Social LAW
`
`• • • • • LI BR ARY
`
`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
`f~_b,::J £ ,' aM~1 0 <? j !; Re. :t=:e. 1 ~"'- <-(:.,
`
`1 r-1 ,)- E J_ ; d- t:,....,.. 1
`
`Is a true and accurate copy of material deposited in the Social Law Library.
`
`Brian Harkins
`Head of Reference
`
`Dated __,_/_':t---'-(_J_r_/ _____ 1 _c~J _
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`

`

`Social LAW
`
`• LIBRARY
`•
`• • • • •
`Research. Education. Services. Answers .
`
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`One Pemberton Square, Suite 4100
`Boston, MA 02108-1792
`Tel: 617.226.1510 Fax: 617.523.2458 Email: copycenter@socialaw.com
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`

`

`SOCIAL LAW LIBRARY
`BOS'l'ON, MAS8ACHUSE'l"l'S
`
`RECEIVED
`
`IAR 2 9 2000
`
`ISBN 1-56363-288-8
`
`I 90000
`
`9 781563 632884
`
`

`

`-
`
`- -
`
`-
`
`-
`
`I
`
`C._I
`
`PDR®
`53
`1999
`
`EDITION
`
`PHYS CANS'
`DESK
`REFERENCE®
`
`Medlcal Consultant
`Ronald Arky, MD, Charles S. Davidson Professor of Medicine and Master, Francis W.eld Peabody Society, Harvard Medical School
`Vice President of Directory Services: Stephen B. Greenberg
`Director of Product Management: David P. Reiss
`Senior Product Manager: Mark A. Friedman
`Associate Product Manager: Bill Shaughnessy
`Director of Sales: Dikran N. Barsamian
`National Sales Manager: Anthony Sorce
`National Account Manager: Don Bruccoleri
`Account Managers:
`Marion Gray, RPh
`Lawrence C. Keary
`Jeffrey F. Pfohl
`Christopher N. Schmidt
`Stephen M. Silverberg
`Suzanne E. Yarrow, RN
`National Sales Manager, Trade Group: Bill Gaffney
`Director of Direct Marketing: Michael Bennett
`Direct Marketing Manager: Lorraine M. Loening
`Promotion Manager: Donna R. Lynn
`Director, Professional Support Services: Mukesh Mehta, RPh
`
`Senior Drug Information Specialist: Thomas Fleming, RPh
`Drug Information Specialist: Maria Deutsch, MS, RPh, CDE
`Editor, Speclal Projects: David W. Sitton
`Vice President of Production: David A. Pitier
`Director of Print Purchasing: Marjorie A. Duffy
`Director of Operations: Carrie Williams
`Manager of Production: Kimberly H. Vivas
`Senior Production Coordinators: Amy B. Brooks, Dawn McCall
`Production Coordinator: Mary Ellen R. Breun
`PDR Data Manager: Jeffrey D. Schaefer
`Senior Format Editor: Gregory J. Westley
`Index Editors: Johanna M. Mazur, Robert N. Woerner
`Art Associate: Joan K. Akerlind
`Senior Dlgltal Imaging Coordinator: Shawn W. Cahill
`plgltal Imaging Coordinator: Frank J. McElroy, Iii
`Electronic Publishing Designer: Robert K. Grossman
`Fulflllment Managers: Stephanie DeNardi, Kenneth Siebert
`
`~ Copyright'a:I 1999-and published by Medlcal Economics Company, inc. ill Montvale, NJ 07645-1742. All right~ res_erved. (',lone of the content of this pubncation
`Ii ■ mey tie reproduc~d, ,stored in a retrieval syste117, resold, redlstrlbuled, or transml\ted In an~. form or by any means,(electronlo, rnecllanloal, photocopying, record •
`•Ing, or otherwlss) without the prior written permission of Iha publisher. PHYSICIANS' DESK REFERENC~, PDR-, PDA For Nonpresorlptlon Drugs-, PDR For
`Ophtl;ialmologye, Poc~et PDR•, .ind Tt)e PDR Family Gulde tp Prescription Drugs® are registered tJ1:1demar1<S useq harelr und!!r llcanse. PDA Companion Gulde™,
`?DAI' fol Herl;)al Medlclnas1M, POR• Med!!1<1I Dictionary'"', PDR' Nurse's Mandbook™, POR- Nurse's Dlcllonmyt"', The POR" family Gulde Encyclopedia of Mlldlcal
`CarEf'M, ~DR• Eleotr:onlo Ubraiy'", and PDR" Drug Interactions, Side Ettects1 lndloaUons, Contrelhdloallons System"'!M are trademarks used herein under llcenae.
`,Offlcera of Medical Economics Company: President and Chief Executlva Officer. Curtis 8. Allen; Vloe President, New Media: L. Suzanne Be Den; Vice President, Corp0rato
`~imian f(eso1,roes: Pamela t,1. Bllash: Vice Pres/dent and Chleflnformetion·Offiae_r: S\even M. Bressle/; Senior Vice President, Ffnance, and Chief F/nBTlc/s/ Officen Thomas
`W. E'.hardr, Vice President, Dlretto,y Se/1/fces: Stepheh 8. Greenberg; Vice President. ('Jew Buslnes:, Pfenning: Linda G. Hope; Executive Vice President, Healthasre Pub/ls/Jing
`!Jnd Communications: Thomas J. Kelly; Executive 'Vice President, Magazine Publishing: Lee A. Mar,Jsqaloo; Vh;:e President, Group Publlsher: Terrence W. Meacock; Vice
`~sltient, Product/on: David A, Pitier; Vice President, Group Publlsher: Thomas C. Plzor; Vlr;e President, Mwtazlne Business Menagem,mt: Eric Schlett: SE/fl/or Vice. Pres/den,,
`1;1tJerst1ons: John R. Ware
`@ Printed on recycled paper
`
`ISBN: 1-56363-288-8
`
`

