País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
AMIODARONE HYDROCHLORIDE
Winthrop Pharmaceuticals UK Limited
AMIODARONE HYDROCHLORIDE
200 Milligram
Tablets
Withdrawn
2008-01-31
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amiodarone Hydrochloride 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200mg amiodarone hydrochloride. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off white, circular, biconvex tablet engraved 200 with action potential on one side and scored on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment should be initiated and normally monitored only under hospital or specialist supervision. Amiodarone is indicated for the treatment of severe rhythm disorders only when 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 including supraventricular, nodal and ventricular tachycardias, ventricular fibrillation, when other drugs cannot be used. Amiodarone is indicated for the prevention of ventricular arrhythmias in high-risk patients following myocardial infarction or in patients with clinical signs of congestive cardiac failure and/or Left Ventricular Ejection Fraction (LVEF) less than 40% who are receiving appropriate cardiac failure treatment which includes Angiotensin Converting Enzyme (ACE)-inhibitors. The minimum effective dose must be used and treatment must be initiated and used only under hospital/specialist supervision. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Amiodarone Tablets are for oral 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 s Leer el documento completo