November 1995 PSYCHIATRIC SERVICE S A Journal American Association Formerl (;ornnlilnitv When Learning Mistakes Less Is Less: From of the the Past #{149} Best Practices: Mental the Health Primary Keeping Care Care in Setting of the Psychiatric Hospital afld Psychiatry #{149} Impact and a VA Program Homeless Cost for Veterans of Decanoate 100 HALDOL#{174} (HALOPERIDOL) Offer INJECTION your patients 100 mg/mL the most consistent relapse protection Establish a safe, effective oral haloperidol dose How Much? Patients 1o who are stabilized mg/day, Initial monthвЂ™s who are elderly, on oral doses or who are debilitated2 Patients who are maintained >10 mg/day, who are tolerant or who are at risk for reIapse dose is 10 to 15 times patientвЂ™s daily oral dose*2 on oral doses to oral medication, ( Initial monthвЂ™s dose is 20 times patientвЂ™s daily oral dose*2 How Often? #{149} Once a month . Since the first injection should not exceed 100 mg, the balance of the first monthвЂ™s dosage can be administered 3 to 7 days later How U High? Maintenance *Supplemcntatin U Total monthly dose should not exceed 450 mg Maximum volume per injection site should not exceed 3 mL U 10 to 15 times daily oral dose depending on clinical response2 with oral haloperidol Decanoate HALDOL can be used during periods ofdose 50 I HALDOL Decanoate adjustments 100 (h.IodoI) T lIsuIg a ammsiy oily. lusts pmaIb, compk. ,scdbEn iuIsrmaon in HALDOLs HkD Dscaaoa -4 tONTRAIICAT1ONI Smce the pharmacog and cmc xo of KkDOI Decanoate 50 and NALDOLDecanoate 1 are attflbuted to H*iDO1 hatopefld the xtM medcabon, CONTRAINOATIONS,WARNINGS,and addon Utormabon are those of HALOOLmodified to reflect tt prolonQedtioit HkD o controddicated in severe toot ceatod nervotmsm premoon or comatose states from any causeand in#{241})divduais whoare hypersensitiveto did drug orhave Parkmsoos disease. WARIIPIG$:TIrdM DysEkissla: Tardivedysisnesi a syndrome consot ot potenhafly rreveodbl involuntary,dysisnodc mements may deodop in patodts tread edth anflpsychohc dmgs. Althoughthe preodence ofthe syndmme appears to be isghest among the isdedy, aspe dertywomen, d o enposmb to retyupon preodence bmatas to predict attt ncepfionotanfipsychofictreatment wflfl pahents am hedlyto developthe nymdrome.Whether anfipsychoficdnig products differin then potented to cause tard dysidnena is unknown. Bothfl osk of deodopisg ta(dM dysisneod ami the kkethood that dwdl become irreversdi are ved to ncrease as the dumfion oftreatment and tt ted cumisatiea dose of anfitmychote:drofisadministered to the it nn:rease.Hnr, the syndmmo can dendop, aJthoih much edo commordy, aften reedvely brief treatment penods at w doses. There o no known treatment for essafifished cases of tard dyskasesia aIthotfl the syndrome may mmd. mty oncompletely, danfihOI trement is withdmon. Mtipsychoeictreatment, died, howeesr, may suppress (an rtiay sopp(ess)ttm signs and symptonm of the sysdmme and thereby may possibty mask the underlyingpross. Tfn effect fled nymptomat soppressmn Z upon the konQ1ermcourse of fl syrismme o unedn. Gwenthese consiserahons, anhpsychotc dni shoskt ed prescisbed is a manner fled is most Iy to nenmoze the xcurrence of rthes dysiosesa Chmn anfipsychot treatment shoukt enery be reserved tor edo sofferfrom acflroni itkresstfoat1)o kno to respond to anflpsychoeicdni, and 2)torntrorn atternafl equallyeffectsie, but tess harmfultreatments am no avadaise or appropisate. In patatnts who do requne chmmc treatment the snodtest dose and the shortest durahonof treatment producm9a sahstactory dinis responseshosidbenaught TheneedforcondonedtreatmeisthouI he reassessedafty. Usons andsymptomsoftardsiedysknessiappearina paflenton aohpsychohcdrog disconfinuahon shoukt he considered. Hovec, somo patients may requne treatment despde the presence of the syndrome. (Fortorther flrformahonabotdttn descispIon cdtarderedystenesiaaod ff5deheat detechon, ptease referto ADVERSERETIONS.) Nsc $s (N A potenhaflyheat symptom com#{216}eo somehmes referred to as Neurisepti Matoaot Syndrome (NMS)f been reported tnassociahnn edth asflpshot( dregs. Ghnicatmandestahoes at NMSam hyperpyreis&muscat rdy, attend menstus(inctudir coseon sigtro)aat esidence ofautonom nrstty(irregular puise or isood pressum tachycardi diaphoresis,and condiec dysrh1hnoas). Adddionatsrm may urctudeatevaedtcreatho phosphisunase, mysgteisnuho(rhabdomyisysm)aod ute rend The diagnostc evatuationof pahents edththis symirome o conyatcated fl arrivv at a diagnosis, d o impoflantto isenhfy cases wherethe choecat presentation includesboth seflous medat iNness(e.g,pneumonasystemi erlechon, etc.)aod untreatedor inadequatelytreated eotrapyramidat ogro and sym (EPS). Other impodant consideratmns inthe ddlerentnddiagnosis Uododecentrat anhchohoerg toiscdy, heat stroke, dregteesr and pismarycerflratnermo system(CNS)pathotogy. The maoement of NMSshouh inchide 1) immediatedisconhnuahon of anhpsychoflc dregs and other drugs not essenthe to concurrent therapy, 2) ntensree symptomafic treatment and method monftoisng,and 3)treatment ofanyconcomdant seflous method proteenroforwhch specifictreatmentsareavadibk. Thereis nogeneris reemerdabout stecific pharmacologacattreatment remerm for uncnmphcated filMS.fi a patient requires anflyshot dreg treatment after recoveryfrom NMS, the patented odntrodoctisnofdnig therystroukt hecarehiftycOns$dered.Thepaflentshouid hecarefuffymoistored, once recurrences of NMS have been reported.ttyperpflleolaand heat stroke, rotassociated withtheabove symom compIe havealso been reported withHALDOL heap Pmpacy(sea PRECAUTKtNS - Usain Pregnancy) camI UN W U1um:(sea PRECAU11ONS-DrUg Interachons) GsNra Bronchopneumnni snmehmes tat has ho am of anfiterychoficdregs.incsidir odognodotProm remededtherapyshonAt he rosfitotedd dehydration, hemoconcentratmo or reducedpulmonaryntntdahonoccur,especiodyn theteddy. Decreasedserumcholesterd andisr cutasenes and acsiar changes kent been reported eath them-rekeed drugn, atthough not eath hatopefldoi See PRECAUTtONS tnlormabon for Pahents for intormafionon mend andierphyncat atethesand on concoodtent usewdh othersobstences. PRECAUTiONS:Mmsnister cauhousty to patents: 1) wrth severe cardiovascuko thsorder due to the possthuldyof transrent hypotenoon and/or preapitahon olaogAratn)davasopressor is required,nnephnneshosid not he used since HALOOImay blockttsvasopressorachvdyand paradoiscatfurther Hweflngof blood pressure may occur metararnino),phenylephflseor norepmephflre shouH he used); 2) recer