`
`\‘ K" fifil‘fln ".9. 1,1.“
`( 5“";
`..'_3a £5010
`
`,
`
`A;
`
`Eton Ex. 1074
`Eton Ex. 1074
`1 of 23
`1 of 23
`
`

`

`-
`
`fl•li-i
`
`Facts & Comparisons®
`
`Eton Ex. 1074
`2 of 23
`
`

`

`Drug Facts and Comparisons,® 2015 Edition
`
`© 1978 1979 1980 by Facts and Comparisons.
`gopyr~g~~ ® 1981: 1982', 1983, 198~, 1986, 19~6~ ~987, HJ88, 19~9, _1990,
`a::_a_~f91 by Facts and Compar1sonB, a dtv1s10n of J.B. Lippincott
`omp~nhyt. " 1992 1993 1994 1996, 1996, 1997, 1998, 1999, 2000, 2001
`Opyng
`002 ~yhFtagt.s2toid foitfJ6~nioo6, 2007, 2008, 2009, 2010, 2011, 2012
`opyng
`'
`'
`1' h I
`'
`.
`2013 by Wolters Kluwer Heat , nc.
`Copiight c 2014 by Clinical Drug Informat10n, LLC.
`
`•
`
`CC
`
`C2
`
`>
`
`1
`
`,
`
`' @
`
`I
`
`All rigbt.s reserved. No part of this publication . may be re~rod~ced or
`transmitted in any form or by any means, electronic or _mecham~al, includ(cid:173)
`ing photocopy, recording, st~red in a database ~r any m~ormabo~ s~ora~e
`or retrieval system, or put mto a computer, without ~nor penruss1on m
`writing from Clinical Drug Information, LLC, the publisher.
`
`Adapted from Facts and Comparisons® eA,iswers online drug reference.
`
`Manuscript indexed by Columbia Indexing Group, Las Vegas, Nevada.
`
`ISBN-10: 1-57439-360-X
`ISBN-13:· 978-1-57439-360-6
`
`Printed in the United States of America.
`
`The information contained in this publication is intended to supplement
`the knowledge of health care professionals regarding drug information.
`This information is advisory only and is not intended to replace sound
`clinical judgment or individualized patient care in the delivery of health
`care services. Clinical Drug Information, LLC disclaims all warranties,
`whether expressed or implied, including any warranty as to the quality,
`acc~acy, or suitability of this information for any particular purpose.
`
`The ~or~ation contained in Drug Facts and Comparisons® is available
`for licensmg as source data. For more information on data licensing,
`please call 1-800-223-0554.
`
`Clinical Drug Information, LLC
`77 Westport Plaza, Suite 450
`St. Louis, Missouri 63146-3125
`Phone 314-392-0000 • 800-223-0554
`Fax 314-392-0030
`factsandcomparisons .com
`
`iv
`
`Eton Ex. 1074
`3 of 23
`
`

`

`founding editor
`ERWIN K. KASTROP, BS Phann, DSct
`
`senior clinical managers
`PAUL B . JOHNSON, RPh
`CATHY A. MEIVES, PharmD
`
`senior clinical editors
`CHRISTINE M. COHN, PharmD, BCPS
`PATRICIAL.SPENARD,PharmD
`ANDREA L. WILLIAMS, RPh
`senior managing editors
`ANGELA J. BUSJ:f
`SARAH W. GREMILLION
`
`senior director content development
`SCOT E. WALKER, PharmD, MS, BCPS,
`BCACP
`director, synthesized referential content
`JOYCE A. GENERALI, RPh, MS, FASHP
`
`clinical manager
`KIM S. DUFNER, PharmD
`
`clinical editor
`ESTA RAZAVI. Ph armD
`president and ceo, clinical solutions
`ARVIND SUBRAMANIAN, MBA
`
`senior editors
`SARAH E. NUNNALLY
`EMILY E. VAN BUREN
`
`associate editors
`MARIE E. BALLEY
`ALFRED HENDERSON Il
`MEAGAN S. LEWIS
`MICHELLE N. WOOD
`
`managing technical editor
`WENDY L. BELL
`
`senior technical editor
`HOLLYE.GREENWOOD
`
`senior composition specialist
`JENNIFER K. WALSH
`t Deceased
`
`managing editors
`JOSEPH R. HOREN.KAMP
`MICHELLE M. POLLEY
`KIRSTEN K. STEVENSON
`
`managing editor, quality control
`SUSAN H. SUNDERMAN
`
`senior quality control editors
`KIRSTEN V. KETNER
`KIMBERLY A. McCLELLAND
`
`quality control editor
`SHARON M. McCARRON
`
`technical editor
`ALYSONJ.MILLAR-BLEVINS
`
`inventory analyst
`BARBARA J. HUNTER
`
`Facts & Comparisons•
`
`Eton Ex. 1074
`4 of 23
`
`

`

`Facts & Compansons
`Editorial Advisory Panel
`
`TM
`
`•
`
`LAWRENCE R. BORGSDORF,
`PharmD,FCSHP
`MTM Con~ulhmt
`Bake~field, California
`
`MICHAEL D. CIRIGLIANO, MD, FACP
`Associate Professor of Medicine
`Perelman School of Medicine
`Univel'l;ity of Pennsylvania
`Philadelphia, Pennsylvania
`
`THOMAS R. CLARK. RPb, MHS, CGP
`"Executive Director
`Commission for Certification in
`Geriatric Pharmacy
`Alexandria, Vu-ginja
`
`TIMOTHY R. COVINGTON, Pharm.D, MS
`President and CEO
`Covington Healthcare Associates, LLC
`Bi.nningham, Alabama
`Adjunct Professor of Phanoacy Practice
`Harrison School of Pharmacy
`Aobll.Tll University
`Auburn, Alabama
`
`DANIEL A. HUSSAR, PhD
`Remington Professor of Pha.no,acy
`Philadelphia College of Pharmacy
`University of the Scieqcea in Philadelphia
`Philadelphia, Pennsylvania
`·
`
`RICHARD W. SLOAN, MD, RPb
`Associate Deon Ior Clinical Education
`Clinical P rofessor of Family Medicine
`Pennsylvania State University
`College of Medjci_ne
`Hershey, Pennsylvania
`Director of Medical Education
`York HospitaVWellspan Health
`York, Pennsylvania
`
`BURGUNDA (GUNDY) V. SWEET
`PharmD, FASHP
`'
`Clinical Professor of Pharmacy
`University of Michigan College of Pharma
`Ann Arbor, Michigan
`L')'
`
`DAVID S. TATRO, Pharm.D
`Drug Information Analyst
`San Carlos, California
`
`THOMAS L. WHITSETr, MD
`Professol' of Medicine and Cell Biology
`Vascular Medicine Program
`OU Regents Professor
`University of Oklahoma
`Health Sciences Center
`Oklahoma City, Oklahoma
`
`vi
`
`Eton Ex. 1074
`5 of 23
`
`

