| PM101: intravenous amiodarone formulation changes can improve medication safety. | |
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MedLine Citation:
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PMID: 20074019 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Importance of the field: Intravenous amiodarone (A-IV) is used to manage ventricular and atrial arrhythmias. The current formulation uses polysorbate 80 and benzyl alcohol to maintain amiodarone in solution, and these co-solvents are linked with clinically-important adverse events and pharmaceutical incompatibilities. PM101 is a recently FDA-approved intravenous formulation of amiodarone that uses a cyclodextrin to solubilize amiodarone. Areas covered in this review: This review describes the clinical and pharmaceutical development of formulations of amiodarone for intravenous administration. The medical and pharmaceutical literature was searched for papers discussing A-IV, PM101 and their formulation components. Relevant literature was identified starting from 1948 to the present. What the reader will gain: The reader will learn about the important medical and pharmaceutical issues complicating A-IV administration, including an understanding of related hypotension and compatibility with commonly used infusion materials and how these issues may impact drug safety. PM101 has been developed to address several of these important issues. Take home message: PM101 is a new formulation of A-IV that is stable in commonly used infusion materials and avoids co-solvent related toxicities. |
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Authors:
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Paul F Souney; Warren D Cooper; Daniel J Cushing |
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Publication Detail:
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Type: Journal Article; Review |
Journal Detail:
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Title: Expert opinion on drug safety Volume: 9 ISSN: 1744-764X ISO Abbreviation: Expert Opin Drug Saf Publication Date: 2010 Mar |
Date Detail:
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Created Date: 2010-02-23 Completed Date: 2010-09-23 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101163027 Medline TA: Expert Opin Drug Saf Country: England |
Other Details:
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Languages: eng Pagination: 319-33 Citation Subset: IM |
Affiliation:
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Prism Pharmaceuticals, Inc., 1016 West Ninth Avenue, Suite 130, King of Prussia, PA 19406, USA. psouney@prismpharma.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Amiodarone
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administration & dosage*,
adverse effects,
chemistry* Animals Anti-Arrhythmia Agents / administration & dosage, adverse effects, chemistry Arrhythmias, Cardiac / drug therapy, metabolism Chemistry, Pharmaceutical / methods* Humans Injections, Intravenous |
| Chemical | |
Reg. No./Substance:
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0/Anti-Arrhythmia Agents; 1951-25-3/Amiodarone |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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