Social LAW
`
`John Adams Courthouse
`One Pemberton Square, Suite 4100
`Boston, MA 02108-1792
`Tel: 617.226.1500 Fax: 617.523.2458
`www.socialaw.com
`
`I certify that the attached copy of
`
`Is a true and accurate copy of material deposited in the Social Law Library.
`
`Brian Harkins
`Head of Reference
`
`Dated __ /_)_.~ ,__/_!_1-'-/;-'--/_i_
`
`

`

`Social LAW
`
`• • • LIBRARY
`•
`• • •
`Research. Education. Services. Answers.
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`I llllll lllll lllll ll]f lJilllllr11llmr~1111111111111111
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`PDR®
`54
`2000
`
`EDITION
`
`PHYSC
`
`·
`
`REFERENCE®
`
`Senior Vice President, Directory Services: Paul Walsh
`
`Director of Product Management: Mark A. Friedman
`Associate Product Manager: Bill Shaughnessy
`Senior Business Manager: Mark S. Ritchin
`Financial Analyst: Wayne M. Soltis
`Director of Sales: Dikran N. Barsamian
`National Sales Manager, Pharmaceutical Sales: Anthony Sorce
`National Account Manager: Don Bruccoleri
`Senior Account Manager: Frank Karkowsky
`Account Managers:
`Marion Gray, RPh
`Lawrence C. Keary
`Jeffrey F. Pfohl
`Suzanne E. Yarrow, RN
`Electronic Sales Account Manager: Stephen M. Silverberg
`National Sales Manager, Medical Economics Trade Sales: Bill Gaffney
`Director of Direct Marketing: Michael Bennett
`List and Production Manager: Lorraine M. Loening
`Senior Marketing Analyst: Dina A. Maeder
`
`Director, New Business Development and
`Professional Support Services: Mukesh Mehta, RPh
`Manager, Drug Information Services: Thomas Fleming, RPh
`Drug Information Specialist: Maria Deutsch, MS, RPh, COE
`Editor, Directory Services: David W. Sifton
`Senior Associate Editor: Lori Murray
`Director of Production: Carrie Williams
`Manager of Production: Kimberly H. Vivas
`Senior Production Coordinator: Amy B. Brooks
`Production Coordinators: Gianna Caradonna, Maria Volpati
`Data Manager: Jeffrey D. Schaefer
`Senior Format Editor: Gregory J. Westley
`Index Editors: Johanna M. Mazur, Robert N. Woerner
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`Senior Digital Imaging Coordinator: Shawn W. Cahill
`Digital Imaging Coordinator: Frank J. McElroy, Ill
`Electronic Publishing Designer: Livia Udina
`Fulfillment Manager: Stephanie DeNardi
`
`•hrJ;,■d Copyright © 2000 and published by Medical Economics Company, Inc. at Montval,e, NJ 07645-17 42. All rights reserved. None of the content of this publication may
`be reproduced, storea in a retrieval system, resold, redistributed, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or
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`Guide to Prescription Drugs® are registered trademarks used herein under license. PDR For Nonprescription Drugs and Dietary Supplements™, PDR Companion Guide™,
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`Officers of Medical Economics Company: President and Chief Executive Officer: Curtis B. Allen; Vice President:, New Media: L SUzanne BeDell; V,ce President, CotporalB Human
`Resources: Pamela M. Bilash; Vice President and Chief Information Officer: Steven M. Bressler; Chief Fina.ncial Officer. Christopher Caridl; Vice President and Controller: Bany
`Gray; Vice President, New Business Planning: Linda G. Hope; Vice President, Business lntegrarion: David A. Pitier; Vice President. finance: Donna Santarpia; Senior Vice Plesident.
`Directory SeNices: Paul Walsh; Senior Vice President, Operations: John R. Ware; Senior Vice President. Internet Strategfes: Raymond Zoeller
`
`@Printed on recycled paper
`
`ISBN: 1-56363-330-2
`
`

`

`CONTENTS
`
`Manufacturers' Index (White Pages)
`
`Section 1
`Lists.all pharmaceutical manufacturers participating in Pf-{YSICIAN§' Q£$K REFERENCE.
`Includes addresses, phone numbers, and emergency contacts. Shows each manufacturer's
`products. and the page number of those described in PDR.
`
`Brand and Generic ~ame lpde;x (Pink Pages)
`
`Section 2
`Gives the page number of e.ach prpdyct bybr,a9d ahd gfJrieric name.
`
`Product Category lndeX(Bll.le Pages)
`
`Section 3
`Lists E!/1 fully described products by prescribing category, An overview of the headings
`appears on pages 201 and 20:Z .
`
`. PrQduct ldentificatio11 Gpide (Grat Pages).
`
`Section4
`Presents full-color, actual-size photos of tablet$ and capsules, plus pictures of a variety of other
`-
`dosage forms and packages. A(ranged alpfyabetically by manufacturer. ·
`
`Procluct Information (White Pages)
`
`Section 5
`Includes ehtrieS for over 3,200 pharmaceuticals. Listings are
`The main section of the book.
`arranged alphabetically by manufacturer.
`
`1
`
`101
`
`201
`
`301
`
`401
`
`Diagnostic Product lnfe>rr11.;1tiQl'l
`Section 6
`Gives usage guidelines for a variety ofc;omrnon diagnostic: agents. Arranged alphabetically by manufacturer.. •
`
`3348
`
`Key to Contolled Substances Categories:, ..... , ....... ;,.: ............................................................................. : .. 345
`Gives the definition of each category and the prescribing limitiations that apply.
`Key to FDA Use-in-Pregnan~y Ratings .......... ;:::····· .. ·· .. ···· .......................................................... , ................. 345
`Provides the exact interpretation of ec1.ch risk/benefit rating.
`U.S. Food and Drug Administration Telephone Qirectory ............. , ........ ; ..... ::.,.• .... : ............ ; .. \ ......... : ... : ........ 346
`Gives numbers of key reporting programs.and information.services.
