MOSBY’S DENTAL DRUG REFERENCE MOSBY’S DENTAL DRUG REFERENCE TWELFTH EDITION Editor-in-Chief Arthur H. Jeske, DMD, PhD Associate Dean for Strategic Planning and Continuing Dental Education Professor Department of General Practice and Dental Public Health The University of Texas School of Dentistry at Houston Houston, Texas 3251 Riverport Lane St. Louis, Missouri 63043 MOSBY’S DENTAL DRUG REFERENCE, TWELFTH EDITION ISBN: 978-0-323-48111-3 ISSN: 2211-5625 Copyright © 2018, Elsevier Inc. All rights reserved. Previous editions copyrighted 2014, 2012, 2010, and 2008. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publisher’s permissions policies and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions. This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein). Notices Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary. Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility. With respect to any drug or pharmaceutical products identified, readers are advised to check the most current information provided (i) on procedures featured or (ii) by the manufacturer of each product to be administered, to verify the recommended dose or formula, the method and duration of administration, and contraindications. It is the responsibility of practitioners, relying on their own experience and knowledge of their patients, to make diagnoses, to determine dosages and the best treatment for each individual patient, and to take all appropriate safety precautions. To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein. International Standard Book Number: 978-0-323-48111-3 Executive Content Strategist: Sonya Seigafuse Content Development Manager: Billie Sharp Associate Content Development Specialist: Laurel Shea Publishing Services Manager: Deepthi Unni Senior Project Manager: Umarani Natarajan Design Direction: Ryan Cook Printed in the United States of America Last digit is the print number: 9 8 7 6 5 4 3 2 1 Drug Monograph Content Contributors and Reviewers Lincoln Edwards, DDS, PhD Associate Professor School of Dentistry University of Texas Health Science Center Houston, Texas Demetra Logothetis, RDH, MS Professor Emeritus and Graduate Program Director Department of Dental Medicine University of New Mexico Albuquerque, New Mexico Meera K. Shah, PharmD, AAHIVP Clinical Pharmacist University of Kansas Health System Kansas City, Kansas Ruth Fearing Tornwell, RDH, MS Associate Professor (retired) Dental Hygiene Program Lamar Institute of Technology Beaumont, Texas Thomas Viola, RPh, CCP Instructor, Writer, and Professional Speaker Burlington, New Jersey v Preface This twelfth edition of Mosby’s Dental Drug Reference represents Elsevier’s commitment to providing comprehensive and current information on prescrip- tion drugs and recommendations for the care of the dental patients who take them. As in past editions, new individual drugs as well as new drug classes are included in this concise reference book, which is designed to address the need of oral health care practitioners and educators for readily accessible and up-to- date drug information and guidance for the dental management of medically compromised patients. This edition incorporates many of the features of past editions, and it now contains updated information on monoclonal antibodies and other biologically targeted agents, in addition to many new monographs for 21st-century drugs used in the management of diabetes, cardiovascular disease, and cancer. A DETAILED GUIDE TO MOSBY’S DENTAL DRUG REFERENCE, TWELFTH EDITION Mosby’s Dental Drug Reference provides essential drug information in a user- friendly format. The bulk of this handbook contains an alphabetical listing of drug entries by generic name. Drug entries include the following: Generic and Brand Names. Drug entries begin with the generic drug name, followed by its pronunciation and its U.S., Canadian, and Australian brand names. Category and Schedule. This section lists the drug’s pregnancy risk category and, when appropriate, its controlled substance schedule or over-the-counter (OTC) status. Mechanism of Action. This section clearly and concisely describes the drug’s mechanism of action and therapeutic effects. Pharmacokinetics. Under this heading, a quick-reference chart outlines the drug’s route, onset, peak, and duration, when known. This information is followed by a brief description of the drug’s absorption, distribution, metabo- lism, excretion, and half-life. Indications and Dosages. Here, you’ll find the approved indications and routes, along with age-appropriate dosage