PDR®
`58
`2004
`
`EDITION
`
`PHYS CANS'
`DESK
`REFERENCE®
`
`- : : - -~ - - - - - - - - - - - - - - - - - -~~ - - - - - - - - - - - - - -- -- - - - -
`¥.jf
`~e Vice President, Directory Services: D vid Duplay
`
`S
`Vice Presld
`ent, ales and Marketing: D1kran N Barsamian
`S
`enlor 01
`f
`t
`.
`rec or o Pharmaceutical Sales: Ant11ony Sorce
`N ti
`a onalA
`Sen·
`ccount Manager: Manon Reid. RPh
`•or Account Manager: Frank Karkows ky
`A
`ccount M
`. M
`anagers.
`arJone A. Jaxel. Denise Ke lley, Eileen Sullivan
`uzanne
`. Yarrow. RN
`Director of Trade Sales: Bill Gaffn 'Y
`Senior Director, Marketing and Product Management:
`!1
`Valene E. Berger
`enlor Product Manager: Jeffrey D. D bin
`nance Dire t
`s I
`c or: M ark S. R1tch1n
`en or Direct
`p
`.
`Se . M
`or, ubllshmg Sales and M arketing· M 1L11ael Bennett
`nior arketing Manager: Jennife r M Fronzagli~
`DI
`rect Mall M
`.
`·
`anager: Lorraine M. Loen1ng
`M
`P anag~r of Marketing Analysis: Dina A. M aeder
`romot,on Manager: Linda Levine
`~~~e President, Regulatory Affairs: Mukes l1 M eli ta. RPh
`torial Director: Lisette Bralow
`Manager Prof
`Man
`esslonal Data Services: Tilomas Flem ing, Pha rmD
`'
`ager, Editorial Services: Bette LaGow
`Manager Con 1
`c se Data Content: Tammy Cl1ernir1. RPli
`•
`
`Drug Information Specialists: Greg Tallis . RPl1; Min Ko, PhannD
`Project Editor: Harris Fleming
`Senior Editor: Lo ri Murray
`Production Editor: Gwynned L. Ke lly
`Senior Director, Operations: Brian Holland
`Director of PDR Operations: Jeffrey D. Schaefer
`Manager of Production Operations: Thomas Westburgh
`PDR Production Manager: Joseph F. Riuo
`Senior Production Coordinators: Gianna Caradonna, Christina Klinger
`Production Coordinator: Yasmin Hernandez
`Senior Index Editor: Sl1annon Reilly
`Index Editor: Noel DelougheIy
`Format Editor: Michelle S. Guzman
`Production Associate: Joan K Al<erl1nd
`Production Design Supervisor: Adeline Rich
`Electronic Publishing Designers: Bryan Dix, Rosalia Sberna, Livia Udina
`Digital Imaging Coordinator: M ichael Labruyere
`Director of Client Services: Stepl1anie Struble
`Fulfillment Manager: Louis J. Bolcik
`
`p
`
`'THO IVI
`d None of Ihe content o f this publication
`SON Copy119hI Cl 2004 and published by Thomson PDR al Montvale. NJ 07645· 1742 All nglits ieseive ·
`( lectronic mechanical,
`may be repIoduced. stored 111 a r tneval system. resold, redistributed. or transmitted 111 any fo~ s~~.~~s~rie';e~~~er:nce . PDR , Pocket
`-
`•
`photocopying. r cording, or otheiw1se) without the pnor wnlfen permission of th? pubilshern:P;escnpt,on Drugs , and PDR Family Gwde to
`DR
`PDR . PDR Family Guide 10 Prescnpt1on Drugs . PDR Family Gwde to Wome~~ ~eali ~prescription Drugs and Dietary Supplements, PDR
`N t
`C~i~;tion and Health a,o registered trademarks used hore111 under license PDR for Ophthatmic
`~~~;;e~6R Me~'.ca~ Dictionary, PDR Nurse's Drug Handbook, PDR
`pan,on Guido, PDR Pharmacopoeia, PDR for Herbal Med1c1nes. PDR for Nutnt,onal Supp
`es and Healmg Therapies. PDR Family Guide to Common
`I M ·d
`N
`c
`urso's Dict,ona PDR
`PDR Family Guide to Natura
`O ,c,n
`M d
`"!· .
`Ail
`Family Guide Encyclopedia of e ,cal are,
`.
`.
`/ements. and PDR Electrornc Library are trademarks used herein under
`. ments, PDR Family Guide to Over-the-Counter Drugs, PDR Family Guide to Nutnt,onal Supp
`license.
`
`1~
`
`r· Richard Noble: C/Jief Financial Officer: Paul Hilger: Executive Vice Pre~idcm, Clinical Trials: Tom Kell .
`Officers O
`.
`I Thomson Healthcare,: Pres,drmr and C/J1ef Execur,ve Office ·
`e P,esidenr. Clinical Solurions: Jeff Rei11I; Executive Vice President. O,recro s
`·
`.
`. .
`y, .
`E
`rye erv,ces. David Duplay.
`Sxccur,ve Vice Prcs1denc, Medical Ectucauon: Jeff MacDonald; Execuuv~ v,~ Human Resources: Pamela M. Bilasl1; President. Pliysician·s W Id· M·
`emor Vice Pres1denc. Busmess Development: w,11,am Golc: v,ce P,es, en .
`or . drty carnal
`
`ISBN: 1-56363-471-6
`
`This materia l w as.copied
`at th e NLM and m ay b-e
`Sub-j e-ct US Copyright Law s
`
`Page 1 of 7
`
`KVK-TECH EXHIBIT 1003
`
`

`

`.... 320, 1683
`
`102/ ACYCLOVIR
`z ovirax Suspension
`(G/axoSmirhKline) .
`Zovirax Tablets
`..... 320, 1683
`(Glax0S111ithKli11 e) .
`.. 25 13
`Acyclov ir Capsules (Pa r).···· ·
`. 3296
`Acyc lovir Ca psules ( War.wn ).
`.... 2 194
`Acyclovir Capsules and Tablets
`(M yfll11 ) .
`·
`· ·
`Acyclovir Tablets (Par) .·· ············ 2 51 3
`ACYCLOVIR SODIUM
`z ov irax for injection
`. . 320, 1685
`(GlaxoSmithKli11e) -
`ADAGEN INJECTION /Enzon) .. . .. . 1252
`+ ADALAT CC TABLETS
`/Bayer) .
`
`... 308, 832
`
`03 470
`ADAL~
`Humira Injcc1ion /Abbo11) · · · · · · · · · 3
`'
`ADAPALENE
`Differin Cream (Ga!demw) . · · · · · · · · · · · 1331
`Diffc rin Gel (Galden11a) . · · · · · · · · · · · · 1332
`Diffain Sohnion/ Plcdgc:ts (Ga /dermaJ .
