Pharmacokinetics in children

A very small-scale study (n=4, ages 1 month to 14.9 years) showed that the half-life in children can be shorter than in adults (6.9 to 11.4 days). The half-life in adults is approximately 40 days. This study also showed that the clearance decreases as age increases. The study by Ramusovic (2013) shows that the serum concentrations in children aged from 6 days to 15 years are the same as those in adults.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Gastrointestinal complaints, hypothyroidism and hyperthyroidism, acute impaired liver function, photosensitization, neuropathy, microscopic corneal precipitation, bradycardia, pulmonary toxicity. Specific side-effects are possible after intravenous administration: localized reactions such as phlebitis, transient flushes and sweating, sudden blood pressure drops and increased heart rate, anaphylactic shock. After intravenous bolus injection: risk of severe hypotension and cardiovascular collapse. The side effects are largely the consequence of doses that are too high; the lowest effective dose should therefore be used.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Amiodarone may only be prescribed by expert specialists under careful monitoring of the hepatic function, the thyroid function, the ECG and X-ray examination of the thorax. Intravenous administration should be done in a clinic with monitoring of the ECG and blood pressure. In severe pulmonary insufficiency, arterial hypotension or stable cardiac failure (in particular in cardiomyopathy), extra caution is recommended and a bolus injection is contraindicated. A second bolus injection may not be given within 15 minutes of the first one. Infusion of amiodarone (repeated infusions in particular) via peripheral veins can cause thrombophlebitis; repeated administrations in particular should be done via a central line. Vials of amiodarone liquid for injection contain benzyl alcohol. There have been reports of fatal gasping syndrome in new-borns, in particular children with a low birthweight, after administration of intravenous solutions with benzyl alcohol

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

• CARDIOVASCULAR SYSTEM
• CARDIAC THERAPY

ANTIARRHYTHMICS, CLASS I AND III

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

References

1. Soult JA, et al., Efficacy and safety of intravenous amiodarone for short-term treatment of paroxysmal supraventricular tachycardia in children., Pediatr Cardiol, 1995, 16, 16-9
2. Saul JP, et al, Intravenous Amiodarone Pediatric Investigators Intravenous amiodarone for incessant tachyarrhythmias in children: a randomized, double-blind, antiarrhythmic drug trial., Circulation, 2005, 112, 3470-7
3. Paul T,, New antiarrhythmic drugs in pediatric use: amiodarone, Pediatr Cardiol, 1994, 15, 132-8
4. Laird WP, et al., Use of intravenous amiodarone for postoperative junctional ectopic tachycardia in children., Pediatr Cardiol, 2003, 24, 133-7
5. Drago F, et al., Amiodarone used alone or in combination with propranolol: a very effective therapy for tachyarrhythmias in infants and children., Pediatr Cardiol, 1998, 19, 445-9
6. Knirsch W, et al., Successful treatment of atrial flutter with amiodarone in a premature neonate. Case report and literature review, Adv Neonatal Care, 2007, 7, 113-21
7. Perry JC, et al., Pediatric use of intravenous amiodarone: efficacy and safety in critically ill patients from a multicenter protocol., J Am Coll Cardiol, 1996, 27, 1246-50
8. McKee MR ., Amiodarone-an \"old\" drug with new recommendations, Curr Opin Pediatr, 2003, 15, 193-9
9. Figa FH, et al, Clinical efficacy and safety of intravenous Amiodarone in infants and children, Am J Cardiol, 1994, 74, 573-7
10. Etheridge SP, et al, Amiodarone is safe and highly effective therapy for supraventricular tachycardia in infants., Am Heart J, 2001, 141, 105-10
11. Ramusovic S et al, Pharmacokinetics of intravenous amiodarone in children, Arch Dis Child., 2013, Dec;98(12), 989-93
12. Akin, A., et al, The efficacy of amiodarone-propranolol combination for the management of childhood arrhythmias, Pacing Clin Electrophysiol, 2013, 36 (6), 727-31
13. Djakow J et al. for the ERC Paediatric Life Support Writing Group collaborators., European Resuscitation Council Guidelines 2025 Paediatric Life Support, Resuscitation, 2025, Volume 215, 110767

Changes

Therapeutic Drug Monitoring

Overdose