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Amiodarone - Paediatrics

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For use in Ward 23b Intensive Observation Area (IOA)

Purpose of guideline

This guideline covers the use of IV amiodarone infusion in ward 23b and covers administration of IV amiodarone via a both central line and peripheral line access.

Please note there are different prescribing and administration guidelines for central and peripheral line administration within the document.

The use of amiodarone and the appropriate dose will be determined by the consultant cardiologist and/or cardiac surgeon only.

Where there is significant ventricular dysfunction the infant / child will be admitted to the PICU for commencement of the amiodarone infusion and starting dose reduced to 10 micrograms /kg/minute.

Action of medication

Complex drug with a broad spectrum of activity. Predominately Class III antiarrhythmic drug but also has actions similar to antiarrhythmic classes Ia, II and IV.

Main electrophysiological action is prolongation of the action potential and refractoriness of all cardiac structures resulting in reduction of membrane excitability in myocardial tissue.

  • prolongs the myocardial cell action potential in phase 3 (repolaristation) and refractory period of atrial, nodal and ventricular tissues 
  • Increases the refractory period via sodium and potassium channel effects.
  • Slows the intracardiac conduction of the cardiac action potential via sodium-channel effects5

Indications

Control of ventricular and supraventricular arrhythmias including those associated with Wolff Parkinson - White syndrome

Dose

INTRAVENOUS2 
1. For haemodynamically stable infant/child
Loading dose  25 micrograms/kg/minute for 4 hours, then 
Maintenance  5 to 15 micrograms/kg/minute 
(Do not exceed dose of 1200mg/24 hours)
2.  Where there is significant ventricular dysfunction
Dose reduced to 10 micrograms/kg/minute
The infant/child should be in PICU for commencement of the Amiodarone infusion

Please note there are different prescribing and administration guidelines for central and peripheral line administration

Central Line Prescription and Administration

CENTRAL LINE Prescription
Prescribe on the Fluid balance chart with a comment on the drug chart stating "IV amiodarone charted on fluid balance chart".
The prescription on the Fluid balance chart must include:
-  Amount of amiodarone to add, in mg
-  Diluent and final volume of infusion
-  Dose in micrograms /kg /minute
-  Rate in mls/ hour
-  Given via CVL
The recommended maximum concentration of prepared solution is 6mg/ml. Concentrations above this have been used and are done so at the prescriber's discretion. 
The concentration in the syringe is altered to administer the prescribed dose. 
Amount of amiodarone to be added  to
diluent to make up to 50mls 
1ml/hour = 
≤ 10kg: 30mg/kg  10 mcg/kg/min 
11‐ 40kg: 15mg/kg  5 mcg/kg/min 
>40kg: 7.5mg/kg  2.5 mcg/kg/min 
CENTRAL LINE Administration
Check your preparation using the examples above. 
- Central line administration is preferred.
- Dilute with glucose 5% only
Not compatible with heparin or sodium chloride.
- Check your preparation using calculation above or PICU drug infusion charts - under <30kg or >30kg.
To set up the pump:
In Guardrails choose 'Amiodarone Central line' for the correct weight range on the pump:
1. Input the amount of amiodarone (in milligrams) to be made up to 50mls
2. Input the child's weight.
3. Use up and down buttons to set the correct rate (mls/hr)

Guardrails will calculate and display delivered dose (micrograms/kg/minute). 

Peripheral Line Prescription and Administration

PERIPHERAL LINE Prescription
Prescribe on the Fluid balance chart with a comment on the drug chart stating "IV amiodarone charted on fluid balance chart".
The prescription on the Fluid balance chart must include:
Amount  of amiodarone to add, in mg
- Diluent and final volume of infusion.
Dose in micrograms /kg /minute.
- Rate in mls/ hour. 
- Given via Peripheral IV

The maximum concentration for peripheral administration is 2mg/ml (2000 micrograms /ml). Solutions of 0.6 mg/ml and less are unstable and should not be used. 

A standard concentration of 100mg Amiodarone in 50mls 5% glucose (2 mg/ml) is ALWAYS used. The rate is altered to administer the prescribed dose. To calculate rate in mls/hour to administer required dose use the calculation below:  
Amiodarone chart

PERIPHERAL LINE Administration
Check your preparation using the example above.
- Central line administration is preferred
- Dilute with glucose 5% only
Not compatible with heparin or sodium chloride.
To set up the pump
In Guardrails choose 'Amiodarone PERIPH' on the pump (4th option for amiodarone)
1. Input solution details (100mg in 50mls)
2. Input child's weight
3. Use up and down buttons to set the correct DOSE (micrograms/kg/minute)
Guardrails will calculate and display the correct rate (mls/hr) 

Observation and Documentation

  1. Child should be nursed in 23B IOA with continuous nursing observation.
  2. Prior to administration take baseline blood levels for:
    1. magnesium and potassium.
    2. liver function and thyroid function.
  3. Prior to administration document:
    1. blood pressure
    2. respiratory rate
    3. oxygen saturations
      Repeat every 10 minutes for first hour, then hourly.
  4. Monitor ECG and saturations continuously. Perform daily 12-lead ECG.
  5. Peripheral infusions: hourly observation of cannula site, as sloughing of the skin and tissue necrosis can occur with infiltration and extravasation.