`. 1333
`+ ADDERALL TABLETS
`/Sh ire US) .
`
`.... 336, 3143
`
`+ ADDERALL XR CAPSULES . . 336, 3144
`/Shire US) .
`ADEFOVIR DIPIVOXIL
`Hepscra Tablets (G ife(I(/) ·
`
`. 315, 1394
`
`.. 314, 1312
`
`+ ADENOCARD INJECTION .. . 314, 1311
`(Fujisawa) -
`+ADENOSCAN /F ajisawa).
`ADENOSINE
`- .Adcnocanl Injection (Fujisau·n) .. . 314, 1311
`i\dcnoscan ( Fr,jisawn) .
`. .. 314, 1312
`ADENOSINE TRIPHOSPHATE
`!A'IT'l
`. . .. ... .. 2 194
`;\: l'P (M0111ijJ) .
`ADIPEX-P CAPSULES (Gate).·· · ··· 1341
`1341
`ADIPEX-P TABLETS /Gate) ··
`ADOXA TABLETS /Biog/an) . ··· ····· · 9 77
`ADRENALIN CHLORIDE
`2
`· · · 2 14
`INJECTION /Monarch)··
`ADRIAMYCIN FOR INJECTION,
`USP /B edford)· · · · · · · · · · · · · · · · · · .... 894
`ADRIAMYCIN INJECTION, USP ... 894
`(B edfiml). ·
`ADRIAMYCIN PFS/RDF
`INJECTION /Pha rma.eta &
`. . . 2702
`Upj ohn) ..
`ADULT STRENGTH PRODUCTS
`( ,;ee base prod11,cl name)
`
`
`
`1406
`+ ADVAIR DISKU_S 100/50
`(GlaxoSmithKl,ne) · · · · · · · · · · · · 315•
`+ ADVAIR D[SKU_S 250/50
`1406 (GluxvSm1thKl1.ne) · · · · · · · · · · · · 315•
`+ ADVAIR DISKUS 500/50
`406 · · 315, l
`
`(GlaxaSm1thKl111e) . . · · · · ·
`ADVATE INJECTION !B axter
`llealth.careJ . ·
`+ADVICOR TABLETS !Kos) .
`+ AEROBID INHALER
`SYSTEM (Forest).· ··
`+ AEROBID-M INHALER
`SYSTEM /Fore.st}. ·· ·
`· ·
`+ AEROCHAMBER PLUS
`AND AEROCHAMBER
`PLUS WITH MASK
`(Forest ) . , .
`AI•'EDITAB CR TABLETS
`(\Vatsnn).
`AGALSID~ I]; Ifl'1'.fA
`- ~a bra7.~~ c fo r ln!ravenous lnru-; io n
`(Gemyme) .
`+ AGENER.ASE CAPSULES
`(Cllaw8mith Kt, n e) · · · · · · · ·
`+ AGE NERASE OR.AL
`SOLUTION
`.
`(G/axoSm. ithK/11,e) · · ·
`AGGRASTAT INJECTION
`(M er c/1) .
`AGGRASTAT INJECTION
`PREMIXED (Merc/1J · · · · · · · ·
`+ AGGRENOX CAPSULES
`(Boehringe r lngellu:im) .
`
`· · · · · · · · 809
`.322, 1792
`
`. . . . 313, 1289
`
`. . 313, 1289
`
`. 314, 1291
`
`.. . 3296
`
`·
`
`.1385
`
`. 315, 1412
`
`... . . 315, 1417
`
`.. . 1920
`
`1920
`
`.. 309, 991
`
`. .. 3389
`
`+ A~~J,1;~S~APSULES . . . . . ... 336, 3146
`AH-ClIEW CHEWABLE
`TABLETS (\Ve) .
`AH-ClIEW D CHEWABLE
`TABLETS /We) .
`
`. . .... . . 3389
`AKINETON TABLETS /Par) ....... . 25 13
`ALACOL DM SYRUP /Ba/lay) . . .. . ... 804
`+ \LMIAST OPHTHALMIC
`. . ... 335, 3038
`' SOLUTION (San ten) . . .
`ALA'l'ROFLOXAQ!N ]VJEl;,)'L,-\'[I];
`- Trova n I. Y. (l'Jicer) . .. .. .. .. .... 331, 2645
`ALBAMYCIN CAPSULES
`(Plw rma cia & Upjoh n) .
`·
`.. 2 702
`+ Shown in Product Identification Guide
`
`. . . 315, 1422
`
`. . . . . . . 568
`
`. . 568
`
`. .. . 558
`
`. . . 2194
`
`. ... 310, 100 3
`
`. . 319, 1655
`
`. . ... . 3 12, 11 93
`
`. . . 315, 1405
`
`ALBENDAZOLE
`Allx: nza Tab k:ts
`(Glcu::0S111irltKli11eJ.
`+ ALBENZA TABLETS
`. .. . . . . . .. 315, 1422
`(Gla.xoSm ithKline) .
`ALBUMARC 5% SOLUTION
`(A merican Red Cross) . . . . . .
`ALBUMARC 25% SOLUTION
`/American Red Cross) .
`. ... ... 568
`ALBUMIN (HUMANl
`-s ~;i-~;tc 5C:t, Solution, USP ( ll(Ltter
`. . . .. 812
`He£1 ltli core) .
`ll uminaie 25% Solu1 io n, USP ( Ba.Her
`. ... 813
`1-iea lrhcare).
`Plasbumin-5 (Bayer H calrhccm:) ... . . . . .. 886
`Pl asbumin -25 (Bayer 1-lealrhwre) .... . . . . 887
`Albumarc 5% Soluti on (Amc:ricar1 Reel
`. . . 568
`Cross) . .
`A lbmnarc 25% Solmion (American Red
`Cross) .
`Albumin 5% Solution (A merican Red
`. . . . 568
`Cran).
`Albumin 25% Solmion (,\ mer icrm Rt d
`. . . 568
`Cross) .
`Albutr.:i n 5% Soluiion (Alpha ) .
`. .. ... 558
`A!butein 25% Solution (Alpha) .
`. . .... 558
`ALBUTEIN 5% SOLUTION (Alpha ) .. 558
`ALBUTEIN 25% SOLUTION
`/A lp ha) .. ..
`ALBUTEROL
`Nt~;; r~Thblcts (Mylan).
`ALBUTEROL SULFAT~
`Acc uN~b Inhalat ion Solut ion
`. . . .. 312, 1194
`(D ey) .
`Combivcnt Inhalation Aerosol
`(lJoc:htin~er lngt'll1 c:i111 ).
`DuoNcb !nhala1ion Solution
`. .. .. . 313, 1198
`(D ey) .
