AMIODARONE INJECTION

Why do you need this medication? Amiodarone injection contains Amiodarone, an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

ACTIVE INGREDIENT

Each ml contains 50 mg of amiodarone hydrochloride

Each 3 ml ampoule contains 150 mg amiodarone hydrochloride

Excipient with known effect: 60.6 mg of benzyl alcohol/ampoule of 3 ml sterile concentrate

CONTRAINDICATION

• Hypersensitivity to iodine or to amiodarone hydrochloride, or to any of the excipients
• Sinus bradycardia, sinoatrial heart block and sick sinus syndrome, unless the patient has a pacemaker
• Evidence or history of thyroid dysfunction.
• Severe respiratory failure, circulatory collapse, or severe arterial hypotension.
• Hypotension, heart failure and cardiomyopathy are also contraindications when using Amiodarone as bolus injection.
• Due to the presence of benzyl alcohol, intravenous amiodarone is contraindicated in neonates, infants and children up to 3 years old.
• The combination of Amiodarone with drugs which may induce Torsade’s de Pointes is contra-indicated

DOSAGE AND ADMINISTRATION

Routes of administration: Intravenous use

Amiodarone injection can be used where a rapid response is required or where oral administration is not possible.

Infusion: 

The standard recommended loading dose is 5 mg/kg bodyweight in 250 ml of 5% dextrose infused within 20 minutes to 2 hours. This may be repeated 2 to 3 times during the following 24 hours (up to 1200 mg/24 hours [approximately 15 mg/kg bodyweight] in up to 500 ml 5% dextrose) and the rate of infusion is to be controlled according to the clinical response.

Injection

In extreme clinical emergency the drug may, at the discretion of the clinician, be given as a slow injection of 150-300 mg in 10-20 ml 5% dextrose over a minimum of 3 minutes, dose should be given from a pre-filled syringe or diluted in 20ml Glucose 5%.

ADDED INFORMATION

Amiodarone should only be used in a special care unit under continuous monitoring (ECG and blood pressure).

WARNINGS AND PRECAUTIONS

Amiodarone is only to be used when other anti-arrhythmics have shown insufficient effect.

Intravenous injection is generally not recommended due to the haemodynamic risk (severe hypotension, circulatory collapse), and intravenous infusion is to be preferred where possible.

POSSIBLE SIDE EFFECTS

The most common adverse reactions (1-2%) leading to discontinuation of intravenous amiodarone therapy are hypotension, asystole/cardiac, arrest/pulseless electrical activity, VT, and cardiogenic shock

Other important adverse reactions are, torsade de pointes (TdP), congestive heart failure, and liver function test abnormalities.

STORAGE

Store in a refrigerator (2°C to 8°C)

Store in the original package in order to protect from light.