Extended stability for parenteral drugs 5th preface

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    Any correspondence regarding this publication should be sent to the publisher, American Society of Health-SystemPharmacists, 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 asan 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 textare constantly evolving and are subject to the professional judgment and interpretation of the practitioner due to theuniqueness 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 anyerrors or omissions, and/or for any consequences arising from the use of the information in the document in any and allpractice 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 arisingout of the use or non-use of any of the information contained in this document.

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    2013, American Society of Health-System Pharmacists, Inc. All rights reserved.

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    ISBN: 978-1-58528-3408

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    DedicationE X T E N D E D S T A B I L I T Y F O R P A R E N T E R A L D R U G S

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    To the ever-growing network of colleagues who continue toinspire and encourage us:It is impossible to recognize and thank you all appropriately for yourcontinued support of this ongoing drug information project.

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    AcknowledgmentsE X T E N D E D S T A B I L I T Y F O R P A R E N T E R A L D R U G S

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    As with the prior editions, the preparation of this updatedreference was a team effort that would not have been possiblewithout the exceptional group of capable writers and reviewers.They spent many hours on what some might consider minutia butthis team considers essential. The editors appreciate the dedicationand focus that these extremely talented and very busy professionalsapplied to this edition.

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    ContentsE X T E N D E D S T A B I L I T Y F O R P A R E N T E R A L D R U G S

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    Preface..................................................... ix

    About the Editors ....................................... xi

    Writers.................................................... xii

    How to Use This Reference ......................... xiii

    Part IApplying Stability Data in Patient Care ............ 3

    Introduction ............................................ 3

    Factors Affecting Extended Drug Stability ........ 3

    Preparation Sterility and Quality Assurance ..... 4

    Professional, Regulatory, and AccreditationExpectations.......................................... 5

    Commercial Products and ExtemporaneousCompounding ....................................... 7

    Infusate Properties .................................... 8

    Vascular Access Devices and CathetersUsed in Medication Administration ............. 9

    Labeling Instructions................................ 12

    Assigning Beyond-Use Dates...................... 12

    Patient and Site-Specific Considerations ....... 13

    Considerations in Selecting AdministrationMethods and Infusion Devices................. 15

    External Factors Affecting Stability ............... 19

    Ethanol and Antibiotic Locks ..................... 20

    Summary.............................................. 20

    References ............................................ 20

    Parenteral Nutrition ................................... 23

    Beyond-Use Dating of Parenteral NutritionFormulations ....................................... 23

    Non-Formulation Factors Affecting PNStability.............................................. 23

    Formulation Factors Affecting PN Stability ..... 26

    Commercial Products and ExtemporaneousCompounding ..................................... 29

    Professional, Regulatory, and AccreditationExpectations and Guidance..................... 29

    Summary.............................................. 30

    Parenteral Nutrition Monographs ................ 31

    Carnitine .......................................... 31

    Chromium ........................................ 31

    Cimetidine........................................ 32

    Copper ............................................ 33

    Famotidine ....................................... 34

    Folic Acid ......................................... 35

    Heparin ........................................... 36

    Iron................................................. 36

    Manganese ....................................... 37

    Ranitidine ......................................... 38

    Selenium .......................................... 39

    Trace Elements .................................. 39

    Vitamin A ......................................... 40

    Vitamin B1 ....................................... 42

    Vitamin B2 ....................................... 43

    Vitamin B3 ....................................... 44

    Vitamin B5 ....................................... 44

    Vitamin B6 ....................................... 45

    Vitamin B12...................................... 45

    Vitamin C......................................... 46

    Vitamin D......................................... 47

    Vitamin E ......................................... 48

    Vitamin K ......................................... 49

    Zinc ................................................ 49

    References ............................................ 50

    Part IIDrug Monographs ..................................... 55

    Acetaminophen...................................... 57

    Acyclovir Sodium.................................... 58

    Aldesleukin ........................................... 60

    Amikacin Sulfate .................................... 61

    Amiodarone Hydrochloride....................... 63

    Amphotericin B...................................... 64

    Amphotericin B Cholesteryl SulfateComplex ............................................ 66

    Amphotericin B Lipid Complex .................. 67

    Amphotericin B Liposome ........................ 68

    Ampicillin Sodium .................................. 69

    Ampicillin SodiumSulbactam Sodium......... 71

    Azithromycin ......................................... 73

    Aztreonam............................................ 74

    Baclofen............................................... 76

    Bevacizumab......................................... 78

    Bleomycin Sulfate ................................... 79

    Bortezomib ........................................... 80

    Bumetanide .......................................... 81

    Bupivacaine Hydrochloride ....................... 82

    Calcitriol .............................................. 85

    Carboplatin ........................................... 86

    Caspofungin Acetate................................ 88

    Cefazolin Sodium ................................... 89

    Cefepime Hydrochloride .......................... 92

    Cefotaxime Sodium................................. 95

    Cefotetan Disodium ................................ 98

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    ContentsE X T E N D E D S T A B I L I T Y F O R P A R E N T E R A L D R U G S

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    Cefoxitin Sodium................................... 100

    Ceftaroline Fosamil ................................ 103

    Ceftazidime.......................................... 104

    Ceftriaxone Sodium ............................... 108

    Cefuroxime Sodium ............................... 112

    Chlorpromazine Hydrochloride ................. 115

    Cidofovir ............................................. 116

    Cimetidine Hydrochloride........................ 117

    Ciprofloxacin ........................................ 119

    Cisplatin.............................................. 121

    Cladribine............................................ 123

    Clindamycin Phosphate........................... 124

    Clonidine Hydrochloride ...............