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FIFTH EDITION
Yaffe and Aranda’s
Neonatal and Pediatric
Pharmacology
Therapeutic Principles in Practice
FIFTH EDITION
Yaffe and Aranda’s
Neonatal and Pediatric
Pharmacology
Therapeutic Principles in Practice
J (J) V. A, , , ,
Professor of Pediatrics and Ophthalmology
Director of Neonatology and the New York Pediatric Developmental Pharmacology Research
Center
Program Director, Neonatal Perinatal Medicine Fellowship
State University of New York Downstate Health Sciences University
Brooklyn, New York
J () N. V D A, , , ,
Evan and Cindy Jones Endowed Chair in Pediatric Clinical Pharmacology
Vice Chair of Pediatrics for Experimental Therapeutics
Chief Division of Clinical Pharmacology
Children’s National Hospital and Professor of Pediatrics
Pharmacology & Physiology, Genomics & Precision Medicine
The George Washington University School of Medicine and Health Sciences
Washington, District of Columbia
Eckenstein-Geigy Distinguished Professor of Pediatric Pharmacology and Pharmacometrics
University Children’s Hospital Basel
University of Basel
Basel, Switzerland
Intensive Care and Department of Pediatric Surgery
Erasmus Medical Center-Sophia Children’s Hospital
Rotterdam, the Netherlands
Acquisitions Editor: Colleen Dietzler/Nicole Dernoski
Development Editor: Robyn Alvarez/Thomas Celona
Editorial Coordinator: Julie Kostelnik
Marketing Manager: Kirsten Watrud
Production Project Manager: Kirstin Johnson
Design Coordinator: Holly McLaughlin
Manufacturing Coordinator: Beth Welsh
Prepress Vendor: S4Carlisle Publishing Services
Fifth edition
Copyright © 2021 Wolters Kluwer.
Copyright © 2011 Lippincott Williams & Wilkins, a Wolters Kluwer business. Copyright © 2005
Lippincott Williams & Wilkins. All rights reserved. This book is protected by copyright. No part of this
book may be reproduced or transmitted in any form or by any means, including as photocopies or
scanned-in or other electronic copies, or utilized by any information storage and retrieval system without
written permission from the copyright owner, except for brief quotations embodied in critical articles and
reviews. Materials appearing in this book prepared by individuals as part of their official duties as US
government employees are not covered by the above-mentioned copyright. To request permission,
please contact Wolters Kluwer at Two Commerce Square, 2001 Market Street, Philadelphia, PA 19103,
via email at permissions@lww.com, or via our website at shop.lww.com (products and services).
9 8 7 6 5 4 3 2 1
Printed in China
Library of Congress Cataloging-in-Publication Data
Names: Aranda, Jacob V., author. | Van den Anker, Johannes, author.
Title: Yaffe and Aranda’s neonatal and pediatric pharmacology : therapeutic principles in practice /
Jacob Aranda, MD, PhD, FRCPC, FAAP, Professor of Pediatrics and Ophthalmology, Director of
Neonatology, Director: New York Pediatric Developmental Pharmacology Research Consortium,
Program Director: Neonatal -Perinatal Medicine Fellowship, State Univ of New York Downstate Health
Sciences University, Johannes van den Anker, MD, PhD, FCP, FAAP, Evan and Cindy Jones Endowed
Chair in Pediatric Clinical Pharmacology, Vice Chair of Pediatrics for Experimental Therapeutics, Chief
Division of Clinical Pharmacology, Children’s National Hospital and Professor of Pediatrics,
Pharmacology & Physiology, Genomics & Precision Medicine, The George Washington University
School of Medicine and Health Sciences, Washington, DC, USA, Eckenstein-Geigy Distinguished
Professor of Pediatric Pharmacology and Pharmacometrics, University Children’s Hospital Basel,
University of Basel, Basel, Switzerland, Intensive Care and Department of Pediatric Surgery, Erasmus
Medical Center-Sophia Children’s Hospital, Rotterdam, the Netherlands.
Description: Fifth edition. | Philadelphia : Lippincott Williams & Wilkins, [2021] | Revision of: Neonatal
and pediatric pharmacology / [edited by] Sumner J. Yaffe, Jacob V. Aranda. c2010. 4th ed. | Includes
bibliographical references and index. | Summary: “textbook in pediatric pharmacology and provides
evidence-based guidelines for safe, effective, and rational drug therapy in newborns, children, and
adolescents”— Provided by publisher.
Identifiers: LCCN 2020028621 | ISBN 9781975112486 (hardcover) | E-ISBN 9781975112493 (ebook)
Subjects: LCSH: Pediatric pharmacology. | Children—Diseases—Chemotherapy.
Classification: LCC RJ560 .P4 2021 | DDC 615.1083—dc23
LC record available at https://lccn.loc.gov/2020028621
This work is provided “as is,” and the publisher disclaims any and all warranties, express or implied,
including any warranties as to accuracy, comprehensiveness, or currency of the content of this work.
This work is no substitute for individual patient assessment based upon healthcare professionals’
examination of each patient and consideration of, among other things, age, weight, gender, current or
prior medical conditions, medication history, laboratory data and other factors unique to the patient. The
publisher does not provide medical advice or guidance and this work is merely a reference tool.
Healthcare professionals, and not the publisher, are solely responsible for the use of this work including
all medical judgments and for any resulting diagnosis and treatments.
Given continuous, rapid advances in medical science and health information, independent professional
verification of medical diagnoses, indications, appropriate pharmaceutical selections and dosages, and
treatment options should be made and healthcare professionals should consult a variety of sources.
