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AMIODARONE is a brand name for Amiodarone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment should be initiated and normally monitored only under hospital or specialist supervision. Amiodarone 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 •…
Verbatim from this product's MHRA label. Tap a section to expand.
Amiodarone should only be used when facilities exist for cardiac monitoring, defibrillation, and cardiac pacing. 6. Amiodarone may be used prior to direct current (DC) cardioversion.
Posology Adults Infusion Loading dose:
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 250 ml 5% dextrose. 4). The therapeutic effect is visible in the first minutes, then decreased gradually, and should be followed by a maintenance infusion.
Maintenance dose: 10 - 20 mg per kg bw in physiological glucose solution every 24 hours (on average 600 to 800 mg/ 24 hours up to a maximum of 1200 mg/ 24 hours accordingly 4-5 ampoules, maximum 8 ampoules) for a few days. On account of the stability of the solution, do not use concentrations below 300 mg per 500 ml and do not add other medicinal products to the infusion fluid.
To prevent local reactions (phlebitis), do not use concentrations exceeding 3 mg/ml. Repeated or continuous infusions via peripheral veins may lead to local reactions (inflammation). Whenever repeated or continuous infusions are intended, administration via a central line is recommended.
5 - 5 mg/kg) in 10-20 ml 5% glucose over a minimum of 3 minutes. This should not be repeated for at least 15 minutes. g. 4). 4). e. 200 mg three times a day). Amiodarone should then be phased out gradually. 5). Paediatric population The safety and efficacy of amiodarone in children has not been established.
2. Due to the presence of benzyl alcohol, amiodarone intravenous administration is contraindicated in neonates, infants and children up to 3 years old. 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. 8). Cardiopulmonary resuscitation Administration by a central venous catheter is recommended when it is immediately available.
If not, the administration must be done by a peripheral venous route, using a large peripheral vein and with a flow as important as possible, or possibly, by a slow injection over a minimum of 3 minutes, followed by administration of 200 ml of infusion fluid.
The following adverse reactions are classified by system organ class and ranked under heading of MedDRA frequency convention: very common (≥1/10), common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000), very rare (<1/10000); Not known (cannot be estimated from available data).
Blood and lymphatic systems disorders In patients taking amiodarone there have been incidental findings of bone marrow granulomas. The clinical significance of this is unknown. 4): Very common: micro-deposits at the anterior surface of the cornea are found in almost every patient, which are usually limited to the area below the pupil.
They may be associated with colored halos in dazzling light or blurred vision. 5 to 3 times normal range) at the beginning of therapy. 5) bronchospasm and/or apnoea in case of severe respiratory failure, and especially in asthmatic patients.
4). Common: eczema slate grey or bluish pigmentations of light-exposed skin, particularly the face, in case of prolonged treatment with high daily dosages; such pigmentations slowly disappear following treatment discontinuation.
Very rare: sweating erythema during the course of radiotherapy skin rashes, usually non-specific exfoliative dermatitis. Not known: urticaria severe skin reactions (sometimes fatal) such as toxic epidermal necrolysis (TEN)/Stevens- Johnson syndrome (SJS), bullous dermatitis and Drug reaction with eosinophilia and systematic symptoms (DRESS).
Vascular disorders:
Common: decrease in blood pressure, usually moderate and transient. Cases of hypotension or collapse have been reported following overdosage or a too rapid injection. 4) Reproductive system and breast disorders Not known: libido decreased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Amiodarone Intravenous should only be used in a special care unit under continuous monitoring (ECG and blood pressure). 8). Circulatory collapse may be precipitated by too rapid administration or overdosage (atropine has been used successfully in such patients presenting with bradycardia).
Do not mix other preparations in the same syringe. Do not inject other preparations in the same line. 2). Data of the SEARCH Study verify an increased risk of myopathy/rhabdomyolysis in combined use of amiodarone and simvastatin, which varies with the daily dose of simvastatin.
The pharmacological mechanism on which this interaction is based is not known. The indication for concomitant therapy of amiodarone with a statin should therefore be made with special caution. As no risk of myopathy/rhabdomyolysis is assumed only in case of a combined daily dose of amiodarone with simvastatin at low daily dose ≤ 20 mg, this simvastatin dose should not be exceeded.
5). Amiodarone may only be prescribed by competent specialists. Only to be used when other antiarrhythmics have shown insufficient effect. The patients must be monitored closely during treatment for radiological lungs examination, thyroid gland function and liver function test and ECG.