`

`Contributing Review Panel
`
`Danial E. Bake.-, PharmD,
`FASHP, FASCP
`Professor of Pharn,nrothernpy
`Director, Drug Infomrntion
`Center
`Washington State Universitv
`Spokane. Washington
`·
`
`Jimmy D. Bartlett, OD, Sc.D
`Professor Emeritus
`Uni\-ersity of Alabama at
`Binningham
`Birmingl,am, Alabama
`
`Jeanelle Beltran, PharmD
`Drug Information Consultant
`Christchurch, New Zealand
`
`Edward S. Bennett, OD,
`MSEd, FAAO
`Professor
`Assistant Dean.
`Student Servi~es and
`Alumni Relations
`College of Optometry
`University of Missouri -
`St. Louis
`St. Louis, Missouri
`
`R. Keith Campbell, RPh.
`FAPhA, FASBP, FAADE,
`CDE,MBA
`Distinguished Professor in
`Diabetes Care/
`Pharmacotherapy
`College of Pharmacy
`Washington State
`University
`Pullman, Washington
`
`Shanti Divvela, PharmD
`Clinical Editor
`Catskill, New York
`
`Richard J. Duma, MO, PhD
`Dirt'ctor. Dcp!lrtmont of
`lnfoct.ious Disonsos
`Infectious Disensc Division
`Hnlifnx Mcdicnl Cent.er
`Dnytonn Beach, Floridu
`
`Michael S, Edwards,
`Pbat·nill, MBA, BCOP,
`FASHP
`Director, Oncology Phar·mncy
`Residency
`Walter Reed National Military
`Medical Center
`Bethesda, Maryland
`
`Edward A. Hartshorn, PhD
`Atljunct Professor
`School of Nursing
`Univorsity of'J'exeR
`Medico( Brunch
`Galveston, 'fcxm,
`Professor Emeritus
`Metlicol University of
`South Carolina
`Charleston, South Carolina
`Instructor
`School of Nursing
`University of Texas
`Health Science Center
`Houston, Texas
`
`Mary J. Ferrill, PbarmD,
`FASBP
`Dean and Professor of
`Pharmacy Practice
`Lloyd L . Gregory School of
`Pharmacy
`Palm Beach Atlantic
`University
`West Palm Beach, Florida
`
`Thomas A. Golper, MD,
`FACP,FASN
`Professor of Medicine
`Division of Neph.rology and
`Hypertension
`Vanderbilt University Medical
`Center
`Nashville, Tennessee
`
`CoL (Ret.) John D. Grabenstein,
`RPh, PhD, FAPhA, FASHP,
`FRSH
`Executive Director,
`Medical Affairs and Policy
`Merck Vaccines
`West Point, Pennsylvania
`
`Siret D. Jaanus, PhD, LHD
`(Hoo)
`Emerita Professor of
`Pharmacology
`Marshall B. Ketchum
`University
`Southern California College of
`Optometry
`Fullerton, California
`
`Robert E. Kates, PharmD,
`PhD
`Consultant
`Santa Barbara, California
`
`Julio R. Lopez, PharmD
`Chief, Pharmacy Service
`VA Northern California Health
`Care System
`Martinez, California
`
`Phiyen Tra, PharmD
`Drug Information Consultant
`Dallas, Texas
`
`vii
`
`Eton Ex. 1074
`6 of 23
`
`

`

`Table of Contents
`FOREWORD.. . . ... . . . ... . . .. . . . . . .. . ..... . . . . . . .. . . ... .. . . . . .
`X
`PREFACE . .. . . .. . . .. .... . . . ... ... . .. , . . . . . . . . . . . . . . . . . . . . . . . .
`xi
`INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`xii
`How to Use Drug Facts and Comparisons') , . . . . . . . . . . . . . . . . . . . . .
`xiii
`CHAPTERS (Note: A detailed table of contents appears on the first page of each chapter.)
`1
`1. Nutrients and Nutritional Agents . . . . . . . . . . . . . . . . . . . . . . . . . .
`189
`2. Hematological Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`3. Endocrine and Metabolic Agents . . , • . . . . . . . . . . . . . . . . . . . . . .
`359
`4. Cardiovascular Agents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`747
`5. Renal and Genitourinary Agents . . . . • . . . . . . . . . . . . . . . . . . . . .
`1039
`6. Respiratory Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`1137
`7. Central Nervous System Agents . . . . . . . . . . . . . . . . . . . . . . . . . .
`1285
`8. Gastrointestinal Agents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`2051
`9. Systemic Anti-lnfectives. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`2195
`10. Biological and Immunologic Agents. . . . . . . . . . . . . . . . . . . . . . . .
`2189
`11. Dermatological Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`3143
`12. Ophthalmic and Otic Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`3319
`13. Antineoplastic Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`3401
`
`APPENDIX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`FDA New Drug Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Controlled Substances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`FDA Pregnancy Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`General Management of Acute Overdosage . . . . . . . . . . . . . . . . . . . . .
`Management of Acute Hypersensitivity Reactions . . . . . . . . . . . . . . . . .
`Drug Induced Prolongation of the QT Interval and Torsades de Pointes. .
`International System of Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Normal Laboratory Values . . . . . . . . . . . . . . . . . • . . . . . . . . . . . . . . . .
`Calculations . ... . .. . . . .... .. .. . .. . . . . . .. • •.. . . . . . . . . . . . . .
`Manufacturers/Distributors Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`INDEX .. . ... .. .. .. ... . ... . .... .. . . ... .. . . ... ... . . .. ... . . .. ..
`
`A-1
`A-3
`A-3
`A-4
`A-4
`A-5
`A-5
`A-7
`A-8
`A-12
`A-16
`1-1
`
`ix
`
`Eton Ex. 1074
`7 of 23
`
`

