BNF for Children 2011-2012

178 4.2.1 Antipsychotic drugs BNFC 2011–20124 Central nervous systemAmisulpride (Non-proprietary) ATablets, amisulpride 50 mg, net price 60-tab pack =£7.18; 100 mg, 60-tab pack = £31.74; 200 mg, 60-tabpack = £16.47; 400 mg, 60-tab pack = £105.68.Label: 2Solian c (Sanofi-Aventis) ATablets, scored, amisulpride 50 mg, net price 60-tabpack = £22.76; 100 mg, 60-tab pack = £35.29; 200 mg,60-tab pack = £58.99, 400 mg, 60-tab pack = £117.97.Label: 2Solution, 100 mg/mL, net price 60 mL (caramel flavour)= £33.76. Label: 2ARIPIPRAZOLECautions see notes above; cerebrovascular diseaseContra-indications see notes aboveHepatic impairment use with caution in severeimpairmentPregnancy use only if potential benefit outweighsrisk—no information availableBreast-feeding avoid—present in milk in animalstudiesSide-effects see notes above; gastro-intestinal disturbances;tachycardia; fatigue, insomnia, agitation,akathesia, drowsiness, restlessness, tremor, headache,asthenia; blurred vision; less commonly depression;very rarely anorexia, dysphagia, oropharangealspasm, laryngospasm, hepatitis, jaundice, hypersalivation,pancreatitis, oedema, thromboembolism,arrhythmias, bradycardia, hypertension, chest pain,anxiety, speech disorder, suicidal ideation, seizures,hyponatraemia, stiffness, myalgia, rhabdomyolysis,priapism, urinary retention and incontinence, blooddisorders, sweating, alopecia, photosensitivity reactions,rash, and impaired temperature regulationLicensed use not licensed for use in children under15 years; not licensed for mania in childrenIndication and doseSchizophrenia and treatment and recurrenceprevention of mania (under specialist supervision). By mouthChild 13–18 years 2 mg once daily, increased to5 mg once daily after 2 days, then further increasedto 10 mg once daily after a further 2 days; furtherincreased if necessary in steps of 5 mg to max.30 mg dailyAbilify c (Bristol-Myers Squibb) ATablets, aripiprazole 5 mg (blue), net price 28-tabpack = £95.74; 10 mg (pink), 28-tab pack = £95.74;15 mg (yellow), 28-tab pack = £95.74; 30 mg (pink),28-tab pack = £191.47. Label: 2Orodispersible tablets, aripiprazole 10 mg (pink), netprice 28-tab pack = £95.74; 15 mg (yellow), 28-tabpack = £95.74. Label: 2, counselling, administrationExcipients include aspartame (section 9.4.1)Counselling Tablets should be placed on the tongue andallowed to dissolve, or be dispersed in water and swallowedOral solution, aripiprazole 1 mg/mL, net price150 mL with measuring cup = £102.57. Label: 2CLOZAPINECautions see notes above; monitor leucocyte and differentialblood counts (see Agranulocytosis, below);susceptibility to angle-closure glaucoma; taper offother antipsychotics before starting; close medicalsupervision during initiation (risk of collapse becauseof hypotension); dose adjustment may be necessary ifsmoking started or stopped during treatmentWithdrawal On planned withdrawal reduce dose over 1–2weeks to avoid risk of rebound psychosis. If abrupt withdrawalnecessary observe child carefullyAgranulocytosis Neutropenia and potentially fatalagranulocytosis reported. Leucocyte and differential bloodcounts must be normal before starting; monitor counts everyweek for 18 weeks then at least every 2 weeks and if clozapinecontinued and blood count stable after 1 year at leastevery 4 weeks (and 4 weeks after discontinuation); if leucocytecount below 3000/mm 3 or if absolute neutrophil countbelow 1500/mm 3 discontinue permanently and refer tohaematologist. Patients who have a low white blood cellcount because of benign ethnic neutropenia may be startedon clozapine with the agreement of a haematologist. Avoiddrugs which depress leucopoiesis; children (or carers) shouldreport immediately symptoms of infection, especially influenza-likeillnessMyocarditis and cardiomyopathy Fatal myocarditis (mostcommonly in first 2 months) and cardiomyopathy reported.. Perform physical examination and take full medicalhistory before starting;. Specialist examination required if cardiac abnormalitiesor history of heart disease found—clozapine initiatedonly in absence of severe heart disease and if benefitoutweighs risk;. Persistent tachycardia especially in first 2 monthsshould prompt observation for other indicators for myocarditisor cardiomyopathy;. If myocarditis or cardiomyopathy suspected clozapineshould be stopped and child evaluated urgently bycardiologist;. Discontinue permanently in clozapine-induced myocarditisor cardiomyopathyGastro-intestinal obstruction Reactions resembling gastrointestinalobstruction reported. Clozapine should be usedcautiously with drugs which cause constipation (e.g. antimuscarinicdrugs) or in children with history of colonicdisease or bowel surgery. Monitor for constipation andprescribe laxative if requiredContra-indications severe cardiac disorders (e.g.myocarditis; see Cautions); history of neutropenia oragranulocytosis (see Cautions); bone-marrow disorders;paralytic ileus (see Cautions); alcoholic and toxicpsychoses; history of circulatory collapse; drugintoxication; coma or severe CNS depression;uncontrolled epilepsyHepatic impairment monitor hepatic function regularly;avoid in symptomatic or progressive liver diseaseor hepatic failureRenal impairment avoid in severe impairmentPregnancy use with cautionBreast-feeding avoidSide-effects see notes above; also constipation (seeCautions), hypersalivation, dry mouth, nausea, vomiting,anorexia; tachycardia, ECG changes, hypertension;drowsiness, dizziness, headache, tremor, seizures,fatigue, impaired temperature regulation;urinary incontinence and retention; leucopenia,eosinophilia, leucocytosis; blurred vision; sweating;less commonly agranulocytosis (important: see Cautions);rarely dysphagia, hepatitis, cholestatic jaundice,pancreatitis, circulatory collapse, arrhythmia,myocarditis (important: see Cautions), pericarditis,thromboembolism, agitation, confusion, delirium,anaemia; very rarely parotid gland enlargement,intestinal obstruction (see Cautions), cardiomyopathy,myocardial infarction, respiratory depression, priapism,interstitial nephritis, thrombocytopenia, throm-