Venous irritation with Cordarone IV and two different formulations of Aqueous Amiodarone

Intravenous amiodarone is irritable to the venous system, however, often administered via a peripheral vein. This study evaluated the the risk of peripheral drug administration with Cordarone IV (C) and 2 aqueous formulation of intravenous amiodarone: Amio‐Aqueous (AA) (Academic Pharmaceuticals) and Aqueous Amiodarone IV (AAIV) (Wyeth). Method In a series of controlled trials, patients were randomized to either AA or lidocaine (L), or to either C or AAIV. Therapy with AA and AAIV were initiated with boluses of 150 mg amiodarone (10 ml, 15 mg/ml), C was initiated with 10‐minute infusion (75 ml, 2 mg/ml), all were followed with a 24‐hour infusion delivering 900‐1150 mg amiodarone over 24 hours. Therapy with L was initiated with 100 mg boluses followed by a 24‐hour infusion. Results A total of 177 patients received C, 168 patients received AAIV, 185 received AA, and 127 received L. The most common adverse events for AAIV and C were injection site inflammation (60% and 32%), injection site pain (55% and 22%), injection site edema (50% and 17%), and phlebitis (35% and 6%), p<0.001. In contrast, the incidence of venous irritation was 2% for AA with phlebitis in 1.6% (p<0.001). There was no venous irritation with L. X‐ray diffraction studies showed that the physical nature of the two aqueous formulations (AAIV and AA) were different. Conclusions Both C and AAIV are irritative to the venous system, while AA is not, a difference that could relate to the different micelle structure of amiodarone among the formulations. The original aqueous formulation (AA) appears to lack significant venous irritation and may be administered via a peripheral vein.