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`
`
`
`
`
`
`
`on
`
`EDITION
`
`I995
`
`
`
`
`
`PHYSICIANS’
`DESK
`REFERENCE
`
`
`
`
`
`-
`_
`Medical consultant
`Ronald Arky, MD, Charles 5. Davidson Professor of Medicine and Master. Francis Weld Peabody Society, Harvard Medical School
`
`President and Chief Operating Officer. Drug Information Services Group: William J. Goie
`
`Senior Vice President and
`General Manager: Thomas F. Rice
`
`Product Manager: Stephen B._Greenberg
`Associate Product Manager: Cy 5. Calne
`
`Sales Manager: James R. Pantaleo
`
`Senior Account Manager: Michael S. Sarajian
`
`Account Managers
`Dik N. Barsarnlan
`Donald V. Bruccoleri
`Lawrence C. Keary
`Jeffrey M. Keller
`P. Anthony Plnsonault
`Anthony Sorce
`
`Cnmmerclal Sales Manager: Robin B. Bartlett
`
`Direct Marketing Manager: Robert W. Chapman
`
`Vice President of Production: Steven R. Andreazza
`Manager, Professional Data: Mukesh Mehta. RPh
`Manager, Database Administration: Lynne Handler
`contracts and Special Services Director: Marjorie A. Duffy
`Director of Production: Carrie Williams
`
`Production Managers: Kimberly Hilier-Vivas. Tara L. Walsh
`Format Editor: Gregory J. Westley
`Index Editor: Jeffrey Schaefer
`Art Associate: Joan- K. Akerlind
`
`Director of corporateitommu nications: Gregory J. Thomas
`
`Digital Photography: Shawn w. Cahill
`'DigltaI Prepress Processing: Joanne Mccloskey. Richard Weinstock
`Editor, Special Projects: David W. Sifton
`
`¥ Copyright ® 1995 and published by Medical Economics Data Production Company at Montvale, NJ 07645-1742. All rights reserved. None of the content
`I I of this publication may be reproduced. stored in a retrieval system, resold, redistributed. or transmitted in any form or by any means (electronic. mechan-
`Wei. photocopying, recording. or otherwise) without the prior written permission of the publisher.
`Pi-l‘i'SlCiAN5' DESK FiEFEFiENCE®. PDR®. PDR For
`gmlirfiscflplion Drugs®, PDR For Ophthalmoiogtfi and The PDFi® Family Guide to Prescription Drugs® are trademarks of Medical Economics Data Production
`W°mn3|'|!-', registered In the United States Patent and Trademark office. PDR Guide to Drug Interactions-Side Effects-Indications”. The PDR® Family Guide to"
`°lT|en‘s Health and Prescription Drugs”. PDRGJ Library on CD-ROM”. PDFi® Drug interactions/Side Effects/indications Dlskettesi“. and Pocket FDR“ are trade-
`rrarlis of Medical Econorrics Data Production Company.
`-
`gfiicers of Medical Economics: President and Chief Executive Officer: Norman R. Snesii: Executive vice President and Chief Financial Dfficer: J. Crlspin Ashworth:
`fenior ‘v'ice_ President of Corporate Operations Group: John R. ware; Senior Vice President of Corporate Business Development: Raymond M. Zoeller; Vice President
`0 information Services and Chief information Officer: Edward J. Zecchinl
`'
`.
`
`® “tinted on recyclaa paper
`
`
`Isen; 1-seasons‘:-r
`
`Amerigen Ex. 10531, p. 1
`Amerigen Ex. 1051, p. 1
`
`

`
`lactoid symtoms develop, appropriate therapy should be
`instituted.
`PRECAUTIONS
`Changes inthc refractive index and lens opacities have been
`seenin monkeys. dogs and rabbits given high doses of di-
`methyl sulfoxide chronically. Since lens changes were noted
`in animals. full eye evaluations, including slit lamp exami-
`nations are recornmended prior to and periodically during
`treatment.
`-
`-_
`-
`Approximately every or months patients receiving di-
`methyl aulfoxide should have a biochemical screening. par
`ticularly liver and renal function tests, and complete blood
`count Intravecical instillation of RIMSOGI)-60 may be harm-
`ful to patients with urinary tract malignancy because of di-
`methyl sulfoxldednduced vasodilation.
`'
`-
`Some data indicate that dimethyl sullbxide potentiates other
`concomitantly administered medications.
`.
`.
`Preg‘nency' Category C. Dimethyl sulfoxidc caused territo-
`genic responses in hamsters, rats and mice when adminis-
`tered intraperitoneally at highdoees (2.5-_l2 gro/lqrl. Oral or
`topical doses of dimethyl sulfoxide did not cause problems of
`reproduction in rats, mice and hamsters. Topical doses (5
`gm! kg first two days, then 2.5 gm/kg-last eight days] pro-
`duced terata in rabbits, but in another study. topical doses of
`1.1 gmflcg days-3 through 16 of gestation-failedlto produce
`any abnormalities. There are no adequate and well con-
`trolled atudies in pregnant women. Dimethyl sulfoxide
`should he used during pregnancyonly if the potential benefit
`justifies the potential risk to" the fetus, It is not known
`whether this iirug is excreted in human milk. Because many
`drugs are excreted in human milk, caution" should be exer-
`cised when dimethyl sulfoxidc is administered to a nursing
`women.