`Vemolin 1-IFA l nha l:1tion Aerosol
`(Gla.wS111itl,K/i11e) .
`VoSpire Ex1cm.Jl!<.I- Relcasc
`. .. .. .. 328, 2375
`Tab le ts (Odyssey).
`A lbu tcrol Sul fate. Inhalation
`Sol111i on (Dev).
`ALCLOMETASONJ,;
`PIPROPIOJ'IA'IB
`Aclovate Cream
`(GloxuS111i1//Kli11e).
`A cl ova1e Ointment
`(Glt1xvS111i1i,K /ine) ... . .. ... . .. 315, 1405
`ALDACTAZIDE TABLETS
`. ....... . 3 103
`(Sea rle) .
`ALDACTONE TABLETS /SearleJ .. .. 3103
`+ ALDARA CREAJl,J, 5% /3M) . . .. 322, 1862
`ALDESLEUKlJ'!
`Prok ukin for l njct:tion (Chiron) . ... ... . 1163
`+ ALDOCLOR TABLETS
`. .... . 324, 1923
`/Mcrclt) .
`+ALDORIL TABLETS (Merck) . . . 324, 1926
`ALDURAZYME FOR
`INTRAVENOUS INFUSION
`(Genzy m e) .
`Af,EF~!;E_P]'
`A mi.:v ivc (/Jio~m /Jt'm w rologr} .
`ALE!\:!TUZl}MAJ!
`Campath Ampu k s ( /Jer/('X).
`
`. .. . . . 1381
`
`. . . 970
`
`. . 932
`
`ALENDI;lONA'l'E SODIUM
`Fosamax Tab lc1s (M ack) . .. .... .. 325, 1986
`+ ALESSE-28 TABLETS
`. . ...... 339, 3401
`(Wyeth ) .
`+ ALFERON N INJECTION
`. . . . 321, 1704
`/f-/cmi,sµh erx).
`Af,f'Ql:Q$J.~ .HYDRQCHLOU!DE
`Uroxairal T,1blt;tS (Sa,10Ji-Sy111hclobo) .. , . 3036
`ALINIA FOR ORAL
`S USPENSION (UomurilJ · ·
`ALITRETINOIN
`Pa nrctin Ge l ( Liga11d) ·
`
`. . . . . 2989
`
`. . . . . 3519
`
`+ ALKEHAN FOR
`INJ ECTION (CelE;cne) . . . . . .. . 312, 1120
`
`... . . . . . 312, 1121
`
`+ ALKERAN TABLETS
`(Celgene) . , ·
`ALL-BASIC CAPSULES /M ont i/T) . . . 2194
`ALLEGRA CAPSULES /A ven tis) . .. ·· · 71 3
`+ ALLEGRA TABLETS (A ven tis) .. 307, 713
`
`. 307, 716
`
`,
`+ ALLEGRA-D
`EXTENDED-RELEASE
`TABLETS /Aucn.tis) .
`ALl,OPUlUNOL
`.. 2194
`Allupurinol Tab lc!s (1\.fy /w1 ) .
`. .... . 2 5 13
`A llopurinol Ti.1blc1s ( Par).
`. 3 296
`A llopurinol Tabk:1s, US P ( Wlll.m 11 ), .
`ALLOPURINOL SODil!M
`A loprim for l njet..: tion (Nnbi).
`ALMOTRIPTAN MALATE
`Axcn Tabk1s (Or1/111~M cNd/) ..... . . ... 2433
`
`326, 2209
`
`. . . . . . 304, 546
`
`+ ALOCRlL OPHTHALMIC
`SOLUTION (AL/ergcrn) .
`+ ALOPIUM FOR
`INJECTION (Nabi) . . . ... . .. . 326, 2209
`+ ALO RA 'I'RANSDERMAL
`. ... . . 337, 3300
`SYSTEM (Wat son) .
`ALOSETHON HYDROCHLORIDE
`Lotroncx T:1blcrs
`(GlaxuSmirhKli11t' ),
`
`. .. 318, 1563
`ALOXI INJECTION /M G/) .. . . . .... . 2127
`ALPHA TOCOPHERAL ACETATE
`(see uuder: VITAMIN E)
`
`~~iOTEINASJ,LNHlBIToR
`
`Prolas1in (Ba)er He<1ltl1t are) . . .. . .. . . . .. 889
`. .. 784
`Zcmairn (rh n 1ri.\' Behring) , .. .
`+ALPHAGAN P
`OPHTHALMIC SOLUTION
`(Allerga n) .
`
`. 304, 546
`
`ALPHANATE SOLVENT
`DETERGENT/HEAT TREA'l'ED
`. ..... .. . 558
`/Alpha).
`ALPHANINE SD SOLVENT
`DETERGENT THEATEDMRUS
`FILTERED (Alpha) ..... ...... .. .. . 558
`ALI>RAZ.9Li\¥
`Xanax Ta bid s ( Phm 111a c_ ia &
`Upjo/m) . .. ... . ... ... . ... . ... 333, 2798
`Xanax XR Tublcts ( Plu11muci(/ &
`. . . . .... .. 2802
`Upjuliu) .
`Alprnwlam lnt1:nsol Orttl Solut ion
`(Conccn1ru11.:) CIV ( l?o., r, 11eJ .. ..... . . 2996
`t\ lprn/.01:un Tablc1s (Mylan ) .
`, . . . . 2 194
`AJ,rB9..ST@1!,
`Cavnjcct Impulse Inj ection
`( Pluin11adu & Upjo/111) . .
`C.tvcrjcc1 S1c:rilc Powder
`(Pli11m1<1<·ia & Upjvh11 ) .
`M US E Urethral Suppoc;i1ory
`(Vh-11s)., . . .
`.. . .. , . . . .
`Edex lnjc<:1ion (Sc/11\'(/ 17. ).
`+ AL'l'ACE CAPSULES
`/Mo11arch) . .... .. . ... . ... .. ... 325, 2142
`AL'l'EPLASE, ll_!<; COMBlNANT
`Ac1iva,c I.Y. (G<'nm11<'d 1) .. . .. ... 314, 1349
`CioihOo Ac1iva,c (G<'ncnt<c/, ) . ... . 315, 1353
`+ALTOCOR
`EXTENDED-RELEASE
`TABLETS /A n d rx t ab,) . . .. . . 305, 3507
`Af, T!!_~'!'A~NJ);
`Hc:rnlen Cap~ulc~ (M G !) . .
`ALU-CAP CAPSULES !3M).
`ALUMINUM CHLORIDE
`Dry•ml Solui ion ( /Jl'nti11 & Cm ·t·y) . . . ... 2568
`Xcrnc AC Solut ion ( Past111 & Cm'L'Y) . . , 2568
`Al,_lmlI~ UM HYDHOXIDE
`Maa lox Max fi.h ximum S11 cng1h
`Am,1citl/A r11i -G.is Liqu id (No1·0 ,1i)·
`. ••. 2218
`C,)1/ \'/{// l l'r}.
