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

600mg in 50ml 5% dextrose (12mg/ml) at 2ml/h NHS PASA Purchasing for safety project – Manchester pilot

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  Caution in patients with hypotension and decompensated cardiomyopathy and severe heart failure  Elderly patients on digoxin therapy NHS PASA Purchasing for safety project – Manchester pilot

 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 2nd 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