`

`IC
`
`.
`
`Foreword
`, fnformution, I;,LC, ha~ serye<l.the clru
`. ,
`. , ,rofcRRl(,nBls Amee ,ta mcepr ~
`II pllr1 of Chnicnl DruJl
`.
`w
`F11cts ~ Comporii;o\'1~,11';1111ciRb, nnd other hcn.11.1~ _cn~<~1
`~11,u0·~ on prescrip~ion and n•ori
`inforn111t1on nee_~~ of/ ·111cJy 1111bi11Rc<l, compnrt1t1vc_ ,nfo ~ (DFC) otJr OagAh1p producto~.
`in ) 94~ l~.v pro,::r ·~:Ji,;:,s.- })l'IIR Far~lfl, ,111d c,,111V'"r1
`1::~ncc (If 'chr,icc for OU r many loy' ~-~
`f h·ul{ infcu•nmtwn nnc t. ,e re C
`~
`~f \ts unco111pr1111nia_hcli~ c~i~;fl:,~~~~U~~ ~~AOU rccll hocuu~c of it: ,,~1~;-·
`f ~1
`l't
`pre11cr1p1loll 1111
`rcliobilil.y, and eaae
`the! pr!1b1~~-v b~~~~~~ 1
`·• d
`,.,,.
`R well as 1n depth
`h
`1 ug
`·,,0 , nmoug ot 101
`su ,sen
`. d
`. viding single drug monogrup a u cJ .
`ni1.11tio11 by t.Jwrnpc11t.1c ui;c, P't" Over the yoora !J/i'C hafl chan~e
`DF'C hni- rcnuunc
`\11)1•, c
`<:r1ni.
`in e1ze !I" f!Cflpc, htit
`pnrii:.ons oi'closcly rel~tcd ogod ·~1·•1int iR wJ1y h1mfth cure pro_fca1:1iontil_A co!"tinu(f to lrtr1k to
`t,hc cmicel>t. hns ,_1cVl'',fi~11\JJf;'. them ubrcusL of importnnL information in their practici;
`Fact.,,; &. Compnr1sons
`o rncp
`.
`Customers who t~re,;, t~e cunc~1,~ta11~® eAm,werH, our electronic library of refon.!~~n
`8 eed and efliciency of electronic product!! c·
`. . CD ROM ln addition to DFC, other content 81.!~
`nccess DFC (,hroug 1 ac .. s bl 0111(!
`infonn!ltion, which is avnila con• 1nt.:J1
`• 1· cle Drug Interaction Facts A to Z D '
`available on Facts and_ CopmparisonsQI> ~~nLswacetrasti~~ u Med Facts (patient drug infor;ati~g
`1d!~W!d ~~d~;rff:i:~'r:~e;rta~~~t~~hi~h is b:~:da~~
`Re
`ti Fl ·t nd C
`I B ·i.ggs' Drugs in regnancy a1iu.
`F,
`!£{~j~,~~1~~~:j~~s0
`~~~~,;:~r~
`orma 10.n
`. !o~e monograph~
`Medi.Span data and has also added comparative efficacy m
`0
`regarding certai~ disease states. Information about Facts & ompa,:,son~M
`nswers can ~
`accessed through www.factsandcomparisons.com. Facts & Compansons
`. also offers drug
`infom1ation for handheld personal data assistants, available for downloadmg at WWW.fact,.
`sandcomparisons.com.
`Drug Facts and Comparisons™ .monograph~ ar~ also integratE;d in~o Medi-Span's Drug
`Io formation Bridge, a pre-programmed af phcation progra_mmmg _mterface (API) that
`includes Medi-Span's drug files and clinica databases. T~e mtegra~on o~ the DFC refer(cid:173)
`ential content with Medi-Span's premier databases proVIdes supenor point-of-care solu(cid:173)
`tions for our professional customers.
`
`,
`
`•
`
`in
`
`Facts & Comparisons™ takes our mission of providing drug information to health care
`professionals very seriously, whlch is why we continue to invest in technology, improve our
`current publications, and stay in contact with our customers to make sure we maintain the
`high standards we set many years ago when Erwin Kastrup, RPh, first developed this con(cid:173)
`cept. We have many people to thank for helping us achleve these goals, including our Edi(cid:173)
`t.orial Advisory Panel, reviewers, contributors, and our excellent, dedicated employees but
`more than anything we want to thank our loyal subscribers who have helped us de;elop
`and improve our drug information publications that are so widely used today.
`
`We ~e dei~cated to maintaining the traditions tha_t are important to both Facts &
`Compansons ~d our custo~ers, but we are al.so dedicated to evolving our products to
`meet the changing technologies and the changing needs of health care professionals
`These goals only can be. accomplished by res_ponding to the comments and suggestion~
`from our subscnbers, which we enc0t_.1rage and appreciate. As always, let us know bow we
`can better serve you and your drug information needs.
`
`X
`
`Eton Ex. 1074
`8 of 23
`
`

