to preventrelapse of underlying fungal infection andprophylaxis in neutropenia when standardtherapy inappropriate. By mouthChild 1 month–18 years 5 mg/kg (max. 200 mg)once daily, increased to 5 mg/kg (max. 200 mg)twice daily if low plasma-itraconazole concentration(see Cautions)Prophylaxis of deep fungal infections (whenstandard therapy inappropriate) in patientswith haematological malignancy or undergoingbone-marrow transplantation who are expectedto become neutropenic. By mouth (liquid preparation only)Child 1 month–18 years 2.5 mg/kg twice dailystarting before transplantation or before chemotherapy(taking care to avoid interaction withcytotoxic drugs) and continued until neutrophilcount recoversAdministration For intravenous infusion, dilute250 mg with 50 mL Sodium Chloride 0.9% and giverequisite dose through an in-line filter (0.2 micron)over 60 minutesItraconazole (Non-proprietary) ACapsules, enclosing coated beads, itraconazole100 mg, net price 15-cap pack = £7.21. Label: 5, 9, 21,25, counselling, hepatotoxicitySporanox c (Janssen) ACapsules, blue/pink, enclosing coated beads, itraconazole100 mg, net price 4-cap pack = £3.67; 15-cappack = £13.77; 28-cap pack (Sporanox c -Pulse) =£25.72; 60-cap pack = £55.10. Label: 5, 9, 21, 25,counselling, hepatotoxicityOral liquid, sugar-free, cherry-flavoured, itraconazole10 mg/mL, net price 150 mL (with 10-mL measuringcup) = £45.80. Label: 9, 23, counselling, administration,hepatotoxicityCounselling Do not take with food; swish around mouth andswallow, do not rinse afterwardsConcentrate for intravenous infusion, itraconazole10 mg/mL. For dilution before use. Net price 25-mLamp (with infusion bag and filter) = £62.58Excipients include propylene glycolVORICONAZOLECautions electrolyte disturbances, cardiomyopathy,bradycardia, symptomatic arrhythmias, history of QTinterval prolongation, concomitant use with otherdrugs that prolong QT interval; avoid exposure tosunlight; patients at risk of pancreatitis; monitor liverfunction before treatment and during treatment; haematologicalmalignancy (increased risk of hepaticreactions); monitor renal function; interactions:Appendix 1 (antifungals, triazole)Contra-indications acute porphyria (section 9.8.2)Hepatic impairment in mild to moderate hepaticcirrhosis use usual initial dose then halve subsequentdoses; no information available for severe hepaticcirrhosis—manufacturer advises use only if potentialbenefit outweighs riskRenal impairment intravenous vehicle may accumulateif estimated glomerular filtration rate less than50 mL/minute/1.73 m 2 —use intravenous infusiononly if potential benefit outweighs risk, and monitorrenal function; alternatively, use tablets or oral suspension(no dose adjustment required)Pregnancy toxicity in animal studies—manufactureradvises avoid unless potential benefit outweighs risk;effective contraception required during treatmentBreast-feeding manufacturer advises avoid—noinformation availableSide-effects nausea, vomiting, abdominal pain, diarrhoea,jaundice, oedema, hypotension, chest pain,respiratory distress syndrome, sinusitis, headache,dizziness, asthenia, anxiety, depression, confusion,agitation, hallucinations, paraesthesia, tremor, influenza-likesymptoms, hypoglycaemia, haematuria,blood disorders (including anaemia, thrombocytopenia,leucopenia, pancytopenia), acute renal failure,hypokalaemia, visual disturbances, (including alteredperception, blurred vision, and photophobia), rash,pruritus, photosensitivity, alopecia, cheilitis, injectionsitereactions; less commonly dyspepsia, duodenitis,cholecystitis, pancreatitis, hepatitis, constipation,arrhythmias (including QT interval prolongation),syncope, raised serum cholesterol, hypersensitivityreactions (including flushing), ataxia, nystagmus,hypoaesthesia, adrenocortical insufficiency, arthritis,blepharitis, optic neuritis, scleritis, glossitis, gingivitis,psoriasis, Stevens-Johnson syndrome; rarelypseudomembranous colitis, taste disturbances (morecommon with oral suspension), convulsions, insomnia,tinnitus, hearing disturbances, extrapyramidaleffects, hypertonia, hypothyroidism, hyperthyroidism,discoid lupus erythematosus, toxic epidermal necrolysis,pseudoporphyria, retinal haemorrhage, opticatrophy; also reported squamous cell carcinoma ofskin (particularly in presence of phototoxicity)Indication and doseInvasive aspergillosis; serious infectionscaused by Scedosporium spp., Fusarium spp.,or invasive fluconazole-resistant Candida spp.(including C. krusei). By mouthChild 2–12 years (oral suspension recommended)200 mg every 12 hoursChild 12–18 years, body-weight under 40 kg200 mg every 12 hours for 2 doses then 100 mgevery 12 hours, increased if necessary to 150 mgevery 12 hoursChild 12–18 years, body-weight over 40 kg400 mg every 12 hours for 2 doses then 200 mgevery 12 hours, increased if necessary to 300 mgevery 12 hours