Special considerations

Handover between staff is important: discussion with medical staff needs to take place at both morning and evening handover and also between nursing staff at each shift change:

  • To confirm that the infusion is to continue
  • To check the current dose (in micrograms/kg/minute) and rate (in ml/hour)
  • To independently double check the infusion dose calculation by both nursing staff members
  • Confirm appropriate prescription and administration used according to type of IV access (CVL or PIV)

Contraindications and Precautions

Contraindications1
Except in cardiac arrest Sinus bradycardia, sino-atrial heart block
Unless pacemaker fitted avoid in severe conduction disturbances or sinus node disease
Thyroid dysfunction; iodine sensitivity 
Avoid intravenous use in  Severe respiratory failure
Circulatory collapse or severe arterial hypotension
Avoid bolus injection in congestive heart failure or cardiomyopathy
Avoid rapid loading after cardiac surgery 
Precautions1
- Liver-function and thyroid-function tests recommended before treatment
- Hypokalaemia (measure serum-potassium before treatment)
- Heart failure, severe bradycardia and conduction disturbances in excessive dosage
- IV use may cause moderate and transient fall in blood pressure (circulatory collapse precipitated by rapid administration or overdosage)
- Severe hepato-cellular toxicity (monitor transaminases closely)
- Benzyl alcohol - containing injections in preterm infants have been associated with the "gasping syndrome"

For detailed information about this drug including clinical pharmacology, please see Medsafe Data Sheet - IV Cordarone in Reference viewer.

Possible adverse effects

  1. Negative inotropic effect
  2. Prolongation of QT interval
  3. Nausea, vomiting, taste disturbances, raised serum transaminases, jaundice, bradycardia, sleep disorders, corneal microdeposits, venous irritation (peripheral), photosensitivity
  4. Pulmonary toxicity
  5. Hypothyroidism and hyperthyroidism - due to iodine content of injection.
  6. Hepatotoxicity
  7. Before treatment, monitor:
    1. pulmonary function and chest x-ray.
    2. thyroid function.
    3. liver function.

Drug interactions

Amiodarone can potentially interact with many other drugs leading to, in some cases, toxic drug reactions.

  • Amiodarone and digoxin: reduce the digoxin dose to half maintenance. If loading digoxin, use full digoxin loading dose and half maintenance dose; take digoxin levels
  • Amiodarone and some drugs may induce torsades de pointes arrhythmias. These drugs should not be used with amiodarone: e.g. Class 1A antiarrhythmics, sotalol, erythromycin, mexiletine
  • Amiodarone may interact with some drugs lowering heart rate or causing conduction disturbances. These drugs are not recommended: beta - blockers, calcium antagonists
  • Amiodarone and drugs affecting electrolyte levels (especially potassium) should be used with caution: diuretics, corticosteroids, amphotericin, senna (stimulant laxative) are not recommended
  • Amiodarone may interact with other drugs leading to altered levels of those drugs e.g. warfarin, sildenafil, flecainide, phenytoin, cyclosporine, fentanyl, midazolam.
  • As amiodarone has a long half life, these drug interactions may potentially occur some time after amiodarone treatment has stopped.

For detailed information about drug interactions please see Medsafe Data Sheet - IV Cordarone in Reference viewer

Presentation

Cordarone X 150mg/3ml ampoule [50mg/ml]

References

  1. BNFc 2012 on-line October 2012.
  2. Shann.F. Drug Doses. On-line 27 November, 2012.
  3. Cordarone data sheet. Auckland, Sanofi-aventis New Zealand Ltd., 2012.
  4. Paediatric Injectable Drugs (4th ed.). Melbourne: The Royal Children's Hospital, 2011.
  5. Medsafe. (2016). Amiodarone Hydrochloride Injection Concentrate [updated 2015 October 1st 2015]. Retrieved March 19, 2016. Available from http://www.medsafe.govt.nz/profs/datasheet/a/Amiodaronehydrochlorideinj.pdf

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Document Control

  • Date last published: 30 March 2016
  • Document type: Drug Dosage Guideline
  • Services responsible: Paediatric Cardiology
  • Patient scope: For use in Ward 23B intensive observation area (IOA)
  • Author(s): Marion Hamer, Brenda Hughes, Jon Skinner
  • Review frequency: 2 years