`

`-
`
`Preface
`As the premier publisher of drug infor1nation, Fads & Comparisons·rM provides a broad
`range of print and electronic resources to fulfill the day-Lo-day needs of practicing health
`care professionals. Drug Facts and Comparisons® (DFC), our nagship publication devel(cid:173)
`oped in 1946 by pharmacist Erwin K Kastrup, was initially designed to provide objective
`information in a format that facilitated unbiased comparisons of drug products in a
`timely manner. After more than 60 years1 the basic concepts remain the same. Howevec,
`the content and presentation of material m DFC continues to evolve to reflect the chang•
`ing needs of the health care environ ment.
`
`The annual bound edition is one of several formats in which DFC is available. The
`original loose-leaf version is kept up to date through monthly print updates. An electronic
`version, updated continuously, is available as part of Facts & Comparisons"' eAnswers
`and can be accessed via www.factsandcomparisons.com.
`
`Facts & Comparisons® eAnswers also provides full monographs with complete pre(cid:173)
`scri~ing information for nearly every single agent drug product, while the print versions
`co~tmue to present abbreviated drug monographs in instances where a class monograph
`exists.
`
`The new 68th edition of DFC incorporates 35 new drugs: Ado-trastuzumab emtan~ine
`(Kadcyla by Genentech), afatinib dimaleate (Gilotrif by Baeringer !ngelheim), botulism
`antitoxin heptavalent (equine) (by Cangene), cabozantinib malate (Cometriq by Exelixis),
`canagliflozin (Inuokana by Janssen), coagulation factor XIII A-Subunit, recombinant
`(Trett~n by Novo Nordisk), conjugated ~stro~ens/bazedo~ifel'!e (Duauee ~Y Pfizer)_, dab(cid:173)
`rafemb mesylate (Tafinlar by GlaxoSmithKline), dapaghflozm propanediol (Farxiga by
`Bristol-Myers Squibb), dimethyl fumarate (Tecfidera by Biogen Idec), dolute.gravir
`sodium (Tiuicay by GlaxoSmithKline), eslicarbazepine acetate (Aptiom by Sunovion), fer(cid:173)
`ric carboxymaltose (Injectafer by Ame.rican Regent), fluticasone furoate/vilanterol trifena(cid:173)
`tate (Breo Ellipta by GlaxoSmithKline), glycerol phenylbutyrate (Rauicti hr Hyperion
`Therapeutics), ibrutinib (Imbruuica by Pharmacyclics), levomilnacipran (Fetzima by For(cid:173)
`est), lorcaserin hydrochloride (Beluiq by Eisai), luliconazole (LuZl.t by Medicis), maciten(cid:173)
`tan (Opsumit by Actelion), metreleptin (Mya.lept by Bristol-Myers Squibb), obinutuzumab
`(Gazyua by Genentech), pomalidomide (Pomalyst by Celgene Corporation), ponatinib
`hydrochloride (Iclusig by ARIAD Pharmaceuticals), prothrombin complex concentrate
`(human) (Kcentra by CSL Behring), radium Ra 223 dichloride ()(ofigo by Bayer), riociguat
`CAdempas by Bayer Healthcare), simeprevir sodium (Olysio by Jenssen Therapeutics),
`sofosbuvir (Soualdi by Gilead Sciences), sucroferric oxyhydroxide (Velplwro by Fresenius),
`trametinib dimethyl sulfoxide (Mekinist by GlaxoSmithKline), umeclidinium/vilanterol
`(Anoro Ellipta by GlaxoSmithKline), unoprostone isopropyl (Rescula by Sucampo),
`varicella-zoster immune globulin (human) (Varizig by Cangene), vortioxetine (Brintellix
`by Takeda).
`
`As this edition goes to press, we continue to update our database daily for use in future
`editions and formats of DFC. We also continue to expand our extensive library of drug
`information resources to remain the full service drug information provider that our cus(cid:173)
`tomers have come to expect. However, this can only be accomplished with feedback from
`the loyal health care professionals who use our information on a daily basis. Comments,
`criticisms, and suggestions are always welcome and encouraged. Please call or visit us at
`www.factsandcomparisons.com.
`
`Eton Ex. 1074
`9 of 23
`
`

`

`Chapter 1
`
`NUTRIENTS AND NUTRmONAL AGENTS
`
`1
`
`DIETARY RE FERENCE INTAKES OF VITAMINS AND
`MINERALS, 3
`VJTAMINS, 5
`fnt-Soluhle Vitamins. 5
`Woter-Solul>le Vit;imim. 19
`MINERALS, 41
`Calcium. 41
`Pbo$phorus, 46
`Magnesium. 48
`TRACE ELEMENTS, 50
`Selenium. 50
`Iron. 51
`Mo.nganese. 67
`Copper. 67
`Zinc Supplements. 67
`fluoride, 68
`ELECTROLYTES, 71
`Sodium Chloride, 7 1
`Pow.i;~ium, 72
`Oral Electrolyte Mixtvres, 75
`Perit.oneal Dialysii; S<ilutions, 76
`SYSTEMIC ALKALINJZERS, 77
`Citrate Citric Acid Solutions, 77
`Tromelhamine, 70
`AMINO ACIDS, 80
`L-Lysine, 80
`Melhion iue, 80
`Threonine!, 8 1
`Amino Acid11 with Viuimin6 and Minerals. a I
`Amino Aci,I Dcrivutive11, 8 1
`LIPO'J'ROPJC PJlODUCTS, 8li
`Cl1111i111,, 86
`lno11iU>l. l:lli
`l,ip11Lrnpi1• U1Jrnbinutions, 85
`
`FISH OILS, 86
`Omega-3 .Polyunsaturated f atty Acids, 86
`ENZYMES, 88
`Lactase Enzyme, 88
`Sacrosidase. 89
`ORAL NUTRITIONAL SUPPLEMENTS, 90
`Probiotic Products. 90
`Flavocoxid. 94
`Capryli dene, 95
`Zinc Citrate/Phytase. 96
`NUTRITIONAL COMBINATION PRODUCTS, 97
`Multi,itam:ins. 97
`Multintamins with Fluoride. 101
`Multivitamins with :Mi nerals (Includin g l ronl, 103
`Multintamins with Minerals 1Except lronl. 111
`Multiminerals , 120
`Prenatal Vitamins 9'ith Minerals, 12 1
`Calcium -with Vitamin D, 125
`.INTRAVENOUS NUTRITIONAL THERAPY, 130
`Protein Substrates, 130
`Caloric Intake. 155
`Lipids, 157
`Vitamin~. Parentera l. 159
`Minera ls. 160
`Elect rolytes, I i O
`Trace Elements. Injections, I 79
`lntrnvenou~ Replenis hment Solut ions, 185
`
`Eton Ex. 1074
`10 of 23
`
`