anficonvuisardmodcokons, edth a hotory at seizures or who EEGahnormatdies, because HALDOImay isrfl convokevethreshoot. fluidceded,ateqUateWbCOnVOISant theryshOUH be concomHArttynskntaaned;(3)w*h knownateogno ora historyof atterg( machorn to dregs; )4) recerving articoagulants. since or notated instance of interferenceoccurred with the effects of one anticoagulant )phenindione). Concomdantanhpattdnson medafion, Hrequired,mayhaveto he confinuedafter HALDOLn disconhmed because of ddterent excrefionrates; d both are disconhnued snouIneousiy, extrryrantttA synrorrm may occor. Intraocolarpressure may iscrease when antichotnergic drugs, wrdodnrganflgsrtonson drugs, am odrmootered concormtanffyeath HALOOLWhen HAW is used for owes in tepoter disorders, there may be a repel mood swmg to depression. Severe nesratoocfly may occur in pahents wok thyrotoiscoso receromganhpsychofic meduiotuir mctudingHALDOL. Wsi*Iu ed PIsutr Mentis ardor physicat abdfiinsreqiared for hazardoes tasire or drerug may be impaned Aicohidshount he avoided dueto pOSSdeeoddOiVeefteCtS and hypotension Drip hdsmchout Pahents receskng kthium pbs hatopendis shosid he monoored cuisidyfor eady evidence of seuhoogat toiscfiyand treatmont disconhnued prornpttyfisuch sigosappear. As edth otheranhpsychohc agents, 0 shount he noted that HALDOLmay he capabteof patesflaflogtNS depressants such asanesthefics, opotes, aodaicohid caicio . ipakusW ii Feff No matageho potentid of hatopendcdwas found in the Ames Satmoneta n*rooonot achvaiion assay. Negafiveor erconsistent posdon fodugs have keen obeaned ir a, wOnid re ides studies of effects at hatopeisdcdon chromosome structure and number The available cytogeoetic evidence is considered too inconsistent to he conctusive at this fime. Carcisogencty stunted orat odopefidis were conducted n Wntar rats)dosed at up to 5 mgthg dy for 24 months)and mAJtenoSatss nice )desed up to 5 mgliQ HA ton 18 months).tr the rat study surevat was edo than openrot is ott dose groups reductug 9 number at ratsat flsktor developingtumors. Hor, atihotigha relaMy greater nundrer at rats sinvoed to fl tint atthe study n hh dose node aid temate gmup these aismals did nat havea greater incidenceattomors then contris aimats. Therefore,altho4 not opfimat,this study does suggest the ahsence at a fndopefldcdrotatedincrease ui the iscotence at neoptesia ii rats at doses up to 20 horns the usuat doty human dose terchrononresotaotpienes. trtemmisett5and2Oflmesffrehflestnded dadydosehothrooicor resished patients, therewasastahshcaffysignthcant nicrease in mammary gtand neo#{216}asis and tent tumor rocidence;at 20 tidies the same dady dose there was a stahshcoty sniflrant increase In pdufiarygtend neoptasia In male m no stahstlcaflysigrdficantdifferencesin inddences at totat tumors or specthc tumor pes were noted. Anhpshot dregs idevatepnntactn veis; theetevahon porsots duflng chmoiodminitraflon Issue cuflureeopeflmeeds indatn that ugproism&y one-druidat human breast cancers am prolacbn dependent is idtro,a factor at potenhat Unportanceif the #{149} 10 to 15 times daily oral dose depending on clinical response2 . 1120 times the daily oral dose is used, monthly dose should be reduced based on clinical response (by approximately 25% of the original dose, each month for 2 months) until appropriate maintenance dose is reached3 until steady state has been achieved. prescnpflon at these dregs o coirteni1ated in a pabent with a preidoustydetected breast cancer. Althoughdisturbances such as gatactorrhet amenorrhea gynecomasb&and kepotence tens been reported,the cbrdcatsnificance at elevatedtenon prokechntends is unknownfor most patients. do increase n mammay rwo#{216}asois has beer found in rodente after chroisc ednuidsOratiOnat anfipoychoficdregs. NidtherctrWcat studies nor epideeneato$ skated conducted to date,hnoer, Poseshownan associahontatweer thmoi odmoristrahOr at these drugs and mammaiytumoisgenesis: theavaitabItevidence iscOns)deredtOOlimied to beconctusiveatthisbnw. Use,. to Pviguoc PregruocyCategory C.Sate use in pregnancyorinwomenOkidytohecomeprnatif has not been estabtehed; useMy if benefitCteaify)UShfieS potentot hazardstothe fetus. N Methenc tnfantsshoute not be nursed duflng drug treatment Petetrfc Use: Controtedtrislsto estabhohthe safetyand effechvenessof intrarnuscuteradminitrahon in chddren havenot been conducted AOVERU REACTiONS:Adverse machoes fotmwmgthe edministrahor of HALDOLDecanoate 50 or HALDOt.Decaooate 1HAare those at HALDOLedopefldot Suice vastexpenence hasaccamufated edth HALDOLtheadveise macboos am reported forthatcoinpourid as t astor hatopeisdo)decanoate. Made at in medicahons, iscatbssoe machoes hans been reported who huopefldd decaooate. csisEIci EThymm Syu#{216}oms($)- EPS doflyp theabniisstrahon at HALDOI(fatopefldot)have teen reported frequenfly,often duisug the first few days of treatment. EPS can be categonzed generafly as Partunson-like symptoms, akethisia,or dystonis (inctioting opisthotonosandacidogyriccrisis).Wtd aftcan occurat refafivety doses, they occar morefreguenttyandwithgreaterseesnityat tegher doses. The synoptonromaybe coiflrofed withdose reductionsor odministrafionat anhparfdnson drugs such as berotropore mesytate USP or thhexyphenid)1hydrochuidde USP. f shotid he noted that persistent EPShans teen reported;fla dreg may have to be disconfimuedin such cases. WftbIrIWII Emst Nsmio,ic& $os - Abrupt disconhnuahon of short-term anh-psyshnhc therapy is generallyunenentful. However,some pahentson matntenance treatment eugeisencetraruterd dystenefic signs after abrupt wifhdrawat.tn certisr cases these am indishnguishabtefreonTarthve DysuinesiaвЂќexcept for durahon, ft is unknown whethergraduat Wifhdrawatad) reduce the occurrence at these signs, but unfi)further evidence is avistebteHALDOLshouot be graduoty wfthdrawn.TardlvsDystdossia - As who at) anttpsychoficagents ItALDOLhas beenassocatted wifhpersisttmdysidnesias. Tardise dysidnesi&asyndronu consisbog of poterthaflyirreversth1 inviduntary,dys#{149} uinetc monements, maypear insorne pabentson king-termtheryor may occarafterdnig thery has been disconhnoed. The flskappeais to begreater is eldedy patents on h#{231}h-dosetherapy, especaNyfemales. Thesymptomsam persistentand insnow patients appearirreversisle Thesyndromeis charactenzedby rhylhskcatinvotantarymovementsat tongut fain, mouthor w e.g., protrusionat tongue,puffingat cheetu, puckenng at month, chewng moesments). Sometunes these may be accompaised trj iruntaty mmests at erifrenibes