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Extended Stability for Parenteral Drugs, 5Th Edition

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Extended Stability for Parenteral Drugs, 5Th Edition Name /bks_52233_bing/52233_fm 12/03/2012 09:21AM Plate # 0-Composite pg 1 # 1 Name /bks_52233_bing/52233_fm 02/27/2013 02:13PM Plate # 0-Composite pg 2 # 1 Any correspondence regarding this publication should be sent to the publisher, American Society of Health-System Pharmacists, 7272 Wisconsin Avenue, 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, contributors, and ASHP have made reasonable efforts to ensure the accu- racy and appropriateness of the information presented in this document. However, any user of this information is ad- vised that the editors, contributors, 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 specifi- cally 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. Director, Acquisitions and Product Development: Jack Bruggeman Editorial Project Manager: Ruth Bloom Project Editor: Johnna Hershey Cover and Page Design: David Wade ஽2013, 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, including photocopying, microfilming, and recording, or by any information storage and retrieval system, without written permission 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 Trademark Office. ISBN: 978-1-58528-3408 ii Name /bks_52233_bing/52233_fm 03/04/2013 03:36PM Plate # 0-Composite pg 3 # 1 Dedication EXTENDED STABILITY FOR PARENTERAL DRUGS o the ever-growing network of colleagues who continue to T inspire and encourage us: It is impossible to recognize and thank you all appropriately for your continued support of this ongoing drug information project. iii Name /bks_52233_bing/52233_fm 03/04/2013 03:36PM Plate # 0-Composite pg 4 # 2 Acknowledgments EXTENDED STABILITY FOR PARENTERAL DRUGS s with the prior editions, the preparation of this updated A 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 appreciate the dedication and focus that these extremely talented and very busy professionals applied to this edition. iv Name /bks_52233_bing/52233_fm 02/28/2013 10:22AM Plate # 0-Composite pg 5 # 1 Contents EXTENDED STABILITY FOR PARENTERAL DRUGS Preface..................................................... ix Ranitidine......................................... 38 About the Editors ....................................... xi Selenium .......................................... 39 Writers.................................................... xii Trace Elements .................................. 39 How to Use This Reference ......................... xiii Vitamin A......................................... 40 Vitamin B1 ....................................... 42 Part I Vitamin B2 ....................................... 43 Applying Stability Data in Patient Care ............ 3 Vitamin B3 ....................................... 44 Introduction ............................................ 3 Vitamin B5 ....................................... 44 Factors Affecting Extended Drug Stability........ 3 Vitamin B6 ....................................... 45 Preparation Sterility and Quality Assurance ..... 4 Vitamin B12...................................... 45 Professional, Regulatory, and Accreditation Expectations.......................................... 5 Vitamin C......................................... 46 Commercial Products and Extemporaneous Vitamin D......................................... 47 Compounding ....................................... 7 Vitamin E ......................................... 48 Infusate Properties .................................... 8 Vitamin K ......................................... 49 Vascular Access Devices and Catheters Zinc ................................................ 49 Used in Medication Administration ............. 9 References............................................ 50 Labeling Instructions................................ 12 Assigning Beyond-Use Dates...................... 12 Part II Patient and Site-Specific Considerations ....... 13 Drug Monographs ..................................... 55 Considerations in Selecting Administration Acetaminophen...................................... 57 Methods and Infusion Devices................. 15 Acyclovir Sodium.................................... 58 External Factors Affecting Stability ............... 19 Aldesleukin ........................................... 60 Ethanol and Antibiotic Locks ..................... 20 Amikacin Sulfate .................................... 61 Summary.............................................. 20 Amiodarone Hydrochloride....................... 63 References............................................ 20 Amphotericin B...................................... 64 Amphotericin B Cholesteryl Sulfate Parenteral Nutrition ................................... 23 Complex ............................................ 66 Beyond-Use Dating of Parenteral Nutrition Amphotericin B Lipid Complex .................. 67 Formulations ....................................... 23 Amphotericin B Liposome ........................ 68 Non-Formulation Factors Affecting PN Ampicillin Sodium .................................. 69 Stability.............................................. 23 Ampicillin Sodium–Sulbactam Sodium......... 71 Formulation Factors Affecting PN Stability..... 26 Azithromycin......................................... 73 Commercial Products and Extemporaneous Compounding ..................................... 29 Aztreonam............................................ 74 Professional, Regulatory, and Accreditation Baclofen............................................... 76 Expectations and Guidance..................... 29 Bevacizumab......................................... 78 Summary.............................................. 30 Bleomycin Sulfate ................................... 79 Parenteral Nutrition Monographs................ 31 Bortezomib ........................................... 80 Carnitine .......................................... 31 Bumetanide .......................................... 81 Chromium ........................................ 31 Bupivacaine Hydrochloride....................... 82 Cimetidine........................................ 32 Calcitriol .............................................. 85 Copper ............................................ 33 Carboplatin ........................................... 86 Famotidine ....................................... 34 Caspofungin Acetate................................ 88 Folic Acid......................................... 35 Cefazolin Sodium ................................... 89 Heparin ........................................... 36 Cefepime Hydrochloride .......................... 92 Iron................................................. 36 Cefotaxime Sodium................................. 95 Manganese ....................................... 37 Cefotetan Disodium ................................ 98 v Name /bks_52233_bing/52233_fm 02/27/2013 02:13PM Plate # 0-Composite pg 6 # 5 Contents EXTENDED STABILITY FOR PARENTERAL DRUGS Cefoxitin Sodium................................... 100 Etoposide ............................................ 175 Ceftaroline Fosamil ................................ 103 Etoposide Phosphate .............................. 177 Ceftazidime.......................................... 104 Famotidine .......................................... 178 Ceftriaxone Sodium ............................... 108 Fentanyl Citrate..................................... 179 Cefuroxime Sodium ............................... 112 Filgrastim............................................. 182 Chlorpromazine Hydrochloride ................. 115 Floxuridine........................................... 183 Cidofovir............................................. 116 Fluconazole.......................................... 184 Cimetidine Hydrochloride........................ 117 Fludarabine Phosphate............................ 186 Ciprofloxacin........................................ 119 Fluorouracil.......................................... 187 Cisplatin.............................................. 121 Foscarnet Sodium.................................. 190 Cladribine............................................ 123 Fosphenytoin Sodium ............................
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