,-1 .I
`
`53
`1999
`
`EDITION
`
`PHYSCANS'
`DESK
`REFERENCE®
`
`Medical Consultant
`Ronald Arky, MD, Charles S. Davidson Professor of Medicine and Master, Francis Weld Peabody Society, Harvard Medical School
`
`Vice President of Directory Services: Stephen B. Greenberg
`Director of Product Management: David P. Reiss
`Senior Drug Information Specialist: Thomas Fleming, RPh
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`Jeffrey F. Pfohl
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`Christopher N. Schmidt
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`!!Ill!!! Copyright© 1999 and published by Medical Ec~nomics Company, Inc. at Montvale, NJ 07645-1742. All rights reserved. None of the content of. this publication
`
`• • may be reproduced, stored in a retrieval system, resold, redistributed, or transmitted in any form or by any means (electronic, mechanical, photocopying, record-
`ing, or otherwise) without the prior written permission of the publisher. PHYSICIANS' DESK REFERENCE"', PDR", PDR For Nonprescription Drugs"', PDR For
`Ophthalmology"', Pocket PDR"!, and The POW Family Guide to Prescription Drugs® are registered trademarks used herein .under license. PDR Companion Guide ™,
`PDR"' for Herbal Medfcines™ , PDR'~ Medical Dictionary™ , PDR-' Nurse's Handbook™, PDR0 Nurse.'s Dictionar)'™, The PDR'" Family Guide Encyclopedia of Medical
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`Human Res.ources: Pamela M. Bilash; Vice President and Chief Information Officer: Steven M. Bressler; Senior Vice President, Rnance, and Chief Rnancial Officer: Thomas
`W. Ehardt; Vice President, Directory Services: Stephen B. Greenberg; Vice President, New Business Planning: Linda G. Hope; Executive Vice President. Healthcare Publishing
`and Communications: Thomas J. Kelly; Executive Vice President, Magazine Publishing: Lee A. Maniscalco; Vice President, Group Publisher: Terrence W. Meacock: Vice
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`Operations: John R. Ware
`
`ISBN: 1-56363-288-8
`
`® Printed on recycled paper
`
`KASHIV1044
`IPR of Patent No. 9,492,393
`
`

`

`126/0RTHO DIENESTROL CREAM
`ORTHO DIENESTROL CREAM
`(Ortho-McNeil Pharmaceutical) . .... 2212
`+ ORTHO TRI-CYCLEN 21
`TABLETS (Ortho-McNeil
`Pharmaceutical) . .... ... ...... 328, 2229
`ORTHO TRI-CYCLEN 28
`TABLETS (Ortho-McNeil
`Pharmaceutical) . . ... .. .. ........ . . 2229 .
`+ ORTHO-CEPT 21 TABLETS
`(Ortho-McNeil
`Pharmaceutical) . ........ . .. . . 328, 2204
`ORTHO-CEPT 28 TABLETS
`(Ortho-McNeil Pharmaceutical) . . . .. 2204
`ORTHOCLONE OKT3 STERILE
`SOLUTION (Ortho Biotech) . . . .. .. . 2160
`+ ORTHO-CYCLEN 21 TABLETS
`(Ortho-McNeil -
`Pharmaceutical) . .... ... .. ... .. 328, 2229
`ORTHO-CYCLEN 28 TABLETS
`(Ortho-McNeil Pharmaceutical) . . ... 2229
`+ ORTHO-EST TABLETS
`(Women First HealthCare) . .... 343, 3253
`+ ORTHO-NOVUM 1135 o 21
`TABLETS (Ortho-McNeil
`Pharmaceutical) , ....... . ..... 328, 2221
`ORTHO-NOVUM 1135 o 28
`TABLETS (Ortho-McNeil
`Pharmaceutical) . .... ...... . . .. .... 2221
`ORTHO-NOVUM 1150 o 21
`TABLETS (Ortho-McNeil
`Pharmaceutical) .. .. ...... ........ . 2215
`+ ORTHO-NOVUM 1150 o 28
`TABLETS (Ortho-McNeil
`Pharmaceutical) ...... .. .... . . 328, 2215
`ORTHO-NOVUM 717/7 o 21
`TABLETS (Ortho-McNeil
`Pharmaceutical) . ............ . .... . 2221
`+ ORTHO-NOVUM 7/717 o 28
`TABLETS (Ortho-McNeil
`Pharmaceutical) . . ....... . .. .. 328, 2221
`ORTHO-NOVUM 10/11 D 21
`TABLETS (Ortho-McNeil
`Pharmaceutical) . . ... .... : . . .. ..... 2221
`• ORTHO-NOVUM 10/11 D 28
`TABLETS (Ortho-McNeil
`Pharmaceutical) . . . .. .... .. ... 328, 2221
`+ ORUDIS CAPSULES
`(Wyeth-Ayerst) . ............... 344, 3350
`+ ORUVAIL CAPSULES
`(Wyeth-Ayerst) ......... .... ... 344, 3350
`OS-CAL 250 + D, 500, 500 + D, AND
`500 CHEWABLE TABLETS
`(SmithKline Beecham Consumer) . . . .. . !!D
`OS-CAL FORTIFIED TABLETS
