Extended Stability for Parenteral Drugs

Description

Extended Stability for Parenteral Drugs, 5th Edition, is an essential reference for anyone working in alternate-site infusion practice. What's New? The 160 stability monographs in this fifth edition include updates to all but five of the monographs from the fourth edition. New to this edition are 10 new stability monographs:

• Acetaminophen
• Ceftaroline fosamil
• Coagulation Factor XIII
• Doripenem
• Ethanol lock
• Ibuprofen
• Pantoprazole
• Telavancin
• Toclizumab
• Ziconotide acetate

The monograph updates include data revisions for a number of container types, and new information for elastomeric infusion device brands. The Parenteral Nutrition chapter includes updates to five nutrition monographs and additional considerations for calcium and phosphate solubility. The Applying Stability Data in Patient Care now includes a nursing perspective, with a primer on the types of vascular access devices used in medication administration and important considerations for pH, osmolality, concentration, and administration device.

The book contains no figures.

The scarcity of published and/or labeled stability data beyond 24 hours at any temperature has historically been a complicating factor in the care of patients in alternate care settings. This text is a compilation of 126 extended parenteral stability monographs for medications that are commonly used in alternate site infusion practice. It focuses on the extended stability of drugs in the containers and infusion devices most likely to be used in this practice setting. "Extended stability" refers to parenteral drugs that will be used/stored for seven or more days. The reference compiles data for stability at frozen, refrigerated, room, and body temperature. Flush compatibility is also listed for each drug, when available.

