Amiodaron-BP (tab)

Amiodaronum

Each tablet contains amiodarone hydrochloride 200 mg. Excipient with known effect: lactose monohydrate 71 mg. Round, biconvex, white or off-white (cream-tinted) tablets marked 'BP' on one side.

Indication: Treatment must be initiated and monitored only in hospital or under specialist supervision; indicated only for severe rhythm disorders unresponsive to other therapies or when other treatments cannot be used: tachyarrhythmias associated with Wolff-Parkinson-White syndrome, atrial flutter and fibrillation (when other medicines cannot be used), and all types of paroxysmal tachyarrhythmias (including supraventricular, nodal and ventricular fibrillation) — for stabilisation and long-term treatment.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications
- hypersensitivity to iodine, to the active substance or to any of the excipients listed in section 6.1
- sinus bradycardia and sino-atrial block without a pacemaker;
- sick sinus syndrome without a pacemaker (risk of sinus arrest);
- high-degree atrioventricular block without a pacemaker;
- thyroid dysfunction (thyroid function tests should be performed in all patients before treatment)
- in combination with certain medicinal products that may cause torsade de pointes (see section 4.5).
- pregnancy, except in exceptional circumstances (see section 4.6);
- breast-feeding (see section 4.6);

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use
Amiodarone-BP may cause serious adverse reactions affecting the eyes, heart, lungs, liver, thyroid gland, skin and peripheral nervous system (see section 4.8). Because these reactions may be delayed, patients on long-term treatment must be carefully monitored. Since adverse reactions are usually dose-dependent, the minimum effective maintenance dose should be administered.
Anaesthesia
Before surgery, the anaesthetist should be informed that the patient is being treated with amiodarone (see sections 4.5 and 4.8). Chronic treatment with amiodarone may lead to a cumulative effect, increasing the haemodynamic risk associated with local or general anaesthesia because of adverse reactions. Adverse reactions include, in particular, bradycardia, hypotension, decreased cardiac output and disorders […]