`-
`'
`'
`='
`- -'
`Safety and effectiveness
`in children have
`not been
`established,
`'
`'
`Information available to be given to the patient is reprinted
`at the end of this text.
`'
`:
`ADVERSE REACTIONS
`A garlic-like taste may be noted by the patient within a few
`"minutes after instillation of Rl'MSO®-ED (dimethyl sulfur!-
`ide). This taste may last several hours and, because of the
`presence of metabolites an odor on the breath and skin may
`remain for T2 hours.
`Tranaientchemical cystitis has been noted following instilla-
`tion of dirnethyl sulfoxide.
`-
`_
`v
`.
`The patient may experience moderately severe discornfort
`on administration. Usually this becomes less prominent with
`repeated administration.
`'
`'
`DRUG JXBUSEAND DEPENDENCE
`None known.
`OVERDOSAGE
`Theoral LD54; of dimethyl sulfoxide in the dog is greater than
`10 gm/lrg. It is improbable that this dosage level could he‘
`obtained Wil.h_intre.vesical instillation DFRIMSOCD-50 in the
`patient.
`'
`In case of accidental oral ingestion, specific measures should
`be taken to induce nemesis. Additional measures which may
`be considered are gastric lavage, activated charcoal and
`forced diuresis.
`'
`-
`.-
`‘DOSAGE AND ADMINISTRATION
`instillation of 50ml of RIMSOGJ-50 (dimethyl sulfoxlde)
`directly into the bladder may be accomplished by catheter or
`asepto syringe and allowed to._ remain for 15 minutes. Appli-
`cation otan analgesic lubricant gel such as lidocaine jelly to
`the urethra is suggested prior to insertion of the catheter to
`avoid spasm. The medication is expelled by spontaneous
`voiding. It is recomrnencled that the treatment be repeated
`' every
`two weeks until maximum symptomatic relief is ob-
`tained. Thereafter. time intervals between therapy may be
`increased appropriately.
`'
`-
`'
`-'
`'
`Ad ministration of oral analgesic medication orsu ppositories
`containing belladonna and opium prior to the instillation of
`RIMSOGD-50 can reduce bladder spasm.
`=
`In patients with severe interstitial cystitis with very senai-‘
`tive bladders, the initial treatment, and possibly the second
`and third (depending on patient response) should be done
`under anesthesia. (Saddle block has_lJeen.su,ggestedJ.
`-
`.
`HOW SUPPLIED
`-
`-
`Bottles
`cont'ai.n' 50 ml of'sterile and nonpyrogenic
`RIMSOGB-fill
`(50% w_f_w dimethyl
`sulfoxido
`aqueous
`solution];
`-
`' Dime-thyl sulfoxide-is clear and colorless
`Protect from strong light
`Store at room temperature {59' to 36°F) (15‘ to 30'Cl
`- if RIMSOE‘)-50 becomes frozen, thaw ‘at room temperature.
`Freezing and thawing does not atl’ect'd.1'ug' stability.
`Do not autoclave
`.
`'
`'
`_
`-
`=
`_
`NDC #043.'}04334}fi
`_
`For additional information concerning RIMSO®-50. contact
`the Pharmaceutical Division, Research Industries Corpora-
`tion. Salt Lake City, Utah
`'
`
`'
`
`PFIODUGT INFORMATION/1959
`
`RIMSO®—50 is manufactured by Tera Pharmaceuticals,
`Inc, Buena Park. Cal rformn, for the Ph arrnaceutical Divi.
`sron, Research Industries Corp., Salt Lake City, Utah.
`
`.____.___,___________________
`
`Rexar Pharmacal
`A division Of filchwood Pharmaceutical
`-. Company inc.
`395 ROCKAWAY AVENUE
`VALLEY STREAM. NY 11581
`
`'
`
`ose‘rnoL‘""' TABLETS .
`
`399 ADDERALF” pace # 193 4.
`
`DEXTROAMI5!-|ErAMlnIE suu-‘acre, use
`5 mg and 10 mg Tablets
`
`(.3
`
`6'
`
`OBY-TRIM Capsules
`Phontsrrnine Hydrochloride. Us P, 30 mp
`lfiqulvslent to 24 mg phentnrmlne base]
`
`@Bs
`
`.
`.
`l1E_)_(ATAL Tablets
`Phenobarbital, USP. ['4 pr] 16.2 rnp
`Hyoscyamlno Sulfate. USP. 0.103? mg
`Atropine Sulfate. USP, 0.0194 mg "
`Scopolarnlno Hydrobromlds; USP, 0.0065 mg
`
`x-rnozme Tablets-
`X-TROZINE Capsules
`Phendimetrazlne Tomato, USP, 35 mg
`
`€33
`
`X-TROZINE LA. EXt£nd0I‘.l Fleleass Capsules
`Phendimctrorino Tsrtrste. USP. 105 mg
`
`@311
`
`
`
`Rhone-Poulenc Borer
`Pharmaceuticals Inc.
`coo ARCOLA noao
`COLLEGEVILLE. PA 19426-010?
