MULTAQ 400 mg tablets.
July 28, 2009 – Sanofi-aventis said today MULTAQ (dronedarone) 400 mg tablets are now available in pharmacies in the United States.
MULTAQ is an antiarrhythmic drug indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ?50 mm or left ventricular ejection >40 percent), who are in sinus rhythm or who will be cardioverted. MULTAQ was approved by FDA July 1.
"MULTAQ may help patients with atrial fibrillation or atrial flutter stay out of the hospital, which is an important factor in treatment that is often not addressed," said Gerald V. Naccarelli, M.D., chief, division of cardiology, Pennsylvania State University College of Medicine. "We welcome a new option that may help patients with Afib or Aflutter manage their disease."
Initiation of MULTAQ treatment is contraindicated in patients with severe heart failure (NYHA Class IV) or NYHA Class II–III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. This unstable population corresponds to the population of the ANDROMEDA trial in which patients receiving dronedarone had a greater than two-fold increase in mortality compared to placebo.
For more information: http://products.sanofi-aventis.us/Multaq/Multaq.pdf