and the trunk There o no knowneftecbve treatment for tendon dyshmesia anbpartenson agents usuafty do not aJeidate fla penifonre at that syredrome. fi n suggested that at)anbpsychot agentsbedisconhooedfithesesymptomsappear.Shouhiifbe rwcessatyto rnnstihdetreatnoen or kicrease thedosageof the agent or switchto a differentanhpsychot agent, this syndrome may he masked. ft has been reportedthat floe venrmcutermovementat the tongue may he an earfysign at tardsie dystunesiaand ifthe medicahon is stopped at that how the fat) syndrome may not devetop.Titles Dysloufa - Tandsiedystona not assoaated edth the above syndrome, has aiso been reported. Tardise #{216}ystorila is charactenuedby detayedonset ofchoroc ordystoruc movement is often persistent, and hasthe potenhatat becoming irreversdot fiber NS Efiscis - )nsornn resttessness, anroety, euph* agifahon, drowsiness, depression, )ethargy, headache, contusion, verfigo, grand mat sesiurns, and enacerbatuin of poychof symptoms inchidinghafluctnahons,and catatoioc-)ikebehaidOot states wfoch may he responsive to drug withdrawatand)ortreatmentedth anhchokneypcdrugs. Bodyas a Wsfs: Nesr mahgnant syndrome )NMS),hyperpyreroaand heat stroke have been reported ado HALDOL.Sea WARNINGS forfurther intormahonconcerningNMS.) Csidtevaacalat Bisdi Tzhycard hypotension, hypertension and EcG changes, iscludAigpridongahon of fla O-Tirftervatand EcGpattern cfwngescornpahhte withthe pofymorphotoconfigurahon attorsades do porntes. Nimaite#{231}k Efl.c Reports at mALusuaty transient edhOpemaand teukocytosis,nodmat decreases ot red Hood cef counts, anernj ora tendencytoward monocytosis; agceoidosy1osisrarefyreported and My inassocishonwhoOthesmedahOn. UWEIPIdE tmred fiverfUnctiOnanWorureiice. OsiiiaI AsasDoerMaradopapufarandacneifonn machors,isofatedcasesofphidoserottMty,isss at hur. EndocetueDteoodsnc Lactahon, breast engorgenient, masta menstniat irreguhohes, gynecomas* impotence, increased libido, hypergceini hypogcernisand hyponatrern GastrointeetloalBhctt Anorexj consbpahon, diarrhea hypersatsiahon,dyspepsa nauseaand vomifing AiNomic Rudloos: Drymouth, blurredvision, urinaeyretenhon, diaphoresis and priapism. Rssoiy tecf Laryogospasin,bronchospasm and ircreaseddepth at respirahon. s_I Sins Cataracts,rehhyandidsuat disturbances. mlii,: Cases atsudder and anexpected death bans teen reported inassociatior withthe administrabonat HALDOLThe natureatttw evidence nodies if impossible to determine deflnthvelywhat rote, if any, HALDOLplaynd in the outcome at the reported cases. The possdoldy that HALDOLcoused death cannot at cours he erduded, bid if is to be kept vi mod that sodden and uneopected death may occur vi when theygo untreatedoration theyamtreated wiffiOthenanhpsychObrdrugs. Psaait Eneir Hyperammonema has teen reported ina 5/ year old cfnd with citrolhnemi an inherded disorder at ammonia tomehoe, tidtuedngtreabneeifidth HALDOL. PORTAIIT: Fell dbadieiwtenaeaalmete be read before NALD or NALD Decaneats prodacteats edmtetensd anpnescotbad. Fot*rmatfse ooppmptsssauhoaImudetevseteaap, see tell prsscdbhig hdonoalloa. Theshoif-achug HWDO1inform isuiteodedoisytoracid&yagdated psychohcpahents who moderatidyseoeretovesysevereponp(orns. 1th192 1. DaviiJM, KanCJM. Marder SR.,et al. Dose response oiprophybctk antipsychotics J a: Piyb:a. 1993;54(suppl 3):24-30. 2. HALDOL2 DecanoatePackc risen. McNeil Pharmaceutical. Spring House. PA i94вЂќ. Revised 0/13/92. 3. Ereshefsky L. Toney G, Lyman RL Saldad S1 Anderson co, RichardSAL. Halopendoldecanoatc an effective dising strategy. Presented at the American Psychiatric Association 44th Annual Meermg. May 991; New Orleans, La. Rcferc&es; 1вЂ™ McNEIL PHARMACEUTICAL RARITAN, 08H02978/02-i4-95 NEWJERSEVOSeOG0002 NOVA P0001000UOICALS I I - HALDOL /morr/i Provides the protection with no increased X T E N 1) 1 N G consistent from relapse... risk as compared E most to oral PROTECTION of side therapy Fioi HALDOL#{174} Decanoate (HALOPERIDOL) V \{ i INJECTION effects R #{128} L A P S E 100 100 rng/mL % 4вЂ™ SheвЂ™s anxious. SheвЂ™s agitated. She canвЂ™t sleep. SheвЂ™s depressed. Paxil effectively relieves depression and associated symptoms of anxiety.14 60% to 90% of depressed patients exhibit associated symptoms of anxiety such as agitation, sleep disorders, weight lossand gastrointestinal problems56 Incidence of agitation with Paxil iscomparable to placebo (2.1% vs 1.9%);incidence of nervousness and of anxiety vs placebo is 5.2% vs 26% and 5.0% vs 2.9%, respectively7 Most common adverse events include: nausea, somnolence, asthenia, dizziness, insomnia, sweating, ejaculatory disturbance and other male genital disorders*7Concomitant use of Paxil in patients taking monoamine oxidase inhibitors (MAOIs) iscontraindicated. вЂ�Incidence of 5%or greater and incidence for Paxil at least twice that for placebo Please see brief summary of prescnbing information on adjacent page of this advertisement ONCE-DAILY 20 MG hC/ LIFTS DEPRESSION. LOWERS ASSOCIATED ANXIETY SYMPTOMS. 3 Sm,thKhne Pharmaceuticals Philadelphia, PA 19101 Beecham _____________________________ В© SmithKline Beecham, 1995 Body as a Whole: headache, asthenia, abdominal pain, fever, chest pain, trauma, back pain. Cardiovaacular: palpitation, vasodilation, postural hypotension. Dermatologic: sweating, rash. Gastrolnteetinal: nausea, dry mouth, constipation, diarrhea, decreased appetite, flatulence, vomiting, oropharynx disorder, dyspepsia, increased appetite. Musculosk&.tal: myopathy, myalgia, myasthenia. Nervous System: somnolence, dizziness, insomnia, tremor, nervousness, anxiety, paresthesia, libido decreased, agitation, drugged feeling, myoclonus, CNS stimulation, confusion. Respiration: respiratory disorder, yawn, pharyngitis. Special Senses: blurred vision, taste perversion. Urogenital System: ejaculatory disturbance, other male genital disorders, urinary frequency, urination disorder, female genital ONCE-DAILY IAKL PAROXET/NEHC/ disorders. Studies show a clear dose dependency for some of the more common adverse events associated with Paxil use. There was evidence of adaptation to some adverse events with continued Paxil therapy (e.g., nausea and dizziness). Significant weight loss may be an undesirable result of Paxil treatment for some patients but. on average, patients in controlled trials had minimal (about 1 Ib) loss. In placebo-controlled clinical trials, Paxi/-treated patients exhibited abnormal values on liver func- References: 1. Dunbar G, 398. 