`(SmithKline Beecham Consumer) .... .. !!D
`OSTIDERM (Pedinol). : . .. ... . .. . .. . 2354
`OSTIDERM ROLL-ON (Pedinol) .... 2354
`OTIC DOMEBORO SOLUTION
`(Bayer) . ........ ...... . .. ... .. . . . .. . 667
`+ OVCON 35 TABLETS
`(Bristol-Myers Squibb) .. . ...... 307, 845
`OVCON 50 TABLETS
`(Bristol-Myers Squibb) . .............. 845
`+ OVRAL TABLETS
`(Wyeth-Ayerst) . . ... . .......... 344, 3353
`+ OVRAL-28 TABLETS
`(Wyeth-Ayerst) . ... ... ... . ... .. 344, 3354
`OVRETTE TABLETS
`(Wyeth-Ayerst) ........ .. ... . ....... 3354
`OXANDRIN TABLETS
`(Bio-Technology) . ............. .. . . .. 866
`OXANDROLONE
`Oxandrin Tablets (Bio-Technology) . . . . . .. 866
`OXAPROZIN
`Daypro Caplets (Searle) .......... 337, 2953
`OXAZEPAM
`Serax Capsu!1es (J.\Yeth-Ayerst) . . . . 345, 3383
`Serax Tablets ("0•eth-Ayerst) ...... 345, 3383
`Oxazepam Capsules (Geneva) .......... 1076
`OXICONAZOLE NITRATE
`Oxistat Cream (Glaxo Wei/come) .. 313, 1194
`Oxistat Lotion (Glaxo
`Wei/come) . .... ..... ....... .. 313, 1194
`+ OXISTAT CREAM (Glaxo
`Wellcome) ..... .. ....... ...... 313, 1194
`+ OXISTAT LOTION (Glaxo
`Wellcame) . . .. . . .. . . . . ........ 313, 1194
`OXSORALEN LOTION 1% (lCNJ ... . 1373
`+ OXSORALEN-ULTRA
`CAPSULES (lCNJ ... .... . ... 317, 1374
`+ Shown in Product Identification Guide
`
`OXTRIPHYLLINE_·
`Choledyl SA Extended-Release
`Tablets (Warner Chi/coli
`Professional Products) . ........ 342, 3208
`OXYBENZONE
`DML Facial Moisturizer with
`Sunscreen (Person & Covey) .... .. ... 2360
`Eucerin Plus For The Face SPF 15
`(Beiersd01f} ........................ 702
`Solaquin Forte 4% Cream (ICN) .. . .. ... 1365
`Solbar PF Cream SPF 50 (PABA Free)
`(Person & Covey) .. ... ... .. .. ..... 2361
`Sol bar PF Liquid SPF 30 (Person &
`Covey) ..... ... . ...... . . . ......... 2361
`Lubriderm Daily UY Lotion with
`Sunscreen (Warner-Lambert
`Consumer) ....... . ....... .. ..... ·. 3215
`OXYBUTYNIN CHLORIDE
`Ditropan Tablets and Syrup (Aha) .. . . · . . . 511
`Oxybutynin Chloride Tablets (H~11son) .. . 3216
`OXYCODONE HYDROCHLORIDE
`OxyContin Tablets (Purdue
`·
`Plumna) . ..... ... ... ... . . ... 333! 2569
`OxyFast Oral Concentrate
`.
`Solution (Purdue Plwrma) ... ... 333, 2574
`OxyiR Capsules (Pul·due
`.
`Plwmw) .... .. ... . ..... .. . .. 333, 2574
`Percocet Tablets ( Endo l..t1bs) ... : . . 310, 984
`Percodan Tablets (Endo Lt1bs) ... . .. 310,.985
`Percodan-Demi Tablets (Endo
`Labs) . . ... ............. .. .... 310, 985
`Percolone Tablets (Endo l..t1bs) ..... 310, 986
`Roxicodone Tablets, Oral Solution &
`lntensol (Ro.rcme) .. .. . ...... . ... ... 2764
`Tylox Capsules (Orrho-McNeil
`·
`Phamwceutical) ........... ... 329, 2253
`Endocet Tablets, USP CII (Endo
`Generics) .... ........ ... ..... ... ... 971
`Endodan Tablets, USP CII (En do
`Generics) .. ....... . ..... . .. ..... .. . 971
`Oxycodone and Acetaminophen
`Tablets, USP (*uson) .. .. . ......... 3216
`Oxycodone and Aspirin Tablets, USP
`(Watson) . . ........ .. . , . . .. . ...... 3216
`Oxycodone Hydrochloride Tablets,
`USP (Watson) ..... . ... ... : ........ 3216
`Roxicet 5/500 Caplets (Remme) .. .... .. 2764
`Roxicet Tablets & Oral Solution
`(Roxcme) ... ... .. .... . . . ........ .. 2764
`Roxilox Capsules (Remme) . . ... . . ..... 2743
`Roxiprin Tablets (Ro.wme) ....... . ..... 2743
`OXYCODONE TEREPHTHALATE
`Percodan Tablets (Endo Labs) ...... 310, 985
`Percodan-Demi Tablets (Endo
`Labs) ........................ 310, 985
`Endodan Tablets, USP CIT (Endo
`Generics) . .. .. .. .. .. . ... ...... ..... 971
`Roxiprin Tablets (Roxcme) ....... : .. .. .. 2743
`• OXYCONTIN TABLETS
`(Purdue Pharma) . . . .... . ... . . 333, 2569
`• OXYFAST ORAL
`CONCENTRATE
`SOLUTION (Purdue
`Pharma) ................... .. 333, 2574
`• OXYIR CAPSULES (Purdue
`Phar·ma) . .. ... . ... ... ... .. ... 333, 2574
`OXYMETHOLONE
`Anadrol-50 Tablet~ (Unimed) .. : .. 341, 3175