`Maalox Rcgul.ir Strcng1h Antacid/
`Antigas Liquid (No l'Urli ,; Co11s11111 erJ . . 2218
`Alu-Cap Cap, ulcs (J M ) . ....... . . ..... 186
`Alu minum I lyd1uxidi.: Gd USP
`(l-'lror111(1c'e111in tl Anof'ia tes) , .. . . .. . . 270 1
`A luminum ll y<.l 1oxidc Gel Cunl'.Cfllrah:
`(Pho111uu e11firnl A \' \ 1Jcit1 t l'\) . . . , . .• .. 2701
`+ ALUPENT INHALATION
`AEROSOL (Jioehri1111er
`. . .... . ... .. 309, 994
`l11gelheim) .
`T.t\DIN E tlYDR!)CHI, OIUDE
`Symmctn::l Syrup ( Endo Lu/J\·) .. . .. . . .. 1247
`Symm ~lrd 'fabk:1s (/:'ll(lt) l.nbs) . . . 313, 1247
`A manrndinc I lydrod1loridr Syn1p U~ P
`. , . .. 270 1
`(l'l,a n,wn,11riwl A \·.H)till tn).
`A ma n1 adini.: I ly<.ln}(hlnridc Sy1 up, USP
`(l:.:1ulo G, ,m ·r il'f} . . . .. , . ... . . .
`+ AMARYL TABLETS (l\ ucntis!.
`+ AM BIEN TABLETS
`/Sa nnfi -Synt lrnluboJ.
`+ AMBISOME FOH
`INJECTION WtLj isc, wo) . .. . . . 314, 1313
`A)Yl<;_INON!DJ;:
`A111cinonidc Cr~a m (Tr110 ).
`Cyelocon Topic:tl t ,~:un 0.11, ( ,
`(Fi1ji w11:·a).
`Cyd oco11 To pic;tl l .otion 0.11
`;,
`(F11jit1111•c1).
`1
`
`. ... . 2724
`
`. . . 332, 2721
`
`. 337,3251
`. 30 90
`
`.. . 325, 2129
`. . 18 63
`
`1235
`307, 718
`
`. . . 334, 3006
`
`. . . 3220
`
`1322
`
`~
`
`1322
`Cycl?~~lr! Turical Oimmcm O. J ',<,
`r hi/l.llll: (lj · · · · · · · · · ·
`· · · · · · · . · . . . l 322
`+ AMERGE TABLETS
`(GlaxoS111it/1Kli nc) . . . . . . ...... 315,
`AMEHI CAINE ANESTHETIC
`LUBHI CANT !Cellt echJ ... . . . . .. . . _ 11
`AMEVIVE (B iogen D,mnoto/ogy) . . .. ..
`
`1424
`
`30
`970
`AMIC,'\R INJECTION (Xo 11ody1,e; . .. 3505
`
`,
`
`111111
`
`. .... 1910
`
`PHYSICIANS' DESK REFERENCE®
`AMILOHIDE HYDROCHLORIDE
`325, 2030
`Midamor "IL.-hlc1, ·(M m .k). . .
`Mod ure 1ic T blc1, (M t't<'k l . . , ... . . 325, 2032
`. .. 25 13
`Am,loriJ c HC\ Table!> (l'a r).. ..
`Am1loride Hydrochlor'itlc and
`Hy<.11ochloroth1nz1dc Ttlble1s
`(Mylan) .
`
`...... 2 194
`AMINO AC[D PHEPARATIONS
`. ... 2194
`All ~D n,ic Capsules (M omijJ).
`Glucn-Dulnncc Cnpsolc, (M {))111ffJ . ..... 2194
`Marlyn Fonnu\ 50 Capsule, (M ar /_1 n) ... 1874
`SON Fonnula Tubk1~ ( /111em ori,111al
`Nw ririon Resem d 1) . . . .
`Renugen 1nblct~ (NO\a
`Nwracellf icalt ) .
`
`1739
`
`2216
`
`AMIN.J)BE!'iZOATE POTASSIUM
`Pornh,1 ·ap:.ulc. (Cilt'll h-,wdJ. ~ 320, 1701
`Pombu Powder (G/e,n,1~,d) ....... 320, 1701
`. . 320, 1701
`Po11oha Tablc ls(G/r n\\ ood) .
`~ @ CAPROJC AC ID
`. ...• 3505
`Amicar Injection (Xm 1od) 11<'J.
`. , 3505
`Amit.tr' Sy111p. 25',{ (Xa110,d nt•).. .
`.. . , .. 3505
`Arn ic,u Tobin., (Xmt<>f.l) 11t•/
`~lNOIUPPU!y\TE SODIUM
`A111inoh1ppu1mc ~cxlmm ··Pl\ ! I''
`lnjet1iun (Merc.k), ., ..
`AMlNOSALICYl.IC ACID
`Pa~cr Grn,wlc-. (Jm ob11\j.
`4-AMTNO-SALI CYI.I C AC ID
`(see 1111d er: AMlNOSALICYLIC AC ID)
`5-AM INO-SAl.l CYU C ACID
`(~ec und er: MESALAMINE)
`
`. ..... 1928
`
`. .. . 1745
`
`AMIODARONE HYDROCIILOHIDE
`Paccronc l :)hlc1~ (U1Hhn -Smill1 } ... 337, 3245
`A miodnronl! HCI l nblctioi (Par)..
`. . . . 25 13
`Am1odaronc llCI 1.ihlc1i. (7(unJ .... , .. . 3220
`AMlTRIPTYLlNE
`HYli_no_c11LoRm!';
`A mi1rip1 ylinc ll yt l1 och\oridc Ttth1c1.
`......... 2 194
`(Mylun ).
`Chlurdffit.l..' [)Ox idc nod Ami1ri ptyhnc
`llydroc.:hlorid1.: Tab lc1.s ( Al) hm }.
`Pc:rphi.:na,.inc nm.I Amitri ptyl1ne
`Hyr.i1l'k..'hlo1 ulc 1: 1hlc1~ (Afrl,1t1 ) . ...... 2 194
`AM LACTI N AP CREAM
`IUp slwr-Smit/, ) . .
`
`. 2194
`
`. 3243
`
`~.l,QDIP!NJ,c BE~Yl.ATE
`1.-om.:I Crip-.ules (Mnw, i r) ...... ,. 327 , 2
`, . 3
`,
`Norvtt-.c Tablcb (Pji: a).
`31
`
`284
`2615
`
`L ACl01i~m 121,: Lo1ion (Puddv,kJ.