2. cohn cohn JB, Fabre LF, et al. BriPsychiatry. 1991;159:394JB, Wilcox J Clln Psychiatry. 1992;53(suppl): 52-56. 3. Feighner JP, Boyer WE JCIIn Psychiatry. 1992;53(suppl):44-47. 4. Fabre LE J Clln Psychiatry 1992;53(suppl):40-43. 5. Sheehan D, Dunbar G, Fuell DL. Psychopharmaco/Bull. 1992;28:139-143. 6. clayton PJ, Grove WM, coryell W, et al. Am JPsychiatry. 1991 ;148: 1512-1517. 7. Paxil (paroxetine HCI) Prescribing Information. cs. PAXIL (brand of paroxtine tion tests hydrochloride) See complete prescribing information In SmithKllne Beecham Pharmaceutior PDR. The following is a brief summary. AND USAGE: Paxil is indicated for the treatment of depression. CONTRAINDICAT1ONS: Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated. (See WARNINGS.) WARNINGS: Interactions with MAOls may occur. Given the fatal intractions reported with concomftant or immediately consecutive administration of MAOls and other SSRIs, do not use Paxllin combination with a MAOI or withIn 2 weeks of discontinuing MAOI treatment. Allow at least 2 weeks after stopping Paxil before starting a MAOI. PRECAUTiONS: As with all antidepressants, use Paxil cautiously in patients with a cal. literature INDICATiONS history of mania. Use Paxil cautiously in patients with a history of seizures. Discontinue it in any patient who develops seizures. The possibility of suicide attempt is inherent in depression and may persist until significant remission occurs. Close supervision of high-risk patients should accompany initial drug therapy. Write Paxil prescriptions for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose. Reversible hyponatremia has been reported. mainly in elderly patients, patients taking diuretics or those who were otherwise volume depleted. Clinical experience with Paxil in patients with concomitant systemic illness is limited. Use cautiously in patients with diseases or conditions that could affect metabolism or hemodynamic responses. Observe the usual cautions in cardiac patients. In patients with severe renal impairment Icreatinine clearance <30 mLJmin.) or severe hepatic impairment, a lower starting dose 110 mgI should be used. Caution patients about operating hazardous machinery, including automobiles, until they are reasonably sure that Paxil therapy does not affect their ability to engage in such activities. Tell patients 11 to continue therapy as directed; 2) to inform physicians about other medications they are taking or plan to take; 3) to avoid alcohol while taking Paxil; 41 to notify their physicians if they become pregnant or intend to become pregnant Concomitant warfarin. during therapy, or if theyвЂ™re use of Paxil with tryptophan When administering Paxi/with nursing. is not recommended. cimetidine, dosage Use cautiously adjustment with of Paxi/after the 20 mg starting dose should be guided by clinical effect. When co-administering Paxil with phenobarbital or phenytoin, no initial Paxil dosage adjustment is needed; base subsequent changes on clinical effect. Concomitant use of Paxil with drugs metabolized by cytochrome P450llD6 lantidepressants such as nortriptyline, amitriptyline, imipramine, desipramine and fluoxetine; phenothiazines such as thioridazine; Type 1C antiarrhythmics such as propafenone, fecainide and encainide) or with drugs that inhibit this enzyme (e.g., quinidine) may require lower doses than usually prescribed for either Paxil or the other drug; approach concomitant use cautiously. Administration of Paxil with another tightly protein-bound drug may shift plasma concentrations, resulting in adverse effects from either drug. Concomitant use of Paxil and alcohol in depressed patients is not advised. Undertake concomitant use of Paxil and lithium or digoxin cautiously. If adverse effects are seen when co-administering Paxil with procyclidine, reduce the procyclidine dose. In 2-year studies, a significantly greater number of male rats in the 20 mg/kg/day group developed reticulum cell sarcomas vs. animals given doses of 1 or 5 mg/kg/day. There was also a significantly increased linear trend across dose groups for the occurrence of lymphoreticular tumors in male rats. Although there was a dose-related increase in the number of tumors in mice, there was no drug-related increase in the number of mice with tumors. The clinical significance ings is unknown. There is no evidence of mutagenicity with Paxil. Serotonergic Impaired compounds reproductive and post-implantation are function losses, known to affect reproductive in rats (i.e., reduced decreased viability pregnancy of pups) was function of these findin animals. rate, increased found pro- at Paxil doses 15 or more times the highest recommended human dose. Pregnancy Category B. Reproduction studies performed in rats and rabbits at doses up to 50 and 6 times the maximum recommended human dose have revealed no evidence of teratogenic effects or of selective toxicity to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Paxil should be used in pregnancy only if the benefits outweigh the risks. The effect of Paxi! on labor and delivery in humans is unknown. Paroxetine is secreted in human milk; exercise caution when administering Paxil to a nursing woman. Safety and effectiveness in children have not been established. In worldwide Paxi/clinical trials, 1 7% of Paxi/-treated patients were 65 years of age. Pharmacokinetic studies revealed a decreased clearance in the elderly; however, there were no overall differences in the adverse event profile between older and younger patients. ADVERSE REACTiONS: Incidence in Controlled Trials-Commonly Obs.rv.d Advrs Events In Controlled Clinical Trials: The most commonly observed adverse events associated with the use of Paxil(incidence of 5% or greater and mcidence for Paxil at least twice that for placebo): asthenia 115% vs. 6%), sweating (1 1 % vs. 2%), nausea (26% vs. 9%), decreased appetite 16% vs. 2%), somnolence 123% vs. 9%), dizziness (13% vs. 6%), insomnia (13% vs. 6%), tremor (8% vs. 2%), nervousness 15% vs. 3%l, ejaculatory disturbance (13% vs. 0%) and other male genital disorders (10% vs. 0%). Twenty-one percent (881/4,126) of Paxi! patients no more frequently than placebo-treated patients. Other Events observed During the Premarketing Evaluation of PaxM During premarketing assessment, multiple doses of Paxil were administered to 4,126 patients, and the following adverse events were reported. Note: frequent = events occurring in at least 1/100 patients; infrequent = 1/100 to 1/1000 patients; rare = less than 1/1000 patients. Events are classified within body system categories and enumerated in order of decreasing frequency using the following definitions. It is important to emphasize that although the events occurred during Paxil treatment, they were not necessarily caused by it. Body as a Whole: frequent: chills, malaise; infrequent: allergic reaction, carcinoma, face edema, moniliasis, neck pain; rare: abscess, adrenergic syndrome, cellulitis, neck rigidity, pelvic pain, peritonitis, ulcer. Cardiovascular System: frequent: hypertension, syncope, tachycardia; infrequent: bradycardia, conduction abnormalities, electrocardiogram abnormal, hypotension, migraine, peripheral vascular disorder; rare: angina pectoris, arrhythmia, atrial fibrillation, bundle branch block, cerebral ischemia, cerebrovascular accident, congestive heart failure, low cardiac output, myocardial infarct, myocardial ischemia, pallor, phlebitis, pulmonary embolus, supraventricular extrasystoles, thrombosis, varicose vein, vascular headache, yentricular extrasystoles. Digestive System: infrequent: bruxism, dysphagia, eructation, glossitis, increased salivation, liver function tests abnormal, mouth dysarthria, dyskinesia, dystonia, euphoria, fasciculations, grand mal convulsion, hostility, hyperalgesia, hypokinesia, hysteria, libido increased, manic-depressive reaction, meningitis, myelitis, neuralgia, neuropathy, nystagmus, paralysis. psychosis, psychotic depression, reflexes increased, stupor, withdrawal syndrome. Respiratory Syst.m: frequent: cough increased, rhinitis; infrequent: asthma, bronchitis, dyspnea, epistaxis, hyperventilation, pneumonia, respiratory flu, sinusitis; rare: carcinoma of lung, hiccups, lung fibrosis, sputum increased. Skin and Appendages: frequent: pruritus; infrequent: acne, alopecia, dry skin, ecchymosis, eczema, furunculosis, urticaria; rare: angioedema, contact dermatitis, erythema nodosum, maculopapular rash, photosensitivity, skin discoloration, skin melanoma. Special Senses: infrequent: abnormality of accommodation, ear pain, eye pain, mydriasis, otitis media, taste loss, tinnitus; rare: amblyopia, cataract, conjunctivitis, comeal ulcer, exophthalmos, eye hemorrhage, glaucoma, hyperacusis, otitis externa, photophobia. Urogenital System: infrequent: abortion, amenorrhea, breast pain, cystitis, dysmenorrhea, dysuria, menorrhagia, nocturia, polyuria, urethritis, urinary incontinence, urinary retention, urinary urgency, vaginitis; rare: breast atrophy, breast carcinoma, breast neoplasm, female lactation, hematuria, kidney calculus, kidney function abnormal, kidney pain, mastitis, nephritis, oliguria, prostatic carcinoma, vaginal moniliasis. Poatmarketing Reports Voluntary reports of adverse events that have been received since market introduction and not listed above that may have no causal relationship with Paxil include elevated liver function tests (the most severe case was a death due to liver necrosis, and one other case involving grossly elevated transaminases associated with severe liver dysfunction), toxic epidermal necrolysis, priapism, thrombocytopenia, syndrome of inappropriate ADH secretion, symptoms suggestive of prolactinemia and galactorrhea, neuroleptic malignant syndrome-like events; extrapyramidal symptoms which have included dystonia, akathisia, bradykinesia, cogwheel rigidity, hypertonia, oculogyric crisis (which has been associated with concomitant use of pimozide), tremor and trismus; and serotonin syndrome, associated in some cases with concomitant use of serotonergic drugs and with drugs which may have impaired Paxil metabolism (symptoms have included agitation, confusion. diaphoresis, hallucinations, hyperreflexia, myoclonus, shivering, tachycardia and tremor). There have been spontaneous reports that abrupt discontinuation may lead to symptoms such as dizziness, sensory disturbances, agitation or anxiety, nausea and sweating; these events are generally self-limiting. DRUG ABUSE AND DEPENDENCE: Controlled Substance Class: Paxil is not a controlled substance. Evaluate patients carefully for history of drug abuse and observe such patients closely for signs of Paxil misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior). BRS-PX:L8 in worldwide clinical trials discontinued treatment due to an adverse event. The most common events (1 %l associated with discontinuation and considered to be drug related include: somnolence, insomnia, agitation, tremor, anxiety, nausea, diarrhea, dry mouth, vomiting, asthenia, abnormal elaculation, sweating. The following adverse events occurred in 6-week placebo-controlled trials of similar design at a frequency of 1 % or more. ulceration, rectal hemorrhage; rare: aphthous stomatitis, bloody diarrhea, bulimia, colitis, duodenitis, esophagitis, fecal impactions, fecal incontinence, gastritis, gastroenteritis, gingivitis, hematemesis, hepatitis, ileus, jaundice, melena, peptic ulcer, salivary gland enlargement, stomach ulcer, stomatitis, tongue edema, tooth caries. Endocrine System: rare: diabetes mellitus, hyperthyroidism, hypothyroidism, thyroiditis. Hemic and Lymphatic Systems: infrequent: anemia, leukopenia, lymphadenopathy, purpura; rare: abnormal erythrocytes, eosinophilia, leukocytosis, lymphedema, abnormal lymphocytes, lymphocytosis, microcytic anemia, monocytosis, normocytic anemia. Metabolic and Nutritional: frequent: edema, weight gain, weight loss; infrequent: hyperglycemia, peripheral edema, thirst; rare: alkaline phosphatase increased, bilirubinemia, dehydration, gout, hypercholesteremia, hypocalcemia, hypoglycemia. hypokalemia, hyponatremia, SGOT increased, SGPT increased. Musculoskeletal System: infrequent: arthralgia, arthritis; rare: arthrosis, bursitis, myositis, osteoporosis, tetany. Nervous System: frequent: amnesia, CNS stimulation, concentration impaired, depression, emotional lability, vertigo; infrequent: abnormal thinking, akinesia, alcohol abuse, ataxia, convulsion, depersonalization, hallucinations, hyperkinesia, hypertonia, incoordination, lack of emotion, manic reaction, paranoid reaction; rare: abnormal electroencephalogram, abnormal gait, antisocial reaction, choreoathetosis, delirium, delusions, diplopia, drug dependence, SB Smsthkhn. 