`

`CONTENTS
`
`Manufacturers' Index (White Pages)
`Section 1
`Lists all pharmaceutical manufacturers participating in PHYSICIANS' DESK 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 Name Index (Pink Pages)
`Section 2
`Gives the page number of each product by brand and generic name.
`Product Category Index (Blue Pages)
`Section 3
`Lists all fully described products by prescribing category. An overview of the headings
`appears on pages 201 and 202.
`
`Product Identification Guide (Gray Pages)
`Section 4
`Presents full-color, actual-size photos of tablets and capsules, plus pictures of a variety of other
`dosage forms and packages. Arranged alphabetically by manufacturer.
`
`Product Information (White Pages)
`Section 5
`The main section of the book. Includes entries for over 2,200 pharmaceuticals. Listings are
`arranged alphabetically by manufacturer.
`
`1
`
`101
`
`201
`
`301
`
`401
`
`Diagnostic Product Information
`Section 6
`Gives usage guidelines for a variety of common diagnostic agents. Arranged alphabetically by manufacturer.
`
`3467
`
`Drug Information Centers ....................................... ; ................................................................................. 220
`A national directory of institutions that answer queries regarding drugs. Arranged alphabetically by state and city.
`Key to Controlled Substances Categories ................................................................. .' ............................... 347
`Gives the definition of each category and the prescribing limitations that apply.
`Key to FDA Use-in-Pregnancy Ratings ...................................................................................................... 34 7
`Provides the exact interpretation of each risk/benefit rating.
`U.S. Food and Drug Administration Telephone Directory ............................................................................ 348
`Gives numbers of key reporting programs and information services.
`Poison Control Centers .......................................................................................................................... 34 78
`A national directory cJtranged alphabetically by state and city.
`
`

`

`312/PHYSICIANS' DESK REFERENCEe
`OlA,1(0 WELLCOME INC
`QLAXO WELLCOME INC
`
`P. 1098 AX
`
`RX
`
`P. 1109 RX
`
`GLAXO WELLCOME INC
`
`P. 1122 RJJ
`
`OLAXO WELLCOME INC
`
`P, 1126
`
`1
`
`,R'X
`
`OLAXO WELLCOME INC
`
`P. 1130
`
`16 g
`120 metered sprays
`
`500-mg vial
`
`1-g vial
`
`Flonase<11 Nasal Spray 0.05%
`_ _ _ (_fluticasone proptcip~fe)
`OLAXO WELLCOME INC
`RX
`
`P. 1124 RX
`
`QLAXO WELLCOME INC
`
`P, 1126
`
`125 mg
`
`250 mg
`
`500 mg
`
`\..._
`25 mg
`
`Daraprlm<II
`(pyrlmethamlne)
`OLAXO WELLCOME INC
`
`P. 1112
`
`RX
`
`i?=~
`
`~
`
`1111111
`
`2% per 27 g
`Also aval/able In 50 g
`
`Ceftln9
`(cefuroxlme axetil tablets)
`QLAXO WELLCOME INC
`
`RX
`
`P, 1104 ~l •
`
`Emgel<II 2% Toplcal Gel
`terythromycln)
`OLAXO WELLCOME INC
`
`P. 1112
`
`;
`
`' 1
`f\ ,,.-
`
`• 10 mg/1 ml
`
`240 ml
`
`,•LA~O ,we LUJ.O!I~ llfO
`
`P. 1107
`
`0.05% per 15 g
`
`c ,1,-.-.,c •, ·,.
`
`---
`
`,1 .. ,n,:•-.
`
`0.05% per 60 g
`Also available in 30 g
`
`Cutlvate<11 Cream
`(fiuticasone propionate cream)
`P, 1108
`GLAXO WELLCOME INC
`
`RX
`
`;.;;;;.;.,,.,,,... . .,,~ ~
`----
`--
`~
`0.005% per 15 g
`
`'
`
`'
`
`'
`
`·-=--
`
`~~~~~-A
`
`0.005% per 60 g
`A/so available In 30 g
`
`Cutlvate<11 Ointment
`(flutlcasone propionate ointment)
`~L,\~o,YII L\'Co_r,l! 1HC
`P, 1110
`
`RX
`
`tr ~
`
`38 mg
`
`Diglblnd9 Dlgoxln
`Immune F'ab
`(Ovlne)
`
`13-g canister
`120 metered inhalations
`Also available In 7.9-g canister
`
`Flovent<11 44 mcg
`Inhalation Aerosol
`(fiuticasone proptonate, 44 mcg)
`,. 112• RX
`ot.i~o WELCCJ>M• lko
`
`Flovent<II Rotadlsk<II 250 mcg
`(ftuticasone prop)llllllta(cid:173)
`lnhalatlon po,W~or, ~59 mcg)
`P. 1130
`QLAXO WELLCOME INC
`
`RX
`
`OLAXO WELLCOME INC
`
`P, 1112
`
`13-g canister
`120 metered inhalations
`
`150 mg
`
`Eplvlr<II
`(lamivudlne tablets)
`OLAXO WELLCOME INC
`
`RX
`
`Flovent<11 110 mcg
`Inhalation Aerosol
`(flutlcasone propionate, 110 mcg,l
`P. 1124
`QLAXO WELLCOME INC
`
`P, 1116 RX
`
`' 1 g/50 ml
`
`10 ml
`
`Exosurf Neonatal<II For
`lntratracheal Suspension
`(colfoscerll palmitate, cetyl alcohol,
`tyloxapol)
`OLAKO WELLCOME INC
`
`fiix
`
`P. 1118 RX
`
`13-g canister
`120 metered inhalations
`Flovent<II 220 mcg
`Inhalation Aerosol
`(ftutlcasone propionate, 220 mcg)
`P. 1126
`QLAXO WELLCOME INC
`
`~-
`
`I
`
`2 g/50 ml
`Fortaz<II
`tceftazidlme sodium l!)jocUOO)
`ai:,.~o Wll LCOftfE ING
`P. 1146
`
`Ti
`., --·
`·
`~
`~-=!--
`~ ==--
`
`20,nil VJQI
`
`h1111r"an•
`'(oza01loprino)
`GLAXO WELLCOME INC
`
`P. 1146
`
`RX
`
`2-g vial
`
`1-g
`IV infusion pack
`
`2-g
`IV infusion pack
`
`6-g
`pharmacy bulk package
`
`0.5 mg/17 ml
`Also available In 1.5 mg/17 ml'
`
`~
`50mg
`
`lmuran<11
`(mtti)opil~e)
`
`1-g
`
`2-g
`Add-Vantage• vials
`
`Fortu9
`(ta\i.a~dlme for li:\JBc\lphJ,
`
`

