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Sang Duk Han, Sang Won Jung, Sun Woo Jang, Miwon Son, Byoung Moon Kim, Myung Joo Kang
The oral absorption of dronedarone (DRN), a benzofuran derivative with anti-arrhythmic activity, is significantly affected by food intake. The absolute bioavailability of the marketed product (Multaq, Sanofi, U.S.) was about 4% without food, but increased to 15% when administered with a high fat meal. Therefore, to reduce the food-effect on the intestinal absorption of DRN, a novel self-microemulsifying drug delivery system (SMEDDS) was formulated and the comparative in vivo absorption studies with the marketed product were carried out using male beagle dogs either in the fasted or fed state...
2015: Biological & Pharmaceutical Bulletin
Sang Duk Han, Sang Won Jung, Sun Woo Jang, Hyuck Jun Jung, Miwon Son, Byoung Moon Kim, Myung Joo Kang
In order to enhance the dissolution rate of dronedarone hydrochloride (DRN), a novel Soluplus(®) (polyethyleneglycol-polyvinyl caprolactam-polyvinyl acetate grafted copolymer)-based solid dispersion (SD) was formulated using a hot melt extrusion technique. The physical characteristics determined using scanning electron microscopy and X-ray powder diffraction, revealed that the active compound was molecularly dispersed in the amphiphilic polymer in a stable amorphous form. The dissolution rate of DRN from the tablet dosage form of SD extrudate consisted of the drug and Soluplus(®) in a weight ratio of 1 : 1, and was obviously more rapid and higher than that of the intact drug and marketed product (Multaq(®), Sanofi, U...
2015: Chemical & Pharmaceutical Bulletin
Pranav K Gandhi, William M Gentry, Michael B Bottorff
OBJECTIVES: To investigate the risk of bleeding events associated with concurrent administration of dabigatran-dronedarone compared with dabigatran standalone therapy using the Food and Drug Administration Adverse Event Reporting System (FAERS) database and to identify the characteristics of patients with bleeding events associated with concurrent use of dabigatran and dronedarone. DESIGN: Retrospective data mining analysis. SETTING: United States, from the dabigatran approval date (October 19, 2010) through the fourth quarter of 2011...
July 2013: Journal of the American Pharmacists Association: JAPhA
Suzanne M Smith, Mohammed Al-Bataineh, Stephen B Iorfido, Jarrod Macfarlane
A 71-year-old white male presented to the emergency department complaining of a worsening lower extremity rash. Thirteen days before presentation, the patient was placed on Multaq (dronedarone) for his paroxysmal atrial fibrillation. Biopsy-proven leukocytoclastic vasculitis (LV) was diagnosed, and causes for the condition other than drug-induced were investigated and ruled out. Rash has been cited as a possible side effect of Multaq; however, a literature search has revealed this to be the first documented case of likely multaq-induced LV...
May 2014: American Journal of Therapeutics
(no author information available yet)
Dronedarone (Multaq-Sanofi), an analog of amiodarone, was approved by the FDA in 2009 for oral treatment of paroxysmal or persistent (non-permanent) atrial fibrillation or atrial flutter. Amiodarone (Cordarone, and others) is more effective for this indication, but its use is often limited by its adverse effects, including thyroid and pulmonary toxicity.
December 12, 2011: Medical Letter on Drugs and Therapeutics
Claire McKenna, Emma Maund, Muhammad Sarowar, David Fox, Matt Stevenson, Chris Pepper, Nerys Woolacott, Stephen Palmer
The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of dronedarone (Multaq®, Sanofi-Aventis Limited, UK) to submit evidence on the clinical and cost effectiveness of the anti-arrhythmic drug (AAD) for the treatment of atrial fibrillation (AF) and atrial flutter, as part of the Institute's single technology appraisal (STA) process. The Centre for Reviews and Dissemination and the Centre for Health Economics, both at the University of York, were commissioned to act as the independent Evidence Review Group (ERG)...
January 2012: PharmacoEconomics
Shueh Hao Lim, Hugh Calkins, Sunil K Sinha
2010 saw the introduction of dabigatran (Pradaxa; Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT), following US Food and Drug Administration approval, into daily clinical practice in the United States as an alternative to Coumadin (Bristol-Myers-Squibb, New York, NY) therapy. Dronedarone (Multaq; Sanofi-Aventis, Bridgewater, NJ), originally approved for use in the United States in 2009, has seen further widespread deployment in contemporary clinical practice. Intravenous vernakalant (Cardiome Pharm, Vancouver, B...
October 2011: Current Cardiology Reports
(no author information available yet)
No abstract text is available yet for this article.
March 7, 2011: Medical Letter on Drugs and Therapeutics
Neelima Penugonda, Adam Mohmand-Borkowski, James F Burke
Dronedarone (Multaq), an analogue of amiodarone (Cordarone), was designed to cause fewer adverse effects than the parent compound. Studies have indeed shown dronedarone to be safer than amiodarone, but less effective. Its official indication is to reduce the risk of hospitalization in patients with paroxysmal or persistent atrial fibrillation or atrial flutter and other cardiovascular risk factors, reflecting the parameters of its effectiveness in clinical trials.
March 2011: Cleveland Clinic Journal of Medicine
(no author information available yet)
Atrial fibrillation (AF) is the commonest sustained heart arrhythmia and is associated with significant morbidity and mortality, with, for example, one in five of all strokes being attributable to the condition. Dronedarone (pronounced dro-ne-da-roan) (Multaq--sanofi-aventis) is a new anti-arrhythmic drug related to the established anti-arrhythmic amiodarone. It is licensed for use in clinically stable adult patients with a history of, or current, non-permanent AF to prevent recurrence of AF or to lower ventricular rate...
November 2010: Drug and Therapeutics Bulletin
(no author information available yet)
Dronedarone (Multaq - Sanofi-Aventis) has been approved by the FDA for oral treatment of atrial fibrillation and flutter. Amiodarone (Cordarone, and others) is the most effective drug for this indication, but has considerable toxicity.
October 5, 2009: Medical Letter on Drugs and Therapeutics
Sylvie Sablayrolles, Bruno Le Grand
sanofi-aventis (formerly Sanofi-Synthelabo) is developing the oral class III anti-arrhythmic agent dronedarone (Multaq) for the potential treatment and prevention of atrial fibrillation. In June 2005, sanofi-aventis submitted EU and US filings for atrial fibrillation. In October 2002, phase I trials for arrhythmia were reported to be ongoing in Japan.
September 2006: Current Opinion in Investigational Drugs
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