Download Sample technical information leaflet: Amiodarone

NHS PASA Purchasing for safety project – Manchester pilot
Sample technical information leaflet: Amiodarone
Amiodarone
Cardarone X intravenous
Presentation of vial
Each 3ml ampoule contains 150mg amiodarone hydrochloride. Solution for infusion.
Licensed indications
Intravenous amiodarone is used for the treatment of severe rhythm disorders not responding to other
therapies or when other treatments cannot be used / rapid response is required or where oral
administration is not possible.
Tachyarrhythmias associated with Wolf-Parkinson-White syndrome.
All types of supraventricular, nodal and ventricular tachycardias, atrial flutter, atrial fibrillation, and
ventricular fibrillation.
Additional ICU indications
As above
Route and Method of Administration
Administration via a central venous catheter using an infusion pump is recommended (essential for
critical care dosing).
Only use where facilities exist for cardiac monitoring, defibrillation and cardiac pacing.
Administered through non DEHP-containing sets is preferable.
Standard dose
Loading dose: 5mg/kg bodyweight by intravenous infusion over 20 minutes to 2 hours as a dilute solution
in 250ml 5% dextrose.
Continuous infusion: up to 1200mg (approximately 15mg/kg bodyweight) in up to 500ml 5% dextrose per
24 hours, the rate of infusion being adjusted on the basis of clinical response.
In extreme clinical emergency: slow injection of: 150mg-300mg in 10-20mls 5% Dextrose over a
minimum of 3 minutes. This should not be repeated for at least 15 minutes.
Critical care dose
Loading dose: 300mg in 100mls 5% dextrose over 30 minutes to 1 hour
Continuous infusion: 24 hour continuous infusion. Doses from
300mg in 50ml 5% dextrose (6mg/ml) at 2ml/h
NHS PASA Purchasing for safety project – Manchester pilot
600mg in 50ml 5% dextrose (12mg/ml) at 2ml/h
900mg in 50ml 5% dextrose (18mg/ml) at 2ml/h
Compatibility
5% Dextrose at concentrations of NOT less than 0.6mg/ml.
i.e. Solutions containing less than 2 ampoules in 500ml dextrose 5% are unstable and should not be used.
Incompatibility
Sodium chloride (saline) solution,
Aminophylline, flucloxacillin, furosemide, heparin, sodium bicarbonate
Instructions for preparation
Use aseptic technique.
Draw up the correct volume of solution for the required dose into a syringe.
For standard dosing add to 5% dextrose bag
For critical care dosing make volume up to 50ml with 5% dextrose.
Renal / hepatic insufficiency
No special recommendations
Contraindications

Sinus bradycardia and sino-atrial heart block.

Thyroid dysfunction.

Known hypersensitivity to iodine, amiodarone, excipients

Neonates / premature babies unless essential

Pregnancy / lactation unless essential

Severe respiratory failure, circulatory collapse, or severe arterial hypotension; hypotension, heart
failure and cardiomyopathy are contra-indications when using a bolus injection.
These contraindications do not apply to the use of amiodarone for cardiopulmonary resuscitation of shock
resistant ventricular fibrillation. Refer to the Summary of Product Characteristics for a complete list.
Special precautions

Continuous monitoring (ECG and blood pressure) required.

Administration by a central venous catheter is recommended. Infusion via peripheral veins may
lead to inflammation.

Thyroid function tests should be performed where appropriate prior to therapy in all patients.

Severe hepatocellular insufficiency may occur within the first 24 hours of IV amiodarone. Monitor
transaminases .

Children < 3 years
NHS PASA Purchasing for safety project – Manchester pilot

Caution in patients with hypotension and decompensated cardiomyopathy and severe heart
failure

Elderly patients on digoxin therapy

Drug interactions. Use beta-blockers, heart rate lowering calcium channel inhibitors (verapamil,
diltiazem).
Side effects
Rapid administration may cause hot flushes, sweating, nausea and a moderate and transient reduction in
blood pressure.
Circulatory collapse may be precipitated by too rapid administration / overdosage.
Bronchospasm and/or apnoea may also occur. Isolated cases of anaphylactic shock reported.
Can cause serious adverse reactions affecting the lung, liver, thyroid gland, skin and peripheral nervous
system. Because these reactions can be delayed, patients on long-term treatment should be carefully
supervised.
Monitoring
Continuous ECG, B/P and CVP recordings
Withdraw drug if bradycardia occurs
Thyroid function
Liver function tests
Overdose
In addition to general supportive measures the patient should be monitored and if bradycardia occurs
beta-adrenostimulants or glucagon may be given.
Spontaneously resolving attacks of ventricular tachycardia may also occur. Prolonged surveillance of the
patient, particularly cardiac status, is recommended.
Not dialysable.
Common issues
Flush with dextrose
Extravasation may cause tissue damage. Stop infusion. Aspirate residual infusion fluid, raise limb and
refer for urgent review.
Pharmaceutical / handling precautions
Do not store above 25 degrees C
References
1. SPC Cordarone X Intravenous at http://www.medicines.org.uk/ accessed 31.01.08
2. UCL Injectable Medicines Administration Guide 2 nd edition. UCL Hospitals 2007
3. Handbook of Drugs in Intensive care 3rd edition 2006
4. http://www.extravasation.org.uk/home.html accessed 31.01.08
5. BNF 54