Amiodarone should only be used in a special care unit under continuous monitoring (ECG and blood pressure). v. injections (bolus injections) is discouraged due to the risk of haemodynamic effects, such as serious hypotension and cardiovascular collapse.
Such injections should only be used in an emergency - within a coronary intensive care unit and under ECG monitoring - when therapeutic alternatives have failed. Circulatory collapse may be precipitated by too rapid administration or overdosage (atropine has been used successfully in such patients presenting with bradycardia).
Its use should proceed with extreme caution - with haemodynamic monitoring - in patients with severe pulmonary impairment, arterial hypotension or stable congestive heart failure. Such patients should not be given a bolus injection (risk of exacerbation).
1 (one ampoule contains approximately 56 mg iodine) • Sinus bradycardia, sino-atrial heart block. 5) • Severe respiratory failure, circulatory collapse, or severe arterial hypotension; hypotension, heart failure and cardiomyopathy are also contraindications when using Amiodarone as a bolus injection.
However, these contraindications are not absolute and the use is allowed only under strict supervision with the greatest caution possible • Evidence or history of thyroid dysfunction. 6) • Lactation. 6). Not all these above contra-indications apply to the use of amiodarone for cardiopulmonary resuscitation of shock resistant ventricular fibrillation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Do not give other medicinal substances in the same syringe with amiodarone. Amiodarone can cause severe irritation of the vein, therefore adequate rinsing after bolus injection must be ensured. In treatment of prolonged, refractory ventricular fibrillation, after administration of adrenaline and defibrillation, 300 mg as bolus injection and repeated, if necessary, with 150 mg bolus injection.
The recommended dose for ventricular fibrillations/pulseless ventricular tachycardia resistant to defibrillation is 300 mg (or 5 mg/kg body-weight) diluted in 20 ml 5% dextrose and rapidly injected. 5 mg/kg body-weight) IV dose may be considered if ventricular fibrillation persists.
Patients with liver and kidney problems Although no dosage adjustment for patients with kidney or liver abnormalities has been defined during chronic treatment with oral amiodarone, close clinical monitoring is prudent for elderly patients.
6. 2 for information on incompatibilities
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The proposed dose of 5 mg per kg, given as a direct injection, must not be exceeded. g. e. use of a pacemaker or beta stimulation. The undiluted solution has not been adequately assessed for safety therefore, it is recommended not to use the solution for injection without prior dilution.
8). When repeated or continuous infusion is anticipated, administration by a central venous catheter is recommended. When given by infusion amiodarone may reduce drop size and, if appropriate, adjustments should be made to the rate of infusion.
5): Before surgery, the anaesthetist should be informed that the patient is taking amiodarone. 3). Amiodarone has a low pro-arrhythmic effect. Onsets of new arrhythmias or worsening of treated arrhythmias, sometimes fatal, have been reported.
It is important, but difficult to differentiate a lack of efficacy of the drug from a proarrhythmic effect, whether or not this is associated with a worsening of the cardiac condition. 8). Despite QT interval prolongation, amiodarone exhibits a low torsadogenic activity.
Too high a dosage may lead to severe bradycardia and to conduction disturbances with the appearance of an idioventricular rhythm, particularly in elderly patients or during digitalis therapy. In these circumstances, Amiodarone treatment should be withdrawn.
If necessary, beta-adrenostimulants or glucagon may be given. Because of the long half-life of amiodarone, if bradycardia is severe and symptomatic the insertion of a pacemaker should be considered.
The pharmacological action of amiodarone induces ECG changes:
QT prolongation (related to prolonged repolarisation) with the possible development of U-waves and deformed T-waves; these changes do not reflect toxicity. As with some other anti- arrhythmic agents, this phenomenon can lead to atypical ventricular tachycardias ("torsade de pointes") in exceptional cases.
5) Cases of severe, potentially life-threatening bradycardia and heart block have been observed when amiodarone is used in combination with sofosbuvir in combination with another hepatitis C virus (HCV) direct acting antiviral (DAA), such as daclatasvir, simeprevir, or ledipasvir.
Therefore, coadministration of these agents with amiodarone is not recommended. If concomitant use with amiodarone cannot be avoided, it is recommended that patients are closely monitored when initiating sofosbuvir in combination with other DAAs.
Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for at least 48 hours in an appropriate clinical setting after initiation of the concomitant treatment with sofosbuvir. Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on sofosbuvir alone or in combination with other direct DAAs.
Patients receiving these hepatitis C medicines with amiodarone, with or without other medicines […]