`OXYMORPHONE
`HYDROCHLORIDE
`Numorphan Injection (Eudo l..t1bs) ....... 982
`Numorphan Suppositories (Eudo Labs) .... 982
`OXYQUINOLINE SULFATE
`Aci-Jel Therapeutic Vaginal Jelly
`· (Ortho-McNeil Phanuaceutica/) _. . . ... 2179
`OXYTETRACYCLINE
`·
`Terramycin Intramuscular Solution
`(Pfizer) .......... ...... .. ... ..... 2412
`OXYTETRACYCLINE
`HYDROCHLORIDE
`Terra-Cortril Ophthalmic Suspension
`(Pfizer) . ... .... .................. 2412
`Terramycin with Polymyxin B Sulfate
`Ophthalmic Ointment (Pfizer) . .. . .... 2414
`Urobiotic-250 Capsules (Pfizer) . ..... .. 2424
`p
`PACAP.S CAPSULES (Lunsco) .. .. . . 1649
`• PACERONE TABLETS
`(Ups her-Smith) . . . ............ 341, 3181
`PACLITAXEL
`Taxol Injection (Bristol-Myers
`Squibb Oucologyllmmwwlogy) . .. 308, 798
`PADIMATE 0 COCTYL DIMETHYL
`PABA)
`Solaquin Forte 4% Cream (ICNJ .. ... . . . 1365
`
`Solaquin Forte 4'7o Gel ( JCN) . .. . . -... .. 1365
`PALIVIZUMAB
`- Synagis Intramuscular (/v/edlmmune) .. .. 1720
`PAMABROM
`Lurline PMS Tablets (FieldinR) .. . · ..... . 1011
`.. PAMELOR CAPSULES
`(Novartis) . ........ ... ........ 325, 2070
`PAMELOR SOLUTION (Novartis) ... 2070
`PAMIDRONATE DISODIUM
`Aredia for Injection (Nov;mis) .. .. 324, .1995
`• PANAFIL OINTMENT
`(Rystan) .... . ............ .. . .. 335, 2770
`• PANAFIL-WHITE .
`OINTMENT (Rystan) ... ..... . 335, 2770
`PANALGESIC GOLD CREAM
`(ECRJ .. ... . ..... ... ... ... .......... 960
`PANALGESIC GOLD TOPICAL
`LIQUID (ECRJ .. ... , ............... 960
`• PANCREASE CAPSULES
`(Ortho-McNeil
`Pharmaceutical) . . . . .... ... ... 328, 2237
`• PAN CREASE MT
`CAPSULES (Ortho-McNeil
`Pharmaceutical! . . ..... ....... 328, 2238
`PANCREATIN
`Donnazymc Tablets (Robim) . ..... 334, 2637
`PANCRELIPASE
`Cotazym Capsules (Orgemem) ..... 326, 2120
`Creon 5 Capsules (Soll'CI)') ........ 340, 3110
`Creon 10 Capsules (So!l'Ciy) ....... 340, 3110
`· Creon 20 Capsules (Solvay) . ...... 340, 3110
`Ku-Zyme HP Capsules (Sdnvar~) ....... 2908
`Pancrease Capsules
`(Ortlw-McNeil
`Plwrmaceutica/). : . ..... . .. ... 328, 2237
`Pancreasc MT Capsules
`(Ortlw-McNeil
`Plwrmacelllica/) . ..... .. ... ... 328, 2238
`Ultrase Capsules (Smlllliplwrm) ... 336, 2815
`Ultrase MT Capsules
`·
`(Scemdiplwrm) . .... ...... ... . 336, 2816
`Yiokase Powder (Arnm) . ... • . . . .... . .. 620
`Yiokase Tablets (Arnm) .. . .... . ... 305, 620
`Zymase Capsules (Orgwum) . . .... 327, 2157
`Cotazym-S Capsules (Orgwwn) ... 326, 2121
`PANCURONIUM BROMIDE
`Pancuronium Bromide Injection
`(Elkins-Simi) . ............ .... ...... 963
`Pancuronium Bromide Injection (Astra) . .. 581
`Pancuronium Bromide Injection
`(Baxrer) . . . . .. . ......... ..... ..... .. 629
`Pavulon Injection (01Xlll1011) ... ... ..... 2146
`• PANDEL CREAM (Savage) . . . .. 336, 2814
`PANGLOBULIN INTRAVENOUS
`(American Red Crass) .. . . .. . .. .. .. .. 521
`PANHEMATIN FOR INJECTION
`(Abbott) .. ......... ...... . ..... ..... 469
`PANOXYL 5 ACNE GEL (Stiefel) . ... 3133
`PANOXYL 10ACNE GEL (Stiefel) ... 3133
`PANOXYL AQ 2 '12 ACNE GEL
`(Stiefel) . ... ............ . ...... ... . 3133
`PANOXYL AQ 5 ACNE GEL
`(Stiefel) . .. .... .............. . . .... 3133
`PANOXYL AQ 10 ACNE GEL
`(Stiefel) . ........ . ...... . . .. ....... 3133
`PANTOTHENATE. CALCIUM
`(see under: CALCIUM
`PANTOTHENATE)
`PANTOTHENIC ACID
`(see under: CALCIUM
`PANTOTHENATE)
`PAPAIN
`Accuzyme Debriding Ointment
`(Healthpoint) ... . . . .. ... ..... 315, 1287
`Panafil Oinunent (Rystan) ... .. ... 335, 2770
`Panafii-White Ointment (Rystan) ... 335, 2770
`PARA-AMINOBENZOIC ACID
`Mega-B Tablets (Arco) .. .. ....... . .. . .. 545
`• PARAFON FORTE DSC
`CAPLETS <Ortho-McNeil
`Pharmaceutical) . . .. ....... . . . 328, 2239
`• PARAGARD T 380A
`INTRAUTERINE
`COPPER
`CONTRACEPTIVE
`(Ortho-McNeil
`Pharmaceutical) . ... .... ...... 328, 2239
`• PARAPLATIN FOR
`INJECTION (Bristol-Myers
`Squibb
`Oncology/Immunology) ..
