Amiodaron-BP (inj)

Amiodaronum

1 ml of solution for injection contains amiodarone hydrochloride 50 mg; each ampoule (3 ml) contains amiodarone hydrochloride 150 mg. Excipient with known effect: benzyl alcohol 60 mg per ampoule.

Indication: Indicated for serious cardiac rhythm disorders when the oral route is not suitable: atrial rhythm disorders with high ventricular rate, tachycardias associated with Wolff-Parkinson-White syndrome, documented symptomatic and disabling ventricular rhythm disorders, and cardiopulmonary resuscitation in cardiac arrest due to ventricular fibrillation resistant to external electric shocks.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications - Hypersensitivity to amiodarone, to iodine, 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-grade atrioventricular conduction disorders without a pacemaker - Hyperthyroidism (amiodarone may aggravate it) - Cardiovascular collapse - Severe arterial hypotension - Pregnancy: 2nd and 3rd trimester - Breast-feeding - Combination with: medicinal products that induce torsade de pointes (other than antiparasitics, neuroleptics and methadone) ▪ class Ia antiarrhythmics (quinidine, hydroquinidine, disopyramide) ▪ class III antiarrhythmics (sotalol, dofetilide, ibutilide) ▪ other medicinal products such as: arsenic, bepridil, cisapride, citalopram, escitalopram, difemanil, IV dolasetron, domperidone, dronedarone, IV erythromycin, levofloxacin, mequitazine, mizolastine, moxifloxacin, prucalopride, IV spiramycin, IV toremifene, IV vincamine (see section 4.5) - telaprevir, - cobicistat. These contraindications do not apply when amiodarone is used in cardiopulmonary resuscitation for cardiac arrest due to ventricular fibrillation resistant to external electric shocks.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Related to the route of administration Central venous infusion used for severe rhythm disorders, when the oral route is not suitable, except for cardiopulmonary resuscitation in cardiac arrest due to ventricular fibrillation resistant to external electric shocks: Amiodarone for injection must be administered via a central venous line. - Intravenous administration into a peripheral vein may cause local effects such as phlebitis. Amiodarone for injection must be used only as an infusion. - Direct intravenous injection, even very slow, may worsen arterial hypotension, heart failure or severe respiratory failure (see section 4.8). Cardiopulmonary resuscitation in cardiac arrest due to ventricular fibrillation resistant to external electric shocks: - […]