`

`19
`
`-
`
`C•III
`
`L\!pron Depot• 3.75 ~g
`/1eutitolld• BOllWl• fpr Meorc5usp9ni[On)1
`
`r T! ~ e ~ARM!O IUTI0~~6 )~ O, P, 0, ~0
`
`P. 3183 U.S. BIOSCIENCE, INC.
`....
`
`U.S. BIOSCIENCE, INC,
`
`P. 3171 OTC
`
`PRODUCT IDENTIFICATION GUIDE/341
`VIVUS, INC.
`USANA
`
`USANA
`
`P, a1es Rx
`
`VIVUS, INC.
`
`P. 3188
`
`UCB PHARMA INC .
`
`5mg/500mg
`
`-
`
`Lortab8 ASA
`(hydrocodone bitartrate, aspirin)
`P. 3102
`UCB PHARMA INC.
`
`50 mg
`Hexalen•
`(altretamine)
`U.S. BIOSCIENCE, INC .
`
`P. 3172
`
`fl :it:
`
`-
`
`l .
`........ "-- '
`
`5mg / 500mg
`
`25 mg and 200 mg
`Neutrexin•
`(trlmetrexate glucuronate for Injection)
`
`UNIMED
`
`C-111
`
`UNIMED
`
`P. 3176
`
`240 tablets
`CalMag Plus
`____ D_l_et_a~ry Supplement
`USANA
`OTC
`
`ACTIS•
`Venous Flow Controller
`VIVUS, INC.
`
`P. 5187
`
`P. 3166
`
`' R~
`
`30 mg
`15 mg
`Delayed-Release Capsules
`PREVACID8
`U~n~;oP@!OJJI!
`TAP PHARMAC!UTICALS INC.
`
`RX
`
`-PREVPAC
`
`L"'!!l.""11'
`~
`
`7.5 mg / 500 mg
`
`10 mg / 500 mg
`
`Lortab•
`(hydrocodone bltartrate,
`&cfota,nli\bp)l,n, USP)
`UCB PHARMA INC.
`
`P, 3162
`
`c,h
`
`50 mg
`Anadro1•-so
`(oxymetholone)
`UNIMED
`
`P. 3177
`
`P. 3156
`
`CUii '
`
`7.5 mg, 500 mg/ 15 ml
`Lortab• Ellxlr
`(hydrocodone bltartrate,
`acetaminophen elixir)
`UCB PHARMA INC.
`
`RX
`
`P, 3184
`
`RX
`
`2.5 mg
`
`5 mg
`
`10 mg
`
`90 tablets
`
`Marino!•
`(dronabinol)
`UNIM~D
`
`P, 3177
`
`OTC
`
`Chelated Mineral
`Dietary Supolement
`
`MUSE•
`(alprostadil)
`
`;;:= ~~
`---- 19
`
`Triple Therapy
`
`PREVPAC™
`(lansoprazole, amoxlclllln, clarithromycin)
`30 mg/500 mg/500 mg
`
`2832* 100 mg
`
`400 mg
`Maxaquln•
`(lomefloxacin HCI)
`
`UPSHER-SMITH
`
`2842* 200 mg
`
`RX
`
`UPSHER-SMITH LABORATORl!S P. 3181
`
`KLOIHJOII
`8 ·
`
`P, 3195 WALLACE LABORATORIES
`
`RX
`
`WALLACE LABORATORIES
`
`P. USl1
`
`USANA -
`
`60 soft-gel capsules
`
`CoQulnone™
`Dietary Supplement
`USANA
`
`P. 3186
`
`fUt.
`
`137 mcg
`A•tenn•
`Nani Spray=
`(azelastine HCI)
`WAUA.O! UflOAATOAIU
`
`P, 31H
`
`OTC
`
`-=
`Felbeld'
`r:::--
`- .==
`
`600 mg/5 ml
`
`600 mg
`
`P. 3186
`
`90 tablets
`
`Mega Antioxidant
`l;)Ti,t~r~ l!.U.olll•m~nl
`USANA
`
`• ..
`
`l■
`
`J)
`
`~•/AI.LAGf.
`
`=---
`
`90 tablets
`
`Proflavanol@
`Dietary Supplement
`
`400 mg
`
`Felbatol•
`(felbamate)
`
`612* 120 mg / 600 mg
`
`Duratu••™
`(pseudoephedrlne HCI, guaifenesin)
`UCB PHARMA INC.
`P. 3160 RX
`
`•
`
`20 mg / 200 mg per 5 ml
`.,Duratuas™ DM Ellxlr
`(d8.llf11!11athorpHan HBr1 :gualfenosln)
`uoe !!~~~Ill~ iµo.
`Pi U!O AX
`
`IU(
`
`A\
`
`2852* 300 mg
`
`2902* 400 mg
`
`Theo-248
`(theophylline anhydrous)
`
`P. 3170 RX
`
`Trlnslcon•
`(hematic concentrate
`with intrinsic factor)
`
`P, 3170 OTC
`
`750 mg (10 mEQ)
`Klor-Con@ 8/Klor-Con@ 10
`(potassium chloride extended-release
`tablets. USP)
`
`600 mg (8 mEQ) -,a
`UPSHER•SMITH LABORATORIES P, 3181 •• 200mg
`
`Pacerone@
`(amlodarone HCI)
`UPSHER-SMITH LABORATORIES P. 3186 OTC
`
`620* 1200 mg
`Duratu .. QT!I
`.o,i,,, __ __,(a..,u~a~lt•~n.!::os~ln::J:._l, ___ _
`P. 3161
`UCB PHARMA INC.
`
`Vicon Forte•
`Therapeutic Vitamins - Minerals
`
`250 mg
`
`-■
`
`500 mg
`
`Designed to help you identify
`drugs, this section contains
`actual size pills and full color
`reproduction of products
`selected for inclusion by
`&lo-Niacin@
`participating manufacturers.
`polygel' controlled-release niacin
`_____________ ____ d_ie_ta~ry su pplement
`
`750 mg
`(Tablets are scored)
`
`