information and, for selected agents, dosage adjustments for preexisting conditions, such as liver or kidney disease. Precautions/Contraindications. Using a practice-oriented format and written specifically for dentistry, this section presents precautions and considerations for each drug entry. Each entry lists conditions in which use of the generic drug is contraindicated. Interactions. For drugs, herbal supplements, and food, this section supplies vital information about adverse interactions of the medical drug with drugs prescribed in dentistry. Adverse Effects. Unlike other handbooks that mix more common adverse effects with rare, minor ones in a long, undifferentiated list, this book ranks side effects by frequency of occurrence, indicating expected, frequent, occa- sional, and rare. Serious Reactions. Because serious adverse reactions can be life-threatening emergencies that require prompt intervention, this section highlights them separately from other side effects for easy identification. vii viii Preface Mosby’s Dental Drug Reference, Twelfth Edition, is an easy-to-use source of current drug information for a wide spectrum of dental care providers. When it comes to providing quality patient care, all members of the dental team can rely on the twelfth edition of Mosby’s Dental Drug Reference for current, dentally relevant information presented in an easy-to-use format. As you use the book, please keep in mind the following: • The majority of the monographs are descriptions of drugs that are utilized on an outpatient basis and are, therefore, more likely to be encountered in dental practice. Vaccines, biologicals, and medications used only intraopera- tively in hospitalized patients are generally not included, and the reader is referred to other resources for this information. • The Evolve website (http://evolve.elsevier.com/Jeske/dental/) can be con- sulted for updates and new information pertinent to this text. • Several important “Dental Considerations” are relevant to all of the drugs described in the monographs, including the following: 1.The use of a prescription medication indicates the presence of a medical condition that is being managed by one or more physicians. The physical status of the patient and his or her ability to tolerate dental treatment must be determined. 2.In collaboration with the treating physician(s), the physician, not the dentist, should guide all decisions related to changes in the use of pre- scription drugs for medical conditions. 3.Vital signs and/or other assessments should be determined at every dental treatment visit, as appropriate and as indicated; many drugs used for systemic conditions result in adverse oral conditions, such as xerostomia. Strict attention must be paid to the prevention of negative outcomes of these conditions, particularly caries and periodontal disease; education of the patient and the patient’s family about his or her medications should be reinforced by the dental team, particularly as it relates to the prevention of oral complications of medication use. 4.This text does not constitute advice about the dental management of specific patients, each of whom must be evaluated individually using all pertinent diagnostic information, and the monographs contained in this book do not constitute full prescribing information for the drugs. In the production of the book, we have endeavored to make it as current and relevant as possible while emphasizing the busy oral health care provider’s need for rapid access and dentally relevant information. On behalf of the Editor-in- Chief and Elsevier, we proudly thank our reviewers, Ruth Fearing Tornwall, RDH, MS, Lamar Institute of Technology; Lincoln Edwards, DDS, PhD, Uni- versity of Texas Health Science Center; and Demetra Logothetis, RDH, MS, University of New Mexico, and our monograph content contributors, Meera K. Shah, PharmD, AAHIVP, and Thomas Viola, RPh, CCP, for their expertise and contributions. Finally, this edition is respectfully dedicated to the teachers and practitioners of dentistry, dental hygiene, and dental assisting around the world whose application of the book for students and patients continues to inspire our work. Internet References for Additional Drug Information and Professional Guidelines 1. ADA Center for Evidence-Based Dentistry: http://ebd.ada.org/ (library of oral health systematic reviews and critical summaries of systematic reviews of dental topics) 2. Cochrane Library Oral Health Group: http://www.ohg.cochrane.org/ (library of systematic reviews of randomized