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Amiodarone hydrochloride: Indications, Dosing, Side Effects and Interactions
Amiodarone hydrochloride clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 6 min read
Amiodarone hydrochloride: Indications, Dosing, Side Effects and Interactions
Amiodarone hydrochloride clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Treatment of arrhythmias, particularly when other drugs are ineffective or contra-indicated (including paroxysmal supraventricular, nodal and ventricular tachycardias, atrial fibrillation and flutter, ventricular fibrillation, and tachyarrhythmias associated with Wolff-Parkinson-White syndrome) (initiated in hospital or under specialist supervision)**
- **Adult** (By Mouth): 200 mg 3 times a day for 1 week, then reduced to 200 mg twice daily for a further week, followed by maintenance dose, usually 200 mg daily or the minimum dose required to control arrhythmia.
- **Adult** (By Intravenous Infusion): Initially 5 mg/kg, to be given over 20-120 minutes with ECG monitoring, subsequent infusions given if necessary according to response; maximum 1.2 g per day.
**Ventricular fibrillation or pulseless ventricular tachycardia refractory to defibrillation [**
- **Adult** (By Intravenous Injection): for cardiopulmonary resuscitation] Initially 300 mg for 1 dose, dose should be given from a pre-filled syringe or diluted in 20 mL Glucose 5%, then 150 mg for 1 dose, dose should be given from a pre-filled syringe or diluted in 10 mL Glucose 5%, dose to be given if required. Consult Resuscitation Council (UK) guidelines for further details.
**Supraventricular and ventricular arrhythmias (initiated in hospital or under specialist supervision) for amiodarone hydrochloride**
- **Neonate** (By mouth): Initially 5-10 mg/kg twice daily for 7-10 days, then reduced to 5-10 mg/kg daily.
- **Child 1 month-11 years** (By mouth): Initially 5-10 mg/kg twice daily (max. per dose 200 mg) for 7-10 days, then reduced to 5-10 mg/kg once daily; maximum 200 mg per day.
- **Child 12-17 years** (By mouth): 200 mg 3 times a day for 1 week, then 200 mg twice daily for 1 week, then usually 200 mg daily adjusted according to response.
- **Neonate** (By intravenous infusion): 5 mg/kg every 12-24 hours, dose to be given over 30 minutes.
- **Child** (Initially by intravenous infusion): Initially 5 mg/kg, dose to be given slowly, over longer than 20 minutes, to avoid bradycardia and cardiac arrest, then (by continuous intravenous infusion) 300 micrograms/kg/hour, dose to be adjusted according to response, increased if necessary up to 1.5 milligrams/kg/hour; maximum 1.2 g per day.
**Ventricular fibrillation or pulseless ventricular tachycardia refractory to defibrillation [for cardiopulmonary resuscitation] for amiodarone hydrochloride**
- **Neonate** (By intravenous injection): 5 mg/kg for 1 dose, dose can be repeated once if required. Consult Resuscitation Council (UK) guidelines for further details.
- **Child** (By intravenous injection): 5 mg/kg for 1 dose (max. per dose 300 mg), then 5 mg/kg for 1 dose (max. per dose 150 mg), dose to be given if required. Consult Resuscitation Council (UK) guidelines for further details.
Cautions
General cautions: Acute porphyrias ; conduction disturbances (in excessive dosage); elderly; heart failure; hypokalaemia; severe bradycardia (in excessive dosage) Specific cautions: With intravenous use Moderate and transient fall in blood pressure (circulatory collapse precipitated by rapid administration or overdosage); severe hepatocellular toxicity Cautions, further information Elderly Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information): potentially inappropriate as first-line antiarrhythmic therapy in supraventricular tachyarrhythmias (higher risk of side-effects than beta-blockers, digoxin, verapamil, or diltiazem).