`

`1122/GLAXO WELLCOME INC.
`Flolan-Cont.
`
`U.S. Patent Nos. 4,335,139; 4,539,333; and 4,883,812 (Use
`Patent)
`Licensed Under U.S. Patent No. 4,338,325
`©Copyright 1996 Glaxo Wellcome Inc. All rights reserved .
`October 1997/RL-474
`Shown in Product Identification Guide, page 312
`
`FLONASE®
`fflo'naz]
`(fluticasone propionate)
`Nasal Spray, 0.05% w/w (50 mcg/actuationl
`For Intranasal Use Only.
`SHAKE GENTLY BEFORE USE .
`
`DESCRIPTION
`Fluticasone propionate, the active ingredient of FLO NASE
`Nasal Spray, is a synthetic corticostei·oid with the chemical
`name of S-fluoromethyl 60<,9a-difluoro-11[3-hydroxy-16a (cid:173)
`methyl-3-oxo-l 7 0<-propionyloxyandrosta-l,4-diene-17!3-car(cid:173)
`bothioate.
`Fluticasone propionate is a white to off-white powder with a
`molecular weight of 500.6. It is practically insoluble in wa(cid:173)
`ter, freely soluble in dimethyl sulfoxide and dimethylforma(cid:173)
`mide, and slightly soluble in methanol and 95% ethanol.
`FLONASE Nasal Spray 50 mcg is an aqueous suspension of
`microfine fluticasone propionate for topical administration
`to the nasal mucosa by means of a metering, atomizing
`spray pump. FLONASE Nasal Spray also contains micro(cid:173)
`crystalline cellulose and carboxymethylcellulose sodium,
`dextrose, 0.02% w/w benzalkonium chloride, polysorbate 80,
`and 0.25% w/w phenylethyl alcohol, and has a pH between 5
`and 7. It is necessary to prime the pump before first use or
`after a period of non-use (1 week or more). After priming
`(three to four actuations or until a fine spray appears), each
`actudion r' ''·-~rs 50 mcg of fluticasone propionate in 100
`mg of formulation through the nasal adapter. Each bottle of
`FLO NASE Nasal Spray provides 120 metered sprays. After
`120 metered sprays, the amount of fluticasone propionate
`delivered per actuation may not be consistent and the unit
`should be discarded.
`CLINICAL P~fACOLOGY
`Fluticasone propionate is a synthetic, trifluorinated cortico(cid:173)
`steroid with anti-inflammatory activity. In-vitro dose re(cid:173)
`sponse studica on 1l clon~d human glucocorticoid, receptor
`system involvi)Jg·l)irulin!l' and gene expression nll'orded SO~
`responses at- 1.26 und ().17 uM concentra.-t:ions,, ruspor:tlvely.
`Fluticasone propionate was threefold to fivefold more potent
`than dexamethasone in these assays. Data from the
`McKenzie vasoconstrictor assay in man also support its po(cid:173)
`tent glucocorticoid activity.
`In preclinical studies, fluticasone propionate revealed pro(cid:173)
`gesterone-like activity similar to the natural hormone.
`However, the clinical significance of these findings in rela(cid:173)
`tion to the low plasma levels (see Pharmacokinetics) is not
`known.
`The precise mechanism through which fluticasone propio(cid:173)
`nate affects allergic rhinitis symptoms is not known. Corti(cid:173)
`costeroids have been shown to have a wide range of effects
`on multiple cell types (e.g., mast cells, eosinophils, neutro(cid:173)
`phils, macrophages, and lymphocytes) and mediators (e.g.,
`histamine, eicosanoids, leukotrienes, and cytokines) in(cid:173)
`volved in inflammation. In seven trials in adults, FLONASE
`Nasal Spray has decreased nasal mucosa! eosinophils in
`66% (35% for placebo) of patients and basophils in 39% (28%
`for placebo) of patients. The direct relationship of these
`findings to long-term symptom relief is not known.
`FLONASE Nasal Spray, like other corticosteroids, is an
`agent that does not have an immediate effect on allergic
`symptoms. A decrease in nasal symptoms has been noted in
`some patients 12 hours after initial treatment with
`Fi..ONASE Nasal Spray. Maximum benefit may not be
`reached for several days. Similarly, when corticosteroids are
`discontinued, syn1ptoms may not return for several days.
`Pharmacokinetics: Absorption: The activity of FLONASE
`Nasal Spray is due to the patent drug, fluticasone propio(cid:173)
`nate. Indirect calculations indicate that fluticasone propio(cid:173)
