AMIODARONE

Class III anti-arrhythmic medicine.

Dosage Forms

Tablet

100 mg
200 mg

Sterile concentrate:

50 mg/ml

Uses

  • Supraventricular arrhythmias
  • Ventricular arrhythmias
  • Ventricular fibrillation
  • Pulseless ventricular tachycardia in cardiac arrest refractory to defibrillation

Dose and Duration

Supraventricular and ventricular arrhythmias

➡️ By mouth

Adult and child above 12 years:200 mg every 8 hours for 1 week, then reduce to 200 mg every 12 hours for another 1 week. Usual maintenance dose 200 mg once daily or minimum required to control arrhythmia
Child 1 month–12 years: initially 5–10 mg/kg (max 200 mg) every 12 hours for 7–10 days, then reduce to maintenance dose of 5–10 mg/kg once a day (max 200 mg per day)
Neonate: initially 5–10 mg/kg every 12 hours for 7–10 days, then reduce to maintenance dose of 5–10 mg/kg once a day

➡️ By IV infusion

Adult: initially 5 mg/kg over 20–120 minutes while monitoring ECG. Give subsequent infusion if required depend ing on response up to max 1200 mg in 24 hours
Child 1 month–18 years: initially 5–10 mg/kg over 20 minutes–2 hours then by continuous infusion 0.3 mg/kg/hour, increased according to response to maxi mum dose of 1.5 mg/kg/hour (max 1200 mg in 24 hours)
Neonate: initially 5 mg/kg over 30 minutes then 5 mg/kg over 30 minutes every 12–24 hours
Ventricular fibrillation and pulseless ventricular tachycardia in cardiac arrest refractory to defibrillation (with epinephrine)
Adult: by IV injection, initially 300 mg (diluted in 20 ml glucose 5%). An additional dose of 150 mg by IV injection can be given if required after at least 15 minutes, followed by an IV infusion of 900 mg over 24 hours
Child 1 month–18 years: 5 mg/kg (max 300 mg) over at least 3 minutes
Neonate: 5 mg/kg over at least 3 minutes

Preparation

  • Dilute with 5% glucose. Concentration of solutions for IV infusion should not be less than 300 mg of amiodarone per 500 ml of glucose 5% (0.6 mg/ml) for stability and they should not exceed a concentration of 3 mg/ml

Contraindications

  • Sinus bradycardia, sino-atrial heart block or sinus node disease in patients without pacemaker
  • Thyroid dysfunction or history of thyroid dysfunction
  • Known iodine or amiodarone hypersensitivity
  • IV use in severe respiratory failure, circulatory collapse or severe arterial hypotension
  • Bolus injection in congestive heart failure or cardiomyopathy

Side Effects

  • Hypothyroidism, hyperthyroidism
  • Dose-dependent bradycardia, torsades de pointes
  • Corneal microdeposits
  • Nausea, vomiting, taste disturbances
  • Raised serum transaminases, acute liver failure, jaundice
  • Extrapyramidal tremor
  • Nightmares, sleep disorders
  • Pulmonary toxicity
  • Photosensitivity, skin pigmentation
  • Dose dependent bradycardia, hypotension
  • Increased heart rate immediately following injection
  • Injection site reactions, phlebitis

Interactions

  • Increased risk of arrhythmias when amiodarone is given with:
    Disopyramide, dronedarone, flecainide, erythromycin, levofloxacin, citalopram, amitryptyline, imipramine, ar temether with lumefantrine, chloroquine, mefloquine and quinine, haloperidol, chlorpromazine, trifluoperazine, fluphenazine, atazanavir, ritonavir, lithium and pentamidine isethionate
  • Beta blockers (increased myocardial depression)
  • Diltiazem, verapamil (increased risk of bradycardia, AV block and myocardial depression)
  • Digoxin (increased plasma concentration of digoxin)
  • Colchicine (increased risk of colchicine toxicity)
  • Simvastatin (increased risk of myopathy)
  • Warfarin (enhanced anticoagulant effect of warfarin)
  • Phenytoin (increased plasma concentration of phenytoin)

Patient Instructions

  • Avoid exposure to direct sunlight during treatment and and for several months after discontinuing amiodarone due to possibility of photosensitivity reactions. Use a wide spectrum sunscreen

Pregnancy

  • Do not use

Breastfeeding

  • Do not use (discontinue breastfeeding)

⚠️ Caution

  • Do not dilute with sodium chloride 0.9% solution
  • Amiodarone has a very long half-life and steady state may be achieved over many weeks or months
  • Reversible corneal microdeposits develop in most patients on amiodarone. They are usually asymptomatic but if vision is impaired or if optic neuritis or neuropathy oc curs, stop treatment immediately to prevent blindness and seek expert advice.
  • Amiodarone contains iodine and can cause disorders of thyroid function. Monitor thyroid function before starting treatment and every 6 months thereafter. Withdraw treatment temporarily if thyrotoxicosis develops
  • Monitor liver function before and every 6 months during treatment with amiodarone due to risk of hepatotoxicity. In case of severe liver toxicity, discontinue amiodarone
  • Excessive doses may lead to severe bradycardia and conduction disturbances
  • Only use in pregnancy if there is no alternative in life threatening or pregnancy-threatening arrhythmias as amiodarone may cause neonatal goiter