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Drug dosage identifier

Amiodarone hydrochloride

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Amiodarone should be used only on the direction of a paediatric cardiologist

Dose and administration

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Intravenous1,2

  1. Loading dose: 25 microgram/kg/minute for 4 hours, then
  2. Maintenance dose: 5 to 15 microgram/kg/minute

Oral1,2

  1. 4mg/kg/dose every 8 hours for one week, then
  2. 4mg/kg/dose every 12 hours for one week, then
  3. 4mg/kg/dose once daily.

Note: if converting from IV infusion to oral dosing, use 4mg/kg/dose and consult cardiologist for oral dose frequency.

Indications

Control of ventricular and supraventricular arrhythmias including those associated with Wolff-Parkinson-White syndrome.

Contraindications

  1. Hypersensitivity to amiodarone or iodine.
  2. Sinus bradycardia.
  3. Sino-atrial heartblock.
  4. Severe respiratory failure.
  5. >Circulatory collapse, severe systemic hypotension, cardiogenic shock, 2nd or 3rd degree AV block.

Precautions

  1. Hepatic disease
  2. Pulmonary disease
  3. Thyroid disorders
  4. Hypotension, AV block, left ventricular dysfunction, heart failure, bradycardia, myocardiopathy
  5. Electrolyte imbalance
  6. Preterm infants less than 32 weeks gestation (the injection contains benzyl alcohol which was associated with the "gasping syndrome" with symptoms of hypotension, bradycardia, gasping respiration, cardiovascular collapse and death).

Drug interactions

Digoxin Reduce digoxin maintenance dose by half. If loading digoxin, use a full loading dose, then half maintenance dose. Monitor digoxin levels.
Flecainide Use carefully. Reduce flecainide dose
Diuretics  Risk of hypokalaemia.
Corticosteroids Risk of hypokalaemia.
Amphotericin Risk of hypokalaemia. 
Phenytoin  Monitor phenytoin levels. Phenytoin level may increase and amiodarone decrease 
Sotalol  Possible increase in QT interval 
Erythromycin IV  Possible increase in QT interval 
Beta-blockers and Calcium Channel Blockers  Not recommended with amiodarone because of possible increase in bradycardia, AV block, and myocardial depression. 
Anaesthetic agents  Use cautiously. 

Clinical pharmacology

Amiodarone is a Class III antiarrhythmic agent. Its broad spectrum of activity is due to prolongation of the action potential duration and refractory period of the atrial, nodal and ventricular tissues. It is extensively distributed into body tissues, accumulating in muscle and fat. Oral absorption is erratic, and may lead to a wide range in bioavailability. Des-ethyl amiodarone is an active anti-arrhythmic metabolite. For both parent drug and metabolite, biliary excretion with some enterohepatic recycling, is the major elimination route; there is very little urinary excretion.

Possible adverse effects

Adverse effects are common. Many are dose-related and decrease with a dose reduction. Possible adverse effects include:

  • Bradycardia, hypotension (possible with rapid infusion rates, or with prolonged use), arrhythmias, heart failure.
  • Fatigue, peripheral neuropathy, tremor.
  • Nausea, vomiting, constipation.
  • Corneal deposits, visual disturbances.
  • Photosensitivity, blue-grey discolouration of the skin.
  • Hepatotoxicity, pulmonary toxicity.
  • Hypothyroidism or hyperthyroidism due to iodine content of injection.
  • Venous irritation (when administered peripherally at concentrations > 2mg/ml.).

Special considerations

  1. Reduce dose in liver disease.
  2. Administration via a central venous catheter is recommended. Can be administered via a peripheral line.
  3. Monitor:
    1. Magnesium, potassium - take baseline levels.
    2. LFTs, thyroid function - take baseline levels.
    3. INR.
    4. ECG and pulse oximetry - monitor continuously
    5. Perform 12 lead ECG (for QTc interval)

Management of Amiodarone administration

Description

  • Amiodarone concentrate injection 150mg/3ml.
  • Amiodarone oral liquid - prepared by Pharmacy. Refer to the bottle label for details.

Prescription

Intravenous

Charted on fluid chart giving:

  • rate in ml/hour
  • dose in micrograms/kg/minute

Also charted on drug chart under "continuous infusions" giving:

  • amount of drug to be added
  • type and volume of base fluid
  • micrograms/kg/ml

Oral

  • Loading doses are charted on stat page of prescription chart in mg/dose.
  • Maintenance doses are charted on prescription chart in mg/dose.

Administration

Intravenous

  1. Compatible with glucose 5% only.
  2. Incompatible with heparin saline, (use glucose 5% as flush solution), sodium bicarbonate, and sodium chloride.
  3. The maximum concentration that can be used is 6mg/ml.
  4. Concentrations of amiodarone less than 0.6mg/ml are unstable and should not be used.
  5. Use a Pall 0.2 micron in-line filter.
  6. Administration via a non-DEHB containing infusion set (use leur lock extension set BC563 and BC561) should be considered to reduce the possibility of plasticisers leaching from the infusion bags.
  7. Infusion solutions should be changed after 24 hours.

Oral

  1. Shake well before administration.
  2. Can be administered with milk.

Nursing considerations

Intravenous

  1. Prior to intravenous administration document: blood pressure, respiratory rate and oxygen saturation level.
  2. Observe the cannula site closely, as sloughing of the skin and necrosis can occur with infiltration and extravasation of amiodarone.
  3. Monitor ECG and pulse oximetry continuously. Perform daily 12-lead ECG (for QTc interval).
  4. If the dose is changed, the patient recordings must be made every 10 minutes for the first ½ hour, then hourly for 2 hours, then 4 hourly.
  5. Diluted solution does not require protection from light.

Storage

  • Intravenous ampoules: store unopened ampoules below 25°C. Protect from light. Do not refrigerate.
  • Oral Liquid: Follow instructions on bottle label.

References

  1. Shann F. Drug Doses. Victoria:Royal Children's Hospital, 2001.
  2. Kemp CA, McDowell JM (eds.). Paediatric Pharmacopoeia (13th ed.). Melbourne: Pharmacy Dept., Royal Children's Hospital, 2002.
  3. Fenster PE et al. Pharmacokinetic evaluation of the digoxin-amiodarone interaction. J Am Coll Cardiol. 1985; 5:108.
  4. Nadamanee K etal. Amiodarone-digoxin interaction: clinical significance, time course of development, potential pharmacokinetic mechanisms and therpeutic implications. J Am Coll Cardiol. 1984; 4:111.
  5. Trissel LA. Handbook of Injectable Drugs (10th edition). American Society of Hospital Pharmacists;1998:Bethesda.
  6. Sweetman S. (Ed.) Martindale: The Extra Pharmacopoeia. (33rd. ed). London : Royal Pharmaceutical Society; 2002.
  7. Medicines for Children. Royal College of Paediatrics and Child Health. London: RCPCH Publications Limited,1999.
  8. Micromedex Healthcare Series Vol. 118.
  9. Amiodarone Data Sheet. Auckland: Baxter Healthcare Ltd, 2001.
  10. Amiodarone Protocol. Starship Health Paediatric and Congenital Cardiac Service, 2005 (available via the intranet on ADHB Intranet/Medication Administration Guidelines/Intravenous/Paediatric).

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Document Control

  • Date last published: 28 June 2005
  • Document type: Drug Dosage Guideline
  • Services responsible: ADHB Pharmacy, Neonatology, Paediatric Cardiology
  • Editor: Sarah Bellhouse
  • Review frequency: 2 years