`nate delivered by the intranasal route has an absolute bio(cid:173)
`availability a¥eraging less than 2%. After intranasal treat(cid:173)
`ment of patients with allergic rhinitis for 3 weeks
`fl1:1ticasone propionate ph;tsrna concentrations were abov~
`the level of detection (50 pg/mL) ouly when recommended
`doses were exceeded and then only in occasional samples at
`low plasma levels. Due to the low bioavailability by the in(cid:173)
`tranasal route, the majority of the pharmacokinetic data
`was obtained via other routes of administration: Studies us(cid:173)
`ing oral domng.ol",ndlola b~leclldn 1g have demonstrated that
`nut icaimnc proflionnte i~ lµ_ghly.exb"octed from plasma and
`etmorptlon .i§ l01v.:Ora l &ioavnilubilJby iB negligible, and the
`majori ty oftl)ociroulu "ingrndioalltivitr is due to an inactive
`metabolite.
`Information will be superseded by supplements and subsequent editions
`
`Distribution: Following intravenous administration, the
`distribution of Jluticasone propionate follows a three-com(cid:173)
`partment open model with an apparent volume of distribu(cid:173)
`tion of approximately 3. 7 L/kg. Tho percentage of Jlutica(cid:173)
`sone propionate bound to human plasma proteins averaged
`91~< with no obvious concentration relationship. Flutica(cid:173)
`• one propionutc •fa ,vcokly and rnverslbly bound to erythro(cid:173)
`cytes n.ncl r"ooly equ.ilibmtcs between erythrocytes and
`pln~mn. FlnUcasonovsopionufo ill not significantly bound to
`human transcortin.
`Metabolism: The total blood clearance offluticasone propi(cid:173)
`onate approximates that of liver blood flow, with renal clear(cid:173)
`ance accounting for less than 1 % of total. The only cii•culat(cid:173)
`ing metabolite detected in man is the 17[3-carboxylic acid
`derivative of fluticasone propionate. This metabolite has
`been shown to have negligible pharmacological activity in
`animal studies. Other metabolites detected in-vitro using
`cultured human hepatomu cells have not been detected in
`man.
`In a multiple-dose drug interaction study, coadministration
`of orally inhaled fluticasone propionate (500 mcg twice
`daily) and erythromycin (333 mg three times daily) did not
`affect lluticasone propionate pharmacokinetica.
`In a drug intcrnction study, coadministration of orally in(cid:173)
`haled fluticasone propionate (1000 mcg, 5 times the maxi(cid:173)
`mum daily intranasal dose) and ketoconazole (200 mg once
`daily) resulted in increased fluticasone propionate concen(cid:173)
`trations, a reduction in plasma cortisol AUC, and no effect
`on urinary excretion of cortisol.
`Excretion: Following intravenous dosing, fluticasone propi(cid:173)
`onate had an elimination half-life of approximately 3 hours.
`Less than 5% of a radiolabeled oral dose was excreted in the
`urine as metabolites, with the remainder excreted in the fe(cid:173)
`ces as parent drug and metabolites.
`Special Populations: Fluticasone propionate was not stud(cid:173)
`ied in any special populations, and no gender-specific phar(cid:173)
`macokinetic data have been obtained.
`Pharmacodynamics: In a trial to evaluate the potential sys(cid:173)
`ffco ofFLONASE Nmial Spray on aller(cid:173)
`huuic and topicru
`gic rhinitis symptoms, the benefits of comp;u-able drug blood
`levels produt:cd by FLONASE Naaal Sp ray and oral flutica(cid:173)
`sone propionate were compared. The doses used were 200
`mcg of.FLONASE Nasal Spray, tho nruiul spray vehiole (plus
`ornl plucebo), and 6 and LO mg of oral Buli taBone propionate
`(plu~ n&Bal sprayv11l1iolc) per day for 14 daye. Plasma leVelJl
`were undot.ootahle In the majority of patient.~ aftel' inb:nnn(cid:173)
`sal dosing, but present at low levels in the majority after
`oral dosing. FLONASE Nasal Spray was significantly more
`effective in reducing symptoms of allergic rhinitis than ei(cid:173)
`ther the oral fluticasone propionate or the nasal vehicle.