`
`. 308, 789
`
`Underline Denotes Generic Name
`
`PHYSICIANS' DESK REFERENCE®
`PARCODE PRODUCT LIST
`(Parke-Davis) ...................... 2265
`PAREPECTOLIN SUSPENSION
`(Rheme-Poulenc Rorer) . ....... ..... 2580
`PARICALCITOL
`Zemplar Injection (Abbort) . . . . ... .. . .... 479
`• PARLODEL CAPSULES
`(Novartis) . ............ .... ... 325, 2072
`• PARLODEL SNAPTABS
`(Novartis) . . . . ... . . ... .... . .... 325, 2072
`• PARNATE TABLETS
`(SmithKline Beecham) .. . . . ... 339, 3076
`PAROXETINE HYDROCHLORIDE
`Paxil Oral Suspension (SmithKiine
`Beecham) . .............. . .. . .. . .. 3078
`Paxil Tablets (SmirhK/ine
`Beecham) ........ ........... 339, 3078
`PASER GRANULES (Jacobus! .. .. .. 1417
`PATANOL OPHTHALMIC
`SOLUTION (Alcon) ....... . . .. ...... 491
`PAVULON INJECTION (Organon) .. 2146
`PAXIL ORAL SUSPENSION
`(SmithKlin.e Beecham) ....... ... . . . 3078
`• PAXIL TABLETS
`(SmithKline Beecham) . ... ... . 339, 3078
`• PCE DISPERTAB TABLETS
`(Abbott) . . . . . . ... ... . . . .. .. . ... 303, 470
`PECTIN
`Kaolin-Pectin Suspension (Roxcme) ..... 2743
`PEDIACOF COUGH SYRUP
`(Sanofi) . ........... ...... . ... ... .. 2794
`PEDIAFLOR DROPS (Rossi ... . . . .. 2743
`PEDIALYTE ORAL
`ELECTROLYTE
`MAINTENANCE SOLUTION
`(Ross) . . ............. ... .... .. ..... 2736
`PEDIAPRED ORAL SOLUTION
`(Medeva) . .. . . .... ..... .. . ..... .... 1703
`PEDIASURECOMPLETE
`LIQUID NUTRITION (Rossi . . ... . 2739
`PEDIAZOLE SUSPENSION
`!Ross) ... .. .... .. . . . . . .. . . . .. . ..... 2737
`PEDI-BORO SOAK PAKS
`(Pedin.ol) . ........... ... . .. .. . ... .. 2354
`PEDI-DRI TOPICAL POWDER
`(Pedinol) . . ....... ....... . ... .. ... . 2354
`PEDIOTIC SUSPENSION
`. STERILE (Monarch) . .... . . . . . . ... 1941
`PEDI-PRO TOPICAL POWDER
`(Pedinol) . . . ........... .. ........ .. 2354
`LIQUID PEDVAXHIB (Merck) . . .... . 1853
`PEGADEMASEBOVINE
`. Adagen Injection (En:on) .. ... .......... 990
`PEGASPARGASE
`Oncaspar (Rheiue-Pouleuc Rorer) ...... . 2600
`PEMOLINE
`Cylert Tablets (Abbort) .. .......... 303, 416
`Cylert Chewable Tablets (Abbott) . .. 303, 416
`PENBUTOLOLSULFATE
`Levatol Tablets (Schwarz) . .. . . ... , , ... 2908
`PENCICLOVIR
`Denavir Cream (SmithK/ine Beecham
`Consumer) ....................... 3010
`PENECORT CREAM (Allergan) .. . . . . 504
`PENECORT TOPiCAL
`SOLUTION (Allerga.n) . .. ... . . . .. . .. 504
`• PENETREX TABLETS
`(RhOne-Poulenc Rorer) .. .. . ... 333, 2602
`PENICILLAMINE
`Cuprimine Capsules (Merck) ..... . 323, 1766
`Depen Titratable Tablets (*rllace) . . ... . · 3192
`PENICILLIN G BENZATHINE
`Bicillin C-R 900/300 Injection
`(H~verh-Ayersr) . .... . .. . .... . . . . .. . 3276
`Bicillin C-R Injection (~·eth-Ayersr) . ... 3274
`Bicillin L-A Injection (Hfl'elh-Ayerst) . ... 3278
`Bicillin C-R in Tubex (H~·erh-Ayersr) ... . 3396
