Amiodarone

SOURCE SCOPE: this entry is from the UK SPC for Amiodarone 150 mg/3 mL concentrate for solution for injection/infusion (50 mg/mL) — an INTRAVENOUS product. This label contains no oral maintenance posology; the only oral figure it gives is for changeover ('As soon as an adequate response has been obtained, oral therapy should be initiated concomitantly at the usual loading dose (i.e. 200 mg three times a day). Amiodarone should then be phased out gradually' — the phasing out refers to the infusion). Oral tablet posology must be sourced separately from an oral amiodarone SPC before being published. Use only when facilities exist for cardiac monitoring, defibrillation and cardiac pacing; use only in a special care unit under continuous ECG and blood pressure monitoring. IV infusion is preferred to bolus due to haemodynamic effects. EXTREME CLINICAL EMERGENCY (slow injection, at the discretion of the clinician): 150 to 300 mg (or 2.5 to 5 mg/kg) in 10 to 20 mL 5% glucose over a minimum of 3 minutes; this should not be repeated for at least 15 minutes, and the patient must be closely monitored, e.g. in an intensive care unit. CARDIOPULMONARY RESUSCITATION — for ventricular fibrillation/pulseless ventricular tachycardia resistant to defibrillation, after administration of adrenaline and defibrillation: 300 mg (or 5 mg/kg body weight) diluted in 20 mL 5% dextrose and rapidly injected; an additional 150 mg (or 2.5 mg/kg body weight) IV dose may be considered if ventricular fibrillation persists. Ensure adequate rinsing after bolus injection (amiodarone can cause severe irritation of the vein) and do not give other medicinal substances in the same syringe. DILUTION LIMITS: do not use concentrations below 300 mg per 500 mL, and do not use concentrations exceeding 3 mg/mL (to prevent phlebitis); do not add other medicinal products to the infusion fluid; do not use the solution undiluted. In patients taking amiodarone concomitantly with simvastatin, the dose of simvastatin should not exceed 20 mg/day. Elderly: use the minimum effective dose; they may be more susceptible to bradycardia and conduction defects, and thyroid function should be monitored. PAEDIATRIC: the safety and efficacy of amiodarone in children has not been established, and due to the presence of benzyl alcohol intravenous administration is contraindicated in neonates, infants and children up to 3 years old.