`
`... 2512
`A mmonium L at:1,ne Ciean,
`l '> 1
`...
`(C!a)- Purk) ,
`'. '
`,.,,
`...
`1172
`Ammonium L.1c1mc c ,~un~ ~ ~f·,;'f~J· .....
`3220
`+ AMNESTE EM CAP SULES
`· · · · · · · · · · · · · · · · · · ... 309, 943
`/Bi,rtek) ·
`AMOXAPI NE
`An1ox.1pinl' T1bkl\ ( lltt/\o").
`AMOXI CII.I.I N
`;\ mox il Ciqh uh.:::-.
`(Glnt1JS111i11tK/int').
`/\ mox 1l Chcw11hk: l ,1hlet:.
`(filc o:tJS11111lt K l i111•).
`· 316, 1427
`A moxil for 0 1,1 1 Su, 1>c rh ion
`(G/,n,,_\·,,,illtKlin <') · · · · · · · · · ·. 316, 1427
`/\. n~ox il Pc,;.<liuuic Di op, fll r' Oin/
`".iu1;p1.·n..,1on (G!u.wfo111l,Kf111c) .. 31 6, 1427
`A mox il l ,1hlc1 ~
`(Gl,n tJS111irlt K!i11e),
`
`... 3296
`
`. .. 315, 1427
`
`..• JlS,
`
`1427
`
`Augrnrn tin Chcw:1hlc i:,i,;e·,~ ·
`
`....... 316, 1438
`
`.. 3 16, 1441
`. ... 336, 3212
`
`.... 31 5, 1427
`
`.... 316, 1427
`
`.... 316, 1427
`
`(fi f,noS111irliK!ine).,. , ....
`. 31 6, 1435
`A11f mc111 ir~ Powder for 0 1,11
`St1:'\fk rl\1on (Ci/(l\115111 irhA'lh11·J .• 316, 1435
`Aur nk r11111 'l.1blc1,
`rr;r., w s ,,,;,1, Ki;,,,.! · · ·
`Augint:ntin XR 1 ,1bkh
`... 316 , 1444
`(<ilc11"S111irhK!i111') ..... ,
`A ugml;'n! in I:\ 600 Pow,fl'r ,:,;r·
`(), ,ti Su-: pc1hio11
`(<il11.,o \'01 ithKfu 1i·).
`PRi.c VPA(' (Ti\/•).
`+ AMOXIL CAI'SULES
`(Ol uxo8111itltl(/ j 11t') ...
`+ AMOXIL CH EWABI E
`'l'~ LETS
`,
`(( ,l cr.t0Sn1ith Klinc•J
`+ AMOXIL f?O R OIL\·~ .
`SUS P ENSION
`rr.taxoS1,,i11, K/;111,J
`+ AMOXIL P EDIATR; ~ .
`DitOPs Fon OH.AL
`SUSPENS ION
`(Gla xo.C.,'111ithKlincJ ..
`. ... . 316, 1427
`+ AM.OXJL TABLETS
`!GiuxoSm itl,K/in e) . . . ........ 315, l427
`AMPHEJ'AMLNE ASPARTA'I'ls
`. . 336, 3143
`i\ddnall l'ab k 1, (Shirr US). . .
`Al~~.r!,'.11 XR C,1psule:, (\'/ii, ('
`
`.. 336, 3144
`M IPIIETAMIN E SULF~Ti: .
`J\dd('.ral\ Tablcl-; (\'l, i, e I/SJ., ..... 336 , 3143
`/\<ldc1.1II XR ( '.aJ)"itdt:, 1<·1i,· .
`USJ.
`. . 336, 3144
`+ AMPIIOTEC Unt crMun cJ ....... 321 , 1733
`
`J
`
`"
`
`l ra/ic l ~a,.w Nw, ,ber l ndkute~ Hricf U ~tin J.;
`
`AMICAR SYRUP, 25% /XanodyneJ . . . 3505
`AMI CAU TABLETS (Xnn od ync) . . ... 3505
`Miff!!§'.l'!~J;
`Eihyul for lnjcCLic)n (Mt'<//m,
`Onco/u~y) . . ..... . , ....... ~ .
`-~ 1~~~·!_!~1~ Denotes Gcncr·ic Nmnc
`Th.is m ateri al w as copiedl
`at the NLM and m ay oe
`Su oj e,ct US Ct:Jipy right Law s
`
`Page 2 of 7
`
`

`

`336/PHYS ICIANS' DESK REF ERENCE"
`SHIRE US INC.
`
`RX
`
`C-11
`
`SHIRE US INC .
`
`P. 3143
`
`SHIRE US INC .
`
`P. 31 5 2 RX
`
`TA P PHARMA CE UTI CALS IN C.
`
`P. 3193 RX
`
`TAP PHA RMA CEUTI CALS INC ,
`
`, . 320 6
`
`SOLVAY PHARMA CEUTICAL S. IN C. P. 316 7 AX
`
`ewe
`
`1026 · 1.25 mg/2.5 mg
`
`5 mg
`
`7.5 mg
`
`10 mg
`
`RX
`
`60 mg
`
`Fareston8
`(toremifene citrate)
`SH I RE US INC.
`
`Lu pron Depot" 3. 75 mg
`ESTRATEST8
`(leuprolrde acetate for depot suspension)
`(esterified estrogens/methyltestosterone)
`TAP PHARMACEUTI CALS INC .
`P. 3196
`SOLVAY PHARMACEUTICALS , INC . P. 316 7 RX
`
`P. 3153 RX
`
`15 rng
`
`12.5 mg
`
`15 mg
`
`250 mg
`Controlled-Release Capsules
`
`1023* 0.625 mg/1.25 mg
`
`SOLVAY
`10 23
`
`Pentasa8
`(mesalamine)
`SH IRE US INC.
`
`ESTRATEST8 H.S.
`(esterified estrogens/methyltestosterone)
`P. 3155 RX
`SOLVAY PHARMACEUTICALS , INC .
`
`Lu pron Depo 7 .S mg
`(leuprollde acetate for depot suspension)
`TAP PHARMACEUTICALS IN C.
`P. 319 8 RX
`RX
`
`RX
`
`30mg
`PREVACID9 SoluTab"'
`(lansoprazole)
`D layed Relea e Orally
`Dislntegra mg Tabl ts
`TAP PHARMACE UTICAL S INC ,
`
`P. 3212
`
`20 mg
`
`30mg
`
`Adderall8
`(dextroamphetarnine saccharate/ .
`ne
`dextroamphetamine sulfate/amphetamI
`aspartate/ amphetamine sulfate)
`P. 3 144
`SHIRE US INC .