`This trial demonstrated that the therapeutic effect of
`FLONASE Nasal Spray can be attributed to the topical ef(cid:173)
`fects of fluticasone propionate.
`In another trial, the potential systemic effects of FLO NASE
`Nasal Spray on the hypothalamic-pituitary-adrenal (HPA)
`axis were also studied in allergic patients. FLO NASE Nasal
`Spray given as 200 mcg once daily or 400 mcg twice daily
`was compared with placebo or oral prednisone 7.5 or 15 mg
`given in the morning. FLONASE Nasal Spray at either dose
`for 4 weeks did not affect the adrenal response to 6-hour
`cosyntropin stimulation, while both doses of oral prednisone
`significantly reduced the response to cosyntropin.
`Clinical Trials: A total of J.3 pivotal, randomized, double(cid:173)
`blind, parallel, multicenter, vehicle-controlled clinical trials
`were conducted in the United States in adults and pediatric
`patients (4 years of age and older) with seasonal or peren(cid:173)
`nial allergic rhinitis. The trials included 2633 adults (1439
`men and 1194 women) with a mean age of 37 years (range,
`18 to 79). A total of 440 adolescents ( 405 boys and 35 girls),
`mean age of 14 (range, 12 to 17), and 500 children (325 boys
`and 175 girls), mean age of9 (range, 4 to 11) were also stud(cid:173)
`ied. The overall racial distribution was 89% white; ·4%
`black, and 7% other. These trials evaluated the total nasal
`symptoms scores (TNSS) that included rhinorrhea, nasal
`obstruction, sneezing, and nasal itching in known allergic
`patients who were treated for 2 to 24 weeks. Subjects
`treated with FLONASE Nasal Spray exhibited significantly
`greater decreases in TNSS than vehicle placebo-treated pa(cid:173)
`tients. Nasal mucosa! basophils and eosinophils were also
`reduced at the end of treatment in adult studies; however,
`the clinical significance of this·decrease is not known.
`There were no significant differences between fluticasone
`propionate regimens whether administered as a single daily
`dose of 200 mcg (two 50-mcg sprays in each nostril) or as
`100 mcg (one 50-mcg spray in each nostril) twice daily in six
`clinical trials. A clear dose response could not be identified
`in clinical trials. In one trial, 200 mcg/day was slightly more
`effective than 50 mcg/day dw-ing the first few days of treat(cid:173)
`ment; thereafter, no difference was seen. Doses higher than
`200 mcg/day were not more effective.
`Individualization of Dosage: Adult patients may be started
`on a 200-mcg once-a-day regimen (two 50-mcg sprays in
`each nostril once-a-day). An alternative 200-mcg/day dosage
`regimen can be given as 100 mcg twice daily (one 50-mcg
`spray in each nostril twice-a-day). Individual patients will
`experience a variable time to onset and different degree of
`
`symptom reh~f. A decrease in nasal symptoms may fro
`soon as 12 hours after h-eatment onset. Mmdmu"1 lllit
`may take several days. Patients who have res1wmd~ ~
`be able to be maintained (after 4 to 7 days) on 100 .,;,
`(one spray in each nostril once daily).
`" \(jg/,
`Pediatric pati ents (4 years of age and older) ahoui
`started with 100 mcg (one spray in each nostril onc:e. ~
`TrontmonL with 200 meg (i.wo sprny11 in encl, n01atr~I
`dnil)I or on apruy ih. ach noslrl I twice dnil.l") ~h911Jd I..,
`not nd,•c1unt •I ' rl$Jlilii,j•
`llllrveu tor pcdi111td pntien
`100 mcg daily. Once adequate control is achieved, th~ It
`age should be decreased to 100 mcg (one spray in Ca<1,
`•
`tril) daily.
`Maximum total daily doses should not exceed two ~Pl'tl
`each nostril (total dose, 200 mcg/day). There is no ""1~ la
`that exceeding the recommended dose is more uffeatii•~"'U.
`INDICATIONS AND USAGE
`FLONASE Nasal Spray is indicated for the mnnauein
`the nasal symptoms of seasonal and perennial 11Uiirg1~!,.
`nitis in adults and pediatric patients 4 years of age~.,.
`I(
`older.
`It is not indicated for the treatment of nonallergic rl\lnj
`•!n . o!llcn_cy line 'li?l h";'n adequl\tely dcmon~tr~t~