`
`Following is a list of Rhone-Poulenc Rorer Pharmaceuticals
`Inc. products. Full prescribing information is provided on the
`following pages for those products indicated by an asterisk.
`For further information. please call the Rhone-Poulenc
`Rorer Med1cal Affairs Information Line at (610J454.31_10 or
`(610) 454-3000.
`.
`'
`
`'
`
`3
`
`ACT!-|AR® for Injection
`25 USP Units and co USP Units
`Cortlcotropin for injection "available as a lyophilioed powder
`in via1s__oontainin'g 25 USP Units or 40 USP Units per vial.
`H.P. ncrnnnej GEL
`'
`1;
`40 LISP lJnlts.fI11L and E0 USP Unlta/mL
`Repository oorticotropin injection available in strengths of
`40 USP Units or 80 USP Units per ml.
`'RZMAOOHT® Oral Inhaler
`Ehch metereddose inhaler contains 60 mg triamcinalone
`ecetonide. Each oral inhaler unit del lvers 240 acttiatlons of
`approximately 100 mcg of triamcinolone acetonide.
`Pictured
`Product Identification Guide. page 325
`nAno1'nAsr"®
`This radiopaque contrast medium contains 92.5% barium
`sulfate, suspending agents, and sodium saccharin.
`
`Continued on next page
`Amerigen Ex. 1051, p. 2
`Ame5ig.en9E2s....l.Q.5.lon-..z..n..
`
`
`
`
`
`
`.;-no aerosol container will deliver a
`ficafions.
`
`PR0HIBI"I‘S msponscvo wrruour
`
`nidustries Corporation
`hal. Division
`' coo weer
`1-,qH 84047
`
`I a nursing
`
`'
`
`mmm arm?
`‘If HPA so
`rlure patients
`:ig.ht ratio.
`ensl
`lH'PAl'
`ntracranisl _
`ieceivlnglqpi :-
`supprmslnn in .
`ieluyed tveighl,
`»|' response lot
`'18] hypertendtin
`bilateral papl
`ortioosterolds
`unt comps I
`mic cortiooslé
`and developme
`
`I
`
`in: reactions
`
`Perioral do
`Allergic
`
`5
`
`"up;-oved to be clini_cally'el'fective for the
`'[ patients with interstitial cystitis.
`_
`'
`'
`'
`
`on of Rtmso®-50 may be harmful to
`
`ghould he used during pregziancy only if
`tjustifies the potential rial: to the fetus.
`
`' R
`
`-
`I
`'
`_
`ll ofdjmethyl sulfoxidc (Dl’l‘lSC‘l
`"solution for intravesical instillation.
`gm dimethyl sulfoxide STERILE AND
`lien for the treatment of interstitial
`
`' v.1N.urc_r1oN
`
`dispensing without a prescription.
`eatof RIll4lSO_(".".l-till is dimethyl sulfoxide
`pirical formula C31-I508.
`sclear. colorless and essentially odot-'
`" miscible with water and roost organic
`al characteristics include: molecular
`point 18.d‘C, and a specific gravity of
`
`
`
`
`
`
`
`
`
`
`
`
`
`'
`: DOLOGY
`9.:1'_8'metabolized in man by oxidation to-
`.'r, by. reduction to dimethyl "sulfide: Di"-
`.:l dirrethyl sulfone tire excreted in the
`
`"ethyl sulfide is eliminated through the
`..lI responsible for the characteristic odor
`hn sulfoxide medication. Dimothyl
`_seruri1for longer than two weeks after
`instillation. No residual accumulation
`.' has occurred in man or lower animals
`tlesbneot for protracted periods of time.
`
`lflllication. dimethyl sutfoxide is absorbed
`
`uted in the tissues and body fluids.
`T BE HE
`' USAGE
`.
`--
`EDlCATl0l'l
`,1},
`1 _lti sulfoxide) is indioated_ibr the syn1 p-
`in the sill!
`" Pia With interstitial cystitis: I_i£MSC_'®-
`Id never
`_ve:l as being safe and effective for any
`" Is no clinical evidence of effective-
`m contaifilafé 3
`-r~tl::l_cEt'1n the trentmentol‘ bacterial infec-
`tor llp.
`.
`
`lnlitl the 5-“
`order to 8%
`parts
`h warm W5
`
`gram £18
`
`$311 Initiate the liberation of histamine
`allopcasional hypersensitivity reaction
`
`hxllon of dimethyl sulfoxide. This hy-
`Ulllorted in one patient receiving
`I
`'
`‘The Physician should be oognizan t
`Prescribing RlIMSO®-50. If anaphy-
`
`

`
`1984/PHYSICIANS’ DESK FlEFEFIENCE®
`
`
`
`I
`_
`PRECAUTION '
`-.
`_
`
`General: Caution is to be exercised in
`'
`mines for patients .\vit_h even mild ha!”
`The least amount feasible fihould be pr
`pensed at one time in order to minimize the’
`overdosage.
`'
`
`ADDERALL 20 mg contains _FD&C Yellow #-
`cause allergic-type reactions (includirg bronchi
`certain susceptible individuals. Although;
`dance of FD&C Yellow #6 sensitivity in the“.
