BNF for Children 2011-2012

BNFC 2011–2012 2.3.2 Drugs for arrhythmias 85neuropathy and myopathy (usually reversible onwithdrawal); very rarely chronic liver disease includingcirrhosis, sinus arrest, bronchospasm (in patientswith severe respiratory failure), ataxia, benign intracranialhypertension, headache, vertigo, epididymoorchitis,impotence, haemolytic or aplastic anaemia,thrombocytopenia, rash (including exfoliativedermatitis), hypersensitivity including vasculitis, alopecia,impaired vision due to optic neuritis or opticneuropathy (including blindness), anaphylaxis onrapid injection, also hypotension, respiratory distresssyndrome, sweating, and hot flushesLicensed use not licensed for use in children under 3yearsIndication and doseSupraventricular and ventricular arrhythmiassee notes above (initiated in hospital or under specialistsupervision). By mouthNeonate initially 5–10 mg/kg twice daily for 7–10days, then reduced to maintenance dose of 5–10 mg/kg once dailyChild 1 month–12 years initially 5–10 mg/kg(max. 200 mg) twice daily for 7–10 days, thenreduced to maintenance dose of 5–10 mg/kg oncedaily (max. 200 mg daily)Child 12–18 years 200 mg 3 times daily for 1week then 200 mg twice daily for 1 week thenusually 200 mg daily adjusted according toresponse. By intravenous infusionNeonate initially 5 mg/kg over 30 minutes then5 mg/kg over 30 minutes every 12–24 hoursChild 1 month–18 years initially 5–10 mg/kgover 20 minutes–2 hours then by continuousinfusion 300 micrograms/kg/hour, increasedaccording to response to max. 1.5 mg/kg/hour; donot exceed 1.2 g in 24 hoursVentricular fibrillation or pulseless ventriculartachycardia refractory to defibrillation (see alsosection 2.3.1). By intravenous injectionNeonate 5 mg/kg over at least 3 minutesChild 1 month–18 years 5 mg/kg (max. 300 mg)over at least 3 minutesAdministration intravenous administration via centralvenous catheter recommended if repeated or continuousinfusion required, as infusion via peripheral veinsmay cause pain and inflammation.For intravenous infusion, dilute to a concentration ofnot less than 600 micrograms/mL with Glucose 5%;incompatible with Sodium Chloride infusion; avoidequipment containing the plasticizer di-2-ethylhexphthalate(DEHP).For administration by mouth, tablets may be crushedand dispersed in water; injection solution should notbe given orally (irritant)Amiodarone (Non-proprietary) ATablets, amiodarone hydrochloride 100 mg, net price28-tab pack = £1.75; 200 mg, 28-tab pack = £2.22.Label: 11Injection, amiodarone hydrochloride 30 mg/mL, netprice 10-mL prefilled syringe = £19.60Excipients may include benzyl alcohol (avoid in neonates unless nosafer alternative available, see Excipients, p. 2)Sterile concentrate, amiodarone hydrochloride50 mg/mL, net price 3-mL amp = £1.33, 6-mL amp =£2.86. For dilution and use as an infusionExcipients may include benzyl alcohol (avoid in neonates unless nosafer alternative available, see Excipients, p. 2)Extemporaneous formulations available seeExtemporaneous Preparations, p. 6Cordarone X c (Sanofi-Aventis) ATablets, scored, amiodarone hydrochloride 100 mg,net price 28-tab pack = £4.28; 200 mg, 28-tab pack =£6.99. Label: 11Sterile concentrate, amiodarone hydrochloride50 mg/mL, net price 3-mL amp = £1.33. For dilutionand use as an infusionExcipients include benzyl alcohol (avoid in neonates unless no saferalternative available, see Excipients, p. 2)FLECAINIDE ACETATECautions children with pacemakers (especially thosewho may be pacemaker dependent because stimulationthreshold may rise appreciably); atrial fibrillationfollowing heart surgery; monitor ECG and have resuscitationfacilities available during intravenous use;interactions: Appendix 1 (flecainide)Contra-indications heart failure; abnormal leftventricular function; long-standing atrial fibrillationwhere conversion to sinus rhythm not attempted;haemodynamically significant valvular heart disease;avoid in sinus node dysfunction, atrial conductiondefects, second-degree or greater AV block, bundlebranch block or distal block unless pacing rescueavailableHepatic impairment avoid or reduce dose in severeimpairment; monitor plasma concentration (seepharmacokinetics below)Renal impairment reduce dose by 25–50% if estimatedglomerular filtration rate less than 35 mL/minute/1.73 m 2 and monitor plasma-flecainide concentration(see pharmacokinetics below)Pregnancy used in pregnancy to treat maternal andfetal arrhythmias in specialist centres; toxicityreported in animal studies; infant hyperbilirubinaemiaalso reportedBreast-feeding significant amount present in milk butnot known to be harmfulSide-effects oedema, pro-arrhythmic effects; dyspnoea;dizziness, asthenia, fatigue, fever; visual disturbances;rarely pneumonitis, hallucinations,depression, confusion, amnesia, dyskinesia, convulsions,peripheral neuropathy; also reported gastrointestinaldisturbances, anorexia, hepatic dysfunction,flushing, syncope, drowsiness, tremor, vertigo, headache,anxiety, insomnia, ataxia, paraesthesia,hypoaesthesia, anaemia, leucopenia, thrombocytopenia,corneal deposits, tinnitus, increased antinuclearantibodies, hypersensitivity reactions (including rash,urticaria, and photosensitivity), increased sweatingPharmacokinetics plasma-flecainide concentrationfor optimal response 200–800 micrograms/litre;blood sample should be taken immediately beforenext dose2 Cardiovascular system