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Indexes Psychiatric Services is covered in index Medicus, MEDLINE, Psychological Abstracts, PsydNFO, Social Science Citation Index, Cumulative Index to Nursing and Allied Health Literature, Current Contents, Excerpta Medica, Hospital Literature index, and other indexes and databases. The journal in December. November publishes 1995 an annual Vol.46 index No. 11 Because lives complicated by psychosis further complicated by EPS. are вЂ�15 C E 8 15 31% 20% 13% 16% 13% 2 6 10 nsperidone placebo 16 (mqJday) Spontaneous complaints of EPSin North Amencan clinical tnal (n=51 3). *Mtipsychotjc efficacy was demonstrated in a dose range of 4 to 16 mg/day in clinical tnals, supporting the effectiveness of RISPERDAL Doses above 6mg/day were not shown to be more efficacious than lower Risperdah.fr R ISPE1 I[)(I)NJ E #{149} symptoms and demonstrated and adverse an not increase effects. inevaluated extrapyramidal safety of doses 16 other mg/day has been The in dinical above trials. Please see the brief summary of Prescribing Information adjacent to this ad. В©Janssen Pharmaceutica Inc. 1995 __________ h2.3-4mg tablets a JPI-RS-123C A first choice in psychosis. In vitro studies indIcate that rridone Ia a relatively weak Inhibitor ci cyhoctircnia PlD, arid la not sapsc$sd hr situhulaly Wild Vu dsswice ci th=*.Houses, dsicito A choice in psychosis. first __ RISPERD*L#{149} (T 8.1cr. prucdbing, consul coMp* pt.wIbng kouIon of iWcli lelolloulna a bdofsumwy. #{149}IDICAT1OI6 AN#{246}IAG RISPEROALвЂ™ dcisd for meilgemed the maofseIoo& I*.oIdelL OIITRAiNDICATIONS: RISPERDAL#{176}contmiidca$sd m patients with a Scm. (NMS) I mikaco moiIoie bee repodud m a,oan ______ edi* th#{231}th.dIat*Ib.caayanudMt iicseainenoas NMShSbNn Mi I a T!e&loL mpoflst A ayn*om. of Iy sbs, iofey dvdnsc movsmeis may cv.k; m hiadah esyhaaugi *Mmu#{216}ith. pievienca ci the sdroma appears to be Ngh.st among the aldsdy, sepeciaMy alderly manei 1 s cssb isly icn pFSValInOSISnISSPIeb. alIve limp - f wd $yVI#{231}IOmSOIIanM dysidnesis pserm a pei1cn R1SPERDAI., iMig deconinuion alocid be conideret I4omar, acne pilents may reqwre ItsWieci ciii RISPERDALвЂ™W*ptsssnc. cite ayr#{243}cme. Potential for Proarrliythmlc Efbcts: Riaperidon. and/or 9.hydroxy. IdoM 3pS$ nhen the 01 mval i erme ps* alioi4i them no emi Weiss i Pealed psi* i al 12.16 m9y, eel thovethe meommei#{224}d dest Omerdei Vial pcdon the 01 smal have been aaoc aled Mth the xcwmnm ci mder de pcia. a lethisdanlig wh1hmir Bm de iithalsm, eoncom ma cith other des th p big 01, er ie .enm ci cang.nl pmloncn m 01 i licreem the h brccoirmiimci1#{224}wIiin ooma& H$1othMIoa. RISPERDAL#{149} may Widece mtho hpcIeneicn ai deziess, ticerda. aid Ii ermaith, seccp. eayedaly m i*al doss1on psdo prcb mlsofng aha.eenevc wdaoiiic piccei The ,Ii ci oithoi* mnuian sal aempe may be mininbed by hnIng the ii#{225}al doss b I m BID m cocci Ub aid 0.5 n BID rn the ekIand pe,dawIth renal er1iepc i#{231}imeci(See DOSAGE NC ADMNSTAATIQI4 A dose isdecion aliccid be ccnldamd I hpcIsnsion xcits RISPERDAL aliocid be used ciii p.bcciw caalcn ii pes eli known caniovascube claeaae (hialoly ci iayocelal ofeofon behenim, best ta o condectlcn denormalls), cembrovaeciiar 1aeaa and elch woiAdpreilupase perU hypcthnsian (dehp&alici hypovclsnj sal odiad - :: pJSpEpnAIe I4wlimath: be used csdeuuly A. eli w #{149}m nta &up thal elagonbe eli dopsalne a tisloiy ci D ramp Tissis cithum .ay.dmsib #{225}idic1st appraidmisly taiNt imii we prciac depended Ii *0, a tader ci palm pmertliui ci the. &m#{231}a Iconimaybeed Ii ap*rdalth prealo detected breast cancerS A. is common with conipounde eltich we.NlmN SI lmcM ki plmy munny mi sal mpcmde: blal cal hWeipl s&maschivedic the layeddan. camnc.nicIy *idln. ccnaldsd ii rain. sal el (S.. CARc1NOGBIES1S) H, neither aliddd alialan ner ayidsddolo audi. ccndaclsd hem ahesi an esodalmi between ciwamic skmddddon ci ida s ci &u aid kimoisnMs bi bems* the avle evidence lmcanmidsied o lmsdb Iid athiiinl*on. ci hiana Ir#{231}cibeim I Ira Iw Scemolsam a caimmnaaly repail.d and dose4eled steams meal ansoceded ciii RISPEADAI? tree. meat Since RISPERDALвЂ™ has the potential to bTia udgmeal thinldn or molar ddI chci#{225}d be cethaned tctd cperelig hasadaus ndinsy, maddemmsancethiIVSPERDk thempy dean nc*althsm advsm4 Raren.eescl sm have been repcdst A aln#{216} cane ci TIP wan rupoitsd m a 28.aar-old female pedeid remiving RISPERDk?Tt*mlicnal#{231}lRISPEIAL thSIVlmIAmn.IL Fdone Pes WI ualuanc alhal ii sdmala II sisal may also coot ki tunsi add may ma ciessal $VIIeSOmIcimaalOU9eII1CeI dnigaor tdcoMlaisiuth an bae#{227}iicbliucci ASy.ay1deCm.. salbainbemor. caiaii I adaled stem aISOtlmQPSIda edia el beeayo.sd blsmpsr ThelItyci a anIddeSIric ichemid ii sthizcphrerda, and di#{231}t mod pdde,* mmngamesd bIOIdSrk radeantha IIkcimaIdOSS. Clrdcal impedance eli RISPEHDAI.вЂ™II pedemis eli ceitin comicoudlati aye. hula lassase la lmnlst Csdan la shwisula m pulsals eli alssanss orco, ilians hal aside allsal malohsm ci bsmodnmdc maycrest Osmaise cite AskaciOsthOalic hepalmnian sidOl ptolonpio, cualon shoald becbesrvsd bicsrdlacpisrds(Sse WARNINGSwd PRECAUTiONS). hr pulerds eli severe renal Impskmsid (cmulr*e dssrsrce 40 mLM*1.73 mвЂ™), oreli sevsrs hspudc hnpsimiss a baeeraludagdosealioiidbe uset Ptisr*s shoidd be sMssd ci the rho ci lmof anperialy altO krgthe pedodci hilti dose lisbon. Ptisnts shoide be car*icnsd shcib cperting hszudous manhijery, hrchialng adamcbllss, raIl they we ressonshlp csrhor Vial RISP8hDALвЂ™ thsrmpy doss sal allul them edveissly. Tel psbssli hr rely thE physician I they become prsrsl or *rhsnd to become prersd dudng Viermp not hr brsant hid err hr hdonnthshpbysidue Itheywetidni crpluihrtim urypmscrвЂ™ terorosmV*cowbsralu toIvOidaloOhaL No sdkhoorIlorylmem isoommsndst The mbsrecbcns ci AISPERDAL sal Ohist alugs have not beer syshamelcaly rist Cusion ahosid be used stan lien to conbilasboir eli Ohisrcss** aIngalugssid1xh msPL5nuysten.VuhmpotamPeelsEcialwVisaysLliagsliell thlapotenbiwehl maysbugoOizsthedlsc1acilmvodopaeraldopui*seugosi Chronic aalnlnlshratlon of caibsnszeplne. or chozsyrine eli rlspsrldone may usiweetudsersicaci dupsddont Fhispsddons m mshoclzsd bycylocteoms P1.IID.. as enzyme Vicar be With. bad by a variety ci psdrotrcp and othsiiugL Analysis ci alnici stulss hrvclehrg a modsi minter ci poor metaholosis (n-70) doss not eruosi Vi poor anasxhsnslvs melicllzarsirsie dismal riesci idoerse .IsotsJlo comrn psnson ci elfecttvsnesa to the two ougs has been made. In vitro studIes ironed that tugs mstircbzed by olrsr P Ieozymss am only usE Wtbors ciriepeddorsemstahcbsnt caichiotisnioly *dan sers conaldad rn Sedan sthro mice aid Wisher rats Ibspsdcbne asbnlniiaisd hr the