`Common Laboratory Test Va.lues
`............................................................................................... .
`Generally accepted normal values for a selection 8f common laboratory assays on serum, plasrria, and blood.
`Poison Control Centers .......................................................................................................................... 3357
`A national directory arranged alphabetically by state and city.
`Adverse Event Report. Forms ....................... , ....................................................... ·•· .........................•...
`Contains master copies andinstructions for completion.
`
`

`

`IJ
`
`GLAXO WELLCOME INC
`
`P. 11 53
`
`RX
`
`GLAXO WELLCOME INC
`
`P. 1161 RA
`
`GLAXO WELLCOME INC
`
`P. 1169
`
`RX
`
`GLAXQ WELLCOME INC
`
`P, 1178
`
`RX
`
`GLAXO WELLCOME INC
`
`P, 118G
`
`PRODUCT IDENTIFICATION GUIDE/313
`
`16..E-!; c.:irilstcr
`t "O r:.etered inhJIJtions
`Beclovent®
`Inhalation Aerosol Refill
`1 :cc:~m'!th3S0n£! dipropion3te. USP)
`P. 1153
`GLAXO WELLCOME INC
`
`..
`
`1_-g
`IV infusion pack
`
`t6.=3! em:ister
`;?\I> rqr!:,"&~ inh-a/;,tions
`• _f ~ /r; :J 6.1-g canister
`Beconase<!>
`i,,fta:.=ltion Aerosol
`:L tr~hi;scn? :11;:,ro~l0nGte+ USP)
`?. 1:!. SC
`GLAXO WELL COME INC
`
`..
`
`25 mg
`
`Daraprim@
`(Qyrimethamine)
`GLAXO WELLCO ME !NC
`
`P .. 1170
`
`RX
`
`""
`
`RX
`
`28 mg
`
`Digibind0 Digoxin
`Immune Fab
`[0vine )
`
`RX
`
`GLAXO WELLCOME INC
`
`p_ 1171
`
`~ ITII III
`
`2~ per 27 g
`Also 31,aiiablc in 50 e;
`
`Emge!® 2% 'Fopica, Ge,
`(erythrom_ycin;
`
`ftX
`
`CLAX O WELLCO ME IN C
`
`P. 11 72
`
`10 ml
`
`Exosurf Neonatal"' For
`lntratracheal Suspension
`(colfosceril p3lmitate. cctyl alcohol,
`tyl oxapol)
`GLAXO WELLCOME INC
`
`P. 1181 RX
`
`13-g c:mi ster
`120 metered inhalations
`
`Flovent0 220 mcg
`Inhalation Aerosol
`(flutlc;:isonc propion~tc, 22 0 mc g)
`P- 1189
`GLAX Q WELLCOME INC
`
`0.5 mg/17 ml
`Also avJi/Jb/e in 1.5 mg/1 7 mL
`
`Flolan(l) for Injection
`(cpoprostenol sodium)
`GLAXO WELLCOME INC
`
`P. 1158 Al:
`
`Flovent0 Rotadisk® 50 mcg
`(flut icosonc propionate
`inhalation powder, 50 mcg)
`GLAXO WELLCOME INC
`
`P. 1189
`
`10-G
`pharm.Jc~' bulk pachage
`
`lG g
`120 metered sp(2.ys
`
`Flovent~' Rotadisk8 100 mcg
`(flutic asone pro;:iion3te
`inh311.tion _pow der. 100 mcg)
`GLAXO WELLCOME INC
`
`P. 11S9
`
`RX
`
`25f
`BeconaseA -
`Nasal Spray, 0.042%
`"!"l!lti,;,;,ml! dl_pluµllllla-m,
`I
`_9111;;!0)
`~
`CWO ~.Et:LCO■E twC
`
`Ceptaze>
`(ceft.:?zidime for injection)
`L-Grgjr.ine form ulation
`GLA X.0 WELLCOME INC
`
`P. 1164
`
`Flonase® Nasal Spray, 50 mcg
`(fluti ca sone propion at e)
`G LAXO WELLCOME INC
`
`P. 1186
`
`RX
`
`Combiv~rT,.,
`(1nmivudinc/zidovudine t3bicts )
`150 m_t / 300 m,1
`GLAXO WELLCOME INC
`
`F. 11 6 7
`
`RX
`
`RX
`
`Epi vir0 Oral Solutio11
`(l3mi vudine oral soluti on)
`GLAXO WELLCOME J~C
`
`P. 1172
`
`10 m~/1 ml
`240 ml
`
`250 mg/5 ml
`100 ml
`
`em'tir.• for Oral Suspension
`(c~ftlrJ.:.;ime exct:1 ~owdcr fer
`er~ suspcnsioo.l
`CiLAXO WELLCOME INC
`
`P .. 1157
`
`---
`
`a.as, per 15 g
`
`130 me
`
`Epivir'i!
`(lamlvuClnc table:ts)
`
`RX
`
`GLA XO WELLCOME INC
`
`P. 1.175
`
`RX
`
`13-g canister
`120 metered inh:!!lotions
`Also J11Ji/:Jb/o in 7. g.g c:;nistcr
`
`Flovent"' 44 mcg
`Inhalation Aerosol
`(f lutlcasonc propionate , 44 mcg)
`P. 1186 RX
`GLAXO WELLCOME INC
`
`Flovent" Rotadisk0 250 mcg
`(fluticasonc propionate
`inhalvt ion powder, 250 mcg)
`GLAXO WELLCOME JNC
`
`P. 1192
`
`0.051<' per 60 g
`,J,/so araflable in 30 g
`
`Cutivate® Cream
`(iluticasonc j)mpionate cream)
`P. ll.GS
`GLAXO WELLCOM~ INC
`
`RX
`
`100 mg
`
`Epivir®-HBV"'
`(lam ivudine)
`
`RX
`
`GLAXO WELLCOME I NC
`
`? .. .1.17 5
`
`/ .,
`
`0.005~. per 15 g
`
`--QnWo!OlitlmGm.QOO!
