AMIODARONE

Amiodarone should only be used when facilities exist for cardiac monitoring, defibrillation, and cardiac pacing. Amiodarone may be used prior to DC cardioversion. The standard recommended dose is 5mg/kg bodyweight given by intravenous infusion over a period of 20 minutes to 2 hours.

This should be administered as a dilute solution in 250ml 5% w/v dextrose. 4). In extreme clinical emergency, the drug may, at the discretion of the clinician, be given as a slow injection of 150-300mg in 10-20ml 5%w/v dextrose over a minimum of 3 minutes.

This should not be repeated for at least 15 minutes. g. 4). e. 200mg three times a day). Amiodarone injection should then be phased out gradually.

Paediatric population:

The safety and efficacy of amiodarone in children has not been established. 2. 4).

Elderly:

As with all patients, it is important that the minimum effective dose is used. Whilst there is no evidence that dosage requirements are different for this group of patients, they may be more susceptible to bradycardia and conduction defects if too high a dose is employed.

8).

Cardiopulmonary resuscitation:

The recommended dose for ventricular fibrillations/pulseless ventricular tachycardia resistant to defibrillation is 300 mg (or 5 mg/kg body-weight) diluted in 20ml 5% w/v dextrose and rapidly injected. 5 mg/kg body-weight) IV dose may be considered if ventricular fibrillation persists.

2 for information on incompatibilities.

01%), not known (cannot be estimated from the available data). Blood and lymphatic system disorders: • In patients taking amiodarone there have been incidental findings of bone marrow granulomas.

The clinical significance of this is unknown • Frequency not known:

Neutropenia, agranulocytosis Cardiac disorders: • Common: bradycardia, generally moderate. 5). 1). 4). 4). • Very rare: Syndrome of inappropriate antidiuretic hormone secretion (SIADH) Gastrointestinal disorders: • Very rare: nausea. • Pancreatitis /acute pancreatitis General disorders and administration site conditions: • Common: injection site reactions such as pain, erythema, oedema, necrosis, extravasation, infiltration, inflammation, induration, thrombophlebitis, phlebitis, cellulitis, infection, pigmentation changes.

5 to 3 times normal range) at the beginning of therapy. They may return to normal with dose reduction or even spontaneously. 4). Immune system disorders: • Very rare: anaphylactic shock. • Frequency not known: Angioneurotic oedema (Quincke's Oedema) Musculoskeletal and Connective Tissue Disorders • Frequency not known: Back pain Nervous system disorders: • Very rare: benign intra-cranial hypertension (pseudo tumor cerebri), headache.

5) − bronchospasm and/or apnoea in case of severe respiratory failure, and especially in asthmatic patients.

Psychiatric disorders: • Frequency not known:

Delirium /Confusional state, hallucination, libido decreased. Skin and subcutaneous tissue disorders: • Common: eczema • Very rare: sweating. • Frequency not known: Urticaria, severe skin reactions sometimes fatal including toxic epidermal necrolysis (TEN)/Stevens- Johnson syndrome (SJS), bullous dermatitis and Drug reaction with eosinophilia and systematic symptoms (DRESS).

Amiodarone injection should only be used in a special care unit under continuous monitoring (ECG and blood pressure). 8). Circulatory collapse may be precipitated by too rapid administration or overdosage (atropine has been used successfully in such patients presenting with bradycardia).

Do not mix other preparations in the same syringe. Do not inject other preparations in the same line. 2). 8). When repeated or continuous infusion is anticipated, administration by a central venous catheter is recommended. When given by infusion amiodarone may reduce drop size and, if appropriate, adjustments should be made to the rate of infusion.

5): Before surgery, the anaesthetist should be informed that the patient is taking amiodarone. 3). Amiodarone has a low pro-arrhythmic effect. Onsets of new arrhythmias or worsening of treated arrhythmias, sometimes fatal, have been reported.

It is important, but difficult to differentiate a lack of efficacy of the drug from a proarrhythmic effect, whether or not this is associated with a worsening of the cardiac condition. 8). Despite QT interval prolongation, amiodarone exhibits a low torsadogenic activity.

Too high a dosage may lead to severe bradycardia and to conduction disturbances with the appearance of an idioventricular rhythm, particularly in elderly patients or during digitalis therapy. In these circumstances, amiodarone treatment should be withdrawn.

If necessary beta-adreno-stimulants or glucagon may be given. Because of the long half-life of amiodarone, if bradycardia is severe and symptomatic the insertion of a pacemaker should be considered.

The pharmacological action of amiodarone induces ECG changes:

QT prolongation (related to prolonged repolarisation) with the possible development of U-waves and deformed T-waves; these changes do not reflect toxicity. 5): Life-threatening cases of bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone.

1 (one pre-filled syringe contains approximately 112mg iodine). − Sinus bradycardia and sino-atrial heart block. In patients with severe conduction disturbances (high grade AV block, bifascicular or trifascicular block) or sinus node disease, amiodarone should be used only in conjunction with a pacemaker.

− Evidence or history of thyroid dysfunction. Thyroid function tests should be performed where appropriate prior to therapy in all patients. − Severe respiratory failure, circulatory collapse, or severe arterial hypotension; hypotension, heart failure and cardiomyopathy are also contra-indications when using amiodarone as a bolus injection.

5). 6). 6). All these above contra-indications do not apply to the use of amiodarone for cardiopulmonary resuscitation of shock resistant ventricular fibrillation.