dii doses ci 0* 2.5, aid 10 is#{231}ior 18mortahrnteandbmostabsshs Thssedossaaeequlriasbhra4, 94 sal 375 haN Vu mudmimis biases dose (16 mday) on a mIsg Iie or 0.2, tl5and3thnssthensetnum lssnmdaan(nice)ora4, 15, aId6VuSS Vu midosim lamer dose (rie) on a ssвЂ™ beuis. There usia ieliciy . sliced rncrsssss hr plitibey #{216}snd shsnoms endocritie percuss adenoman Sal mwsnsiy cisal arlsnocssinomst Thus neoplemu we conidsmd hr be scthr.rnsrb#{243}t The relevance tar homes risk ci Vu hirings ci prohobn. rn.dshedendocdnebinors hr rodsibs laradmona Noevidenoeci msiugsnic pcissli Iardupsddonausstount Fhsdone (Oil ho 5 mcilmj wan irmar to licE msbn t*a not Isslily, hr Wisher rim hr Ivan rdve skdss at doses Oi hr 3 trims Vu masters recommended human dose on a mm#{176} basis The sIsal appeared hr be hr fsmis& hr a aitcirroibo abide hr Issala dog mpsnn mobilly sat conceiVilon usia dscrssasd at douse 04 to 10 those the turner dose on a mgho besis Doae4sIisd decrsssss we also soled hr aerum hastosharcne et the sane dcses. Serum tealosherone aid spans psranetera partially recovered but mmsted dacrsansd star itsahosal clsccolnuet No nodsal doses were notedhrelwust ordo =Jscsisssy The harshogsnic ci doiu studIed Es ardthlisr me sal hr flaw Zalend riel Thu Esddsnca ci mikiminalons not hscreaned ccnwsd hr carded rn disyshig ci rala or tu his vsn t4hr6*nsste humeri dosson a mn#{176} tea. hr three rsprochicbvs ahides to rst Vurs an Escisane hr pr. delis cEJIErgVuVi 4 days ci sian at doses 0.1 hr 3 hose Vu Issuer dose on a mn0 basis I la not knoms wtisthsr these deal. were situ hr a dEed alsal as the Ishiass or pu or hr elsots onteiess Themwan no riodsi dOssIOrhIcreaned ratpmp mosely. hr one Segsrs,d I shady, Vureussas hrciswe hr silicon ratps#{231}satadass 15 hose i#{216}ssrthsr Vu tuners doseon amn#{176}bis. Piecenti trasslar ci dnpsddane ascurs rn rat act Them we no sdsgsie sal wslkcsbrclsd sitidan hr prsgserb wcmst However, tern wan one Impost a ci agurast ci Vu corps. caisson hr err Wait mpcsed hr dspsddons hr Iisr Tiucuisal rsliionslhr RISPERDALвЂ™Vurapyie wmmmat RISPEIALвЂ™&sosidbeuaedrEidngprugnsncycnlyVupclssblibensVijusb. basVu risittoVutius Itudsalon Wioraiddslivssyhrtunssa la radmows N ie not incus wtisthsr ci not dspsddene I eacrelad hr humor m& hr animi atudea, rispeddons add 9.hy&oxydspddone usia excreted hr breast soils. ThsreIo werner .csling FISPERDAL Ohcsid notbmsihest Saalelssstssus hrdrltsn hsiunotbSsnssEliisd. Ohrici dsdlan Id not hrdsde aIlcisid mistime ci plumbs aped 65 ash mar hrdsIsnin.stsVwtheymsdismsshyimmyswsger hr gsnsr a lower atarthrg doss Is recommended for an elderly patient. reflecting a decreased mscoidnst: clawaice hr Vu elderly, usi a grsisr he. gssncy ci dsc,sansd renal, or ceidec itmalos aid a gusher hndsncy hriul tion(Sse cLINICAL PHACLOGY aid DOSM3E AND ss*t*dusreseanEssntrscsiisghiopsdni(3f126). Ottur Ev.ats Observed Dunlag this Pre.Msrhathisg Evalestlos of PERDAL#{149} During Is prsmatk.bng asaeasmnsnt msitsls doses of RISPERDAL were adaisilsiad hr 07 pissla hr phase 2 aid 3 skalan sal Vu blowing man. hose ware reported: (Note вЂ�tmquss( we those occurring hr at least 11100 _s* kiss( we Isima ociunhrg hr 11100 hr 111000 pdssba a. 1mm occurrIng hr I thus 111000 pssdi it la hs#{231}cstsd hr sssshulaa that, asaurVusmsderspodedisisdtinrQbsahssibeli FISPDALвЂ™Vuy wese not nSCSssUIycSISsdbyL PlyiIl#{224}kiew Fmpenthsonusd doses_, dulnlshed seoul dei, nsmausnsss Mfreys*t i.d ds ,cieont msalo e#{231}hoda hrowsidtid asmesa Rs emoloni silty, nholnersa dste* datuwi syndecmp, cMfrwIasdMwsese Sysis. es*re Frequent increased sleep tmian. omt dysertep, walgp, * coEi oc p, th tcme, isulp, Wiu psmlysj Iegciumpatonllaoli asma ndgtinp, hugsndudp,dremoddais Oasfro4vfsstlnal Disorders: Frequent anorexia, reduced salivation. d hoaned shomelp, misnp, gia. hemorrhOids, tis. Rsre focal incontinence, eructatlon, gastroe. Vip, tongue sdsma, Ilverliculitia. nvltIs, discolored faces. GI hemorrhage, hsma.tsmesis. lady as a Whote.ussI Dbaordsrar Frequent fatigue. Infrequent adams, rigors, malls., hrfluenza.hIke symptoms. Rare: pallor, - - Disiis t homanid p9nwmsbon, photouerisity Emesssd ses* amp, dscisssd da iopsdp, sdaieia po kp,ihredolsbolL Ibaerbdmaoaiisiosrsbaa tunmoidosip, vsrrucp, dansaths bobeno hypelhonis, gerdli urticads wolousscubor Dbao,iear Infrequent psigliatien, hsflsnslon, hyPotSn5IOn,AVbIOcE,IIIyOc.diEOSt erVSI*IOiVWihyCsdII,ar. ire pectods, premature Eli coitactions, I wave inversions, ventrIcular szkss STdsoa nymcur1 bVwMbmpatsknOr. mieccommomiop,nis opjsyepitrsphadbaphohap sip, isbupholsj ahnamsb hotnalos hb* aid ffitsi is,w Wi hy t homane, cuhore phcuphddnans homa., thkstdahetanmdtus R.ocdacmesidssnmnimacachmdp, -. Wi_ hrcodasnci, hsmiudp, dysuds Ilast retention, cysth masi insufficiency. ibaacubakdasi Syslie DViieoc *t mysi#{216}s &st adamip, sninia teasilp, skeletal pain. fleproahsctlsвЂ™. orisrs, Fssseho Frequent msnordsaaвЂ™, - tsp, Vials bmsi pip, hlsissniwi eriearhrowaned, chOie bea Phi Rare: bemge, ,_ Msoclierlwlii 0ISCW1IsMsbOSofTNsIl 9%psrcssdl2m4l2eol) ciRISPBIDAL Waled psbssdehr#{216}rme 2 studIes treatment tie to as adieme sisal, cosugered eli about 7% on o aid 10% on ecbvs control tuqs. The more common event ( 0%)sescclisdelr daccilirualon asdcoswsdsrsdbbepossitlycr tued et sdempsOidd ayn#{231}ham dsstss * alsomnohnciaalmmut iddadssrodiadiVdacooimaIonEs 12%ciRlSPE.вЂ™.Wisd sni colr*wsd hr 0.6% cibo psbssba bs. #{216}vsn Vu sknoi 404o1d ciuiermpcstse Visa hr FiSPBIAL0asnisuwd hr plsosbo I la isaluly #{234}tisolOidaIlusdieaFilSP.вЂ™seliadhossiemad(SsePRECAUTIONS). EICIdIuCSIeCaelsISdTdiI usesvWwe E bo Chutd 7EVi hr tan 6. hrBwsEsboixmbmisdhlis, mpcstersousIy.mposls Wiesaalemsrgss* adverse events wIth an incidsnce ci 5% or greater Es at seat one ci the mSPERDAL#{149} oi* and at Iesi nice that ci plscubo eeoc stisty, sonme. == dssinmL as mmse - - nip, titunhea Iessdnp, i mulila mamnt Vials pemial hamoithsgs UInderySys iims.sdSGFT. stbeila dideldaip, be ste. IM1daoctspImia prapust pidirila VirombugNEila thmotoc1opeds d simi sri VesS .orE Rast bonbap, hypsmmudp, decresssd sh*oc ht hymchromla wends Rast non.xc wends mahwli, ariea I Fieqsatemalh ddion. Infrequent ejaculation failure WIsIba Call arid AssIstance ar Rust Iesiusyhaip, hisythadensyday, twmope P&gHmi -. daw Asus gurecomu mis hosi w*bemimsdaontr. . hrddsncsbessdon eldlnd reports tethsosiMvemamant reportadiecemadsinto. rhiction eNds we hampordy (bib not nscessariy caussly) mIsled hr RISPERDAL.