When prescribing medication, healthcare professionals are advised to consult the product information
sheet (the manufacturer’s package insert) accompanying each drug to verify, among other things,
conditions of use, warnings and side effects and identify any changes in dosage schedule or
contraindications, particularly if the medication to be administered is new, infrequently used or has a
narrow therapeutic range. To the maximum extent permitted under applicable law, no responsibility is
assumed by the publisher for any injury and/or damage to persons or property, as a matter of products
liability, negligence law or otherwise, or from any reference to or use by any person of this work.
shop.lww.com
To our loved ones
Kenneth Frederic and Christopher James Aranda
and
John Nicolaas Yuri van den Anker and Natella Yurievna Rakhmanina
and the Editorial and Production Team:
Julie Kostelnik, Robyn Alvarez, Collen Dietzler, Nicole Dernoski,
Thomas Celona, and Kirstin Johnson
For their dedication, enthusiasm, guidance, and invaluable
assistance in the preparation of the fifth edition
Tribute to Sumner J. Yaffe, MD
The fifth edition of this textbook, Yaffe and Aranda’s Neonatal and Pediatric
Pharmacology: Therapeutic Principles in Practice, pays tribute to its
founding editor, Dr. Sumner J. Yaffe. He is acknowledged as the Father of
Pediatric Clinical Pharmacology and on his passing in 2011, the international
community of neonatal and pediatric clinical pharmacologists lost a true
pioneer, a long-standing leader, a preeminent scholar, and an unwavering
advocate for pediatric therapeutics. Those of us who were privileged to have
known, worked, and/or interacted with him, many of whom are authors of the
chapters in this edition, were all impacted by Sumner in so many ways. His
academic history, professional life, and immense impact on pediatric
pharmacotherapeutics have been comprehensively reviewed (Giacoia G,
Reed MD. Sumner J. Yaffe: The father of pediatric clinical pharmacology. J
Pediatr Pharmacol Ther 2011;16:162–166) and what follows is our
personal reflections on our colleague, mentor, and dear friend, Sumner J.
Yaffe, MD.
Accolades are often used to describe individuals from all walks of life
describing courageous actions, game-changing accomplishments, out-of-thebox innovations but at times many can ring hollow. In the case of Dr. Yaffe,
these accolades describing his illustrious career are well earned,
unembellished, and enduring. A sampling of our list includes the following:
Pioneer and Trailblazer. Sumner was an early leader in the scientific and
clinical research of the ontogeny of drug metabolism and action in the
maturing infant and child with a special interest in the prematurely born
infant. Early in his academic career, he studied the age-dependent
differences in cardiac responses to digitalis, recognizing that
understanding the mechanism(s) of drug action provided the path to
optimal therapeutics and evolving innovations. His pioneering efforts in
scientifically sound clinical pharmacology and toxicology research
techniques in infants and children across the age continuum were
foundational, as were his insightful, visionary approaches to education,
teaching, and clinical research. His career included many important firsts
and landmarks in the field of pediatric pharmacotherapeutics, with
components and variants emulated throughout the world today. Sumner
was the first director of the then-newly established Clinical Research
Center for Premature Infants at Stanford University and the first division
director of the then-newly established Division of Pediatric Clinical
Pharmacology at the Children’s Hospital of Philadelphia. He joined the
National Institute of Child Health and Human Development (NICHD) of
the National Institutes of Health (NIH) as its director of the Center for
Research for Mothers and Children in 1980 and became a tireless
advocate in the field.
Advocate. As the NIH/NICHD director of the Center for Research for
Mothers and Children, he recognized very early on the power and
synergy of clinical research networks and was instrumental in leading the
establishment of the neonatal and fetal/maternal medicine network and
then to his personal crowning achievement, the establishment of the
Pediatric Pharmacology Research Units (PPRUs) network. He ensured
that drugs in newborns and children were addressed in national and
international forums and congresses. The international communities of
educators, students, practitioners, organizational leaders, and government
agencies embracing multiple disciplines focused on improving the health
of children of all ages continue to flourish, innovate, and direct forward
actions and road maps.
Visionary. From his early laboratory-based work in identifying the
mechanism of drug action to his clinical pharmacology and toxicology
research and bedside application of evolving age-dependent, age-
directed therapeutics and to then operationalize these life-altering
activities through continuously successful enduring, ever-expanding
clinical research collaboratives is a testament to the person he was.
These accomplishments reflected not only his visionary abilities but also
his unbiased and boundless inquisitiveness, intelligence, and unwavering
commitment to do what he knew was right, combined with his ability to
accept each setback as a new challenge to overcome—all peppered with
a healthy dose of common sense! He always looked forward to the day
when newborns, children, and adolescents will be therapeutic orphans no
more.
Mentor. Sumner embodied the true meaning of a mentor. Although extremely
busy and consumed by a multitude of complex, dynamic issues, he would
always make time to speak directly with you, uninterrupted, with his
focus on you. He offered thoughtful, insightful, practical advice, always
following up to determine outcome, next steps, and lessons learned.
Above all, he expected nothing in return other than your success. His
success was your success.
The fifth edition of this book is not only a tribute but also a testament of
the foundation that Sumner prepared for our specialty so many years ago to
ensure safe and effective drug therapies for newborns and children. He
prepared our community to meet the challenges and to expand the dynamic
evolution of neonatal and pediatric clinical pharmacology research and
practice now and in the future. He helped shorten the timeline until
newborns, children, and adolescents will be therapeutic orphans no more.