Regulatory Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
INJECTION
**Posology and Method of Administration** Cordarone Intravenous should only be used when facilities exist for cardiac monitoring, defibrillation, and cardiac pacing. Cordarone Intravenous may be used prior to DC cardioversion. The standard recommended dose is 5mg/kg bodyweight given by intravenous infusion over a period of 20 minutes to 2 hours. This should be administered as a dilute solution in 250ml 5% dextrose. This may be followed by repeat infusion up to 1200mg (approximately 15mg/kg bodyweight) in up to 500ml 5% dextrose per 24 hours, the rate of infusion being adjusted on the basis of clinical response. _(see Special Warnings and Special Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)._ In extreme clinical emergency the drug may, at the discretion of the clinician, be given as a slow injection of 150–300mg in 10–20ml 5% dextrose over a minimum of 3 minutes. This should not be repeated for at least 15 minutes. Patients treated in this way with Cordarone Intravenous must be closely monitored, e.g. in an intensive care unit. _(see Special Warnings and Special Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)._ **_Change over from Intravenous to Oral Therapy_** As soon as an adequate response has been obtained, oral therapy should be initiated concomitantly at the usual loading dose (i.e. 200mg three times a day). Cordarone Intravenous should then be phased out gradually. **_Pediatric population_** The safety and efficacy of amiodarone in children has not been established. Due to the presence of benzyl alcohol, intravenous amiodarone is usually contraindicated in neonates and premature babies _(see Contraindications)._ **_Elderly_** 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 Contraindications, Special Warnings and Special Precautions for Use and Undesirable Effects_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. **_Cardiopulmonary resuscitation_** The recommended dose for ventricular fibrillations/pulseless ventricular tachycardia resistant to defibrillation is 300 mg (or 5 mg/kg bodyweight) diluted in 20 ml 5% dextrose and rapidly injected. An additional 150 mg (or 2.5 mg/kg bodyweight) IV dose may be considered if ventricular fibrillation persists. _See Incompatibilities_ for information on incompatibilities – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
INTRAVENOUS
Medical Information
**Therapeutic Indications** Treatment should be initiated and normally monitored only under hospital or specialist supervision. Cordarone Intravenous 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. All types of tachyarrhythmias including supraventricular, nodal and ventricular tachycardias; atrial flutter and fibrillation; ventricular fibrillation; when other drugs cannot be used. Cordarone Intravenous can be used where a rapid response is required or where oral administration is not possible. Cardiopulmonary resuscitation in the event of cardiac arrest related to ventricular fibrillation resistant to external electric shock.
**Contraindications** Sinus bradycardia and sino-atrial heart block. In patients with severe conduction disturbances (high grade AV block, bifascicular or trifascicular block) or sinus node disease, Cordarone should be used only in conjunction with a pacemaker. Evidence or history of thyroid dysfunction. Thyroid function tests should be performed where appropriate prior to therapy in all patients. Severe respiratory failure, circulatory collapse, or severe arterial hypotension; hypotension, heart failure and cardiomyopathy are also contraindications when using Cordarone Intravenous as a bolus injection. Known hypersensitivity to iodine or to amiodarone, or to any of the excipients. (One ampoule contains approximately 56mg iodine). The combination of Cordarone with drugs which may induce torsades de pointes is contraindicated _(see Interactions with Other Medicinal Products and Other Forms of Interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)._ Cordarone Intravenous ampoules contain benzyl alcohol. There have been reports of fatal 'gasping syndrome' in neonates (hypotension, bradycardia and cardiovascular collapse) following the administration of intravenous solution containing this preservative. Cordarone Intravenous should not be given to neonates or premature babies unless the rhythm disturbance is life threatening and either resistant to other medication or alternative therapy is deemed inappropriate. Pregnancy - except in exceptional circumstances _(see Pregnancy and Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)._ Lactation _(see Pregnancy and Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)_ All these above contraindications do not apply to the use of amiodarone for cardiopulmonary resuscitation of shock resistant ventricular fibrillation.
C01BD01
amiodarone
Manufacturer Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
SANOFI WINTHROP INDUSTRIE
Delpharm Dijon
Active Ingredients
Documents
Package Inserts
Cordarone Injection PI.pdf
Approved: May 19, 2020