`
`tion is law, it is frequently seen in pafiem -
`as ‘Fin ypersensitivit .
`'
`..
`_
`Inflgimation for Potieiits: Amphetamines“;
`
`ability of the patient to engage in potenfiflu.
`tivities such as operating machinery .;._-“hi
`'
`
`should therefore be cautioned accordingly.
`Drug Interactions: Acidifying agar."
`
`
`acidifying agents (guanethidine.
`'
`HGI, ascorbic acid, fruit jiiices,
`
`amphetamines.
`Urinary-acidifying agents (ammonium cl-tlnri
`
`phosphate, etc.) increase the concentration
`species of the amphetamine molecule,
`.
`urinary excretion. Both-groups of cg-eiiLg1g..'ifl.
`and efficacy of amphetamines.
`_
`.
`Adrenergic bIocicers—.-tdrenergic blockers
`. amphetamines.
`'
`
`Alitslinizing agents—-Gastrointestinal altar]
`(sodium bicarbonate, etc.) increase abscrpti
`mines. Urinary aikaliniaing agents‘-(acetate III
`thiazidesl increase the concentration of the 1.
`cies of the amplietamine molecule. thereh
`
`nary excretion Both groups of agents inc
`and thereforepotentiate the actions of ainp
`
`Antidepressants,
`tricyclic—Amphetanii.nss
`'
`the activity of tricyclic or syrnpathomimetic
`phetamine with desipramine of protriptyliu
`other tricyclics cause striking and sustained ‘
`concentration of d-amphetamine in the brain
`lar effects can be potontiated
`'
`MAO Inhibitors-—-NIAOI antidepressanm, saw '
`olita of furamiidone. slow 'amphetarnine_ in
`slowing potentiates, amphetamines. increasing
`.on the release of norepinephrine and other _
`adreoergic nerve endings:
`this can can:
`other signs of hypertensive crisis. A variet)?
`toxic effects and malignant hyperpyrcrie can
`times with fatal results.
`.
`-'
`Antihistamines—A'mphetamincs—Amphettuni
`counteract the sedative effect ofsntihistsmu:
`Anl:ihypertensives——A_mpheta.mines may Ell
`
`h
`otensive effects of antihypertens1'ves.'
`_
`orpromasin&Chlorpron1erine bio-elI3_ d
`. norepinephrins reuptake. thus inhibiting 939
`lant_.effects of amphetamines, and can I39
`amphetamine poisoning.
`_
`
`Ethosuxi_mi_de_—.Amphetamines may dole! 13.‘.
`tion of ethosuximide.
`-
`blocks
`I-Ia|operido1—Halopsridol
`tlcptunlll
`phinaphrine reuptake, thus inhibiting the 0*’-‘I
`effects of amphetamines.
`Lithium carbonate—-'I‘he antiobesit? 3“‘I_‘
`.
`of amphetamines may be inhibited I1)’ I19‘
`Mepe_ridine—Ampheta_mine-5 po|»e11*1=l° ‘I’-° '
`of meperidine.
`'
`'
`'.
`"
`Methenamine therapy-—Ur1’na1'J" "-l_‘°"tI
`mines is increased. and efficacf 13 '
`agents used in methenamine tl1eIBIJ)'
`Norepineph.rine—Amphetu.rni.nss ooh“
`effect of norepinephrine.
`'
`'
`-
`Phenobarbital-—Amphetamines anay deg!
`sorption of phenobarbital; CO-atll_'nIII11.E_tt'B]3:m
`' tel may produce a synergistic eIIl3°9m'.“
`Phenytoin—Amphetsmine§ ma)’ ‘l°l“5'"'
`'
`of phenytoin; co—administra_til1_fl Dlpilenylo
`sinergistic antioonvulsant action.
`ham.
`Propoxyphene—ln case: of l_3l'°P°"3'g M '
`p_hetamine CNS stimulation is P‘?I'°."'
`‘
`slonscan occur.
`.
`- in
`Veratrum alkaloids-AmPh9lEa““"ES
`sive effect of veratrum alka|oI_|'-I5- _
`
`in
`Dri.rgfLoborolorjr Tbs! .lnt2i'flCl'°”5‘ i
`
`0 Amphetamines can cause 9 5
`plasma corticosteroid levels. This
`_.
`.
`the evening.
`'
`'
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`_
`
`-
`
`Fih-fine-Poulenc Florer Consumer—‘Cont.
`
`'
`'
`'
`HOW SUPPLIED
`Maa.iox® "I‘CSuspension is available in a 12-1] uid ounce (355
`mLl plastic bottle (NDC 0067-U33-1-71).
`[See PDR For Nonprescription Di-ugs.)
`
`P E R DI EM ®
`[pér "dc ’tIr'm ]
`Hulk-Forming Laxative
`Rhone-Poulenc Borer
`
`D TC
`
`-
`'
`ACTIONS
`Perdiem®. with its 100% natural, gentle action provides
`comfortable. overnight relief from constipation. Perdiem®
`is a unique combination of bulli-forming fiber and natural
`stimulant. The vegetable mucilages of Perdiem® soften the
`stool and provide pain-free overnight evacuation of the bowel
`with no chemical stimulants. Pei-diem® is effective as an aid
`to elimination for the hemorrhoid or fissure patient prior to
`and following surgery.