Contraindications
General contra-indications: Avoid in severe conduction disturbances (unless pacemaker fitted); avoid in sinus node disease (unless pacemaker fitted); iodine sensitivity; sino-atrial heart block (except in cardiac arrest); sinus bradycardia (except in cardiac arrest); thyroid dysfunction Specific contra-indications: With intravenous use Avoid bolus injection in cardiomyopathy; avoid bolus injection in congestive heart failure; avoid in circulatory collapse; avoid in severe arterial hypotension; avoid in severe respiratory failure
Side effects
General side-effects: Common or very common Arrhythmias; hepatic disorders; hyperthyroidism; nausea; pulmonary fibrosis; skin reactions Rare or very rare Bronchospasm (in patients with severe respiratory failure); headache; idiopathic intracranial hypertension; nerve disorders; SIADH Frequency not known Angioedema; confusion; delirium; pancreatitis; severe cutaneous adverse reactions (SCARs) Specific side-effects: Common or very common With oral use Constipation; corneal deposits; hypothyroidism; interstitial lung disease; movement disorders; photosensitivity reaction; respiratory disorders; sleep disorders; taste altered; vomiting With parenteral use Hypotension (following rapid injection) Uncommon With oral use Cardiac conduction disorders; dry mouth; myopathy (usually reversible on discontinuation); peripheral neuropathy (usually reversible on discontinuation) Rare or very rare With oral use Alopecia; aplastic anaemia; epididymo-orchitis; erectile dysfunction; haemolytic anaemia; pulmonary haemorrhage; thrombocytopenia; vertigo With parenteral use Hot flush; hyperhidrosis; interstitial pneumonitis; pulmonary toxicity Frequency not known With oral use Altered smell sensation; appetite decreased; parkinsonism; vasculitis With parenteral use Agranulocytosis; libido decreased; neutropenia Side-effects, further information Side-effects can occur at any time during treatment with, or in the months after stopping amiodarone. Corneal microdeposits Patients taking amiodarone may develop corneal microdeposits (reversible on withdrawal of treatment). However, if vision is impaired or if optic neuritis or optic neuropathy occur, amiodarone must be stopped to prevent blindness and expert advice sought. Thyroid function Amiodarone contains iodine and can cause disorders of thyroid function; both hypothyroidism and hyperthyroidism can occur. Hypothyroidism can be treated with replacement therapy without withdrawing amiodarone if it is essential; careful supervision is required. Hepatotoxicity Amiodarone is also associated with hepatotoxicity and treatment should be discontinued if severe liver function abnormalities or clinical signs of liver disease develop. Pulmonary toxicity If new or progressive shortness of breath or cough develops in patients taking amiodarone (or recently stopped), pulmonary toxicity should always be suspected. Pulmonary toxicity is usually reversible following early withdrawal of amiodarone.
Interactions
**Severe interactions:**
- Potentially severe complications have been reported in patients taking amiodarone undergoing general anaesthesia: bradycardia unresponsive to atropine, hypotension, disturbances of conduction,...
- Other drug interactions with amiodarone (see section 4.4) Coadministration of amiodarone with sofosbuvir-containing regimens may lead to serious symptomatic bradycardia.
**Other interactions (28):**
- In view of the long and variable half-life of amiodarone (approximately 50 days), potential for interactions with other medicinal products exists not only with concomitant medication but also with...
- Drugs inducing "Torsade de Pointes" or prolonging the QT interval Some of the more important active substances that interact with amiodarone include oral anticoagulants warfarin, digoxin, phenytoin...
- Combined therapy with the following drugs which prolong the QT interval is contra-indicated (see section 4.3) due to the increased risk of torsades de pointes; for example: Class Ia...
- Amiodarone raises the plasma concentrations of CYP2C9 substrates such as oral anticoagulants (warfarin) and phenytoin by inhibition of the cytochrome P450 2C9.
- Oral anticoagulants (warfarin) Amiodarone raises the plasma concentrations of oral anticoagulants (warfarin) by inhibition of CYP2C9.
- The dose of anticoagulants (warfarin) should be reduced accordingly.
Pregnancy
Possible risk of neonatal goitre; use only if no alternative.
Breast feeding
Avoid; present in milk in significant amounts; theoretical risk of neonatal hypothyroidism from release of iodine.
Medicinal forms
Solution,Tablet,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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