`__ ......,.__..
`
`0.005~ per 60 g
`:~/so a~•3ifable in 30 g
`
`5 mg/1 ml
`240 ml
`
`250 mg
`
`sec rr-t
`
`Cefiir.~
`7cefu:-o:dm e-.;,::ct1i t3blets)
`
`C'-!Uva:Q:e~> ODntmernt
`(fluttcaso nc propion ate ointment}
`
`~pivir"'-HB'o"• Oral Sohlltior1
`(IGmivudinc)
`
`13-g canister
`120 metered inhalations
`
`Flovent 0 110 mcg
`Inhalation Aerosol
`{flutic ;:isone ;:irop1onate , 110 mcg)
`While every effort has been
`made to reproduce products
`faithfully, t his section is to be
`considered a quick reference
`identification aid. In cases of
`suspected overdosage. etc.,
`chemical analysis of the
`product should be done.
`
`I
`
`1 g/50 ml
`
`2 g{50 ml
`Fortaz"'
`(ceft:nidime sod ium injcctic n~
`
`

`

`USANA
`
`P_. 3142 R.l
`
`VIVUS, INC.
`
`P., 3143 RX
`
`PRODUCT IDENTIFICATION GUIDE/341
`
`WALLACE LABORATORIES
`
`WATSON LABORATORIES INC.
`
`P. 3180
`
`90 tablets
`
`Chelated Mineral
`Dietary Supplement
`
`P. 3142
`
`MUSE"'
`(alprostadil)
`WALLACE LABORATORIES
`••
`
`WALLACE LABORATORIES
`
`P, 3147
`
`Rynatan®-S Pediatric
`Suspension
`(phcnylephrine tannate, chlorphcniraminc
`tannate, pyrilaminc t:innate)
`5 mg / 2 mg/ 12.5 mg/ 5 ml
`
`Ill
`
`Tussi-Organidin"' DM-S NR*
`{guaifenC'i:sin, dextromethorphan HBr)
`100 mg / 10 mg / 5 ml
`( · newly reformulated)
`
`WATSON
`
`WATSON LABORATORIES INC.
`
`---0252* 240 mg
`
`28-day
`
`P. 3172
`
`Also 3VJilablc in a 21 d2y unit
`without placebo tabl ets.
`
`Necon° 0.5/35
`(norethindrone and cthinyl
`cstradiol tablets USP)
`0.5 mg/35 mcg_
`WATSON LABORATORIES INC.
`
`RX
`
`P. 3180
`
`GO soft-gel caps ules
`
`CoQuinone'M
`Df•'e[Y Supplement
`
`USA NA
`
`P~J!.42
`
`RX
`
`137 mcg
`Astelin"'
`Nasal Spray
`(azelastinc HCI)
`WALLACE LABORATORIES
`
`P. 3151
`
`RX
`
`0251* 180 mg
`
`RX
`
`~ 11! ~ .... -Rynatuss"'
`
`(carbetapent.:rnc tannJte,
`chlorpheniramine tannate, ephedrine
`tannate. phenl'!ephrine tannate)
`WALLACE LABORATORIES
`P. 3160
`
`90 tablets
`
`Mega Antioxidant
`Dietary Supplement
`
`F. 3142
`
`90 tablets
`
`Proflavanol®
`Dietary Supplement
`While every effort has been
`made to reproduce products
`faithfully, this section is to be
`considered a quick reference
`identification aid. In cases of
`
`)/
`
`0250' 120 mg
`
`350 mg
`Soma®
`(carisoprodolL
`WALLACE LABORATORIES
`
`Rll
`
`Dilacor XR"'
`(diltiazem HCI)
`Extended-re lease Capsules
`WATSON LABORATORIES INC.
`
`P. 3174
`
`P, 3161
`
`·n
`
`r, ~~'
`
`~-"
`
`GOO mg/5 ml
`
`Soma° Compound
`(curisoprodol. aspirin)
`200 mg j 325 mg
`WALLACE LABORATORIES
`
`P. 3161
`
`c.111
`
`28•day
`
`Also available in a 21 day unit
`without placebo tablets.
`
`Necon"' 1/35
`(norethindronc ;:ind ethinyl
`estradiol tablets USP)
`1 mg/35 mcg
`WATSON LABORATORIES INC,
`
`P. 3180
`
`Soma"' Compound
`w/Codeine
`(carisoprodol, aspirin. codeine phosphate)
`200 mg / 325 m&} 16 mg
`WALLACE LABORATORIES
`
`C.V
`
`P. 3163
`
`RX
`
`--
`
`60C mg
`
`Felbatol"'
`(felbamate)
`WALLACE LABORATORIES
`
`P. 3151
`
`400 mg
`
`FelbatoI0
`(felbamate)
`WALLACE LABORATORIES
`
`P. 3157
`
`RX
`
`RX
`
`200 mg
`
`Tussi-12™
`(c.Jrbetapcntane tannatc. chlorpheniramine
`tannate, phcnylcphrln e tannate)
`30 mg/ 4 mg/ 5 mg per 5ml
`WALLACE LABORATORIES
`P .. 3157
`
`c-v
`
`Also available in a 21 day unit
`without pl.Jcebo tablets.
`Levora"'
`(levonorgestrel 0.15 mg and
`cthiny cstradiol 0.03 mg)
`WATSON LABORATORIES INC.
`
`p_ 3177
`
`-5 mg • 10 mg
`
`25 mg
`
`50 mo
`
`100 mg,'5 ml
`
`Organidin° NR
`{guaifcnesin)
`
`RX
`
`P. 3158
`
`I I
`
`~·
`
`Loxitane"'
`(loxapinc succinate)
`WATSON LABORATORIES INC.
`
`P. 3179
`
`28•day
`
`Also 3vailable in a 21 day unit
`without placebo tablets.