`—
`HOW SUPPLIED
`EEO-gram (3.8 oz) (NDC D067-D690-T0) canisters.
`as g individual packets (NDG ODE?-D690-16).
`(See PDR For Nonprescription Drugs.)
`
`PERDlEM® FIBER
`[per "dé ’EI'm ]
`Bulk Forming Laxative
`Rtufine-Poulenc Borer
`
`OTC
`
`, ACTIONS
`Perdiem® Fiber. is a 100% natural bulk-forming fiber that
`gently helps maintain regularity and prevents constipation.
`Perdiem® Fiber-’s unique form is easy to swallow and re-
`quires no mixing but must be followed by at least 8 ounces of
`cool liquid. Perdiern Fiber contains no chemical stimulants
`and may be used daily by those who may lack sufficient di-
`etary fiber. When recommended by a doctor, Perdiem Eibcr
`is also useful for the treatment ofbovvel disorders other than
`constipation.
`'
`HOW SUPPLIED
`250-gram (3.8 oz} (NDC DUE?-DYB5-TD) canisters, 42-gram (IA
`Dz] (NDU 006'?‘-£l?95—42) and 42-gram sample (1.4 oz} (NDC
`0067-U395-52).
`(See PDR For Nonprescription Drugs.)
`
`Ftichwood Pharmaceutical
`Company Inc.
`rsoo TANNEFVS GATE DRIVE. SUITE zoo
`FLORENCE, KENTUCKY 41o42
`
`ACUFRIN 8175" Adult Low Dose Aspirin.
`Contains 81 mg of enteric coated aspirin.
`
`OTC
`
`31 mg 12D‘s NDC 58521-081431
`31 mg 500's NDC 58521-081435
`
`AoosaALI."" TABLETS
`
`(E B.
`
`AMPHETAMINES HAVE A HIGH POTENTIAL FOR
`ABUSE. THEY SHOULD THUS BE TFIIED ONLY IN
`WEIGHT REDUCTION PROGRAMS FOR PATIENTS IN
`WHOM ALTERNATIVE THERAPY HAS BEEN tNEF-
`FECTIVE. ADMINISTRATION OF AMPHETAMENES
`FOR PBOLONGED PERIODS OF TIME IN OBESITY
`MAY LEAD TO DRUG DEPENDENCE AND MUST BE
`AVOIDED. PARTICULAR ATTENTION SHOULD BE.
`PAID TO THE POSSIBILITY OF SUBJECTS OBTAIN-
`ING AMPHETAMINES FOR NON-THERAPEUTIC USE
`OR DISTRIBUTION TO OTHERS. AND THE DRUGS
`SHOULD BE PBESCRIBED OB DISPENSED SPAR--
`INGLY.
`'
`-
`
`
`
`20 mg
`10 mg
`EACH TABLET CONTAINS:
`5 mg -
`2.5 mg
`Dextroamphetemine Saccharate
`5 mg
`2.5 mg
`Amphetamine Aspartate
`
`ii mg
`2.5 mg
`Dextroamphetamine Sulfate ..
`5 mg
`.. 2.5 mg
`Amphetamine Sulfate
`Inactive ingredients: Sucrose. Lacmse, Cornstarch, Acacia
`and Magnesium Stearate.
`_
`Colors: ADDERALL 10 mg contains FD&C Blue #1
`Colors: ADDERALL 20 mg contains I-‘D&C Yellow #6 as a
`color additive.
`'
`ACTIONS
`Amphetamines are "non-catecholamine sympathornimetic
`amines with CNS stimulant activity. Peripheral actions in-
`clude elevation of systolic and diastolic blood pressures and
`weal: brcnchodilator and respiratory stimulant action.
`Drugs of this class used in obesity are commonly known as
`“anorectics” or "anorexigenics". It has not been established.
`however, that the action of such drugs in treating obesity is
`primarily one of appetite suppression. Other central nervous
`system actions, or metabolic effect, may be involved. for
`example.
`Adult obese subjects instructed in dietary management and
`treated with “anorectic” drugs. lose more weight on the aver-
`age than those treated with placebo and diet, as determined
`in relatively short-terorclinical trials.
`The magnitude of increased weight loss of drug-treated pa-
`tients over placebo—treated patients is only a fraction of 9.
`pound a week. The rate of weight loss is greater in the first
`weeks of therapy for both drug and placebo subjects and
`tends to decrease in succeeding weeks. The on‘ ‘ns of the
`increased weight loss due to the various possible rug effects
`' are not established. The amount of weight loss associated
`with the use of an "anorectic" drug varies from trial to trial.
`and the increased weight loss appears to be related in part to
`variables other than the drug prescribed, such as the physi-
`cian-investigator, the population treated, and the diet pre-
`scribed. Studies do not permit conclusions as to the relative
`importance of the drug and non-drug factors on weight loss.
`The natural history of obesity is measured in years, whereas
`the studies citedare restricted to a few weeks duration, thus.
`the total impact of drug-induced weight low over that of diet
`alone must be considered clinically limited.
