Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
AMIOTACH (sterile iv injection) SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): AMIOTACH (sterile iv injection) COMPOSITION: Each ampule contains Amiodarone Hydrochloride 150 mg/3 mL (50 mg/mL) and benzyl alcohol as preservative (2.02% m/v) PHARMACOLOGICAL CLASSIFICATION: A 6.2 Cardiac depressants PHARMACOLOGICAL ACTION: Amiodarone prolongs the duration of the action potential, particularly in the nodal and Purkinje tissue. Amiodarone does not appear to alter the resting membrane potential, but depresses membrane responsiveness, and prolongs the refractory period in the artria, AV-node, His-Purkinge system, ventricles and accessory antrioventricular conduction pathways. Amiodarone also demonstrates non-competitive-alpha and beta-adrenoceptor antagonism. INDICATIONS: Where rapid response is required in the control of tachyarrhythmias associated with Wolff-Parkinson-White syndrome and other types of tachyarrhythmias of paroxysmal nature including supraventricular, nodal and ventricular tachycardias, atrial flutter and atrial fibrillations and ventricular fibrillations which have proved to be resistant to other anti-arrhythmic therapy. CONTRA-INDICATIONS: AMIOTACH should not be used when the following medical problems exist: • Hypersensitivity to amiodarone. • Atrioventricular (AV) block, pre-existing 2nd or 3rd degree, without pacemaker (risk of complete heart block). • Bradycardic episodes resulting in syncope, unless controlled by pacemaker. • Severe sinus node function impairment, causing marked sinus bradycardia, less controlled by pacemaker (AMIOTACH reduces sinus node automatically and may cause atropine-resistant sinus bradycardia). • Acute hepatitis. • Severe respiratory failure, circulatory collapse and severe arterial hypotension. • Pregnancy and Lactation (see PREGNANCY AND LACTATION Read the complete document