** Cardio-Mep® (Amiodarone Hydrochloride) 150 mg/3 ml 6 Ampoules. Sterile. For I.V. infusion. Diluted in glucose solution. For Recurrent ventricular arrhythmias.
Recurrent ventricular arrhythmias.
** Dosage && Administration:
Amiodarone shows considerable interindividual variation in reponse.
Thus, although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose as needed is essential. The recommended starting dose of Cardio-mep I.V. is about 1000 mg over the first 24 hours of therapy, delivered by the infusion regimen:
– Loading infusions: First Rapid: 150 mg over the FIRST 10 minutes (15 mg / min.)
Add 3 mL of Cardio-mep I.V. (150 mg) to 100 mL D5W (concentration = 1.5 mg/ mL).
Infuse 100 mL over 10 minutes.
– Loading infusions: Followed by Slow;: 360 mg over the NEXT 6 hours (1 mg/min).
Add 18 mL of Cardio-mep I.V. (900 mg) to 500 mL D5W (concentration = 1.8 mg/ mL).
– Maintenance infusion: 540 mg over the REMAINING 18 hours (0.5 mg/min).
Decrease the rate of the slow loading infusion to 0.5 mg/min.
After the first 24 hours, the maintenance infusion rate of 0.5 mg/min (720 mg/24 hours) should be continued utilizing a concentration of 1 to 6 mg/mL (Cardio-mep I.V. concentrations greater than 2 mg/mL should be administered via a central venous catheter). In the event of breakthrough episodes of VF or hemodynamically unstable vt, 150 mg supplemental infusions should be administered over 10 minutes to minimize the potential for hypotension. The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.
– Certain cardiac rhythm and/or conduction disorders.
– Very slow heart rate.
– Known allergy to iodine.
– In combination with cardiac drugs that may cause cardiac arryhthmia or rhythm disorders.
In cases with doubt you should consult your doctor.
Cardio-Mep is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity.
If dyspnea prolonged or unexplained coughing, fatigue, fever, diarrhea or weight loss occurs, in addition to any new respiratory symptoms, which suggests the possibility of pulmonary toxicity, it is essential to consult your doctor.
Elevation of liver enzymes level may occur, if the level doubles or triples the normal dose, reduction or discontinuation of medication should be considered.
Avoid severe sun exposure during the treatment period in order to avoid sunburn reaction.
Cardio-Mep should not be used in familiar thyroid disorders, or if the patient is suffering of thyroid diseases.
** Pregnancy && Lactation:
Cardio-Mep is not generally recommended during pregnancy, except under exceptional circumstanes.
Cardio-Mep passes through breast milk, consequently breast-feeding is not recommended.