`
`Each light yellow tabl12t (10) cont3ins
`0.5 mg norcthindrone m1[l 35 mcg ctflinyf
`cstradiol. Each dad< yel!owiabjet (ti)
`contains 1 mg noretfundome .anil 3? mag
`ethinyl cstrad,ol.. Eacjt wpiltl>mhfet fl) co~
`tains inert ingredient.
`
`Necon° 10/11
`(norethindronc and ethinyl
`estradiol tablets USP)
`
`Designed to help you identify
`drugs, this section contains
`actual size pills and full color
`reproduction of products
`selected for inclusion by
`participating manufacturers.
`
`ACTIS"'
`Venous Flow Cantroller
`
`Rynatan°
`(phcnylephrinc tannate, chlorphcniramine
`tanMtc, pyri!3mIne t;mnate)
`25 mg l 8 mg i 25 mg
`
`Tussi-Organidin@-s NR*
`(guaifenesin. codeine phosphate)
`100 mg / 10 mg / 5 ml
`(• newly reformulated)
`
`12.5 mg
`
`Microzide'"
`{l,ytjlOChlOIOtlliaz!de)_
`
`

`

`ov.BLCOME
`
`Rolan---Q>nt.
`
`to
`10
`
`100
`
`~
`40
`60
`60
`10
`
`90
`100
`
`u
`17
`u
`u
`
`u "
`2.6
`u
`,,
`,U
`111
`
`:1 4
`:,_,
`4 3
`
`....
`u
`◄ % 60
`u
`◄
`6.li
`110 u
`6 ◄
`
`60
`u
`.,
`117
`
`.. 4
`
`&
`u
`71
`.. ,
`""
`
`-·
`c-tn- of 15.000 ng(ml.
`
`T..,._ "
`
`i,,/uoion Ra,_ lo, R.ou.N •• •
`
`~ Dtl, ,...,. l!at.o 1,al,'llr -
`I '
`I ◄
`U
`10
`22
`19
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`13
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`40
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`L7
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`
`18
`
`19
`2.6
`32
`Sb
`.u
`5.1
`5,b
`6 ◄
`
`FLONASEe
`1/fll'no.zl
`( f l ~ prop!onat•I
`f\laNISpnoy, 50fflCII
`For lntr•ntsol UM Only
`SHN(E GENTLY BEFORE use
`
`T - 5. . , _ - t o r R.OlAH •
`c-1n,ion of -
`.,.,.,.,.
`
`•
`
`"""'pw
`
`0 - or Dnir 0.-,, -
`10
`
`q
`
`2
`
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`
`1.2
`
`I◄
`
`6
`4
`W-. Doliffry Ra~(.mlA,r
`2.◄ :!8
`I i;l %.0
`12
`- 1.6 H
`82 ◄.O 48
`!16
`u 24 36
`i.2 Q4
`4 ~ 60
`18 3.! ◄• 64 Qo 96 I I !
`lO 40 60 ~o 100 12.0 140
`7.2 98 12.0 1-14 16 S
`2 ◄ 0
`l-1.0 16.> 196
`q
`II%
`%• 56
`32 6.4 96 JUI 160 192 !1 ◄
`IOR 14 ◄ ISO %16 2.S2
`,.2
`3i;
`:?80
`
`16
`
`3.2
`6.4
`96
`iz,
`160
`192
`22_4
`256
`28.8
`320
`
`... i . :-!
`
`IU'"
`
`oESCRIP'flON
`f , 1 u - prop,onnte th<- llClt . . ~ I tf
`o.am• of $-ftuorom•lhyl 6".9.,-d,Jl-.u~ "-s
`:,lual Spnoy. u • f)-nlhc-tic - . . . i 1'\tl, ~
`5tone-ondsw,lily L,__i-ria!.olFLOLA.'1 .,.m(cid:173)
`blo ua,til 11>, ..... i.odKaw ... tho ~ •hfll dl>ffd .,
`moUl)'l-3-oxo-170 prop1onylmc:yan<1ro&to.1,...,_ ~ 11,.
`ts• to~ C tS..<>" to ,,"Fl aad prc,l«t4d from hcbt ~~
`- l ~
`f l u . - pn;poooat.t to• wruie to Q(f.,.hu,
`l,olhio&l"
`t·....,.....i .;.J. o1 STERILF. D!Ll"E.'\1 i>r
`-
`are ,ubl• wutl lbt dat<> Uldka...i an w packq:t' "i,.n
`moleculorwt1"'1tof500ti. l t " p ~ ......... 1
`t.er, C-ly solubl• tn dimethyl 1ulfoude 111d ~ ll . .
`oton,c1 , t 15• to 2.5'C ,s.q• to TT"Fl
`be
`au<M. and s!Jthtly oolabl• ID -th&DOI 111d "-'--::?"-'
`" ' - 1o ..._ _,,,ut..i ..iul.>ODI cl FLOI.A.'I aual
`-...,..i &- l,d,1 ....i ....... i,. rempnted •• ~ to s·c
`fLON'ASE Xuol SP"'!' 50 mq ao an a q - ~
`136' to t6'F of out o-' uwned'""'I• Do not-• -
`micn1lln• flou<UOM prop1oaa1< ror I.Opl,-j ~ "
`stiNtod aolutJono ol flOLAN. Discard •ny ,.c,>11,tltvt..S
`to the nual mut'OS8 by meant of • ~ ---:'.""1'>ll
`ITonft. - . I ony -mtut..S
`,pray pump Fl.ONASE :-/a.al ~pn) oloo CIIID •~
`-
`-
`solutJon -
`- o n d i t h u - .......... ..Slo,mor.thetl4'11c>un.
`tryotAlhne c,,llu!OM and t11rbo~th~n.i:- ~
`l>mma u.e. • •lfllle l'Mel'\"OU' of l'ffl>DOUtullOCI ,olulion of
`... ,., boni.alkonium cbJond. pol,
`d ~ . 0.02
`FLOLA.'i"..., be ..imu,,,urec1 at room ~mpo,.tW't' for• to(cid:173)
`and 0.25-.,. fw phenylethyl akohol. llld ~•Iii~.