Table of Contents

Preface .................................................................vii

Acknowledgments ................................................ix

Dedication ............................................................ix

About the Editor ...................................................xi

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

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

Applying Stability Data in Patient Care ................ 3

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

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

Preparation Sterility and Quality Assurance ........4

Professional, Regulatory, and Accreditation Expectations .......5

Commercial Products and Extemporaneous Compounding......7

Labeling Instructions ..........................................8

Assigning Beyond-Use Dates ..............................9

Patient and Site-Specific Considerations .........10

Considerations in Selecting Administration Methods and Infusion Devices ...12

External Factors Affecting Stability ....................16

Ethanol and Antibiotic Locks ............................17

Summary .........................................................17

Parenteral Nutrition .......................................... 21

Beyond-Use Dating of Parenteral Nutrition Formulations ............ 21

Non-Formulation Factors Affecting PN Stability ..........................21

Formulation Factors Affecting PN Stability ........23

Commercial Products and Extemporaneous Compounding ............27

Professional, Regulatory, and Accreditation Expectations and Guidance ......27

Summary .........................................................28

Parenteral Nutrition Monographs .....................29

Carnitine .....................................................29

Chromium ..................................................29

Cimetidine ..................................................30

Copper .......................................................31

Famotidine .................................................32

Folic Acid ....................................................33

Heparin ......................................................33

Iron .............................................................34

Manganese .................................................34

Ranitidine ...................................................35

Selenium ....................................................36

Trace Elements............................................36

Vitamin A ....................................................37

Vitamin B1 ..................................................39

Vitamin B2 ..................................................40

Vitamin B3 ..................................................41

Vitamin B5 ..................................................41

Vitamin B6 ..................................................42

Vitamin B12 ................................................42

Vitamin C ...................................................43

Vitamin D ...................................................44

Vitamin E ....................................................44

Vitamin K ....................................................46

Zinc ............................................................46

Drug Monographs ..............................................53

Acyclovir Sodium .............................................55

Aldesleukin ......................................................57

Amikacin Sulfate ..............................................58

Amiodarone Hydrochloride .............................60

Amphotericin B................................................61

Amphotericin B Cholesteryl Sulfate Complex ...62

Amphotericin B Lipid Complex ........................63

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

Ampicillin Sodium ...........................................65

Ampicillin Sodium–Sulbactam Sodium .............67

Azithromycin ...................................................69

Aztreonam .......................................................70

Baclofen ..........................................................71

Bevacizumab ...................................................72

Bleomycin Sulfate ............................................73

Bortezomib ......................................................74

Bumetanide .....................................................75

Bupivacaine Hydrochloride..............................76

Calcitriol ..........................................................78

Carboplatin ......................................................79

Caspofungin Acetate ........................................81

Cefazolin Sodium ............................................82

Cefepime Hydrochloride .................................85

Cefotaxime Sodium .........................................87

Cefotetan Disodium .........................................89

Cefoxitin Sodium .............................................91

Ceftazidime .....................................................93

Ceftizoxime Sodium ........................................96

Ceftriaxone Sodium .........................................98

Cefuroxime Sodium .......................................101

Chlorpromazine Hydrochloride .....................103

Cidofovir .......................................................104

Cimetidine Hydrochloride .............................105

Ciprofloxacin .................................................106

Cisplatin ........................................................108

Cladribine ......................................................110

Clindamycin Phosphate .................................111

Clonidine Hydrochloride ...............................113

Coagulation Factor VIIa Recombinant ............116

Coagulation Factor VIII ..................................117

Coagulation Factor IX .....................................121

Colistimethate Sodium ...................................123

Co-Trimoxazole (Trimethoprim–Sulfamethoxazole) .....124

Cyclophosphamide ........................................125

Cyclosporine ..................................................127

Cytarabine .....................................................128

Dacarbazine ..................................................130

Daclizumab ...................................................131

Daptomycin ...................................................132

Daunorubicin Hydrochloride (Daunomycin) ....133

Deferoxamine Mesylate .................................134

Dexamethasone Sodium Phosphate ...............136

Dimenhydrinate .............................................138

Diphenhydramine ..........................................139

DOBUTamine Hydrochloride ........................140

Docetaxel ......................................................141

Dolasetron Mesylate ......................................142

DOPamine Hydrochloride .............................143

Doxorubicin Hydrochloride ...........................145

Doxycycline Hyclate ......................................147

Enoxaparin Sodium ........................................148

Epirubicin Hydrochloride ...............................149

Epoetin Alfa ...................................................150

Epoprostenol Sodium .....................................151

Ertapenem .....................................................152

Erythromycin Lactobionate ............................153

Etoposide .......................................................154

Etoposide Phosphate ......................................156

Famotidine ....................................................157

Fentanyl Citrate .............................................158

Filgrastim .......................................................160

Floxuridine ....................................................161

Fluconazole ...................................................162

Fludarabine Phosphate ..................................164

Fluorouracil ...................................................165

Foscarnet Sodium ..........................................168

Fosphenytoin Sodium ....................................170

Furosemide ....................................................171

Ganciclovir Sodium .......................................172

Gemcitabine Hydrochloride ..........................174

Gentamicin Sulfate ........................................175

Glycopyrrolate ...............................................177

Granisetron Hydrochloride ............................178

Haloperidol Lactate .......................................179

Heparin Sodium ............................................180

Hydralazine Hydrochloride ............................182

Hydrocortisone Sodium Succinate .................183

Hydromorphone Hydrochloride ....................184

Hydroxyzine Hydrochloride ...........................185

Ifosfamide ......................................................186

Imipenem–Cilastatin Sodium .........................188

Immune Globulin (Human) ............................190

Infliximab ......................................................193

Interferon alfa-2b ...........................................194

Irinotecan Hydrochloride ...............................195

Ketamine Hydrochloride ................................196

Ketorolac Tromethamine ...............................197

Leucovorin Calcium .......................................198

Levofloxacin ..................................................200

Linezolid ........................................................201

Lorazepam .....................................................202

Meperidine Hydrochloride ............................204

Meropenem ...................................................206

Mesna............................................................208

Methadone Hydrochloride.............................210

Methotrexate Sodium ....................................211

Methylprednisolone Sodium Succinate ..........213

Metoclopramide Hydrochloride .....................215

Metronidazole, Metronidazole Hydrochloride ..217

Micafungin Sodium ........................................219

Midazolam ....................................................220

Milrinone Lactate ...........................................222

Mitomycin .....................................................224

Mitoxantrone Hydrochloride ..........................225

Morphine Sulfate ...........................................226

Nafcillin Sodium ............................................229

Octreotide Acetate ........................................231

Ondansetron Hydrochloride ..........................232

Oprelvekin (lnterleukin-11) ............................234

Oxacillin Sodium ...........................................235

Oxaliplatin .....................................................237

Oxytocin ........................................................238

Paclitaxel .......................................................239

Peginterferon alfa-2a ......................................241

Pemetrexed Disodium ...................................242

Penicillin G Potassium ....................................243

Penicillin G Sodium .......................................245

Pentamidine Isethionate ................................246

Piperacillin Sodium ........................................248

Piperacillin Sodium–Tazobactam Sodium .......250

Prochlorperazine ...........................................252

Quinupristin-Dalfopristin ...............................253

Ranitidine Hydrochloride ...............................254

Rituximab ......................................................256

Ropivacaine Hydrochloride............................257

Sargramostim .................................................258

Sufentanil Citrate ...........................................259

Thiotepa ........................................................261

Ticarcillin Disodium–Clavulanate Potassium ...262

Tigecycline.....................................................264

Tobramycin Sulfate ........................................265

Topotecan Hydrochloride ..............................267

Trastuzumab ..................................................268

Treprostinil ....................................................269

Valproate Sodium ..........................................270

Vancomycin Hydrochloride ...........................271

VinBLAStine Sulfate .......................................273

VinCRIStine Sulfate ........................................274

Vinorelbine Tartrate .......................................276

Voriconazole .................................................277

Zidovudine ....................................................278

Zoledronic Acid .............................................279

Appendix A: Guidelines for Writers ....................283

Appendix B: Glossary of Terms ...........................287

Index ..................................................................289

Author

Caryn Marie Dellamorte Bing, RPh, MS, FASHP holds a BS from University of Illinois College of Pharmacy, an MS in Health Systems Management from Rush University, and she completed a pharmacy residency at Rush-Presbyterian-St. Luke’s Medical Center in Chicago. Ms. Bing has over 25 years of practice, management, and leadership experience in alternate site pharmacy services. She is currently Corporate Clinical Services/Residency Program Manager at Critical Care Systems, a national home and specialty infusion provider. Her current responsibilities include development of clinical standards of practice and management of PGY1 Pharmacy Residency programs in five locations. Ms Bing has remained involved in professional association leadership throughout her career, and is currently the President-Elect for Nevada Society of Health-System Pharmacists. She also held leadership roles with Illinois Council of Health-System Pharmacists, served on the ASHP HACCP Section Executive Committee, and was Chairperson for the ASHP Continuity of Care Task Force. She has been a frequent ASHP Delegate and Alternate Delegate (IL, NV). Caryn is a Fellow of ASHP, and received the first Distinguished Service Award from the ASHP HACCP Section. Ms. Bing is Editor of Extended Stability of Parenteral Drugs. She has served on the Editorial Boards of AJHP, the Journal of Pharmacy Practice, and Perspectives in Pharmacy. She has published a number of articles and book chapters, and has presented at many state and national meetings.