`Bicillin C-R 900/300 in Tubex
`(Hf\'elh-Ayersr) . ................. .. 3396
`Bicillin L-A in Tubex (~·erh-Ayerst) . . .. 3396
`PENICILLIN G POTASSIUM
`Pfizerpen for Injection (Pfizer) ... . . .... 2400
`
`Italic Page Number Indicates Brief Listing
`
`KASHIV1044
`IPR of Patent No. 9,492,393
`
`

`

`P. 2582 RX
`
`PRODUCT IDENTIFICATION GUIDE/333
`P. 2590 RX
`P. 2599
`
`RH6NE-POULENC RORER
`
`RH6NE-POULENC RORER
`
`l~
`20 mg/2 ml ampule
`
`RH6NE-POULENC RORER
`
`'1
`
`. \ -; ~
`
`~
`
`1 ml
`4 mcgjml
`
`10 ml
`4 mcg/mL
`
`THE pURDUE FREDERICK CO. P. 2561
`
`RX
`
`PURDUE PHARMA L.P.
`
`RX
`
`C-11
`
`PURDUE PHARMA L.P.
`
`P. 2569
`
`t)
`
`ilC
`
`10 mg
`
`(~
`20 mg
`
`l. '
`
`()
`
`I,
`
`40 mg
`
`RX
`
`500 mg
`
`7 ') ()
`I ) li·
`
`750 mg
`
`DDAVP® Injection
`(desmopressin acetate)
`RH6NE·POULENC RORER
`
`P. 2583 RX
`
`iii
`
`.. ,
`
`80 mg
`OxyContin®
`(oxycodone HCI controlled-release)
`P. 2574
`PURDUE PHARMA L.P.
`
`C-11
`
`• 0
`
`1 ml
`15 mcgjml
`
`.. 2 mL
`15 mcgjml
`
`DDAVP® Injection 15 mcgjmL
`(desmopressin acetate)
`RH6NE·POULENC RORER
`
`P. 2584
`
`RX
`
`1000 mg
`
`Trilisate®
`(choline magnesium trisalicylate)
`THE PURDUE FREDERICK CO. P. 2561
`
`RX
`
`Immediate-Release
`Oral CONCENTRATE Solution
`20 mg/1 mL in plastic bottle
`of 30 ml with child-resistant dropper
`OxyFAST'M
`(oxycodone HCI)
`PURDUE PHARMA L.P.
`
`Metered dose 0.4 mgjactuation
`
`Nitrolingualll'l Spray
`(nitroglycerin lingual aerosol)
`P. 2602
`RH6NE-POULENC RORER
`
`5100* 200 mg
`
`5140* 400 mg
`
`lntal® Nebulizer
`Solution
`(cromolyn sodium inhalation
`solution, USP)
`RH6NE-POULENC RORER
`
`P. 2591 RX
`
`I
`~ ' ' • Jj"
`
`I
`
`I i 30 mg
`I
`
`40 mg
`
`Penetrex'M Tablets
`(enoxacin)
`RH6NE-POULENC RORER
`
`P. 2604
`
`RX
`
`; ~ ; ' ~~
`..!:2.~
`50 mg
`
`Rilutek® Tablets
`(riluzole)
`RH6NE-POULENC RORER
`
`P. 2609
`
`C-11
`
`P. 2574
`
`RX
`
`0.1 mg/mL
`
`60 mg
`
`80 mg
`
`100 mg
`
`DDAVP~~'> Nasal Spray
`(desmopressin acetate)
`RH6NE-POULENC RORER
`
`P. 2586
`
`RX
`
`Lovenox® Injection
`(enoxaparin sodium)
`RH6NE-POULENC RORER
`
`P. 2596
`
`RX
`
`a-::;
`
`IOOCap-
`
`,,,
`
`<~
`
`(),.>
`
`<)
`
`500 mgj 5 ml
`
`Trilisate®
`(choline magnesium trisalicylate)
`THE PURDUE FREDERICK CO. P. 2563
`
`RX
`
`400 mg
`
`600 mg
`Controlled-release tablets
`Uniphyl®
`(theophylline, anhydrous)
`
`Designed to help you identify
`drugs, this section contains
`actual size pills and full color
`reproduction of products
`selected for inclusion by
`participating manufacturers.
`
`Because tablets and capsules
`are shown in this section,
`do not infer that these are
`the only dosage forms
`available. Where a product
`name is preceded by the
`symbol t, refer to the descrip-
`tion in the Product Information
`(White Section) for other forms.