`'!l~lienL wrth t ll!9 aoudl tiort . SnfcL.v fli1 d' uftoutiv~np
`lo' tON'ASl!l Nruial -~pray in chil dr<irt bolow ~ years oi'
`ha,•e not been adequately established.
`CONTRAINDICATIONS
`FLONASE Nasal Spray is contraindicated in 1mli.e1t
`a hypersensitivity to any of its ingredients.
`WARNINGS
`TIit• r~_plo1.'tlll)eJli of a syi,tcmic oortioosteroid wlU1 11 ~~le(
`Ct,lrLico,;t~oicican bil accO!]>pnni_ed Hy si/fn~ 6f ndtlll\lll ll\111&
`flc.iet,~Y, mi'd lu nddl.liop s<i'm~ pntipnts II ny oxwcl
`•Y!")Jtonls of wil11~·n\val, ~.g,, j,oint on<l/~r m1111eulnn l\lllii;
`l(tRS1Lude,1 mul, dl\Jl':';Sl'\Oll. P~~GJ I.a ~rcvto~ly lmaW!1 ij
`prol9oged po~od~ 1v1th sy.trto~ c cort,cos~.e,·011:la nna'lraii,.
`fecred to topical cortlcosteto1ds sho11ld be carefully mtlQI.
`tared for acute adroual iniiufficiency in response t:o~rn
`those patients who 'lu,ve asthma or ot her c!inicnl oond!!lJliir
`requiring long-term systemic corticosteroid troolll\Ml ~
`rapid a decrease in systemic corticosteroids may cause~.
`vere exacerbation of their symptoms.
`The concomitant use of intranasal corticosteroids wltl! alhlt
`inhaled corticosteroids could increase the risk of si(!DI fl
`symptoms of hypercorticism and/or suppression of the 118,
`axis.
`Patients who are on immunosuppressant drugs are 11l!llf
`s_upceptlhle to 'infectioni! t hen•hea.Jt.liy indivjdu1da. 01!11'-!,
`pox and mellllles, for e xample; can h'ave a more sru-jous ir
`even fatal cou;se \n patients on im'?unosuppresssnt il\1111
`of ci,}rticosterlnds. In ~uch patients ,vho have not h.11a \liiit
`di~.iia.s~ . Rartio'ula.r cate should'bo tuk:l!n to 'livold exgoiin
`Row the dQ!I~, route, and duroti~n of corjicoatorol<Lodimli,
`i.Bt-ralion nffects t:he risk of. d~veloping a dissemlnal>ld in~
`tion is not known. The" contribution of the 1mderlyirtg ~I,.
`ease and/or prior corticosteroid treatment to the riek II aliw
`not known. If exposed to ch_ickenp!)X, prophylaxis wilh.yir.
`icella zoster immune globulin (VZIG) may be indlcatt4iJ
`exposed to m!,'a.elep, ptophylnitia ,vith pooled intrnm~IICII ..
`immunoglobulln C!Ol maj,' he indiCiltecl (See the r~
`pa~nge ·insert~ for complete VZ!O end IQ pi:9~rl~g In~
`mat1ort). l(" chickenpox devol6t38, llreatment w,th ~ntM111
`~geJlts may be cot\Siilc-r<!d.
`PRECAUTIONS
`c,;,enerel: ~ l y, immedia te '1,yi,orso1l!litivily renotiDllnl C!!
`cont.act denna,titis may ()(!CUr after the admWstra ~]
`FLONASE Nasal Spray. Rare instances ofwbonzinfl't!r
`traocular pressure have been reported Io)lowing th•. i:
`septum perforation, cataracts, t:la\Jcon\n:, and -incrlljliQI la•
`nasal application of corticosteroids, including riulli:A
`nd/01· reductio11 of growth vclociLy in children o~f \•'ll I
`II(
`propionate.
`Use of excessive doses of corticosteroids may lead to I~~ ....
`symptoms of hypcrtotticlsm, supprossi~tL of Ul?A ftJllll..,,.
`Physicinru, should clnsoly f91!.ow tho ~,rowth -of a 1J,dt1!P
`atloleston\:!t·(:llki111r corticoateroids 1 bJ uny 1·oul~, at!d lb
`tho·Uenefits of corlicosl:eroid thcrup;I' sgain~~ t he pO!IS
`mended doses of FLONAS:El Nb$ol Sprny, 1mlortial ';rl
`of growth suppression If gi:owth ap11etl.rs slowed . . l
`Although systemic effects have beoo 1nioim.1l \Y tt 1 -'••
`creaslll! with lnrgor ·poses. Therefor.a, 'larger \Mn vu
`mendoll doses QfFLONASE '.t(lasnl $pray should J,c itio
`Whan U11ed at hii:hor thbn rt~Otnn\eilrlcc;I doi)OS, Pf
`individu111s at i;ce utruertded do_sep, ~yat<lmic om~I~~
`ff"e~bi ~ud1 Oij hypercortialam ani! ad,-eniil 11upprt!!,;',;gt
`11ppem·. lf s uch changes occ11r, ~he dosilt.~ or_FtO"i;,~1111
`s,nl Sprny ~hou1~ J>e diacmitlnued alowly aon! istcn~llt
`cep!ejl ,proe1>du.-!ls tor discontinuing oral " rt,oostf
`f~~linical studies w.ith fluticasone pfopionltte ~11::j'of
`lntrana1111'lly, tho d 1•clop,nienl of loeutlfaed iufe1lt ~
`no o-nnd phnryil.x ivitll Ca11dllla albica,1$"ht1a (Mlc\ll'
`r orely, When Much nn !rtfoction develops, It ,rnd~lt ·
`tr<!atmont wi th a_pproprlnte loci!l thompy nd
`
`

