Cordarone X

What it is

Cordarone X contains amiodarone hydrochloride as its active ingredient. The tablet formulation is available in 100 mg and 200 mg strengths. The intravenous injection contains 150 mg amiodarone hydrochloride in 3 mL.

Approved indications —

Severe cases of tachyarrhythmias (including Wolff-Parkinson-White Syndrome, supraventricular, nodal and ventricular tachycardias, atrial flutter and fibrillation, and ventricular fibrillation) not responding to other therapy. — Severe cases of tachyarrhythmias (atrial, junctional and ventricular) not responding to other therapy when a rapid response is required, for treatment initiated in hospital using the intravenous formulation.

Dosing overview

Due to poor absorption and wide inter-patient variability of absorption, the initial loading and subsequent maintenance dosage schedules must be individually titrated. **Oral tablets — Adults** Initial stabilisation should be started with 200 mg three times daily and may be continued for one week, then reduced to 200 mg twice daily for a further week. After the initial period the dosage should be reduced to 200 mg daily, or less if appropriate. **Intravenous injection** The standard recommended dose is 5 mg/kg body weight given by intravenous infusion over a period of 20 minutes to 2 hours, administered as a dilute solution in 250 mL 5% glucose. This may be followed by repeat infusions up to 1200 mg (15 mg/kg body weight) in up to 500 mL 5% glucose per 24 hours, with the rate of infusion adjusted on the basis of clinical response.

Key safety warnings

Treatment should be initiated in hospital. Cordarone X Intravenous should only be used where facilities exist for cardiac monitoring and defibrillation should the need arise. As amiodarone may induce thyroid disorders, particularly in patients with personal or family history of thyroid disorders, clinical and biological monitoring (ultrasensitive TSH assay) is recommended before starting treatment, during treatment and for several months following treatment discontinuation. Clinical and radiological evidence of pulmonary fibrosis and/or pneumonitis has been reported, and regular chest X-ray should be performed routinely in patients undergoing long term therapy or when diagnosis is suspected. Corneal deposits develop in almost all patients, and regular ophthalmological monitoring is recommended. Regular monitoring of liver function tests (transaminases) is recommended as soon as amiodarone is started and during treatment, as hepatotoxicity has occasionally been reported. Photosensitivity is quite common, and the intensity of these reactions could be alleviated by a reduction in dosage or by application of a protective sunscreen; patients should be instructed to avoid exposure to the sun or use protective measures during therapy. Cases of severe, potentially life-threatening bradycardia and heart block have been observed when amiodarone is used in combination with sofosbuvir alone or in combination with another hepatitis C virus direct acting antiviral such as daclatasvir, simeprevir or ledipasvir, and co-administration of these agents with amiodarone is not recommended.

Contraindications

Known hypersensitivity to iodine or amiodarone or to any of the excipients. Pregnancy and lactation. In patients in whom bradycardia or AV block is sufficient to cause syncope, patients with sick sinus syndrome (risk of sinus arrest) or with severe atrioventricular conduction disorders, amiodarone should only be used in conjunction with a pacemaker. Sinus bradycardia and sino-atrial heart block. Amiodarone is contraindicated in patients with evidence, or a history of thyroid dysfunction. Combined therapy with drugs which may induce torsades de pointes. Cordarone X Intravenous injection is contraindicated in the case of hypotension, severe respiratory failure, cardiomyopathy, heart failure, circulatory collapse and severe arterial hypotension. It is also contraindicated in bi- or tri-fascicular conduction disorders, unless a permanent functioning pacemaker is fitted or, unless the patient is in a special care unit and amiodarone is used under the cover of electrosystolic pacing. Due to the benzyl alcohol content, Cordarone X Intravenous injection is contraindicated in neonates (children less than one month of age) or premature neonates.

Regulatory history

Cordarone X tablets (100 mg and 200 mg) and Cordarone X Intravenous injection were first registered on the Australian Register of Therapeutic Goods on 30 September 1991.