• certain antihistamines e.g.
No other agents may be added to amiodarone infusions.This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.From a microbiological point of view, the product should be used immediately.For single use only. 4.5 Interaction with other medicinal products and other forms of interaction6.6 Special precautions for disposal and other handling9.
• Class Ia anti-arrhythmic drugs e.g.
This medicinal product is contraindicated in neonates (see section 4.3) and should be used with caution in infants and young children up to 3 years old (see section 4.4).As benzyl alcohol may cross the placenta, this medicinal product should be used with caution in pregnancy (see section 4.3 and 4.6). A possible interaction with a high oxygen concentration may be implicated (see section 4.4).Amiodarone and/or its metabolite, desethylamiodarone, inhibit CYP1A1, CYP1A2, CYP3A4, CYP2C9, CYP2D6 and P-glycoprotein and may increase exposure of their substrates. Class Ia and III antiarrhythmic agents should be avoided, as they are associated with QT interval prolongation and induction of Torsades de Pointes. Keep the ampoules in the outer carton in order to protect from light.For storage conditions after dilution of the medicinal product, see section 6.3.Each folding box contains 5 ml clear glass ampoules, type I, with 3 ml sterile concentrate.Before use, the sterile concentrate should be visually inspected for clarity, particulate matter, discolouration and the integrity of the container. After this time there is distribution into the tissue and a fast decrease of the plasma level within 4 hours.To achieve saturation of the tissue treatment needs to be continued intravenously or orally. grapefruit juice and certain medicinal products) during treatment with amiodarone.
2019 May;33(5):1214-1215. doi: 10.1053/j.jvca.2018.11.022. Intensive care unit admission should be considered. These effects on the thyroid in rats and mice are most likely due to effects of amiodarone on the synthesis and/or release of thyroid gland hormones.
• Class Ia anti-arrhythmic drugs e.g. After adjustment for other factors affecting survival, the adjusted ratio for survival to hospital admission was 2.49 (95% confidence interval, 1.28 to 4.85; p = 0.007) in the group receiving amiodarone, compared with the group receiving lidocaine. Following substantial overdose, onset of hypotension, heart block and Torsades de Pointes should also be expected. The following doses were used in paediatric clinical trials.- Loading dose: 10 to 20 mg/kg/day for 7 to 10 days (or 500 mg/m- Maintenance dose: the minimum effective dosage should be used; according to individual response, it may range between 5 to 10 mg/kg/day (or 250 mg/m- Loading dose: 5 mg/kg body weight over 20 minutes to 2 hours,- Maintenance dose: 10 to 15 mg/kg/day from few hours to several days.If needed oral therapy may be initiated concomitantly at the usual loading dose.Amiodarone has a slow elimination rate and a marked affinity for tissue. Furthermore, amiodarone is a non-competitive antagonist at both ß- and α-adrenoceptors and, therefore, has haemodynamic effects: dilatation of coronary arteries and peripheral vasodilation leading to a reduction of systemic blood pressure. During saturation amiodarone is accumulated particularly in the fat tissue and steady state is reached within a period of one to several months. Further treatment should be supportive and symptomatic.
In published uncontrolled studies, effective doses for children were:Loading dose: 5mg/kg body weight over 20 minutes to 2 hoursMaintenance dose: 10 to 15mg/kg/day from a few hours to several days. • The concomitant administration of amiodarone with drugs which may prolong the QT interval (see section 4.5)
The flecainide dose should be reduced accordingly and the patient closely monitored.Some of the more important drugs that interact with amiodarone include warfarin, digoxin, phenytoin and any drug which prolongs the QT interval. Optic neuropathy/neuritis that may progress to blindness.- Severe bradycardia (in cases of sinus node dysfunction and in the elderly) or (more rarely) sinus arrest: this may necessitate discontinuation of the treatment.
However, the possibility of cardiac defects should be kept in mind.