`
`C-11
`
`~(cid:173)
`i,lll
`
`10 mg
`
`5 mg
`
`,~
`
`15 rng
`
`20 mg
`
`25 mg
`
`30 mg
`
`10,,
`
`2.5 mg
`
`5 rng
`
`10 rng
`
`ProAmatine8
`(midodrine HCI)
`SMITH & NEPHEW
`
`RX
`
`SM ITH & NEPHEW
`
`P. 3162
`
`RX
`
`RX
`
`I JJ.. .
`
`11
`
`4492" 300 mg
`LITHOBID8
`(lithium carbonate, USP)
`Slow-Release Tablets
`SOLVAY PHARMACEUTICALS, INC . P. 3170 RX
`
`Lupron Depot" -3 Month 11.25 mg
`J!._euprollde acetate for depot suspension)
`TAP PHARMACEUTICALS IN C. P. u o1
`
`200 rng
`
`1 708" 100 rng
`PROMETRIUM8
`(progesterone, U~ - - -
`SOLVAY PHARMACEUTICAL S, INC . P. 3173 RX
`
`Lupron Depot"-3 Month 22.S mg
`(leu prolide acetate for depot suspension)
`TAP PHARMACEUTICALS IN C.
`P. 32 0 3
`
`Il l
`
`.~
`
`Lupron Depot" -4 Month 30 mg
`~prolide acetate for depot suspension)
`P. 3204
`RX
`TAP PHARMA CEUTI CALS INC.
`
`I
`
`'"""""
`
`1924·
`4g/60 ml unit dose
`
`ROWASA8 Rectal
`Suspension Enema
`(mesalam ine)
`
`Triple Therapy
`30 mg/500 mg/500 mg
`
`PREVPAC9
`(lansoprazolc/arnoxlclllln/clar,thrornycln)
`
`Because tablets and capsules
`are shown i1 , t! iic·, sr.ct inn,
`do not infer U .,
`. the only dosc16
`available. Where a pro:.Ju~, "U" '-
`1s preceded by the
`symbol 'I', refer to the description
`1n the Product Information
`(White Section) for other forms.
`
`TARGACEPT, INC.
`
`RX
`
`TARCA CE PT , INC,
`
`P. 3219
`
`2.5 mg
`lnversine9
`(mecamylarn1ne HCIJ
`
`Extended-Release Capsules
`Adderall XR8
`(dextroamphetarn ine saccharate/
`mine
`dextroamphetarnine sulfate/ampheta
`aspartate/amphetamine sulfate
`I
`. 3146
`SH IRE US INC .
`
`RX
`
`....
`
`.,
`
`0.5 mg
`
`1 mg
`
`Agrylin 8
`(anagrelide HCI)
`SH IRE US INC .
`
`P. 3148
`
`RX
`
`Gladase™
`Papain-Urea Debriding
`Ointment
`SOLVAY
`
`SOMERSET
`
`RX
`
`SOLVAY PHARMAC EUTI CALS, INC . P. 3163 RX
`
`SOMER SET PHARMACE UTI CAL S P, 3175
`
`Lu pron Depot-PED" 7 .5 mg
`(leuprolide acetate for depot suspension) _
`RX
`
`TAP PHARMAC EUTICALS IN C.
`
`P. 3204
`
`C a.E'
`"'
`
`5 mg
`ELDEPRYL8
`(seIegil1ne HCI)
`TAKEDA
`
`,II
`
`Lupron De pot-PED" 1 1 .25 mg
`~
`rol1d~etatc for depot u pen Ion)
`P. 320 4
`RX
`TAP PHARMA CE UT ICALS IN C.
`
`RX
`
`TAKEDA PHARMACMlCALS AMERICA, INC, P. 3186
`
`2 rng
`
`4 mg
`
`8 rng
`
`TEVA NEUROSCIENCE, INC.
`
`RX
`
`TEVA NEURO SCIE NCE, IN C.
`
`P. 3 22 1
`
`l
`
`20m&f l111L
`
`200 rng
`
`300 mg
`
`Carbatrol8
`(carbamazepine extended-release ca
`psulesJ
`c .11
`SHIRE US INC ,
`
`P. 3150
`
`I,,.
`
`5 mg
`
`I
`- 52-
`
`j
`
`Cl;-'\
`' '
`
`10 rng
`
`DextroStat®
`_ ~troarnphetamine sul fate )
`- -
`
`ACEON 8
`(perindopril erbumine)
`SOLVAY PHARMA CEUTI CALS. INC. P. 3 165
`
`R
`
`1205•
`
`CREON" 5
`MINIMICROSPHERES8
`(pancrelipase delayed-release
`__ ~u les .~
`SOLVAY PHARMA CE UTI CAL S, IN C. P. 31 66
`
`R
`
`1210•
`CREON" 10
`MINIMICROSPHERES"
`(pancrelipase delayed-release
`; ; - - -· capsules, ~P)
`SOLVAY PHARMACEUTI CA~
`
`IN C, P. 31.67
`
`1220 •
`CREON" 20
`MINIMICROSPHERES"
`(pancrelipase de layed-release
`caps_llles, USPJ
`
`15 rng
`
`30 rng
`
`45 rng
`
`Lupron Depot-PEoe 15 mg
`(lcuprohdc ac~ato for clcpot suspension)
`TAP PH ARMA CEU TI CALS IN C.
`P. 3206
`
`RX
`
`COPAXONE9
`(glat an
`ac ' lat , 1 , cwon)
`
`THER-RX
`
`THEA RX
`
`THX 0129
`
`p, , 22
`
`RX
`
`PREVACID"
`(lansoprazol l
`Delayed Release C psule
`
`TAP PHARMA CE UTI CALS INC,
`
`P. 320 & RX
`
`Chromagen9
`TH EA RX
`
`p, , 22"
`
`----···
`
`i-1 1, 11,,,
`I.I PH< )
`1t
`1, 1,r ,11· 1
`
`14 Day Patient Ad1111nrstratron Kit
`1 rng/0 .2 ml
`
`15 mg
`
`Chromagen• FA
`TH EA RX
`
`RX
`
`, , __
`
`30 lllil
`
`Luprone Injection
`Ihis mat!!<ri~b,v,aS:~
`Je-O
`at the NLM and m ay t>e
`Subje.c.t US Copy right Laws
`
`PREVAC1oe
`(lansop, azo1~I
`Delayed Rel(!a~e Oral Susp ·n s 1011
`
`Chromagen" f orte
`
`Page 3 of 7
`
`

`

`PHYSICIANS' DESK REFERENCE®
`
`anorexia), dos-
`.
`.
`.
`adve rse re uct,ons appea r (e.g., 111som111 a or k
`·ng· add1-
`age should be reduced. Give first close on awe em
`'
`lion al doses ( I or 2 ) nl inlc1va ls of 4 to 6 hours.
