Product Description:

• This medicine is used to treat certain serious heartbeat problems and to resuscitate patients experiencing cardiac arrest where a defibrillator (medical device that delivers electric shocks to restore normal heartbeat) has not worked to stop ventricular fibrillation (heartbeat problem that stops the heart from pumping blood properly).

How to Use:

• Cordarone 150 mg/3 ml solution for (IV) injection in ampoules should be used in a specialized hospital setting with continuous monitoring of the electrocardiogram (ECG) and blood pressure, except in life-threatening emergency situations.


• The dose should be adjusted on a case-by-case basis. The usual dose is as follows: At the start of treatment (loading dose), 5 mg per kg bodyweight.


• Administration may be repeated 2 or 3 times over a 24-hour period.


• Then, the following days (maintenance treatment), 10 to 20 mg/kg bodyweight per day, administered over several days.


• The switch to Cordarone tablets to be taken by mouth will also be started from the first day of infusion at a dose of 3 tablets per day.


• The dosage may be increased to 4 or even 5 tablets per day, as needed.


• Resuscitation of patients experiencing cardiac arrest where a defibrillator has not worked to stop ventricular fibrillation


• The initial intravenous dose is 300 mg (or 5 mg/kg bodyweight) diluted in 20 ml of 5% glucose solution, injected rapidly.


• An additional intravenous dose of 150 mg (or 2.5 mg/kg bodyweight) may be considered if ventricular fibrillation persists.

Caution & Warnings:

• This medicine should only be used in a specialized hospital setting under continuous monitoring, except in life-threatening emergency situations;


• Heartbeat problems, low blood pressure or heart failure may worsen with Cordarone injection, even if it is given very slowly;


• The injection can also cause lung and/or liver problems. For this reason, blood tests may be required during treatment in order to check how your liver is working;


• This medicine should be used with caution if you have electrolyte disorders, particularly a lack of potassium;


• If you are going to have surgery, tell your anesthesiologist that you are using this medicine before the operation;


• This medicine contains benzyl alcohol; this can cause gasping syndrome which can be fatal in premature and full-term newborns;


• If you experience severe skin reactions such as a blistering rash with peeling of the skin which can rapidly spread to the whole body and be life-threatening, immediately stop your treatment and consult a doctor.


• If your eyesight becomes dim.

Ingredients:

• The active substance is:


• Amiodarone hydrochloridefor one 3 ml ampoule 150 mg


• The other ingredients are: Polysorbate 80, benzyl alcohol, and water for injection.