Document Detail


Bioavailability of amiodarone tablets administered with and without food in healthy subjects.
MedLine Citation:
PMID:  11179527     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The tablet form of amiodarone is indicated for the treatment of recurrent ventricular fibrillation or hemodynamically unstable ventricular tachycardia. It is recommended that the tablet be taken with meals in cases of gastrointestinal intolerance. However, the effect of food on its bioavailability is unknown. The primary objective of this study was to determine the effect of food on the bioavailability of amiodarone. This was a 2-period crossover study conducted in 30 healthy male subjects. Subjects were randomly assigned to 1 of 2 sequences in which the following 2 treatments were administered: (1) a single-dose of amiodarone (three 200-mg Cordarone tablets) after an overnight fast, and (2) the same dose immediately after a standard high-fat breakfast. Plasma concentrations of amiodarone and desethylamiodarone (DEA) were measured for 6 weeks after each dose. Food enhanced the extent of absorption, resulting in a peak concentration (Cmax) and area under the curve (AUCT) 3.8 and 2.4 times the respective values under fasting conditions. Food also significantly increased the rate of absorption, reducing the time (tmax) to Cmax from 7.1 to 4.5 hours. The effect of food on DEA levels was significant but less pronounced. An in vitro dissolution study confirmed a marked difference between amiodarone release under simulated fed and fasting conditions. Thus, food significantly enhances both the rate and extent of absorption of amiodarone, which is attributed partially to the effect of food on drug release from its formulation. Therefore, it is recommended that amiodarone tablets be taken consistently with meals.
Authors:
X Meng; P Mojaverian; M Doedée; E Lin; I Weinryb; S T Chiang; P R Kowey
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  The American journal of cardiology     Volume:  87     ISSN:  0002-9149     ISO Abbreviation:  Am. J. Cardiol.     Publication Date:  2001 Feb 
Date Detail:
Created Date:  2001-03-01     Completed Date:  2001-04-12     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0207277     Medline TA:  Am J Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  432-5     Citation Subset:  AIM; IM    
Affiliation:
Wyeth-Ayerst Research, Philadelphia, Pennsylvania, USA.
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MeSH Terms
Descriptor/Qualifier:
Adult
Amiodarone / administration & dosage,  pharmacokinetics*
Analysis of Variance
Anti-Arrhythmia Agents / administration & dosage,  pharmacokinetics*
Area Under Curve
Biological Availability
Chromatography, High Pressure Liquid
Food*
Humans
Male
Tablets
Chemical
Reg. No./Substance:
0/Anti-Arrhythmia Agents; 0/Tablets; 1951-25-3/Amiodarone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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