CORDARONE TABLET 200 mg

Therapeutic Indications

Treatment should be initiated and normally monitored only under hospital or specialist supervision. Oral Cordarone is indicated only for the treatment of severe rhythm disorders not responding to other therapies or when other treatments cannot be used.

Tachyarrhythmias associated with Wolff-Parkinson-White Syndrome.

Atrial flutter and fibrillation when other drugs cannot be used.

All types of tachyarrhythmias of paroxysmal nature including: supraventricular, nodal and ventricular tachycardias, ventricular fibrillation: when other drugs cannot be used.

Contraindications

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, Cordarone should be used only in conjunction with a pacemaker.

Evidence or history of thyroid dysfunction. Thyroid function tests should be performed in all patients prior to therapy.

Known hypersensitivity to iodine or to amiodarone, or to any of the excipients. (One 200mg tablet contains approximately 75mg iodine).

The combination of Cordarone with drugs which may induce torsades de pointes is contraindicated (see Interactions with Other Medicinal Products and Other Forms of Interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pregnancy – except in exceptional circumstances (see Pregnancy and Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Lactation (see Pregnancy and Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Posology and Method of Administration

Adults

It is particularly important that the minimum effective dose be used. In all cases the patient’s management must be judged on the individual response and well being. The following dosage regimen is generally effective.

Initial Stabilisation

Treatment should be started with 200mg, three times a day and may be continued for 1 week. The dosage should then be reduced to 200mg, twice daily for a further week.

Maintenance

The minimum effective dosage should be used according to individual response. It may range between 100mg daily to 400mg daily. Cordarone may be given on alternative days (200mg may be given every other day where 100mg are recommended daily); therapeutic windows have been also recommended (2 days a week): they are possible due to the prolonged therapeutic action of Cordarone.

General Considerations

Initial dosing

A high dose is needed in order to achieve adequate tissue levels rapidly.

Maintenance

Too high a dose during maintenance therapy can cause side effects which are believed to be related to high tissue levels of amiodarone and its metabolites.

Amiodarone is strongly protein bound and has an average plasma half life of 50 days (reported range 20–100 days). It follows that sufficient time must be allowed for a new distribution equilibrium to be achieved between adjustments of dosage. In patients with potentially lethal arrhythmias the long half life is a valuable safeguard, as omission of occasional doses does not significantly influence the overall therapeutic effect. It is particularly important that the minimum effective dosage is used and the patient is monitored regularly to detect the clinical features of excess amiodarone dosage. Therapy may then be adjusted accordingly.

Dosage reduction/withdrawal

Side effects slowly disappear as tissue levels fall. Following drug withdrawal, residual tissue bound amiodarone may protect the patient for up to a month. However, the likelihood of recurrence of arrhythmia during this period should be considered.

Pediatric population

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

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 Contraindications, Special Warnings and Special Precautions for Use, and Undesirable Effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Cordarone Tablet 200mg is for oral administration.