`tal du,a...., of 8 baan, or ll CSA be """' w,tl, a cold pouch
`"""~up.., 2A baun w,lh 1M u.o/tWO , . _
`~ - ,
`and7
`It ,. n<!ClltllSV)' to pnme tho pump i..r.,,, fim.,..., • ._
`6-<lz rel pecb ID• cold poud, \Yh,-o •torNI or m \lllO, , _ ,.
`~ a{ nan·UM! ( I Wfflt or morel An.. IDltiol .,,_;:::, I
`rot..W not.AN maat be ..,...i.Lfd Crom ~ml"'ratilttll
`aauaU<,u\ . . ,h .c<WlllOG deJn..,.. 50 aq .;.;;:,:
`.,....,.r than 2-5 ·c 77' F ud .... lhan O"C (32' F •• and must
`pTOp1onate in 100 me of formulallocl lhniqh Ibo
`DOI be upaeed lo dlffd. •unbdlL
`adapter Eacl> bottle of FLONASF. Nual S~ ..,_._ 1-.l
`U. •t Room T..,_.tu,_: Prior lO UH 81 room ... ,,,peril·
`-~....i •pn> After 120 motered sin,, die
`Ul
`t1lff I~ to :?S'l 59 to TT"F1, ,.,......,u141d eolu!JOAS of
`Fl.01...\.'1 may i,. <etand ~fril:"nted u 2" to s·c 36' m
`ftubcuone pTOP,on&te dell\-ettd po,- -
`coruuatenl and the urut thould be <h.."<a.Nled
`◄6"F) for DO longer than ◄0 boun \\n,n adJ1111U&tered at
`romn ~.mporatun,, .....,.,.Ututed ""lulionl II\&)' be uoed for
`CLINlCAL PRARMACOLOCY
`aa Jooct r dwl 8 how,,. This 4S-bour poriod .U0,. • 11M P"·
`FlutlCaoclOe prop1onat.t .. a •:,ntlwbc, tnJl-llld -
`bent to rt!COMUlute • 2-<iay upply :!00 mW of Fl.01.A.'i"
`•tero1d with anti-inflammatory actmt) In nu-o daot
`Each 100.mL cl.oil~ supply mas be w,ided into thrH equal
`•ponM atad, .. on • cloned human I I ~ ~
`poru · Two~ : h o ~ a.-. llorod .-.tn,ented ••:?'to
`.,-.tcl<D lD.-oMIII! btndut& and pa. ~a&,,taJSO\
`5-C ~ t. 46°F' UJUil tlwv att ......t..
`tt!!pot118 al I 25 and 0.17 nM ro=ntnUons,t11!lfft.'l!J
`Uu wrth • C<,kJ PO<Jdl Pnor LO i.nl\won " ,th tho UM of a
`Flulln90ne prop,onatt was lhh~rold to 6-.l'old """'!'<la
`cold po.,ch. ""1uUOll5 may be stored .-.fnp-rated at 2• to 8'C
`than deumethascme u, these ._yo Ow. " - l!it
`3o' "' ~6"1' " ' up to 2~ boon \\1- a cold pouch IS •m(cid:173)
`McK.on11e vuoconstnctor ~ tn man a b o - 111
`plo1.d during tM ,nfutlon. reconst,tutt-d ,oluuons or
`,.
`rent elucooortico,d actl\~t>
`f'LOL"-'i" 1ru1y be u6<'d £or no l<mj;,·r uw, 24 hour,;.. The g•I
`In prtclinical ,tudil.'tl, llutic:uocw pn>plOOW m...W ID
`packs oboald be chan;,,d .-ny 12 hours l!-,,,ututt'd ,o.
`g,,.terone-lib activity nmilar to the u1ural _,,_
`lutiom may t,, k<'J)l at Z' LO i;•c (36• to 46'F etWr ,n re(cid:173)
`findmp,. ,._
`Howr.-er, the <hnic:al 11grufirnnce of 1h
`rnj;erated ,ton,l:l' or tn a c,,ld pouch or a combllllltlon of the
`tion to the lov. plasma levels l!K'<' Phannaro~l • ..
`t--o. fl)r oo more th.an -18 hour,.
`know-n
`Pare,11.-..J dnl4: prodacta .i.ould I» uap.-'<"\ed V1Saally for
`The precise m.duu,.,.m lhroup wbJcl, ftutxamo ~
`pamculai.- matttr llrul d,..,,Jontion prior to aclmini•tntion
`•ht-nt Hr 10lut1t1D and C'Ontai.ntr pennil tr e1thc·r O<."'C\Lr.l:,
`nate alfecta aUergic rh1rubs aymptoOli II not lmo,m C..,,
`C06Wro1d., ha,·e bttn abown to have a ..-id,, f'ID£t of ,6111
`FLOL.\.\" ,hould n,,t Ii. 11dmuu•u•ttd
`oo .muluple a,JI t.ypet! le.g. ID85t cell,;. ~ -
`HOWSUPPUED
`phils, macropbui;es, nnd lymphocytesl and mooi>tm •t
`FWL4..'1 for li\,,<tiun ,. 1upplil'd a,, a st.-nle li-effi.--dried
`b.tstam,ne. eico.anouls. leukotneneo. anti C)1"kiott• •
`powd,:r ui I, -ml. 11.uit i;l4" via.k w11h cr:ay but}! rubber do(cid:173)
`•ures. ind1nd11Ally ...,._g..i m a can.on.