`

`DIETARY REFERENCE INTAKES OF VITAMINS AM> MINERALS
`nutril ional nttd& by a ~pecif,ed indlcalM af adequacy in 5fY.I, of an age- and gender...,peci6c group. RDAs
`le 1941, lh<> Food and Nutriliou Board (!"NB) of I.he lnatil'Ute of Medicrne, Notional Academy of Sci(cid:173)
`•re hued on EAR,, nr>d nre ""tlmat.cd to m""t I.he need,i .,r mosl i.ndivid<>ols 197% to~ ,. Ah are used
`ences. published the 6rat. editioo of Lhe Recommended Dietary Allowance,, (RD.As) to be used Lo evaluate
`when an RDA cannot be dete·rmined. UL;,. the maximum amnunl .,rdai.ly nutrient intake (from rood,
`the nutritional intalteo oflarge populations. The primMY purpose for the RDA.s wru Lo prevent disee!leS
`wal.er, a,nd su pplementa) lMl io lilu,ly to pose no risk of adver.,;e reaction5.
`caused by nutritional deficiencies. Over the years, these guidelines were periodically updated and
`revised based on romulative scientific evidence, and th.e tenth edition was publi• h.ed 1n 1.989, Jn
`In the followin.g DR! tobles. the RDAB an, in bold typ,, a nd the Alli are in onlina.ry type followed by an
`response to the growth or scientifie knowledge regarding_ the roles of nolrierus. in human health, lhe
`asteri~k (• ). Th<!:!ie values may be ""ed "" goal8 for indivi(l,,~ I intak~. For heal thy bre3!!1l-fed infaols. l he
`FNB in partnenhip with Health Canada revised the RDAs and developed the Dielllry Reference
`Al n,presenta mean intake. For all <>Lher li(e-!t.age g7ou p,,. the A( i.B believed to rover tbe needs o f all
`lctakes (l)Ris}.
`indjv,dua.ls1 but a lac:k of data o r uncenafoty ,n u,., d a ta pn,"mt 3peciryi og with confidence lh.e per(cid:173)
`cenl.ilge of mdividuaJ8 covered by thi,i intalce.
`The DRis "'"'" published as a series of 8 reports from 1997 lo 2005 and include lhe foUowing nutrient
`reference vnlues: Estimated Average Req~enl (EAR), RDAs, Adequa\e Intake (Al) and Tolerable
`..... y~--·
`,take Leve.I (UL}. EAR refers to the mtake value of a nulrienl that is estimated to meet the
`"'
`ORls: Recommended Intakes for lnchiduMS tvrtaminsl
`Life.Slage ~t Vitamin C
`Vrtamin B0
`Thiarrnne
`Riboflavin
`Nlacin
`Vitamin K
`Ul'9'dl
`(mg/di"
`h,~dl
`lmg/dl
`lrncgldl
`
`Folate
`Cmco/dl'
`
`Vstan,;:_n 8-,,
`Cmc:gtdl
`
`aad lmg/dl
`
`fmcgldl
`
`lmgtdj9
`
`rmnkil
`
`Votamin D
`l,n<-nlri)1'c
`
`Vit.amin E
`4mgldl"
`
`400•
`500'
`
`300
`400
`
`600
`900
`900
`900
`900
`900
`
`40•
`50•
`
`lS
`25
`
`45
`75
`90
`90
`90
`90
`
`10•
`10'
`
`15"
`15"
`
`15•
`15'
`
`,s~
`15•
`,s~
`20•
`
`4'
`s•
`
`6
`7
`
`11
`15
`15
`15
`,:5
`15
`
`z-
`2.s•
`
`30'
`.55•
`
`so•
`75•
`120•
`120•
`120•
`120•
`
`0-2"
`o..3•
`
`0.5
`cu;
`
`0.3•
`0.A"
`
`05
`0.6
`
`0.9
`1.3
`1.3
`1.3
`-1.3
`1.3
`
`'
`
`2·
`4•
`
`6
`8
`
`12
`16
`16
`16
`16
`16
`
`0.1'
`03"
`
`05
`0.6
`
`,
`
`1.3
`1.3
`1.J
`1.7
`1,7
`
`65•
`eo·
`
`150
`200
`
`0,4•
`o.s·
`
`0.9
`12
`
`1.7'
`1.a"
`
`r
`3'
`
`150'
`
`250'
`
`550•
`550•
`
`6 "
`
`12·
`
`zs·
`JO'
`
`I
`
`QrotJP
`Infants
`Oto6mo
`7 to 12 mo
`Clli/dten
`1 toJy
`4to8y
`Men
`9101Jy
`14 to 18 y
`19to JOy
`Jlto 50 y
`51to 7Dy
`70y
`Women
`9 lO 13 y
`14 lo 18 y
`19 lO 30 y
`31to50y
`51 lO 70 y
`10 V
`Preg,a,rncy
`14 lO 18y
`19to30y
`31 to50y
`Lac:aoon
`1s•
`19
`14l0 1B y
`115
`1:.200
`19to30y
`1.300
`19
`1'2.0
`15'
`,s•
`31 IOSOy
`1,300
`19
`1.20
`NOTE: Als are in O<dina,y ivpe followed bv an a5'erist l'l. and ADAs an, In bold IYJ>8.