controlled trials only) 3. American Heart Association: http://circ.ahajournals.org/cgi/content/full/ 116/15/1736 (complete publication on antibiotic prophylaxis to prevent infective endocarditis) 4. Global RPh: http://www.globalrph.com/corticocalc.htm (calculator to convert corticosteroid supplemental dosages to equivalents of various drugs) 5. Food and Drug Administration: http://www.fda.gov/ (comprehensive infor- mation on drugs, drug safety, drug approvals, etc.) 6. American Association of Oral & Maxillofacial Surgeons (AAOMS), medication-related osteonecrosis of the jaw: http://www.aaoms.org/docs/ govt_affairs/advocacy_white_papers/mronj_position_paper.pdf (AAOMS guidelines for managing medication-related osteonecrosis of the jaw) 7. University of Washington Oral Health Fact Sheets: http://www.dental. washington.edu/departments/omed/decod/special_needs_facts.php (concise information on dental care of patients with a variety of childhood and adult medical conditions) 8. American Association of Endodontists: http://www.aae.org/colleagues/ (archives of “Colleagues for Excellence” publications, guidelines on the management of endodontic patients, including antibiotic use and local anesthesia) 9. American Academy of Pediatric Dentistry: http://aapd.org/policies/ (guide- lines on fluorides, local anesthesia, antibiotics, and more in pediatric dental patients, updated q. 3 yrs) 10. Guide to Diagnosis and Management of Common Oral Conditions: http:// www.intechopen.com/books/diagnosis-and-management-of-oral-lesions -and-conditions-a-resource-handbook-for-the-clinician/ (open-access oral medicine reference text) xi Medication-Related Osteonecrosis of the Jaw In 2014, the American Association of Oral and Maxillofacial Surgeons (AAOMS) updated its Position Paper on Medication-Related Osteonecrosis of the Jaw (MRONJ), formerly termed bisphosphonate-related osteonecrosis of the jaw (BRONJ). This update expanded the list of drugs known to increase the risk for MRONJ to include antiangiogenic drugs (e.g., denosumab, Prolia®) and corticosteroids. The updated document provides estimates of risk for MRONJ, comparisons of the risks and benefits of medications related to osteonecrosis of the jaw, guidance for clinicians on the differential diagnosis of MRONJ, and prevention measures and management strategies for patients with disease-stage MRONJ. The complete document can be accessed at: http://www.aaoms.org/ docs/govt_affairs/advocacy_white_papers/mronj_position_paper.pdf According to this AAOMS document, medication-related risk for MRONJ is increased in cancer patients who have been exposed to zoledronate (Zometa®, Reclast®) and antiangiogenic monoclonal antibodies (e.g., denosumab) and tyrosine kinase inhibitors (e.g., sunitinib), but it is not as frequent in osteopo- rotic patients exposed to the same agents. Local factors for risk of MRONJ include the following: • Operative treatment (e.g., tooth extraction) • Anatomic factors (e.g., mandible, denture use) • Concomitant oral disease (e.g., inflammatory dental disease) The position paper also provides information on genetic, demographic, and systemic factors in MRONJ and a summary of the dental management strate- gies for patients at risk for MRONJ, including the following: • Extraction of nonrestorable teeth and those with a poor prognosis prior to initiation of antiresorptive/antiangiogenic therapy • Elimination of mucosal trauma by removable prostheses • Consultation with the patient’s physician(s) to follow osteonecrosis-preven- tion protocols; • Maintenance of good oral hygiene and dental care • Avoidance of dental implant placement in oncology patients receiving intra- venous antiresorptive therapy or antiangiogenic medications For patients taking oral bisphosphonates (e.g., alendronate, Fosamax®), specific guidance for cases based on length of exposure to medications includes the following: • For individuals who have taken an oral bisphosphonate for less than 4 years and have no clinical risk factors, no alteration or delay in planned oral surgery is necessary (this includes any and all procedures common to oral and maxillofacial surgeons, periodontists, and other dental providers). • For those patients who have taken an oral bisphosphonate for less than 4 years and have also taken corticosteroids or antiangiogenic medications concomitantly, the prescribing physician should be contacted to consider discontinuation of the oral bisphosphonate (drug holiday) for at least 2 months prior to oral surgery if systemic conditions permit. • For those patients