for Extended Stability Parenteral Drugs Third Edition Caryn M. Bing, R.Ph., M.S., FASHP Editor
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1 Extended Stability for Parenteral Drugs Third Edition Editor Caryn M. Bing, R.Ph., M.S., FASHP 1 American Society of Health-System Pharmacists Bethesda, Maryland
2 Contents Preface Acknowledgments x/ Dedication About the Editor x Writers How to Use This Reference x Applying Stability Data to Everyday Practice Factors Affecting Extended Drug Stability Preparation Sterility and Quality Assurance Professional, Regulatory, and Accreditation Expectations Commercial Products and Extemporaneous Compounding Labeling Instructions Assigning Expiration Dates Site of Care Considerations for Stability Dating Considerations in Selecting Administration Methods and Infusion Devices External Factors Affecting Stability Parenteral Nutrition Beyond-Use Date of Parenteral Nutrition Formulations Appendix I. Published Studies on Vitamin Stability in PN/TNA Appendix II. Published Studies on Trace Elements and Other Minerals in PN/TNA Appendix III. Published Studies on Drug Additives to PN/TNA Drug Monographs Acyclovir Sodium Aldesleukin Alemtuzumab Amikacin Sulfate Amiodarone Hydrochloride Amphotericin B Amphotericin B Cholesteryl Sulfate Complex Amphotericin B Lipid Complex Amphotericin B Liposomal Ampicillin Sodium Ampicillin Sodium-Sulbactam Sodium Aztreonam Baclofen
3 ontents Bleomycin Sulfate 68 Bumetanide 69 Bupivacaine Hydrochloride 70 Calcitriol 71 Carboplatin 72 Cefamandole Naftate 73 Cefazolin Sodium 74 Cefepime Hydrochloride 76 Cefoperazone 77 Cefotaxime Sodium 78 Cefotetan Disodium 80 Cefoxitin Sodium 82 Ceftazidime 84 Ceftizoxime Sodium 86 Ceftriaxone Sodium 87 Cefuroxime Sodium 89 Chlorpromazine Hydrochloride 91 Cidofovir 92 Cimetidine Hydrochloride 93 Ciprofloxacin 94 Cisplatin 96 Cladribine 98 Clindamycin Phosphate 99 Clonidine Hydrochloride 707 Co-Trimoxazole (Trimethoprim-Sulfamethoxazole) 703 Cyclophosphamide 704 Cyclosporine 705 Cytarabine 706 Dacarbazine 707 Dadizumab 708 Daptomycin 709 Daunorubicin Hydrochloride (Daunomycin) 7 70 Deferoxamine Mesylate 77 7 Dexamethasone Sodium Phosphate 712 Dimenhydrinate 7 74 IV
4 Contents Diphenhydramine 7 75 Dobutamine Hydrochloride 7 76 Docetaxel 7 77 Dopamine Hydrochloride 7 78 Doxorubicin Hydrochloride 7 79 Doxycycline Hydate 727 Enoxaparin Sodium 722 Epirubicin Hydrocloride 723 Epoetin Alfa 724 Epoprostenol Sodium 725 Ertapenem 726 Erythromycin Lactobionate 727 Etoposide 728 Etoposide Phosphate 730 Famotidine 737 Fentanyl Citrate 732 Filgrastim 734 Floxuridine 735 Fluconazole 736 Fludarabine Phosphate 737 Fluorouracil 738 Foscarnet Sodium 740 Fosphenytoin Sodium 747 Furosemide 742 Ganciclovir Sodium 743 Gatifloxacin 744 Gemcitabine Hydrochloride 745 Gentamicin Sulfate 746 Glycopyrrolate 748 Granisetron Hydrochloride 749 Haloperidol Lactate 750 Heparin Sodium 757 Hydralazine Hydrochloride 753 Hydrocortisone Sodium Succinate 754 Hydromorphone Hydrochloride 755
5 Contents Hydroxyzine Hydrochloride 756 Ifosfamide 757 Imipenem-Cilastatin Sodium 758 Infliximab 759 Interferon alfa-2b 760 Irinotecan 767 Itraconazole 762 Leucovorin Calcium 763 Levofloxacin 764 Linezolid 765 Lorazepam 766 Meperidine Hydrochloride 767 Meropenem 768 Mesna 7 70 Methadone Hydrochloride 7 77 Methotrexate Sodium 772 Methylprednisolone Sodium Succinate 773 Metodopramide Hydrochloride 7 74 Metronidazole, Metronidazole Hydrochloride 776 Midazolam 7 78 Milrinone Lactate 7 79 Mitomycin 780 Mitoxantrone Hydrochloride 787 Morphine Sulfate 782 Nafcillin Sodium 784 Octreotide Acetate 786 Ondansetron Hydrochloride 787 Oprelvekin (lnterleukin-11) 789 Oxacillin Sodium 790 Paditaxel 792 Peginterferon alfa-2a 793 Penicillin G Potassium 794 Penicillin G Sodium 795 Pentamidine Isethionate 796 Piperacillin Sodium 797 VI
6 VII EXITENDED STABILITY FOR PARENTAL DRUGS Contents Piperacillin Sodium-Tazobactam Sodium 798 Prochlorperazine 799 Quinupristin-Dalfopristin 200 Ranitidine Hydrochloride 207 Ropivacaine Hydrochloride 202 Sufentanil Citrate 203 Thiotepa 204 Ticarcillin Disodium 205 Ticarcillin Disodium-Clavulanate Potassium 206 Tobramycin Sulfate 207 Topotecan Hydrochloride 208 Treprostinil 209 Vancomycin Hydrochloride 270 Vinblastine Sulfate 272 Vincristine Sulfate 273 Vinorelbine Tartrate 275 Voriconazole 276 Zidovudine 27 7 Appendix A: Guidelines for Writers 227 Appendix B: Glossary of Terms 225 Index 227
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