`• As retinol aaM!y equival<nu IRA&~ 1 RAE• relinol I mcg, )korocl!fle 12 mcg, , ,_ 24 mog, or jkryporucanthin
`24 mcg, 1be RAE for dial>ry pravitamin A CMCJt'"10icls Is 2-fokl grwter than rellnol eQui.,.,tents IRE(cid:141)• whereas uie RAE
`for peformed \ritamin A is the same .,. RE.
`111 As cho~iftirot. Cholacatcif'erol 1 mcg - vitamin O 40 tJMS..
`• As c,~OCQllhen,I. a-T<>c:ophetcl lncludes RAAa-40COphetol, !tie only tom, or <>·tccopherol 1hal oca,,s n.aturally in foods.
`
`600
`700
`700
`700
`700
`700
`
`750
`770
`770
`
`45
`615
`75
`75
`75
`75
`
`80
`85
`85
`
`1s·
`15•
`15•
`,s•
`15•
`20•
`
`15'
`15•
`,s•
`
`11
`15
`15
`15
`15
`15
`
`15
`15
`15
`
`0.9
`12
`1.2
`1.2
`t.2
`1.2
`
`0.9
`1
`
`,.,
`
`1.1
`1.1
`1.1
`
`1,4
`1.4
`1,4
`
`1.4
`1.4
`1,4
`
`so•
`75•
`90"
`90"
`90•
`90•
`
`75•
`90•
`90•
`
`75•
`90•
`go+
`
`C Vafues based OC11he -of edequaie expoou,e 10 """1>liQN.
`and Che -ric forms ol o~ooopl,erol lRRR-. RSR-, RR$, and RSSu~oeo9hero1(cid:141) lhal ocn,r in foctilled foods
`
`and supplemems. • does nae ~ tl>e 25 - s~ fonns of <>·looopherol rSRR-, SSR-, SRS.. and SSS<t(cid:173)
`,ocop11ero11. atso fOCJnd in lo<tified foods and a,pp;ements,
`• lndudes nicotinic acid amide, nicotnlo ilCid lpyndine-3-cal1>oxylic acid). ~nd derivaliYes Olat exhibit lhe biological eofvily
`o f nicotfnamicle. As niacin equiva1ents INE). Niacin 1 mg• 1~n 60 mg; Q to 6 mooths ~ pmlonned niacin (J,ol NEl.
`
`300
`400
`400
`«JO
`400
`400
`
`300
`4ool
`400'
`4ool
`400
`400
`
`600'
`600'
`600'
`
`1.B
`2A
`2A
`2A
`2.N'
`2.4"
`
`1.8
`2.4
`2"
`2..,
`Z.4!'
`2..•"
`
`2'6
`2..6
`2.6
`
`0.9
`1
`1.1
`1.1
`u
`1.1
`
`1.4
`u
`1,4
`
`12
`14
`14
`14
`14
`14
`
`18
`18
`18
`
`1
`1.2
`1.J
`1.3
`1.5
`1.5
`
`1.9
`1.9
`1.9
`
`o"
`
`I .,.
`...
`-
`
`PantotMnic l Biooo I Choline
`I s·
`I 125'
`I 200'
`I 8'
`I 20· I 375•
`30• I 550•
`
`4•
`5•
`s-
`5•
`s·
`5 '
`
`...
`
`;•
`;;•
`5 •
`5 •
`5 •
`
`JO'
`JO+
`
`sso·
`sso·
`
`2lr
`25•
`30•
`30•
`.30•
`30•
`
`30"
`30'
`JO•
`
`375•
`400•
`425•
`425•
`425•
`425•
`
`¢50'
`
`~-
`
`.:.so.
`
`500 I 2.8
`
`1.6
`17
`2
`550•
`35•
`.,..
`1.6
`17
`2
`500
`.JS•
`2.8
`SSQ•
`1.6
`17
`500
`2
`3S•
`7-
`550·
`2.8
`As dietary l<>™e eqwvalefn COFE~ One 0FE • food lolalJ! 1 mcg ~"""'acid 0-o mc:,g !Tom 'onmed OOC<l 0< as a SU~
`1
`ment consumed with load • O..S mog of a su~ ~ ""' .,... empty sromacl'l.
`"Although Als have been ser fo, C:hofine. ~ are fe.h d:ata to assess v.ncmer .l aierar; suppfy of O>Olane cs needed at al•
`~ ol lhe lile-q,ci<,, and it may b& thac mi, chc4,r., requament coo .,.. """' 1:1v ~ .,,...,,_.. .n some of
`lh...,Slages.
`• Seeause 10% to 30% of olde< people may ma'3oso!b ~ a.,,.. ~ .s -""osaboi! tor ,_ ._ oioe< cnan 50-..,ars
`or age 10 meet thew FtOA. maiatv bv ~ loods romr....i ,.,m s,, or ~ ... ...,,..,.,.,... ~ a,,.
`1 In \l'iew ot evidence linking fol.ace intake '-._;th neur.sa tubit de.feas: "' ~ f'iilfus.. 11 cs re:::ommenoed maa a ll ,'w0f11e'n capab&e
`olbecomingpreg,ianc CO<\SlJmO .WOmcyf rom~ _,, ftin11i<,d """<ls ,n .aoooon 10 "'~
`of food folate from a
`varied diel.
`11\ is assumed that women will coru,nui! <'Qn:SIJn:ung ~ mcog from ~ ,.y rt,,rafie,o ·fooa until tnetr ip,regnancy cs
`confirmed alld they en.1er pr en.nail canJ~ ,,h.t...""l\ c,.rd1n..M'il'/ o.."\."'6t'S .ll'tEN' ~ ~ ot lnl!- Pi!nconc:eccicwl3J oenod--lhe CJ1DCal
`t;me !or fonnalion ol tt,e neu,dl tub,,.
`
`...
`
`Eton Ex. 1074
`11 of 23
`
`