`
`C·V
`
`RECKITT & COLMAN
`
`P. 2578
`
`OxyiR®
`(oxycodone HCI immediate-release)
`RECKITT & COLMAN
`~r=-w ,
`-... ,,~...,
`!iii~ -,~Jtf ~. ~'~ 0
`0.3 mg per 1 ml ampul
`Buprenex® Injectable
`(buprenorphine HCI)
`RHONE-POULENC RORER
`
`RX
`
`RH6NE-POULENC RORER
`
`P. 2580
`
`l )
`
`60 mg/20 gram inhaler
`Azmacort®
`Inhalation Aerosol
`(triamcinolone acetonide)
`
`0.1 mg
`
`0.2 mg
`
`DDAVP® Tablets
`(desmopressin acetate)
`RH6NE-POULENC RORER
`
`P. 2587
`
`RX
`
`Gliadel® Wafer
`(polifeprosan 20 with carmustine implant)
`RX
`P. 2589 RX
`RH6NE·POULENC RORER
`
`-:::~
`; ~~ 3
`
`Metered dose 55 meg/actuation
`
`Nasacort® Nasal Inhaler
`(triamcinolone acetonide)
`RH6NE-POULENC RORER
`
`P. 2597
`
`I ...
`
`Metered dose 800 meg/inhalation
`
`lntal® Inhaler
`(cromolyn sodium inhalation aerosol)
`
`Metered dose 55 meg/actuation
`
`Nasacort® AQ Nasal Spray
`(triamcinolone acetonide)
`
`· -~ '
`
`20 mg Concentrate
`for Infusion
`
`Diluent
`
`-..... _
`
`• TAXOTERE%
`(docetaxel)
`
`~~5'='.:;.,=~::
`':' .. ~.;-.o<T).....,_
`
`TIIXOTERE fi!l
`C~etru:ev .. ...-"""
`:o.r·.~;:~""''"'"
`~=;;',:.;'.";''
`~z:~:~-
`
`~~
`
`80 mg Concentrate
`for Infusion
`
`·- -:-""-~-- .;-
`Diluent
`
`Taxoterell'l for Injection
`Concentrate
`(docetaxel)
`While every effort has been
`made to reproduce products
`faithfully, this section is to be
`considered a quick reference
`identification aid. In cases of
`suspected overdosage, etc.,
`chemical analysis of the
`product should be done.
`
`KASHIV1044
`IPR of Patent No. 9,492,393
`
`

`

`--- _f
`
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`pRODUCT INFORMATION
`
`neal dialysis is ineffective for theophylline removal; ex-
`change transfusions in neonates hav·e been minimally effec-
`tive.
`-
`-
`-
`-
`~OSAGE ANn ADMINISTRATION-
`Uniphyl® 400 or 600 I)lg Tablets can be taken once a day in
`the morning or evening. It_is recommended that Uniphyl be
`th en with meals. P~j;ients should be advised that if they
`choose to take Uniphyl® with food it should be taken cc,m-_
`sistently with food and if they take it in a fasted condition it
`should routinely be taken fasted. It is important that the
`product whenever dosed be dosed consistently with or with-
`out food.
`· _
`· ·
`·
`Uniphyl® Tablets are not to be ch~wed or crushed. The
`scored tablet may be split. Infrequently, patients receiving
`Uniphyl® 400 or 600 mg Tablets may pass an intact matrix
`tablet in the stool or via colostomy. These matrix tablets
`usually contain little or no residual theophylline. ·
`·
`Stabilized patients, 12 years of age· or older, who are taking
`an immedii}te-release oi: controlled-release theophylline
`product may be transferred to once-daily administration of
`400 mg or 600_mg Uniphyl® Tablets on a mg-for-mg basis. -
`It must be recognized that the peak and trough serum the-
`ophylline levels produced by the once-daily dosing may vary
`from those produced by the previous product and/or regi-
`men.
`_
`General-Considerations: The steady-state peak serum the-
`ophylline concentration is a function of the dose, the dosing
`interval, and the rate of theophylline absorption and clear-
`ance in the individual patient. Because of marked individ-
`ual differences in the rate of theophylline clearance, the
`dose required to achieve a peak serunt theophylline concen-
`tration in the 10-20 mcg/mL range varies fourfold among
`otherwise similar patients in the absence of factors known
`to alter theophylline clearance (e.g., 400-1600 mg/day in
`adUlts <60 years old and 10-36 mg/kg/day in children 1-9
`years ~ld). For a given, popul!J.tion there' is n~ single theo-
`P,hyllin~ dose that will provide both safe and effective serum
`concentrations for all patients. Administration of the me-
`diiu't 'theophylline dose required to achieve a therapeutic
`seruni theophyll~e concentration in a _give!). population may
`result in either sub-therapeutic or potentially toxic serum
`theophylline concentrations in individual patients .. For ex-
`antple, at a dose of 900 mg/d in adults <60 years or 22 mg/
`kg/d.in children 1-9 years, the steady-state peak serum the-
`ophylline concentration will be <10 mcg/mL in about 30% of
`patients, 10-20 mcg/mL in about 50% and 20-30 IIicg/mL in
`~bout 20% of patie~ts. The dose of theophylline must be
`individualized on the basis of peak serum theophylline con-
`centration measurements in· order to achieve a dose that
`will provide maximum potential benefit with minimal risk
`of adverse effects. ,
`_
`_
`- Transient caffeine-like adverse effeCts and excessive serum
`concentrati~ns in slow metaboli~ers can_be a~oided in most
`patients by starting with a sufficiently low dose and slowly
`increasiri.g the dose, if judged to be clinically indicated, in
`SII\all increments (See .Table V). Dose increases should only
`be made if the previous dosage is well tolerated and at in-
`tervals of no less than 3 days to allow serum theophylline
`concentrations to reach the new _ steady-state. Dosage ad-
`jUstmentc should be guided by serum theophylline concen-
`fration measurellient (see · PRECAUTIONS, Laboratory
`tests and DOSAGE AND ADMINISTRATION, 'i'~bl~ VI):
`He;uth care PX:<;>viders should in~truct patients and care giv-
`ers to discontinue any dosage that causes adverse eff-ects, to
`~thhold the medication until these symptoms are gone and
`to then resume therapy at a lower, previously tolerated dos-
`age (see WARNINGS).·
`If the patient's symptoms are well controlled, there are no
`apparent adverse effects; and no intervening factors that
`might alter dosage requirements (see WARNINGS and
`PRECAUTIONS), serum
`theophylline concentrations
`should be mollitored at 6 month intervals for rapidly grow- -
`ing children and at yearly intervals for all others. In acutely
`ill patients, serum theophylline concentrations should be
`monitored at frequent intervals, e.g., every 24 hours.