`There is neither specific evidence which clearly-establishes
`the mechanism whereby Amphetamine produces mental
`and behavioral'eife'ct:s in children. not conclusive evidence
`regarding how the-ie_ell'ects relate to the condition of the
`central -nervous system.
`-
`'
`INDICATIONS
`In Attention Deficit Disorder tpith Hyperactivity; Amphet-
`amine is indicated as an integral part. of a total treatment‘
`program which typically includes other remedial measures
`( ychological educational; social) for a stabilising effect in
`c 'dren with behavioral syndrome characterized by the
`following group of developmentally inappropriate symp-
`toms: moderate to severe -distractihility. ‘short attention
`span, hyperactivity, emotional“ liability. and impulsivity.
`The diagnosis of this symdrome should not be made with‘
`finality when these symptoms are only of comparatively
`recent origin. Nonlocalizing (soft) neurological signs. learn-
`ing disability and abnormal EEG may or 'ma not be present,
`and a diagnosis of central nervous system ysfunction may
`or may not be warranted.
`Exogenous Obesity as a short-wrin (a few weeks) adjunct in a
`regimen of weight reduction basedon caloric restriction. for
`patlenta refracmry to alternative therapy. e.g.. repeated
`diets. group programs. and other drugs. The limited useful-
`ness" of amphetamines (see ACTIONS) should be weighed
`against possible risks inherent in use of the drug, such as
`those described below.
`_..
`Nfirwiepsy
`CONTRAINDICATIONS
`Advanced arteriosclerosis. symptomatic cardiovascular dis-
`ease, moderate to severe hypertension. hyperthyroidism.
`known hypersensitivity or idiosyncrasy to the sympathorni-
`metic amines, glaucoma.
`-
`Agitated states.
`. Patients with o history afdruiobuss.
`During or within 14 days fol wing the administration of
`monoamine oxidase inhibitors (hypertensive crises may
`result).
`.
`WARNINGS
`the
`When tolerance to the "anorectic" effect develops,
`recommended dose should not be exceeded in an attempt to
`increase the elfect; rather. the drug should be discontinued.
`Clinical experience suggests that in psychotic children, ad-
`ministration of Amphetamine may exacerbate symptoms of
`behavior disturbance and thought disorder. Data are inade-.
`quate to determine whether chronic administration of.
`-
`DESCl'tIP"i‘ION
`Amphetamine may beassociated with growth inhibition;
`therefore, growth should be monitored during treatment.
`A single entity amphetamine product combiningthe neutral
`sulfate salts of dextroamphetamine and amphetamine, with
`Usage in Nursing Mothers: Amphetamines are excreted in
`human milk. Mothers taking amphetamines should be ad-
`the dextro isomer of amphetamine saccharate and d, I am-
`viaed to refrain from nursing.
`phetamine aspartate.
`Inlormatlon will be superseded by supplements and subsequent editions
`
`
`
`
`
`
`
`,
`
`.
`
`Cl1rcinogenesisXlrfu!ogen_e5i3~'
`.
`.
`long—term studies in animal
`' potential of Ainphetamme. ha”
`P."€gl'.lfll'tCj'—T9!'fi'tO
`nic Eff
`_-
`.
`_
`Amphetamine has sen sh
`atogenic effects when adminisml
`-
`057131. mice in doses appromme331” '
`Amerigen Ex. 1051, p. 3
`A merigeniEie:o1°o
`
`

`
`
`
`
`
`
`
`.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` whim given the drug in doses 7 times the '
`'
`in rats given 12.5 times the maximum hu-
`
`
`
`E no adequate and well-controlled studies
`. 9;. Amphetamines should he used during
`
`fight; potential benefit justifies the potential
`-Bfyecgg;
`Infants born to mothers dependent
`
`ve an increased risk of premature deliv-
`' t Also, these infants may experience
`demonstrate: by dysphoria. in-
`'
`ificant lassltu e.
`-
`°i':a:;,gSr1§ineffects of arnphetsnu‘nes'in chil-
`wm well established. Amphetamines are not
`.- use as anorectic agents in children under
`'
`I00, in children under 3 years ofsge with At-
`
`isorde
`'
`1- with Hyperactivity described under
`"Dino U5-tGE~
`.
`.
`.
`-
`wee suggest that in psychotic children, ad-
`nfnmphel-8l'l]ll'B3 may exacerbate symptoms of
`,. .;e and thought disorder.
`3 hm.-e been reported In exacerbate motor and
`Tnurette's syndrome. Therefore, clinical
`11., and 'I‘ou1'ette's syndrome in children and
`-should precede use of stimulant medications.
`_, “are to determine chronic administration of
`
`_ may be associated with growth inhibition;
`.
`should be monitored during treatment.
`he not indicated in all cases of Attention Def-
`ifly. "Hyperactivity and should be considered
`
`fthe complete history and evaluation of the
`-3319]; to prescribe amphetamines should cle-
`
`physician's assessment of the chronicity and
`s symptoms and their appropriateness
`Prescription should not depend solely on
`
`or one or more of the behavioral characteris-
`
`
`associated with acute stress
`°E'’mi“°“ 1”
`lhesu-vmlixims are
`r
`-
`-
`homlmetuc
`
`mtriptflm
`tment W'll.l'l amphetamines is usually not
`iustained m
`'
`;_,Pa1pitations.-_tac.liycardia, leleviation of
`
`amino In
`s. increas
`dolher moo
`sn cause
`
`recom-
`in System: Psychotic episodes {at
`[rm-el.overstirnulation,rcatlessness.dirsiness.