`

`DIETARY REFERENCE INTAKES OF VfTAMINS AND MINERALS
`
`.b
`
`I
`
`Calcium
`lmQMI
`
`Chromium
`(mcgrd)
`
`Copper
`lmcg/CII
`
`Auoride
`lm9'dl
`
`Iodine
`Cmcgldl
`
`Cmg/dl
`
`rmg/d)
`
`lmcg/ol
`
`DRls: Recommended Intakes for Individuals IE!emenbl
`Iron
`Magnesium
`(mg/d)•
`(mg'dl
`
`lm09"dl
`
`Mangaoese Molybdenum r Pnosphorus I Selenium
`
`200·
`2so·
`
`700•
`1,000·
`
`o.:r
`5,.5+
`
`11·
`15•
`
`200"
`220·
`
`340
`440
`
`0.01•
`o.s·
`
`0 .7'
`1•
`
`110'
`130"
`
`90
`90
`
`o.zr
`11
`
`7
`10
`
`30•
`75•
`
`80
`l30
`
`0.003"
`0.6'
`
`1.2·
`1.s•
`
`2'
`3•
`
`17
`22
`
`34
`43
`45
`45
`45
`45
`
`100·
`vs•
`_,
`
`500
`
`1,,250
`1,250
`700
`700
`700
`700
`
`20•
`
`l 1s•
`I 20
`
`30
`
`40
`55
`55
`55
`55
`515
`
`Zinc
`lm9'dl"
`
`Potassium
`(g/dl
`
`Sodium
`19'<11
`
`O.laricle
`lglcll
`
`0,,12·
`11.37•
`
`,.
`
`1.2•
`
`0.16"
`057 •
`
`1.s·
`1.9•
`
`2'
`J
`
`3
`5
`
`o.,4•
`0.7 ·
`
`3•
`'.l.8"
`
`4.5•
`4 ,7·
`,,_7 •
`4 .J•
`4-7"
`11.1 ·
`
`Lile-stage
`group
`Infants
`0to6mo
`7IO 12 mo
`CT'lildren
`1 to3v
`dto8y
`Men
`9to Uy
`14 'lO 18y
`19to 310y
`3lto 50y
`51 to 70 V
`70y
`
`""""""
`
`21•
`24'
`25•
`25•
`20·
`20•
`
`29•
`30•
`30•
`
`1,300"
`1,300•
`1.000•
`1,000•
`1.200·
`1.200•
`
`1.,300"
`1/)00"
`1.000·
`
`1,300"
`1.000•
`1.000•
`
`700
`890
`900
`900
`900
`900
`
`1,000
`1,0CN)
`1,000
`
`1,300
`1,300
`1,300
`
`2•
`3'
`3•
`3•
`3 •
`3 •
`
`3•
`3•
`3"
`
`120
`150
`150
`1'50
`150
`150
`
`220
`220
`220
`
`8
`15
`l8
`18
`8
`8
`
`'D
`'D
`27
`
`10
`9
`9
`
`240
`360
`310
`320
`320
`320
`
`400
`350
`360
`
`360
`310
`320
`
`1.6'
`1.6'
`1.B"
`1.a·
`1.s•
`1.s•
`
`2·
`2·
`2·
`
`34
`43
`45
`45
`45
`45
`
`50
`50
`50
`
`1,250
`1.250
`700
`700
`700
`700
`
`1.250
`700
`700
`
`1,300'
`1,300•
`1.000·
`1.000•
`1.000•
`1,,200•
`
`25'
`35•
`35•
`35•
`30•
`30'
`
`700
`890
`900
`900
`900
`900
`
`2•
`3•
`4•
`4•
`4•
`4 •
`
`120
`150
`150
`150
`1.50
`l50
`
`B
`11
`8
`8
`8
`8
`
`240
`410
`400
`420
`420
`420
`
`1.9"
`2.2·
`2.3•
`2.3'
`2.3"
`2.3"
`
`8
`11
`11
`n
`11
`11
`
`40 I 8
`
`55
`515
`55
`55
`55
`
`9
`8
`B
`8
`8
`
`1.s•
`1.5'
`1.5'
`1.s·
`).J•
`1.2·
`
`1.5•
`1.s·
`1.s·
`1.s·
`1.3'
`1.2'
`
`l j "
`d..7"
`4 ,7·
`d..7"
`47•
`d..7"
`
`d..7"
`4-7•
`
`1.5'
`1.s·
`
`2.3•
`2.3'
`2.3"
`2.3•
`r
`1.11'
`
`2.3•
`2.3•
`2.3'
`2.3"
`2·
`1.s•
`
`2.3'
`2.3"
`2.3'
`
`9 to 13 V
`14 lo 'lB y
`19to30y
`31 to 50y
`51 to70y
`70V
`hegnancy
`l4to18y
`19I030y
`31 ro 50y
`Lactation
`3•
`44•
`14 IO 18 V
`290
`45•
`290
`3*
`19 to 30y
`290
`3"
`31 toSOv
`45'
`NOTE: Ats are in ordinaty type folowed by an asierisl< l'l and RDAs are in bold type.
`_
`.
`• Non-tleme iron aboorpuoa is lower ror those oonsumitl!J vegelarian diets than ro, lhose eating nom,egetanan dlt!tS.
`lheremre. ii has beeR suggested lha1 the ,ron requirement for ind'Mduals consuming a wgetan811 diet Is approl<imately
`2-fold greate, 1l1an rcr incfrvicltJals constJming a nonvegetarian dieL
`Reprinted ,,,.;(h permission from Dktary Re(erenll lnta.ke.o. Copyright 2004, Natitmal Academy of Sciences. Courtesy of the National Academies. Press. W8$hi.ngtoo. DC.tm:O
`
`60
`60
`
`11
`11
`
`ts•
`2.6'
`2.3'
`50
`70
`1.250
`5..1 •
`2.6"
`1.s•
`50
`2.3'
`700
`12
`70
`\
`\
`1
`1.:s•
`2.J•
`5.. 1·
`2.6"
`50
`12
`700
`70
`• Zinc absorption ls lower for those oonsuming vegetarian diets than lo< a,ose eaong ~ diets. Therefore. ,t
`has been suggested thM \he zinc requirement rw ind'Mduals a,nswrnng-a _,,.,,... die, is aAPR>,'l<imalelv 2-4old
`greater than lor ;,,ctividuals consuming a ncmvege«anan diet.
`
`\
`\
`60 I 12 I d..7' I 1.s·
`13 l s.1·
`
`~
`
`l
`
`Eton Ex. 1074
`12 of 23
`
`