`Theophylline distributes poorly into ·body fat, therefore,
`mg!kg dose should be ~alculated on the basis of ideal body
`weight.
`.
`-- -
`Table V contains theophylline dosing titration schema rec-
`ommended for patients in various age groups and clinical
`circumstances. Table VI contains recommendations for the-
`ophylline do~age adjustment b~sed upon serum theophyl-
`line concentrations. Application of these general dosing
`recommendations to individual patients must take into ac-
`count the unique clinical characteristics of each patient. In
`general, these recommendations should serve as the upper
`limit for dosage adjustments in order. to decrease the risk
`of potentially serious adverse events associated with un-
`expected large increases in serum theophylline concentra- _
`~
`
`Table V. Dosing initiation and titration
`(as anhydrous theophylline).*
`A. Children (12-15 years) and adults (16-60 years)
`without risk factors for impaired clearance.
`Children > 45 kg
`and adults
`
`Titration Step
`
`Children < 45 kg
`1~14 mg!kg/day
`up to-a maximum ·
`of 300 mg/day
`admin. QD*
`16 mg!kg/day up to
`2. After 3 days,
`a maximum of,4QO
`if tolerated,
`mg/day admin. QD*
`increase dose to:
`3. After 3 more· 20 mg!kg/day up to
`days, if tolerated a maximum of 600
`and if needed
`mg/day admin. QD*
`increase dose to:
`
`1. Starting
`Dosage
`
`300-400 mg/dayt
`admin. QD*
`
`40~00 mg/dayt
`admin. QD*
`
`· As with all theo-
`phylline products,
`doses greater than
`600 mg should be ·
`titrated according
`to blood level
`(See Table VI)
`
`tlf caffeine-like adverse effects occur, then consideration
`should be given to a lower dose and titrating the dose more
`slowly (see ADVERSE REACTIONS).
`B. Patients With Risk F~ctors For Impaired Clearance, The
`Elderly (>60 Years), And Those In Whom It Is Not Feasible
`To Monitor Serum Theophylline Concentrations:
`In children 12-15 years of age, the theophylline dose should
`not exceed 16 mg!kg/day up to a maximum of 400 mg/day in
`the presence of risk factors for reduced theophylline clear-
`ance (see WARNINGS) or if it is not feasible to monitor
`serum theophylline concentrations.
`-
`In adolescents ~16 years and-aduits, including the elderly,
`the theophylline dose should not exceed 400 mg/day in the
`presence of risk factors for ·reduced theophylline clearance
`(see WARNINGS) or if it is not -feasible to monitor serum
`theophylline concentrations.
`~'Patients with more rapid metabolism clinically identified
`by higher thari. average dose requirements, should receive a
`smaller .dose -more frequently (every 12 hours) to prevent
`breakthrough symptoms resulting from low trough concen-
`trations before the next dose.
`Table VI. Dosage adjustment guided by _serum
`theophylline concentration.
`Peak Serum
`Concentration
`
`.Dosage Adjustment
`
`<9.9 mcg/mL
`
`10-14.9 mcg/mL
`
`15-19.9 mcg/mL
`
`20-24.9 mcg/mL
`
`25-30 mcg/mL
`
`... _ _If symptoms are not controlled and
`cirrrent dosage is tolerated, increase
`dose about 25%. Recheck serum
`concentration after three days for
`further dosage adjustment ..
`If symptoms are controlled and
`current dosage is tolerated,
`maintain dose and recheck serum
`concentration at 6-12 month
`intervals.'JI
`If symptoms are not controlled and
`current dosage is tolerated consider
`adding additiqnal medication(s) to
`treatment regimen.
`Consider 10% decrease in dose to
`provide greater margin of safety
`even if current dosage is tolerated. 'll
`Decrease dose by 25% even if no
`adverse effects ate present. Recheck
`serunt concentration after 3 _days to
`guide further dosage adjustment.