`vol\«! ID inJ!arnmauon lo ..-.en lriala ID adults, M\."5t
`Na,,al Spray hu d;,cN,lliOO MAI mucooal eo,,nophm a
`I 7-mL Hal cont.aining epopn,slenol 110,hum cqwvelent to
`66'\ 135'1 for placebo) of pau..ni. and ba,opbil.un m1ffl
`O.S me 500,000 ng~ carton of l (NDC 0173-0617-00I
`for plac ... bo of patienL, The, d1~ ttlationsbip of._
`11-ml. ,ial canuurune ~popro.ttnul l!Od.ium eqw,·alent to
`finding,. to lon,:-tenn •ymptom ttlief II out lDffll'1I.
`1.5 mg tl,500,000 nel, carton of I INDC 0173-0519-00)
`FLONASE Nllllal Spray, like otner cort1wttN11d.l. II•
`agent that d0t ~ not ha,·• an unmed.iale elfoct oo allsll'
`St.,,. Ille viela of fLOlAN et 15" to ZS'C 159' to 77' FJ. Pro(cid:173)
`symptoms: A d<-«ell!l<, tn nasal oymptoma bas bftll lllllH •
`tect from light.
`The STERILE DILUENT for FLO LAN is •upplicd tn 60.mL
`some patient,\ 12 hours al\(!!' initial tttalm<nl WO
`FLONASE Nasal Spray. Maximum booefit . . , Id 11
`60-mL ,,al of STERILE DILUE..,-r for FLOL.\.~ tra, of 4
`reached for ~veral dar-. S,milarh wlwn ~ . ,
`•
`•
`discontinued, aymptnm• may not· ;..tum for M""trel ~
`Ixoc 01;a.os1s-001
`~kinetics: Absorption The aru,;ty of FLOSA.'i
`l\asaJ S"!3y i• due to the parenl ~ . ftuuca,ant ictpt
`nate. lnclirec:t calculations indicate that ftubCL<ODf pNII'
`nat.e deliveroo by the intra.naaal route 1w an ahlol•11 •
`availability a,·eraging 11!"5 than 2". After 111~ l!llt
`ment of patients with allergic rhm111! for S . (cid:173)
`ftuhCQone prop1ona1Al plasma concrntreoon:;,::::
`the level of detec:Uon (50 pgflnl.i only -..bm
`doee.. were exceeded and then only m oo:a,10n.l ~ •
`low Pluma levels. Due to the 10-,,: bioavailabilitr tr, ~.:
`trana.l route, the ma,onl'i of the ~ lit
`,._ obtained ,.,a other roulft of ad.mirumabol\ ~ ._
`mg oral dosina of radiola.beled drug have demon>uwi,il -
`811t1caaone propionate 1a highly eruacted from . - : 111
`aheorption 111 Im:'· Oral bioa, a1labtlity II oeglipblt ~
`majonty of the mrulatina: rad1oacfo1tv is due 1o 911
`..
`.
`metabolite
`~ : . ~ollowing intravenou admJAI!~ ti
`~ dispoattion pbue for 8utiauone prv~lill"
`• .._ and CIIDSiatent with ,ta high lipid IOluhili1Y
`
`10
`20
`30
`
`llQ
`
`'° 50
`10 so
`90
`I"''
`
`.Pauent
`Wright
`(q1
`
`10
`20
`30
`40
`50
`60
`
`70 so
`
`90
`100
`
`.ft h.0 12..D 160 200 24 0
`
`Tobie 7; W........ Rat• I« A..Ot.AN I t •
`~ of 5000 "II/ml
`.0- ar Dnia Oolive,y Ra .. 1-, per
`
`2
`
`12 U
`
`16
`
`.... 60 7.2
`
`11W11.ael
`10
`II
`lnfum De!ivw, Ra .. t m.UhrJ
`l.9
`1.2 14 17
`10
`3 ◄ u
`2.◄ '2.ll
`1.9
`IA
`JO
`u
`5.11
`.f.3 50
`3.6
`2..2
`2.ll
`6.7
`7.7
`◄.8 5.8
`1.0 1.9 2.9 8.8
`8 ◄ 9.6
`1.2 24 86
`14 2.9 u
`7~ 86 101 lU
`,'j'
`8.◄ 101 JJ.8 13.4
`3.◄ 60 67
`I 7
`9.6 11.S 13 ◄ 154
`1.9 38 6b
`7.7
`2.2 43 6.6 8.6 l0o 130 15.1 17.3
`24 u
`9.6 12.0 lH 16 ij 192
`72
`
`Tabl. 8 Infusion Rat• lot A.OLAN It •
`C-nlrWtiOn of 10,000 ng/ml
`
`Patieal
`Y.clgf::
`qi
`
`20
`30
`◄0
`50
`
`10
`1.2
`
`l), or Drug Deli.-ery Rat.- (a,/q pn
`auna~
`u
`10
`IMIQOII Delm!ry Ro~ (mUbr)
`I 2
`1.7
`1 ~
`10
`2.5
`22
`IS
`14
`2.9
`2.4
`1.9
`3.◄
`3.0
`3.6
`24
`◄ 2
`
`6
`
`8
`
`12
`
`11
`I ◄
`lo
`
`16
`
`19
`29
`38
`-4.8
`
`I ftmt gl.ua \"WI ,nlh ftuoroh"!lUl·Ca«>d butyl rubber dOliun,s
`
`To MOU 100 ml of .. lutiaa wnh
`Jinal CIIIIC!:DlnU. tni,ml.1 of.
`3000,wou.
`
`6000 o,,'mL
`
`10.000.-mt
`
`w
`
`A
`
`. . . C
`
`J)jrecbons:
`~Wh~ ,cantenta or one Ob-mg vial with 5 mL of STERILE DILUENT for
`t o ~ - . . ~ ~ :t. and add to 11118iarnt STERILE DILUENT for noLAN
`~~ ~~f one O 6-mg vtal wtth 5 mL of STERILE DILUENT for
`
`l'LOUN to:....: =~t~ :..lffita and add 1ullicien1 STERILE DILl'ENT for
`....