`
`HOW SUPPLIED
`. !el debossed
`ADDER/\LL® 5 mg: Blue doub le-sco r~d tab
`'
`"AD" on one s ide a n<l "5" on the othe r side
`lNDC 5,1092-03 l -0 l J
`I t de bossed
`J\DDERALL® 7.5 mg: Blue double-scored tab e'
`"J\D" on one s ide and '·7.5" on the other side
`1 t debossed
`<NDC 54092-076-0 1)
`ADDERALL® 10 mg: Blue double-scored tab e '
`''AD" on one side and ·' IO" on the other side
`. d tablet, de·
`rNDC 54092 -032-01)
`ADDERALL® 12.5 mg: O range doublc-sco,e . ··de
`bossed ·'AD" on one side a nd "12.5" on the othe• si
`. cl tablet, de-
`<N DC 54092- 125-0 I)
`/\DDERJ\LL® 15 mg: Orange double-scoi e
`'d
`0
`bossed ''AD" on one s ide a nd ·'15'' on the others,
`cl t ablet, de-
`(NDC 54092-150-0 l )
`ADDERALL® 20 mg: Oran ge double-score
`. 1
`bossed ·'AD" on one s ide and "20'' on the other s" e
`. d tablel, de-
`rNDC 54092-033-01 )
`J\DDERALL® 30 mg: Ora n ge doubl e-scoi e_
`'de
`bossed "AD" on one s ide and "30" on the othc• s,
`<N DC 54092-034-0 1)
`l n bott les of l 00 tab lets.
`. defined in
`.
`.
`Dispense in a ligh t, light-rcsisla nl co nln1ne1 as
`6' F)
`tho USP.
`Store al 25'C f77°F J excurs ion s 15- 30°C r59- S
`·
`Rx only.
`MG #10185
`Mfg. fo r :
`Shire
`S hire US lnc.
`One Rive rfront Pl ace
`Newport, KY 41071
`Made in U.S.A.
`1-800-828-2088
`© 2002 S hire US Inc.
`. 1, a ,e 336
`,
`.
`. .
`Rev 12/02
`S hown in Producl hlenl1/1ca/1011 G111c c, P g
`
`@ I$<
`ADDERALL XR<II>
`psULES
`5 mg, 10 mg, 15 mg , 20 mg, 25 mg , 30 mg_ C\ oduct)
`{Mixed Salts of a Single-Entity Amphetamlll 8
`. re
`Dextroa mph etam ine Sulfate Dextroampheta~lll te
`Saccharate Amphetami ne Aspartate MonohV ra
`Amphetamin e Sulfate
`
`ADDERALL XRO!> CAPSULES
`
`, NTI AL FOR
`AMP!lETAMlNES 1-IAVEA Ill G il PO1E ' TAM!NES
`FOR PROLONGED PERIODS OF TIME M; .. -rrEN·
`ABUSE. ADM IN !ST RATTON OF AMPI-IE y LEAD
`' rrY OF
`TO DRUG DEPENDE NCE. PJ\RT!CU LA
`TION S II OU LD BE PAID TO T!JEPOSSIBl\ s FOR
`SUB JE CTS OBTA IN I NG J\MP!IETAMl ~~ON 'l'O
`NON-'1'1-rnRAPEUTI C USE OR DJ STHJBU~ j, pRE-
`OTIIERS /\ND T !IE DRUG S S JJO ULD
`,
`SCHJBED OR DI S PENSED S PARINGLY.
`
`ly only
`DESCRIPTION
`so single·
`J\DD1':RJ\LL XH® is a once daily cx~c ncled-•~ \~; c~n1bines
`enl ily a mph etamin e produ ct. J\DD1':R~ LL hotn n1in o "." '.'.
`t he ne uir'.ll s ulfate s a ils of_ dc xt., oL~~n~ hctn ininC ;~c
`amphcta m1110, with the dcxtro 1somc 1 of '11 P
`drut.c . .I he
`I
`cha ra te and <l,1 -a mph cta mine aspa riaic mon~ ~· drug-con·_
`i\DD1':RALL XR® capsule conta in s two type, 1 cJcliverY of
`laini ng beads des i,, ned lo g ive a double-pu l~e<. , hot.aJlline
`.
`.
`"I
`. I,. -e of a n11
`. 1
`~
`, co nvonl1011 ·
`a mph eta min es, w hich prolon gs l l O , c c,1:;
`f'rom J\DDERJ\LL XHl!J compared lo
`l~w
`lotion .
`J\DDERJ\LL® (immedialc-releuso/ tablet fonnu
`redients
`!Sec ta bl e al lo p of next pai;cl
`. .
`.
`11
`. 1·1CllVO I g
`Tl
`1,y-
`11
`ln active lnh1Tedi cnt.s and Colors:
`. caps11Jcs,
`.
`l C
`'
`in J\DD1':RJ\LL XJl® capsul es in clude: ge lnlin I co polyn101
`
`Ge·
`Ylic acic
`opadry beige, s uga r s pheres , t.a lc, a nd lrwll:r tin , and u;:
`d
`I
`I
`roxypropy melhylce llul osc, met lll Cr
`.
`.
`1 cilralC-
`atm caps ules co n lain ed ible in ks , koshe; ge 9
`• ,,,JICS as
`0
`IO mg' and ID mg "
`! ,,d 30 nig
`nium d ioxide. The 5 111 .,
`g "
`10;v iron oS'
`·J e
`conta in FD&C Blue 112. Th e 20 mg, 2D 111
`·
`caps ul es a lso con ta in red iron ox ide a nd yel
`
`b•
`
`,
`
`1•
`
`-
`
`CLINICAL PHARMACOLOGY
`.
`tic
`thon11n1c
`Pharrnacodynam ics
`J\
`-yn> pa ·
`. pcu·
`.
`I
`.
`,r1,11c1n
`.
`mp 1etarn111 es a rc n0n.cn tccholn rn1 ne ::;
`')' I e ,nOl O ( o· -ordOl
`1
`'ti C
`·1111 '
`.
`.
`. .
`1
`15
`k
`. ·ty
`'
`•ncs w, 1 NS s l,m ul nn t acl1v1ly.
`lie action in Allen lion Deficit 1 [ypc rnct,vi ,1,l to bloc
`(ADl-lD) is not known. Amphetamines arc [),ou~lO t.h0 pre:
`I d nn11ne 1
`t k
`ti . ·
`1oon>
`·hesc 11101
`1e rcuy a e of norepineph rine anc op,
`synaptic neuron and in crease th e rclcnsc oft
`n-
`,
`ines into the cx tra nc u ronal s pace.
