| Bioavailability of amiodarone tablets administered with and without food in healthy subjects. | |
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MedLine Citation:
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PMID: 11179527 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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X Meng; P Mojaverian; M Doedée; E Lin; I Weinryb; S T Chiang; P R Kowey |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: The American journal of cardiology Volume: 87 ISSN: 0002-9149 ISO Abbreviation: Am. J. Cardiol. Publication Date: 2001 Feb |
Date Detail:
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Created Date: 2001-03-01 Completed Date: 2001-04-12 Revised Date: 2004-11-17 |
Medline Journal Info:
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Nlm Unique ID: 0207277 Medline TA: Am J Cardiol Country: United States |
Other Details:
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Languages: eng Pagination: 432-5 Citation Subset: AIM; IM |
Affiliation:
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Wyeth-Ayerst Research, Philadelphia, Pennsylvania, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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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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