`
`YiaJa
`o..i.. aiawnta oltwo O 6-
`Nell whb 6 mL of STERILE DILUENT ro,
`. mg
`PLOIAH Wi.....,_
`......,. fill.IN vial CIIDlellCa and add _,-..,_.
`S1'ERD..E DlLl'ENT for
`-
`~ 18 . . -a total ol 100 mL
`liaohwanm111 alOOJt 1.5-mg ml with 6 mL ofSJ'EJUJ.E DILUENT
`for
`ILOUH. Widadr.w mbrll vial CIID&eata and add satlia:ieat .,._nn ..
`ft.DUN•--• total fA 100 mL
`"'' .......r. DILUENT for
`_,•.lllllirldilr,.._ wlao l'ICllift FLOLAN ~
`I_,
`$ 'tr 55
`
`

`

`- . . ........ s, ........ 100
`oprny Ill OMii -•nl t • ~ - < I ~ hob dolly C- 0mcg
`lnd,widua1 PJ1lwn•- w 11
`1 l'I.Pl'f\('l\C8 • vanab&r- ume to CNINl
`-
`and d1fr1~a
`doubl.blit>dt ~ o l •-plom f-1iel In 4 , _ _ _ _
`nn.lo n...i-•-~rollad -•U. ,rroup •IJ.,pc ,t,,.
`'''°Att-d •u~-t•com~ ~~:~ 1!. n11 , :u!': :!
`111,QQi ' - Mud.&W of s-1 M"Tltl m "" OU1dou
`...
`1r,•
`.a.I
`r par
`FLO!',ASf; N-1 Spra) M.UJmum •W..• may =-en!
`Mtu.nc lpurk 11tudu~t ll ck
`
`doN, of
`
`GIJ\XO WELLCOME 1185
`
`I Information t-o, Petfentt Pali"nh bP1n1 trt'Alrd .-1th
`
`lOC).
`
`~~ ~----u,....i .....
`
`--IIG, ~blind, parallel. vehicle-controlled
`
`r 1Nf0Rf-4ATION
`l'flooUC
`riodicallv tor ,rideo<i' of ('andida ID·
`___ ,_...,
`thto naMI murosa
`: : : - - - : : . ,,t cb,fril,ul- •YffaC<d • 2 I ~ 11,.,
`..i-td b o = " v I"'
`•
`1Ca1
`~oroth<r""°"Gfad•~•lftcUOD
`~ ol •"'.pd 911, ••th no olw1<> . . '°"""''"
`~ 11W
`loU<O . . M - - - bound to lwmAA
`f1.,()NA.SF. Nual Spray ahauld bo ua«I "t1:;,:'."infrc•
`t lOCl;, un,,..i,;1 local or •1Jlk=I' funpl er boctnw °' •Y•·
`th IM"IIVt' or ~ n t u
`all. i.n p:tillfflU •
`..-~ .. ~ IIIJd 6"17 oqwlihutH ho.
`h uur ,'\ral rnf(.'1(1.on> or r-,ru1t1" tnfortk,m. or onal.u hrrp.~
`,-;,,;t,11 _,""' anJ ~ Flut-., pn,-« ,.
`....- ..,, ,h· 1,ound tohum,1n lrlln-rtto
`turnri1~.,
`s.c.,_ or tbr Lllh,bttcl)' ,t!,-ct <>I tortJ<u.1<21 tdt on wound
`_. ~ ~ t4UI blood c~ or f l u = - prvp(cid:173)
`h<ahnc, pt,IWDla who h o n ~ N<CDI uaoaJ ..-puJ
`~ 1 • ...,...,, IOOJ -.L/mulJ, ,.1th ronal <~
`IOOII U 12 bou,- Afl.r U-.U..-nt wtth
`ulcrn. nuaJ 1Uf1CII"''), or na&al tnumA ,huu1d not UM • DA·
`fur 1- Lh.us o.cri• ur I.he l<X~l Th. only an:u(cid:173)
`...-,::!i.,,.i. Jct<<W<I LD man ,. I.he 1711-<:arboxyhc end
`..,.tr I<
`dav- Plb,•nt1 "'ho hl\f ....-pond('(! may be ablP to be, mat4•
`aal con1t'Ollho•ro1d until hc-.aalma hM de.Olm-cl
`wnod <aftn 4 IO 7 day11 on 100 -1cby lone"""'' 111 Md\
`of dul.lRIOD~ prc>pionat• •b.ich •• formf'd
`bid
`.
`-tnlOIIC9daiM.
`FLOSA.<;F. N-1 Spray ohould - ~ the folk,..,ftl: m!ur(cid:173)
`ddt.atinlho , , . . , - P<50 3.\1 peth,.ay. Tlua inactn
`Ptd11tnc pau,~c.. 14 )IN.ff of •kt' and ulrlff ,.huuld be
`tnahon and inUn&tt10n11 Thi• mfonn.1t10n t1 lnu-ndN.l to kid
`~ .. hA<I app,vX1n"1lal1 :lOOO UIIIN t ... el!in,ty than
`lht·ru ,n lht' 14(, and tft~'<11vr U!K' ot lhia nwJ1aa.uon It a
`atartfld w1t.h 100 mqr lone i,pray in eMh no.tnl once-a4ly,
`,o,tob'- •• drus f<r ~ cluco<0ruro,d ....,.,,..,, •f human
`• .i..,io.,,,. or all _,ble advoroo or 1011.ndNI drt<t•
`Tn.tment w,t.h 200 mq ti-..o 1pray11 m Mith noiotnl ont»
`•~..,....,..,and -1,pbl~ ~ acu,uv
`-
`Pat ... ntt •hould brr, warnrd to a-.okl npat"ufl'! 14 duck:l'ftpn
`daily or...., 1p,.y ,n - h ~ I .....,. dady1 aho,11d be ro(cid:173)
`rune JDdl ttudtt.-.. Odwr met.oboLtn cktt,.ud 1n ,,tro \la.lftf
`;::'...i h\ltMD b,-p.,wma «•Ila h.o•c nul i,,,.n deu,cu_'CI In
`><·rvod (or p,,d,atno pollrnu nol adequntely rnpond1nr IO
`or fflt'OJlilMi and_ 1f ~ . t.o contuh t.~1r phy,1oan •1th
`100 mq d■1l)· Once, adoqua1t ..,n,rol ,a ach""'od the doa
`out dt·lay .