`

`~nt with FLONASE Nasal Spray. Patients US·
`
`.-,~rw!;$E Nu,iol.Spmy ,,v~r e_cvera'l monU.i~ or lorl~lif
`Jlll'r~O
`mine4 pctiodicnlly fo1 uvidenco ofCa11d1tln µ1-
`...W'~ be C:er signs'of adverse effects on the nasal mucosa.
`~l!l)or; Nasal Spray_should b~ used with caution,_ ifat
`tlonl.6 with active or quiescent tuberculous mfec(cid:173)
`(6d local or systemic fungal or bacterial, or sys-
`'
`):nfections or parasitic infection; or ocular herpes
`• vlriv 1
`
`,~! ·' f the inhibitory effect of corticosteroids on wound
`.-~
`
`' 0 ntlent.• who have experienced recent nasal septa!
`(li,l:!1~
`flltllMg1•~ ~11rgcey. or nasal trauma should not use a na-
`~!!>'f-1• ~. tw11id until healing has occurred.
`,
`1111 ilil111~'•~ /or patients· J'ationte bolng• traaWd with
`,wo'!"..!!e , ,tBal Spto)' B <111111 rocoiy~ lh?i:ollowing info,r(cid:173)
`fLClr<""
`In en1cti~n..,'ihiB J.n Ol!!llllbon Ill 1nli!r1tlc,d tomd
`~a~ amJ .,m ctlve-tlSC of this medirotfo 1. It is
`11111
`urff of all 11osslblo ndv(lrse or intend~d
`lfccls.
`~ ~
`should b wnniod !o ovoid oxposuro LO ch.id'kcnpOx(cid:173)
`Patl~nl:11·•• 411d, if expoaed, to consult their hys'ioian with-
`
`.
`
`Qlll d&;:Y~hould use FLO NASE Nasal Spray at regular in(cid:173)
`r-11;, •• directed since its effectiveness depends onjts reg(cid:173)
`uJDr ":urs after start4)g thernpy with FLO!'l E Nasal
`flf\
`A decrease in nasal •ympto111JS mny QrCur os soon
`jl?; ~ ,~I ,n se.v rnl cliniC11l trials indicate statistically
`Sp/1\hcirnt foiptovomnut witWn the fi.rat day. or two ·of treat(cid:173)
`AJall~ hl!W vcr, lho full benefit of FLONASE Nasal Spray
`111~n rtt,1, b~ &1:hiev~4 until _\y~o4'1<1{),; b~• J,~n adminis\ d
`:1I»lV••rrll d.ny~. 1,lb,,-, p13tum.t- hhP~1
`i L !ncr ·,~11, ~o vro•
`~ doAJlgel.lut itlll)Uj\L~<Ull:f)C~ ~ l p 1~ 111l1µur!IJ',lllP 1!1118
`111"1iqfl~:. o/• \I'!' proper
`dol(Ot Improve or if the 11'/P,fll,li,on
`of tli nasal !lJlray unil (I> a~\:l\lll m~Tf!um 1m1m1ve(cid:173)
`#flt..lliiJ lll'ticnt ~h9/•kj,_read. a,nd f1 ll~v ,y111:vr~Jly-t\l JIil•
`11~~1'~ Inllint l]Qll8 11,~nlJlQJJY,llllt ~ 11rQ~l!Ci,
`'
`'
`OIUll lntorao ions: jn Pl c~,bq-~11. r91l
`, w;p~er ~tucly
`lo uiglil hoolthy v9lµ1tt!'
`, Jl1idm1i1i, ~rutiqn, ptn ~h1~Je
`ilBiJ<1 Qf orally ii)~\ d tl.u . anB,Qn 0 proJ!10~!:t\ iltlOV ,me~,
`ifmil!i the 111aidmu/l) a11[ly in~I .IIO!!e) ,~ti, )nu.lUPJ
`~ Qr kef.o !Wi•Z!/1, )(~00 "'~' ,\p iih ndy ala ~ T.'!•ultiltl lJ1
`tol'll!ll.!lO!l 111cru1 Ont ca$.C)l1e prt,pibnn~ oouoon tr;,~ionlj1 n l'\l(cid:173)
`iluttiw;i,ln phISmn COdl~pl '. ll •, 11.lld,t?,o eifect..on, urlnnt)' ~
`C{IIIOD of ~,rti,ql, T4/~ l~tc~uot1on Y-'"Y lio du~ ((? an iuhlh1-
`lim drtl1~ 1;ytl.lcl1r~m~ P45Q 3A4. •~~fIDY,Y, Q ~>'fl n ,liy'ii.eto•
`IUllft~lllq, which
`i~ ruj\\"l' tl,l~ f ;oute Yt mq\ab. o·.u~m Qt
`fbl ' . an~ 0prnpionnll!, No drui: 111te~~0f.!.q.n, ._iu_q)ea, hnye
`iiefn olndu l:!ld will' .FL6NA!jE No~ !jprny·,how'7"el' •C!lre
`iho1~n w X •
`!Wd wb~.Jl;ul'l"!'~fille 't»"\'.tPiM )n Is to1131hfn-
`wl~I l(,nl(-t nri lioto oilazolc. p~ clth~r J<,:lbw,!LCYt.Q-
`d/fdmo P4/i0 ~A4 J11bibitors,
`-
`Cllroln_pQenlisls, Muhigcn~slJ,, lmpalrme1ft ,of Fetf,llltv: f•'lw
`iloliaJio pror,iqn11,\t, doril91,U1tr~tQd flQ t umprig11nle !I lli,I i111
`ll'IJnillll av omJ doijllll up P 1000 01~111( pp,~a~qmta),~1iQ
`lllnl't tho 11ioximunl (euonuoend d tL!Dy iplnuir;i,ial d0!W ii
`!dull,q1,11d np~rox:i:mjltsly 10 ~ell t:he. -o;uoo.rn\Un rooon\·
`111ndt!ddnil:t,inltt1nlW.LI tloae-~ bildi·®i9n o:mcglm' b!J,Sis/
`