who have taken an oral bisphosphonate for more than 4 years with or without any concomitant medical therapy, the prescribing physician should be contacted to consider discontinuation of the antiresorp- tive for 2 months prior to oral surgery if systemic conditions permit. The complete AAOMS position paper should be consulted for detailed patient- care information, including management of patients with established MRONJ. xiii Monoclonal Antibodies and Other Biologic Drugs Summary: Monoclonal antibodies, anti–tumor necrosis factor (anti-TNF) agents, and other preparations are now in widespread use as immune modulators in the manage- ment of autoimmune disorders and account for a very high proportion of drug sales in the United States. Although limitations on their use include the need for injection of many of these agents, they have had a significant impact on the treatment of several important diseases, particularly rheumatoid arthritis, Crohn’s disease, and more severe forms of psoriasis. They are generally large proteins that can be manufactured via recombinant DNA methodologies. The types of agents described in this section may be recognized by the suffixes of their official (“generic”) names, (e.g., “-mab” indicates “monoclonal antibody,” “-ib” indicates “inhibitor,” etc.). Classification: T-cell modulators: e.g., abatacept (Orencia®) B-cell cytotoxic agents: e.g., rituximab (Rituxan®) IL-1 (interleukin-1) blockers: e.g., anakinra (Kineret®), rilonacept (Arcalyst®), canakinumab (Ilaris®) Anti-IL-6 (interleukin-6) receptor antibodies: e.g., tocilizumab (Actemra®) Janus kinase (JAK) inhibitors: e.g., tofacitinib (Xeljanz®) TNF-α blockers: e.g., adalimumab (Humira®), certolizumab (Cimzia®), etan- ercept (Enbrel®), golimumab (Simponi®), infliximab (Remicade®) DENTAL CONSIDERATIONS FOR MONOCLONAL ANTIBODIES/BIOLOGICALLY TARGETED AGENTS General: • Consult prescribing information for specific drug interactions. • Patients taking biologic agents are being treated for serious systemic auto- immune disorders, which may require postponement or modification of dental care. • Patients are at increased risk of infections because of the immunosuppressive effects of biologic agents; patients should be monitored accordingly. • Screen for latent or active tuberculosis and opportunistic infections. • Consult physician to assess disease status and ability of patient to tolerate dental procedures. • Many biologic agents must be injected; injection site discomfort and acute symptoms may occur following injection (nausea, diarrhea). Monoclonal Antibodies Approved for Use in the United States Official Name Trade Name(s) Primary Indications/Uses Abciximab ReoPro Adjunct for prevention of thromboembolism Adalimumab Humira Rheumatoid arthritis Alemtuzumab Campath Chronic lymphocytic leukemia Basiliximab Simulect Anti-rejection (for renal transplantation) Bevacizumab Avastin Metastatic colorectal and other tumors Canakinumab Ilaris Cryopyrin-associated periodic syndromes (Continued) xv xvi Monoclonal Antibodies and Other Biologic Drugs Official Name Trade Name(s) Primary Indications/Uses Certolizumab Cimzia Rheumatoid arthritis Cetuximab Erbitux Squamous cell carcinoma and other tumors Daclizumab Zenapax Anti-rejection (for renal transplantation) Denosumab Prolia Osteoporosis with high risk of fractures Eculizumab Soliris Nocturnal hemoglobinuria Golimumab Simponi Rheumatoid arthritis Ibritumomab Zevalin Non-Hodgkin’s lymphoma tiuxetan Infliximab Remicade Rheumatoid arthritis Ipilimumab Yervoy Unresectable metastatic melanoma Muromonab Orthoclone Anti-rejection (for renal transplantation) Natalizumab Tysabri Multiple sclerosis, Crohn’s disease Ofatumumab Arzerra Chronic lymphocytic leukemia Omalizumab Xolair Allergic asthma Palivizumab Synagis Respiratory syncytial virus Panitumumab Vectibix Metastatic colorectal cancer Ranibizumab Lucentis Macular degeneration Rituximab Rituxan Non-Hodgkin’s lymphoma Tocilizumab Actemra Rheumatoid arthritis Trastuzumab Herceptin Breast and gastroesophageal cancers Ustekinumab Stelara Plaque psoriasis Vedolizumab Entyvio Adult ulcerative colitis, Crohn’s disease Consultations: • Consult patient’s physician to determine disease status and ability of patient to tolerate dental procedure. Teach Patient/Family to: • Report changes in medical status and drug therapy. • Report signs and symptoms of infections. • Use effective oral hygiene to prevent soft tissue inflammation. REFERENCE: Katzung BG, Trevor AJ, editors: Basic and Clinical Pharmacology, ed 13, New York, 2015, McGraw-Hill.