CORDARONE X Solution for injection Ref.[6724] Active ingredients: Amiodarone

Cordarone X Intravenous should only be used when facilities exist for cardiac monitoring, defibrillation, and cardiac pacing.

Cordarone X Intravenous 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% dextrose. This may be followed by repeat 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 (see section 4.4).

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% dextrose over a minimum of 3 minutes. This should not be repeated for at least 15 minutes. Patients treated in this way with Cordarone X Intravenous must be closely monitored, e.g. in an intensive care unit (see section 4.4).

Changeover from Intravenous to Oral therapy

As soon as an adequate response has been obtained, oral therapy should be initiated concomitantly at the usual loading dose (i.e. 200mg three times a day). Cordarone X Intravenous should then be phased out gradually.

Paediatric population

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

Currently available data are described in sections 5.1 and 5.2.

Due to the presence of benzyl alcohol, intravenous amiodarone is contraindicated in neonates, infants and children up to 3 years old.

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. Particular attention should be paid to monitoring thyroid function (see sections 4.3, 4.4 and 4.8).

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 20 ml 5% dextrose and rapidly injected. An additional 150 mg (or 2.5 mg/kg body-weight) IV dose may be considered if ventricular fibrillation persists.

See section 6.2 for information on incompatibilities.

There is no information regarding overdosage with intravenous amiodarone.

Little information is available regarding acute overdosage with oral amiodarone. Few cases of sinus bradycardia, heart block, attacks of ventricular tachycardia, torsades de pointes, circulatory failure and hepatic injury have been reported.

In the event of overdose, treatment should be symptomatic, 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. Due to the pharmacokinetics of amiodarone, adequate and prolonged surveillance of the patient, particularly cardiac status, is recommended.

Neither amiodarone nor its metabolites are dialysable.

24 months.

Do not store above 25°C. Store in the original container.

Cordarone X 150mg/3ml Solution for Injection is supplied in boxes containing 6 or 10 glass ampoules.

Not all pack sizes may be marketed.

Refer to 4.2 above.