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ASHP-Extended-Stability-2017.Pdf Purchased by [email protected], Anna Cunningham From: ASHP eBooks (digital.ashp.org) Any correspondence regarding this publication should be sent to the publisher, ASHP, 4500 East-West Highway, Suite 900, Bethesda, MD 20814, attention: Special Publishing. The information presented herein reflects the opinions of the contributors and advisors. It should not be interpreted as an official policy of ASHP or as an endorsement of any product. Because of ongoing research and improvements in technology, the information and its applications contained in this text are constantly evolving and are subject to the professional judgment and interpretation of the practitioner due to the uniqueness of a clinical situation. The editors and ASHP have made reasonable efforts to ensure the accuracy and appropriateness of the information presented in this document. However, any user of this information is advised that the editors and ASHP are not responsible for the continued currency of the information, for any errors or omissions, and/or for any consequences arising from the use of the information in the document in any and all practice settings. Any reader of this document is cautioned that ASHP makes no representation, guarantee, or warranty, express or implied, as to the accuracy and appropriateness of the information contained in this document and specifically disclaims any liability to any party for the accuracy and/or completeness of the material or for any damages arising out of the use or non-use of any of the information contained in this document. Editorial Project Manager: Ruth Bloom Production Manager: Johnna Hershey Cover & Page Design: David Wade Library of Congress Cataloging-in-Publication Data Names: Bing, Caryn M., editor. | Nowobilski-Vasilios, Anna, editor. | American Society of Health-System Pharmacists, issuing body. Title: Extended stability for parenteral drugs / [edited by] Caryn Dellamorte Bing, Anna Nowobilski-Vasilios. Description: Sixth edition. | Bethesda, MD : American Society of Health-System Pharmacists, [2017] | Includes bibliographical references and index. Identifiers: LCCN 2017001433 | ISBN 9781585285273 Subjects: | MESH: Drug Stability | Drug Storage | Time Factors | Home Infusion Therapy | Parenteral Nutrition | Handbooks Classification: LCC RS424 | NLM QV 735 | DDC 615.8/55--dc23 LC record available at https://lccn.loc.gov/2017001433 © 2017, American Society of Health-System Pharmacists, Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, includ- ing photocopying, microfilming, and recording, or by any information storage and retrieval system, without written permis- sion from the American Society of Health-System Pharmacists. ASHP is a service mark of the American Society of Health-System Pharmacists, Inc.; registered in the U.S. Patent and Trade- mark Office. ISBN: 978-1-58528-527-3 10 9 8 7 6 5 4 3 2 1 Purchased by [email protected], Anna Cunningham From: ASHP eBooks (digital.ashp.org) EXTENDED STABILITY FOR PARENTERAL DRUGS Dedication To the ever-growing network of colleagues who inspire and encourage us: It is impossible to recognize and thank you all appropriately for your continued support of this ongoing drug information project. Acknowledgments The preparation of this updated reference was a team effort that would not have been possible without the exceptional group of capable writers and reviewers. They spent many hours on what some might consider minutia but this team considers essential. The editors appre- ciate the dedication and focus that these extremely talented and very busy professionals applied to this edition, and are grateful to others who contributed extensively to prior editions. iii Purchased by [email protected], Anna Cunningham From: ASHP eBooks (digital.ashp.org) Contents EXTENDED STABILITY FOR PARENTERAL DRUGS Preface ......................................................................................vii Selenium .............................................................................. 38 About the Editors .......................................................................ix Trace Elements ..................................................................... 38 Writers’ Affiliations .................................................................... x Vitamin A ............................................................................. 39 How to Use This Reference .......................................................xi Vitamin B1 ............................................................................40 Vitamin B2 ............................................................................41 Part I Vitamin B3 ............................................................................42 Applying Stability Data in Patient Care ......................................1 Vitamin B5 ............................................................................42 Introduction ............................................................................3 Vitamin B6 ............................................................................43 Factors Affecting Extended Drug Stability ................................ 3 Vitamin B12 ..........................................................................43 Preparation Sterility and Quality Assurance .............................4 Vitamin C ............................................................................. 44 Professional, Regulatory, and Accreditation Expectations .........5 Vitamin D .............................................................................45 Commercial Products and Extemporaneous Compounding ......................................................................6 Vitamin E ..............................................................................46 Infusate Properties .................................................................. 7 Vitamin K ..............................................................................47 Vascular Access Devices and Catheters Used Zinc ......................................................................................47 in Medication Administration ............................................... 8 References ............................................................................47 Labeling Instructions ............................................................. 11 Part II Assigning Beyond-Use Dates .................................................11 Drug Monographs ....................................................................53 Patient and Site-Specific Considerations ................................12 Acetaminophen ....................................................................55 Considerations in Selecting Administration Methods Acyclovir sodium .................................................................. 56 and Infusion Devices ..........................................................14 ADO-Trastuzumab Emtansine ...............................................58 External Factors Affecting Stability .........................................18 Aldesleukin ...........................................................................59 Ethanol and Antibiotic Locks .................................................19 Amikacin Sulfate ...................................................................60 Summary ..............................................................................19 Amiodarone Hydrochloride .................................................. 62 References ............................................................................20 Amphotericin B..................................................................... 63 Parenteral Nutrition ................................................................. 23 Amphotericin B Lipid Complex .............................................64 Beyond-Use Dating of Parenteral Nutrition Formulations ...................................................................... 23 Amphotericin B Liposome .....................................................65 Non-Formulation Factors Affecting PN Stability .....................23 Ampicillin Sodium ................................................................ 66 Formulation Factors Affecting PN Stability .............................25 Ampicillin Sodium–Sulbactam Sodium ..................................68 Commercial Products and Extemporaneous Azithromycin ........................................................................ 70 Compounding ....................................................................29 Aztreonam ............................................................................71 Professional, Regulatory, and Accreditation Baclofen ............................................................................... 73 Expectations and Guidance ................................................ 30 Bevacizumab ........................................................................75 Summary ..............................................................................31 Bleomycin Sulfate .................................................................76 Parenteral Nutrition Monographs ............................................32 Blinatumomab .....................................................................77 Carnitine ...............................................................................32 Bortezomib ...........................................................................78 Chromium ...........................................................................32
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