`Skip next dose and decrease
`subsequent doses at least 25% even'
`if no adverse effects are present.
`Recheck serum concentration after 3
`days to guide further dosage
`adjustment. If symptomatic,
`consider whether overdose
`treatment is indicated (see
`recommendations for chronic
`overdosage).
`Treat overdose as indicated (see
`recommendations for chronic
`overdosage). If theophylline-is
`subsequently resumed, decrease
`dose by at least 50% and recheck
`serunt concentration after 3 days to
`guide further dosage adjustment.
`'ll Dose reduction and/or serum theophylline concentration
`measurement is indicated whenever adverse effects are pre-
`sent, physiologic abnormalities that can reduce theophylline
`clearance occur (e.g., sustained fever), or a drug that inter-
`acts with theophylliile is added or discontinued (see WARN-
`INGS).
`.
`
`-
`
`>30 Ill.Cg/!JlL
`
`PURDUE PHARMN2569
`
`HOW SUPPLIED
`Uniphyl® (theophylline, anhydrous) 400 mg Controlled-
`Release Tablets are supplied in white-opaque plastic bottles
`containing 100 tablets (NDC 0034-7004-80) or 500 tablets
`(NDC 0034-7004-70).
`-
`-
`Each round, white, scored 400 mg tablet bears the sym_bol
`-
`PF on one side and is marked U400 on the other side.
`Uniphyl® (theophylline, anhydrous) 600 mg Controlled7
`Release Tablets are supplied in white-opaq!le plastic bottles
`-
`containing 100 tablets (NDC 0034-7006~80).
`Each rectangular, concave, white 600 mg scored tablet bears
`the symbol PF on one side and is marked U600 on the other
`side.
`Store at controlled room temperature 15•-3o•c (59.-86.F).
`Dispense in tight, light-resistant container.
`CAUTION: Federal law prohibits dispensing without pre-
`scription.
`The· Purdue Frederick Company
`Norwalk, CT 06850-3590
`Copyright ©1996 The Purdue Frederick Company
`U.S. Patent Numbers 4,235,870 and 4,366,310
`June 12, 1996
`R1374
`Shown in Product Identification Guide, page 333 ·
`
`EDUCATIONAL MATERIAL
`
`Laxative Protocol Sheets (PS77) 1 page (pad of 25)
`Available to physicians, nurses and phanitacists
`
`Purdue Pharma L.P. ·
`100 CONNECTICUT AVENUE
`NORWALK, CT 06850-3590
`
`DHCplus® Capsules
`
`MS Con tin® Tablets-see listing under The Purdue Freder-'
`ick Company, page 2556
`
`MSJR® Capsules-see listing under The Purdue Frederick
`Company, page 2559
`·
`
`· MSIR® -Tablets-see listing under The Purdue Frederick
`Company, page 2559
`
`MSJR® Liquid-see listing under The Purdue Frederick
`. Company, page 2559
`'
`
`_ @: :ij:
`OXYCONTIN®
`(OXYCODONE HCL CONTROLLED-RELEASE) TABLETS
`Warning-May be habit forming.
`10mg 20mg 40mg 80mg*
`
`*80 mg For use in opioid tole~-ant patien~s only.
`
`DESCRIPTION
`OxyContin® (oxycodone hydrochloride controlled-release)
`tablets are an opioid analgesic supplied in 10 mg, 20 mg, 40
`mg, ·and 80 mg tablet strengths for oral administration. The
`tablet strengths describe the amount of oxycodone per tab-
`let as the hydrochloride salt. The structural formula for oxy-
`codone hydrochloride is as follows:
`
`-
`
`H3CO~-
`"""'
`.
`I
`'
`#
`OH ~C~
`O/ .
`.
`'CH:i
`
`0
`
`MW 351.83
`The chemical formula is 4, 5-epozy-14-hydroxy-3-methoxy-
`17-methylmorphjnan-6-one hydrochloride.
`Oxycodone is a white, odorless crystalline powder derived
`from the opium alkaloid, thebaine. Oxycodone hydrochlo-
`ride dissolves in water (1 g in 6 -to 7 mL). It is slightly sol-
`uble in alcohol (octanol water partition coefficient 0.7). The
`tablets contain the following. inactive ingredients: ammonia
`
`Continued on next page
`Consult 1 9 9 9 PDR® supplements and future editions for ·revisions
`
`KASHIV1044
`IPR of Patent No. 9,492,393
`
`

`

`2570/PURDUE PHARMA
`OxyContin-Cont.
`
`methacrylate copolymer, hydroxypropyl methylcellulose,
`lactose, magnesium stearate, povidone, red iron oxide (20
`mg strength tablet only), stearyl alcohol, talc, titanium di-
`oxide, triacetin, yellow iron oxide (40 mg strength tablet
`only), yellow iron oxide with FD&C blue No. 2 (80 mg
`strength tablet only), and other ingredients.
`OxyContin® 80 mg Tablets ARE FOR USE IN OPIOID TOL·
`ERANT PATIENTS ONLY.
`CLUITCALPHARMACOLOGY
`Central Nervous System
`0X"jcodone is a pure agonist opioid whose princ