Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Zentiva Pharma UK Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Trading as: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Treatment should be initiated and normally monitored only under hospital or specialist supervision. Oral Cordarone X 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.
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.
Treatment should be started with 200 mg, three times a day and may be continued for 1 week. The dosage should then be 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. Rarely, the patient may require a higher maintenance dose. The scored 100 mg tablet should be used to titrate the minimum dosage required to maintain control of the arrhythmia. The maintenance dose should be regularly reviewed, especially where this exceeds 200 mg daily.
A high dose is needed in order to achieve adequate tissue levels rapidly.
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.
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.
The safety and efficacy of amiodarone in children has not been established.
Currently available data are described in sections 5.1 and 5.2 but no recommendation on posology can be made.
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).
Cordarone X 100 is for oral administration.
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, gastric lavage may be employed to reduce absorption 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.
36 months.
Do not store above 25°C, protect from light.
Cordarone X 100 tablets are supplied in blister packs of 28 and 30 tablets packed in cardboard cartons.
Not all pack sizes may be marketed.
Not applicable.
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