`horia. dyskineaia, dysphcria. tremor, head-
`tion of motor and phonic tics and ’I‘our'ett._e’s
`
`I; -Ilryness of the mouth, unpleasant taste,
`__ tlpstion. other gastrointestinal disturbances.
`_
`... weight loss may occur as undesirable effects
`' etamines are used for other than the anorectic
`
`
`
`
`nsivcs.
`‘ill
`llloclfl
`ibiting the ten
`
`dopamine -
`Ling the central
`
`v
`
`-
`
`_
`;_uegn'a_
`'-
`_
`'
`_j
`' potence. changes in libido.
`-'-. UBEAND DEPENDENCE
`-
`' esulfate is a Schedule II controlled sub
`as have been extensively abused. Toler-
`=
`paycholcg-ical dependence. and severe social
`occurred. There are reports of patients who
`the dosage to many times that recommended.
`'on following prolonged high dosage adminis-
`extreme fatigue and mental depression:
`‘also noted on the sleep EEG. Manifestations
`xicaticn with amphetamine: include severe
`Iced insomnia,
`irritability» hfleiaceisty,
`changes. The most severe manifestation of
`
`tion is psychosis, often clinically indistin-
`_. Inccbirophrenia. This is rare with oral amphet-
`
`lresponse to amphetamines varies widely.
`
`-‘,l'WPloms occasionally occur as an idiosyncrasy
`-_
`,9-5 2 me. they are rare with doses of less than
`
`
`lllgf-In prod uce severe reaction a. yet doses of 400 to
`0|: necessarily fatal.
`'
`'
`'
`_
`LDW of dextroamphetamine sulfate is 96.3
`_
`Manlsfestations of acute overdusage with
`nclude restlessness, tremor, hyperreflexia
`. confusion, assaultiv-eness, hallucinations,-
`-_'|'P°1'l!yrexia and rhabdomolysia.
`llfllresssion usually follow the central
`elfecls include orrhytlunias. hypertension
`collapse.
`'
`' _3l-‘trlptonia include nausea. vomiting. diar-
`" _ ul cramps. Fatal poisoning is usually pre
`tons and come.
`‘Management ofacute amphetamine intoxi-
`almptomatic and includes gastric lavage
`' Who barbiturate.Erpe1-lance with hemodialye
`-
`dialysis is inadequate to permit recommen-
`"card. Acidification of the urine increases
`filcretion. If acute. severe hypertension oom-
`-- inc overdoage administration of intrave-
`
` '
`
`xyphe
`enlifilfll
`‘
`nes li'll'|1
`
`"
`
`-
`
`I
`
`PRODUCT INFORMATION/1905
`OF A DUODENAL ULCER, DEGRE
`
`OF RECURRENCES OR PREV'EtlA'§Eg§1EpEfi;ElF
`TIONS. Final classification of the leS5~l.ha,n.effecfi‘.3-
`ind-icafiom 1'9¢ll-liTB3 further investigation.
`
`
`
`
`
`
`nosaon AND annunrsovwrioiq
`l3°5aH*-‘ Should be adjusted to the needs of the individual
`patient to assure symptomatic control with a minimum of
`adverse effects.
`four times a day
`_0l‘¢1l
`On‘;t0_1' twflatablets three or
`g
`accor
`con ’ ion on _severity gf 5’.-1-np[oms_
`Overdosage: The S]g1'I.EIEn_|‘] symptoms of overdose are head-
`ache. nausea. vomi '
`blur
`'
`'
`'
`-
`and dry skin. diaziiiriagsb. dryr:dfiswf)l?n£1t?il;i?1fie §;Ili§h{::
`3Wl1ll°Wi118.'CNS Btimulfitlon. '1‘reatu1ent should consist of
`E9-‘3tl‘l'-‘ lfiluige. cmetics. and activated charcoal. If indicated
`parenteral-cholinerg-ic agents such as phygostig-mine or he:
`thauechol chloride should be added.
`_
`CAUTION
`_
`Federal law prohibits _diapena-lng without P1-gm-rjpfiom
`HOW SU'.PPLIElD
`'
`Scored. white. compressed o 31 tab| ts ‘
`MTBIE477
`I
`,
`_
`_ _r
`e
`unprinted.
`Bottle of mo NBC 53521-162.431
`Bottleof 500 NBC 53521-152-(J5 -
`Dispense in 3- lightcontainer as defined in the USP.
`Malnufacturfid For:
`'
`RIGHWOOD rnanauaceuricm. COMPANY me.
`FLORENCE, KY 41042
`‘
`Manufactured by:
`REXAH PHAFIMACAL
`VALLEY STREAM. tlt.Y. 11581
`March 1994
`Shown in ‘Product Identification Guide. po,::G33210179
`
`-
`
`-
`
`-
`
`-
`
`osxrno's-ra1-TM
`osxraonmeusramrue SULFATE TABLETS. use
`
`(ER
`
`ca.