`Pa1,.nt.1 •'-Id u.< fLOSASE Su.al Sprat al ..,_.1., In·
`~ •howd I,, d...,.._..., lo 100 mrt fom P"'l in • di ,.,..
`...,._ ult>~ dnic ,ntcrvtlon otudv, coednuruatrallan
`tt-rvat,.,. cL-"'<'t..d iiinC¥ ,t,. t:ff«ti'\:1':fH"U deptnds oo ,ta rec
`trill diuly
`In• mlly inh.akd ftutic.asoot• prop1onai4.~ t500 mcg ,w1u
`t;: one! rrylbrom)an (383 tr1J thn,,• umes do,lyl did not
`ul1U' U,,4' A dfriCJ't>ue in nuo.l 1ympttmu1 may ,JCCUT aa MMm
`Mn"mum IJ>lnl dmly do.Ill Ahould not <'11tred two ,p,,.ya ,n
`u 12 hou~ an, r ,t.uting lh•rapy ,.,th t'LONASF. Nual
`tach noatnl I tolal .S-, 200 mqlday1. Thrrt ii 0<1 ov,den<e
`16«' B u • - prop,on,a~ phanoacoku,.-tx.
`Spray Re.ult., ln .,.."t"T'al dinic:al tria11 tndiatl4- sututacall)
`tru,t UCl'!eolWI( the N- mmended d_, L II\Of1' •11"•<"11•~
`In • drut mt,rvtJ<>n >wd}· coadmuw1"'uoo of on,Uy 1n•
`tigruflcant 1mprnvtmf'nt wn.lun Ow fi.rtt da~ or two of tl?tlt(cid:173)
`lNOJCATIONS AND USAGE
`i,alfd nuuce10n• propionate t 1000 m<s, 6 1Jm01 tho mo,a
`m1•n1, howw,,,, the full benefit of t'LONAl!t: Na . . 1 Spray
`..- daJy ,no-aoa.al d_, and ketoconuolo <200 m& once,
`fLONI\SE Na.al Spray• md1<aled for too mana11<monl or
`may not ht, athit•·ved untJI \N!atmf'nt has beC'n 1dnunl1t4!ffd
`the - 1 •ymp<oma o f~ and prn,nrual ali.rpc and
`dAlb> -,Jud Ill 1ncn-uN! auua,- prop,onat• - ·
`ror lt"\'t ra) day. ,,.. petu nt ,hould Ml lncre.uP 11w, Pft"'
`ocnbod d -but <hould t<>O'-"rt tho phywiclan ,r I) mplomo
`nonollo,rpc rh1n1110 m odulta and ped1atnc pat,, nu ◄ yoano
`t,ttW04- • t'l-dudJM 1n pla.ima ccn·tu,ol AUC. and no tfrt."Ct
`or •R• ruul oldt•r
`do nut iruprovi:- or if I.ht' condiUtan woMk.•nH. PoT 1he propi. l'
`00 unll,BJ'Y -.-.ct't'ti~ or comaol
`, _ -, foll_,DC ,ntra,·•nou• doo,,.., ftulica,,(lne propl(cid:173)
`Saf.-ty and tfr"Cll,·enOII of FLONASE Nual Spnty Lil chi!,
`use of lhe n.ual !;pray and to JlUam maxtmum ,mp"°"e'"
`monl. the paUPlll .bould read •nd folio,, rareCully tho pa,
`..,. ... ,boud poJyT,pon.oLi&l lineba< .,nd had a trnrunal
`bMn adequatolr eoub(cid:173)
`dnn below • -,w of~ hav• -
`0i,m,n1t1on half-life or opprox1maioJ.y 7.S houro Leo than
`uenl"• mstn1ct10111 accnmpany,nr the procluci
`hshed
`Drug lnterac11ona! In o placcbo-controllrd, c-roMO\"l'r ,tudy
`6• of 1 ,ad,olabeled oral d - wu OXl!N'l.ed m th• urine a,
`COt-TRAlNDJCATIONS
`..,._..i.,~••·• ,. th th<· .-.,mamder Uettlffl in Lh
`feces
`in f1~ht bt-allh)' \"OlunlN·n:. toadminu,trabon of a un1tlf'
`FLONASE Xa.al Spray ia cont.ra.u1d1cat.ffl ,n pellenu with
`d - of orally 1nhal,d ftuucuon, propionat~ (1000 mcg. 6
`pennl dru, and ~t.,bohlb..
`a h)·pe,,.,n•111vity to a.ny of 1lll mgredienla..
`llmu thP mtunmu.m druly intrannao.l d~) with mult.Jplt
`ap.cial Populahont, fluhctU10ne propionote """' not stud
`iod tn any ,p,oal populetions. and no t<·nder-epocific phar(cid:173)
`d01!t"8 of kdoconazol~ 1200 mR> to 1teady •lntt> .,..ull<'d m
`--u, data bin. boffl ohlamed.
`WARNINGS
`~ fl)f'•n flutiau!oo,.. propeonat.to cenn:-ntn110ru a rto(cid:173)
`Tho .-.,plattmont of• •)'OUmic cort>co.l<,,01d wtth a topical
`durt1on m pla•ma COJ11M1I AUC, ond no d,<1 on unnary n
`~ n am i c s• In a tn.al lo evaluou the po1rnt1lll •J'
`cor11c .. t.ern1d tlln IM- ne<ompen1NI by 1ian• of adN>Ml IMU(•
`cn>tion of cort.ll!<ll Tiu• 1nteract1on may b, due I.a nn mh1b1
`lotl>I< and topical eff