`0
`Pharmacokinetics
`® have bee'' ccts,
`---) subJ0 th
`Ph annacok ,nctic stud ies ofADDERALL XH
`t d ·
`cl
`· (6 I 2 Y'"
`Bo
`J
`- DJ-ID-
`uc c
`lll 1ealthy adult a nd pedi at n c
`and
`and
`ped iatric
`with
`A nblets
`d 1-
`pat ients
`J\DDEHJ\LL®
`(immcd iatc-rc lcasc)
`\an1 in° "\is·
`1
`win[; J1d1"'0;k
`J\DDEHJ\LL XR® ca ps ules conta in d -a n1P
`amphctam1110 salts in the mlio of 3: I. Fa O
`th0 toth
`)
`t,l·~llon of ADDEHALL® fimm ediRle- rel~O~~~rs for
`P llsma concentrations occurred in nboui
`d·ampheta minc and l·amphetn minc.
`
`1t
`
`3144/SHIRE US
`
`Adderall-Cont.
`
`MAO inhibitors-
`MAOI antidepressants, as well as a metabolite of furazoli (cid:173)
`done, slow a mpheta mine metabolism. This s lowing potenti -_
`ates amphetamines, increas ing their effect on the release of
`no,·epinephrine and other monoa mines from a drenerg1c_
`nerve endings; t his can cause headaches and other signs of
`hypertensive crisis. A variety of neurological_ toxic effeds
`a nd malignant hyperpyrexia ca n occur, so metnnes with fa(cid:173)
`tal results .
`Antihistamines-
`Amphetamines may cou nteract the sedative effect of anti(cid:173)
`histamines.
`Antihyperlensiues-
`Amphetamines m ay antagonize the h ypotensive effects of
`anti hypertensives.
`Ch/orpromazine-
`Ch lorpromazine blocks dopam ine and norepinephrine re(cid:173)
`ceptors, thus inhi biting the cen t ral sti mul a nt effects of
`amphetamines, a nd can be used to treat a mphetamine poi(cid:173)
`soning.
`E/./wsuximicle-
`Am phetamines may delay intestin al absorpt ion of ethosux(cid:173)
`imide.
`Halopericlol-
`[-l a loperidol blocks dopamine receptors, thus inhibiting t he
`cen t ra l stimulant etfocts of a mphetamines.
`Lithium carbonate-
`The anorectic a nd stimu latory cflCds of amphetami nes may
`be inhibited by lithium ca rbonate.
`,Weperidine-
`Amphetam in es potentiate the a na lgesic cffoct of meperi(cid:173)
`dine.
`Methenamine therapy-
`Urinary exc retion of amphctmnines is increased, and e ffi (cid:173)
`cacy is reduced , by acid ifying agents used in methcna m ine
`therapy.
`Norepinephrine-
`Amphetamines enhance t he adrenergic effect ofn orepine ph (cid:173)
`rine.
`Phenobarbital-
`Amphetamines may delay intestinal a bsorption of pheno(cid:173)
`barbita l; co-administration of phenoba rbi tal may produce a
`synergistic anticonvulsa nt action.
`Plwnytoin-
`Amphetamines may delay intes tinal absorption of phcny(cid:173)
`toin; co-adm inistration of phcnytoin may produce a sy ner(cid:173)
`b>istic anticonvu lsant action .
`P,·opoxyphe,w-
`ln cases of propoxyphene overdosage, ampheta min e CNS
`stimulation is potentiated and fata l co nv uls ions ca n occur.
`Veratrnm allw/oids-
`A1nphetamines inhibit t he hypotensive effect of ve ratru m
`alkaloids.
`Drug/Laboratory Test Interactions:
`in
`• A rr1phe tam.in es can ca u8c a s ig nifi cant e levatio n
`pl asma corticosteroid leveb. This increase is greatest in
`the evening.
`• Amphetamines rnay interfere with urin a ry steroid deter-
`minations.
`Ca rcinogenesis/Mutagenesis: Mutagenicity s tudi es a nd
`long-term studies in a nima ls to dete rmine the carcinogenic
`potential of amphetamine, have not been performed.
`Pregnancy-Teratogenic Effects: Pregnancy Category C.
`Amphetamine has been s how n to have cmbryotoxic an d ter(cid:173)
`atoge nic e ffects when adm ini ster ed to A/Jax mice and
`C57BL mice in doses a pproximately 4 1 times the maximum
`human dose . Embryotoxic e ffects were not see n in New
`Zealand while rabbits given t he dru g in doses 7 t imes t he
`huma n dose nor in rats given 12.5 t imes th e maximum hu(cid:173)
`man dose. While there are no adeq uate and well -cont rolled
`studies in pregnant women , there has been one report of se(cid:173)
`vere congenital. bony deformity, tracheoesophageal fi stu la,
`and anal atres,a (vater association ) in a baby born to a
`woman who took dextroa mpheta mine sul fate with lovasta(cid:173)
`tin during th e first trimester of pregnan cy. Am pheta mines
`should be used during pregna ncy only if the potential ben(cid:173)
`efit justifies t he potentia l risk to the fetus.
`Nonteratogenic Effects:
`In fants born to mothers de pen(cid:173)
`dent on ampheta min es have an increased ris k of premature
`delivery and low birth we_ight. Al so, th ese infants may
`expen ence sy mptom s of withdrawal as demonstrated by
`dysphoria, includ ing agitation, and sign ificant lassitude.
`Pediatric Use: Long-term effects of amphetamin es in chil (cid:173)
`dren have not been well establi shed . Amphetami nes are not
`recommended for use in children under 3 years of age with
`Attention Defi cit Disorder with Hyperactiv ity described un (cid:173)
`der INDICATIONS AND USAGE.
`Amphetamines have been reported to exace rbate motor and
`phonic ti cs a nd Tourette's sy ndrom e. There fore, clin ica l
`eva lu ation for ti cs and 'l'ourett c's sy ndrome in chi ldren and
`their fami lies should precede use of s timu lant medication s.
`Drug treatment is not indicated in a ll cases of Attention
`Deficit Disorder with H yperact ivity and s hould be consid(cid:173)
`~~~c\~~~~ in, light ~f .the complete hi story and evalu ation of
`<lcpcm~ 0~,1~~ d~ci ~i~n to p rescribe amphetam ines s hou ld
`severity or the ~l~~{:i~1un's assessment of the chronicity a nd
`8 sy mptoms und ti
`I ·
`· . .
`·
`r
`1011 c1ppropnutc ness
`ior 11s/her age. Prescription sl
`.
`-
`-~"~~!
`Id
`ci
`presence of one or more or the behav ioral charu~Zc,°;:lic~e
`
`When these symptom s a rc associated with acute s tress re(cid:173)
`action s, treatment with a mpheta mines is usually not indi(cid:173)
`cated.
`ADVERSE REACTIONS
`Cardiovascular: Palpitation s, ta<.:hyca r<li a, eleva tion of
`blood pressure . There have been isolat