The recommended dosage of Multaq is 400 mg twice daily in adults. Patients should immediately report any symptoms of potential liver injury (such as sustained new-onset abdominal pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine or itching) to their physician. Appropriate investigation and close observation of patients should continue until normalisation of ALT. A synergistic effect on heart rate and atrio-ventricular conduction is possible. That’s why people with afib, their caregivers, and their doctors and other health care providers need to keep up with the latest research.Doctors and patients need to consider questions such as:The opening salvo from those concerned about Multaq came in an April 2010 article, Of interest is that one of the co-authors, Dr. Kaul, actually voted in favor of Multaq as a member of the FDA Advisory Committee that recommended that the FDA should approve it.Let's look at the three primary issues the JACC article raised: safety, efficacy and when to try Multaq.In pointing to pooled data from six dronedarone trials, Dr. Singh said, "These data suggest that dronedarone has modest antiarrhythmic efficacy (effectiveness)," and that it is only half as effective as amiodarone. If patients treated with dronedarone develop permanent AF, treatment with dronedarone should be discontinued.Dronedarone is contraindicated in patients in unstable hemodynamic conditions, with history of, or current heart failure or left ventricular systolic dysfunction (see section 4.3). The digoxin dose should be reduced by approximately 50%, serum levels of digoxin should be closely monitored and clinical and ECG monitoring is recommended. In ESC and ACC/AHA/HRS guidelines dronedarone has a class IA recommendation in patients with paroxysmal/persistent AF and coronary artery disease.In elderly patients ≥75 years with multiple co-morbidities, clinical signs of heart failure and ECG should be monitored on a regular basis (see sections 4.2 and 5.1).Hepatocellular liver injury, including life-threatening acute liver failure, has been reported in patients treated with dronedarone in the post-marketing setting. These medicinal products should be initiated at low dose and up-titration should be done only after ECG assessment. These effects most likely result from its electrophysiological properties belonging to all four Vaughan-Williams classes. Patients ranged in age from 28 to 90 years, 49% were more than 65 years old. Dronedarone (400 mg twice daily) increased simvastatin and simvastatin acid exposure by 4-fold and 2-fold respectively. There was a weak interaction between dronedarone and statins transported by OATP, such as rosuvastatin (which resulted in a mean 1.4-fold increase in rosuvastatin exposure).In clinical trials, there was no evidence of safety concerns when dronedarone was co-administered with statins metabolised by CYP 3A4. If an increase in creatininaemia is observed, serum creatinine should be re-measured after a further 7 days. Forty seven percent (47%) of patients were female and a majority was Caucasian (89%). Monitoring of their plasma concentrations and appropriate dose adjustment is recommended in case of coadministration with dronedarone.No decreases in ethinylestradiol and levonorgestrel were observed in healthy subjects receiving dronedarone (800 mg twice daily) concomitantly with oral contraceptives.Sotalol must be stopped before starting dronedarone (see sections 4.2 and 4.3). In patients already on calcium antagonists at time of dronedarone initiation, an ECG should be performed and the calcium antagonist dose should be adjusted if needed (see section 4.4).Other moderate inhibitors of CYP3A4 are also likely to increase dronedarone exposure. How Should Betapace Be Taken? Concomitant use of rivaroxaban and dronedarone is not recommended.Dronedarone may increase the exposure of apixaban (a CYP3A4 and P-gp substrate). It also prevents ventricular tachycardia and ventricular fibrillation in several animal models. Monitoring of co-administered medicinal products like digoxin and anti-coagulants is necessary. A number of patients had been previously exposed to amiodarone (see section 4.4).Reporting suspected adverse reactions after authorisation of the medicinal product is important. The study was stopped prematurely due to an observed imbalance of deaths in the dronedarone group [n = 25 versus 12 (placebo), p = 0.027] (see sections 4.3 and 4.4).