`
`2
`
`
`
`
`
`
`
`
`
`
`
`
`.
`wamvnvc: AMPHETAMINES HAVE A
`TENTIAL ms ABUSE. ‘TI-IEY SHOULD I'i'Iti1$Pd.)c
`‘TRIED ONLY IN WEIGHT REDUCTION PROGRAMS
`FOR PATIENTS LN WHOM itL'I‘ERNA'1'IVE THEE.
`APY HAS BEEN INEFFECTIVE. ADM.l‘.NIS'I‘RA'1‘ION
`01-‘ Allol_l?HE’I‘AM1l‘~IES FOR PRCJLONGED PERIODS
`OFTIME ll~l0BESITY MAY LEADTO DRUG DEPEN-
`DENCE AND MUST BE AVOIDED. PAR'I‘IGULAR
`AI'I‘EN'I'ION SHOULD BE PAID ‘F0 THE POSS.
`BLITY or SUBJECTS OBTADJING A.MPHEI‘A-
`MINFS FDR NON-TI-IERAPsU'1'Ic USE on DIST}-'tL
`BUTION T0 OTHERS. AND THE DRUGS SHOULD
`BE PRESCZRIBED on DISPENSED SPARINGLY.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`DESCIIIPTION
`Dertroamphetsrnuie Sulfate is the dextro isomer of the com.
`sound it l-Amphetamine Sulfate, a sympathomiznetic mine
`of the amphe tanune group. Chemjca|_[_y_ flat.-oamphetamine
`is d-alpllga-methylphenelliylamiue, and is present as the ma.
`tralsu al.e.Hasa Chemical formula f[ H
`90
`d
`a molecular weight of 368.49.
`0 C9 wmzflz
`‘ an
`Each tablet for oral administration contains 5 mg of Dextro-
`orophetaminc Sulfate. Inactive ingredients consist of 511.
`cross. Lactose, Corn Starch, Acacia, Magnesium S|,e1-ale and
`FD&C Yellow #5.
`INDICATTONSAND USAGE -
`In Attention Deficit Disorder with Hyperactivity: A_|]1phg[__
`amine is indicated as'u integral part of a total treatment
`program which t pically includes other remedial measures
`(psychological,
`ucstiona], social} for a stabilizing effect in
`children with behavioral syndrome characterised by the
`following group of developmentally inappropriate 33:-mp.
`toms.
`rnoderatej to severe distractibility, short attention
`span, hyperactivity. emotional lability. and impuleivity. The
`d.zagnos1s_of this syndrome should not be made with finality
`when these symptoms are onlyofcompartively recsntorigin.
`Nonlocalizing (soft) neurological signs,
`learning disability
`and. abnormal EEG may or may not be present, and a
`diagnosis of central nervous system dysfunction may or may
`not be warranted.
`.
`
`nous phentolamine ('Regitine®. CIBA) has been suggested.
`However. a gradual drop in blood pressure will usually result
`when sufficient sedation has been achieved. Chlorpromazine
`antagonizes the central__stimulant effects of amphetamines
`and can be used to treat amphetamine intoxication.
`Saline cathartics are useful for hastening the evacuation of
`pellets that have not already released medication.
`DOSAGE AND ADMINISTRATION
`Regardless of indication, amphetamines should be adminis-
`tered at the lowest effective dosage and dosage should be
`individually adjusted. Late evening doses should be avoided
`because of the resulting insomnia.
`Norcolepsnv. Usual dose 5 to El] milligrams per day in di-
`vided diam. depending on the individual patient response.
`Narcolepsy seldom occurs in children under 12 years of age;
`however, when it does. dextroamphetamine sulfate. may he
`used. The su.'egesl:ed'initial dose for patients aged 6-12 is 5
`mg "daily; daily dose may be raised in increments of 5 mg at
`weekly intervals until optimal response is obtained. In pa-
`tients 12 years of age and o1der.sta_rt with 10 mg daily; daily
`dosage may be raised in increments of 10 mg at weekly inter-
`vals until optimal response is obtained. If bothersome ad-
`vverse reactions appear (e.g., insomnia or anorexia).- dosage
`should be reduced. Give first dose on awakening; addition
`doses (1 or 2) at intervals of 4 to 6 hours.
`-
`Attention Deficit-Disorder with Hyperactivity: Not _recom-
`mended for childrcn under_3 years ofage. In children from 3
`to 5 years ofage. start with 2.5 mg daily, daily dosage may be
`raised in increments of 2.5 mg at weekly intervals until opti-
`mal response is obtained;
`.
`.
`1‘
`In children 6 years of age and older, start with 5 mg once or
`twice daily; daily doage may be raised in increments of 5 mg
`at weekly intervals until optimal response is obtained. Only
`in rare cases will it be necessary to exceed a total of 40 mill.i-
`grsrns per day. Give first dose on awakening; additional
`doses (1 or 2) at intervals of 4 to 6 hours.
`Where possible, drug adrninistralion.,shou.ld be interrupted
`occasionaly to determine if there is a recurrence of behav-
`ioral syrnptoms sufficient to require c