`

`CRYSTALLINE AMINO ACIDS
`
`C
`
`INTRAVENOUS NUTRITIONAL THERAPY
`Protein Subs1rates
`
`Amino acids (essential) (mQ/100 mU
`
`Amlno acids (nonessentiah mjj'tDO ml
`
`Eleclro/yles lmE:¢1
`
`.... w _,._,
`
`. -
`
`C:
`
`.,
`1
`
`0
`
`&
`
`..
`
`..
`!
`
`C
`
`C:
`C:
`.2
`.c
`lo
`::;
`252 140
`368 I 60
`360 200
`
`0
`C
`
`0
`C
`
`..
`
`.,
`c
`C
`.c
`;;;
`c
`0.
`>
`.,
`0
`~ a.
`0
`C
`t
`.c
`.c
`a.
`I-
`182 56
`154
`104
`140 70
`220 260 BO
`
`C
`
`C
`
`..
`"
`·c
`.,
`J
`<t
`280
`448
`175 348
`640
`400
`
`.
`
`C
`
`.,
`e
`
`Cl
`£
`0
`
`{/)
`
`...
`.,
`C
`e~ s
`'i5
`x
`"-
`105 300
`147
`105 253
`186
`150
`430 210
`
`C
`C:
`
`4 ·
`343
`356
`490
`
`.
`.
`
`!
`
`..
`.,
`.J
`
`C
`
`C)
`
`448
`17S
`640
`
`C
`
`.,
`C
`·c
`:,
`(!
`
`L:
`i .
`'i i
`I
`"
`·g
`~
`JI
`95
`44
`
`149
`
`200 100
`
`250 497
`
`509
`
`150
`
`361
`
`135
`
`250
`
`369
`
`300
`
`32
`!il
`- .!l
`E
`s
`:,
`a
`
`'tJ
`u
`.!l
`C
`
`.
`..
`£
`a
`0
`lo
`~ t;
`
`E
`::,
`]
`
`258
`
`245
`
`16.3
`
`0
`
`C
`
`-
`
`'
`350
`
`-
`
`'"'
`:, .
`
`438
`
`.
`Labeled inmcations
`.:c
`.,,
`C
`o:
`-c
`s
`..
`c:.:.
`i
`..
`e
`i
`c
`d
`:::;
`-
`• .5 -
`!!
`E
`E
`~
`a__ z
`.. .
`,:
`a.
`; ~ £
`e
`E
`::, •
`"-
`.,
`• ~ 0
`0
`'tJ
`j-
`.c
`"rJ
`'tJ
`e
`.!!
`a.
`,:
`.c
`. 51
`0 1 0
`c
`g. .
`~
`E
`Q.•
`B
`-"i
`:c,
`d
`f
`· O
`0.. u
`~
`"- .
`~
`Cl)
`. Yes ,
`1,000 Yes No
`322
`t
`-
`· yes No Yes
`.
`25.2_
`-
`308
`• 1,000
`66
`~ - 500" Yes Yes
`Yes
`-
`1,000'
`.
`. : 35..!t
`500
`Yes Yes Yes
`- 1,000
`500" Yes
`Vess . No
`·yes Yes , Yes
`50(J<"
`.
`5IXY' Yes Yes
`
`< 3
`
`'
`
`.
`
`:
`
`No
`
`561
`
`54.4
`525
`1015j
`..; 655
`. .
`32.5 ~
`..
`- - - -
`
`-
`
`. 50 .
`
`. 589
`
`35
`
`90
`
`802
`
`5<iF- Yes
`
`Yes
`
`Yes
`
`Yes
`-
`Yes Yes
`
`' -
`
`7'.
`
`1..117 534 831
`
`125 300 ~ 125
`
`1"-
`
`1.07 462 700
`
`735
`
`120
`
`2119
`
`280 140
`
`8.5% 1.34 621) 810
`
`624 340
`
`380 460 150
`
`470
`320
`560 900
`.
`462 490 . 861
`
`350
`
`-695
`
`220
`
`:311 :
`
`' 189 350
`
`"265
`•
`..
`7.10
`290 410 Z30 15 140
`Z20
`690 210
`610
`300
`4;_4 ~ 900
`570 347 50 . 44; 270
`~-
`--
`713 210 505
`.
`·
`680 1.100 850 260
`
`750
`
`:J70
`
`'
`44 1,100
`,-
`
`-
`
`8.5'% 1.3 561
`
`ll50
`
`893
`
`146
`
`253 340 170
`
`425
`
`844
`
`866
`
`255
`
`614
`
`)ISO
`
`19.3
`..
`-
`190 <14 5.5
`
`576
`
`370
`
`517
`
`490
`
`·-
`
`~
`
`. . 25~
`
`---- . .
`
`.
`
`.
`40
`
`88
`
`107.6
`
`127
`
`<3
`< 3
`
`57
`94
`
`.2 e c
`:::;
`E
`8
`C
`8
`s
`.,,
`..
`~
`u
`.,
`~
`g
`"'
`C
`u
`.,
`0
`E
`::,
`z
`...,
`<
`Aminosyn 3.5% !Hospital ~ D.55 2S2
`329
`Aminosyn I ~
`CH05'>iral 3.S,,,, ) 0.54 231
`3SO
`5'lo 0.79 360 1 470
`Aminclsyn 5%
`(Abboa)
`5% o.n lll I 500
`Aminosyn 15%
`86
`525
`Wibonl
`8'4 10.93 490 I 840 I 490 200
`TrophAmine &,r. (B. llnlunl
`290 250 120
`Aminosyn7'4
`1.1 510
`7%
`510
`660
`280 310 370 120
`-
`{Hospral
`Amil--,,>ff
`475
`7,c. (Hospiral
`Aminosyn I 7%
`(liospraf
`Amino5yn&S%
`(Hospiral
`Ammsynll5%
`(Hospiral
`lffAmine (cid:127)
`4B. Braunl
`TrophAmine 10%
`re. 8taw>J
`Aminosyn 10"-
`(Hospira]
`Aminoq,w'F
`1°" (Hospira)
`Aminosyn ~ 10%
`(Hospira)
`Travuol lO'II.
`IBaxterl
`FreAmkle(cid:127)
`10'4 re.. Braun)
`Aminosynl
`15"" [Hospira(cid:141)
`Clinisol 15% ll!axterl
`
`10%
`
`1.53 690 910
`
`730 530 560 400 150
`
`15%
`
`2.3 990 1.500 1.575 2S8 447
`600 300
`15'% 2.37 749 1,040 1,180 749 1,040 749 250
`6% 0.93 490 840
`
`Pnmasol a,r. (Baxte<)
`Premaso1111'11.\Bax1erl
`
`-~-""-
`
`Eton Ex. 1074
`13 of 23
`
`'~
`
`'°"' 1.55 820 1,400 820
`\
`\
`I
`I
`I
`• ... ~~~~n ' IA l a.mino