#{149} ______ therapy, Include to. following: anaphytactic reaction, an_ athi Vio ouretwowascular dIanea dIsbehas mdaa aggravated. hypothermia. intestinal ObstructiOn, jaundice, mania, PsIldnsons dssmm aggsaelsd, psimonery embolIsm, suddsn dads. w Cuntr Pelsiba - Si*stiici ches RISPERDALвЂ™ Is not a controlled sststance. sirosid be evalulad carefully or a hIstory ci demahsup, sal such shard be ctsssved dossly ho shins ci RlthвЂ™ERDA[вЂ™ ndauan or skies Bdledadraransvent hr one cithssstwotdisprsssrbiat Iesi 5%WdtsIOe Vu rie ci be wsus Wscrsansd teen ushelly, Esciesed daraloss ci step, accunmiodalon dsh malicad sinio, stabs abmcsp, d tep, gip, me dntduhsd sawn deE smdie d#{216}malos lMmirmSPEA.вЂ™(sIepsddane)isoide be ahadidnlsisdon a BID sdrsrkia, g5IW*bSI5*IgelI I srgillDhdldy,elshars.sshrhicrsmsrbs ci 1 sap BID on Vu ucosal sal brEd day. halsrIla hr atigat dose ci 3 leg BID by the third day. In some patients, slower tItration may be medIcally lie toSsing edossie swede occwnid at as Eimdsnce ci 1% or mo sat usia appiopilie. FulVi*shsisIde Ihdcisd, alsoridgsnsralyocawat Ebeivals ci not less than I week, since shady ies for the solve mslisoila at Issi a id among RISPEL4eisd psbssba Waled at douse ci would not be achiaved for approxinisly I week hr Vu typical pallet When 10 mthan smongplscsbotreshadpalssbshrtepocladmsstscitao6.hr 6.weE coalmiad st OVideroc WiomOip, aliim sudety, *sEnsnts are nsossessy, mmd dose hrcmmsrbsfdacmmsstis ci I rug BIDwe recosomsodat mst limman S Aa*ssycholcdicscywednmonskstadhradoee rasaci4to l6mqitieyhrVu beadsip, dsn.st EuViM Smm asnuloi mmssp, pop r*dccilrlis ss#{231}sg dsalvsnsss ci RISPERDAL however, mssdmci ilIad sip,vemliahdonini SalvaEscmansctoOVisEs RasplasherySysbaus dinil cou#{216}risoila, phsubs dyspnss. BodyaWlsoler beds pE sea generally seen Esa range ci 4to 6 mgfday. Doses shove 6 mgtey were not hr be mars elilcecious than lower doses were aaaccislsd eli chsipsk1sver. iasbOi*t ma tysld ssbonhss. tisolsuer i#{231}pst dsmonetrisd respiratory. Viasal: abnormal vision. U.scslo.Sk.twtal: arthralgla. mars utadi ______ onre sat olwshimma eisds aid we nb gsnsrdy moonsoendat The sthty ci dosan ahues 16 mchbay ten not been ev#{224}isdEs cwdIsv.cal I hrcludas tremor, nls, hnesip, hypertonla, hypsddn.sia, oculo. darici his Dosage its scsiPspidaisnm The mccmmindsd eli doss ie gyric crisis. ataxia. abnormal gait. involuntary muscle contractions, 0.5 me 01Dm paleieilmemeldsdycidsbihia pilasdselsesvsse mnalor tupdssr andpsbsalaslherpmdspossdhrlegalsnuhocibstom hyporsileala, and extispyramidi diaordsrs. Although the Incidence ci tapalsireirer wosti pose a rIe Dosage Escresan hrtess pelside irasid be Es вЂ�extrepyrernidi symplairu does not sppsw hr dINer or Vu вЂ� 10 mcidW Ercrssnsrdecinomorsthuro.5mgBm. hrCmSSShrdOSsgNahOVS lSmgBID croon aid phoebe, Vu data tar hrdlviskii dose ciosme Es lied doss bids alioidd ly ocowi Ebsivis ci al Iesi I wss hr some paula stew ;7t a dos&rssponse islalonihis (See DOSE DEPENDENCY OF *danmsybemsdciyapprcpstis Bdedycrdabliiad aidadssde sir renal hr#{231}ims*may 1mm Wa Dos.oepsiAdmmsEvuuliDalaimmVibeddoseIis provided abilty to siminste RISPERDALвЂ™thsn normal stilts. PatIents with svldsnce ci dosersIischreas for extrepyramidi syn#{231}tonrs associated wIlts hs function may have Increases hr the free fraction ci theвЂ™ dona Wsknsst Asrse sisal die dialled by a chsduat for Ida dads po msulbng Es an enWacedillsd(SseaJNICAL PHARMACOLOGY). 1mm alsge*idycoss#{231}stngshssaddosssci RISP8bALвЂ™(1, p, 12, aid 16 Psbsdadaapradsposlanhrhysdnnshomsolansortwwhomaudlmsalons _1 reveisda Vi burst torte Iolruhrg adverse mmli isepiessa hrcmanedrhirsbon dslesp, aocosrsnodsbon disibuross csthoida dozkresa would pose a cciw rIsk Sundae need hr be bashed cudously arid caddy mud (See PRECAUTiONSsp*mastMapWidsThem we no svslsmdcdv oalsclsd die hr spscllcly adrksss milchhrg from slier arlrcbcsto RISPERDAL#{149}, orconcsiningasncom*uisdsbillonelr Ss usest RISPERDAL Es ansocishad eli osthoetatic tymclsnslon other antipsychotica. While Immediate discontinuation of the previous asihotucuds (SsePRECAUTiONS anbps treatment may be amepisbie for some patients, more gratial as:1huprcpcalonscilbSPERDM.вЂ™ardsbo.Imiad dIscontinuation may be most approprIate for other patients In all caasp, the ms*gawedgisodlntnci7%cibodyni#{216}dwemcosspwedhrapoOici ci ovsdng amisycholc acksiemsbadoir should be mhslmtret When 6. hr&.SSkVi5bO.OOI*sOI5dtdiS mesisigailsbcdyiw*sdygseisr WiemaciwebREDAL(16%)con#{231}ssdhrphosbo(9% LaIsmiy : A biesen vssy cossyuiscrr or 6. hr ussk coslmleia*jSmsdcdonshosidbemadIiadPsdad*. coi*clsd this revealed ire sbciy iilcub IiSPEWslsosbo sr incus hr Vu prcpoaloswcipdaiempsisnsthigpclsslslyir#{231}asterddsangsshr Anguat iisnter 1994 roses semis dry, tumialogy, or udniysls psiuniers Slmlerty, them were no R$SPEALlecsbo darenoss hi Vu hrcldanoe ci dIscoslnusbons for cMngein serum chemistry, hematology, or urinalysis. However, .-==.. RISPERDAL atnhrlstrsbon wan .soclisd eli hromanan hr susan prols - - - - JANSN T1TUSV5LLE. r electrocardio9rams of 8 out of 380 patients taking RISPERDALвЂ™ whose baseline QTc mtsrval wan lana than 450 mass were observed ho have QTc hrhssvals st Vies 450 mesa tabsg Irslinssd (ass WARNINGS). Qiangus ci this type we not mann ernong shout 120 phoebe jpsnc May1995 NJ 08560 Printed si USA Because a whole person is waiting to emerge. Although the exact mechanism of action is unknown: #{149} Improvement of negative symptoms and lessened risk of EPS are thought to result from blockade of serotonin 5HT2 receptors, possibly through a modulatory effect on dopamine D2 activity in the frontal cortex and the basal ganglia #{149}lmprovementof - symptoms is thought to result from blockade of dopamine D2 receptors in the limbic systent* r *Ereshefky L Lacombe S. Pharmacological Can iPsychiatry. SPERI DONE adjacent to this ad. В©Janssen Pharmaceutica Inc. 1995 JANSSEN Serotoninergic profile of 1993;38(Suppl 3):S80-S88. Please see the brief summary of Prescribing Information rispendone. iic JPI-RS-123D cTiSmsthKhn. B..ch.m A first choice in psychosis. system Calendar a free Psychiatric For listing ofyour meeting in ServicesвЂ™ monthly calenus a note giving the details dar, drop of the meeting-sponsor(s), inclusive dates, location, type ofmeeting (workshop, conference, annual meeting), theme or topicarea (ifapplicable), and the name, address, and telephone numher of the person to contact for more information. only meetings Because oflimited consideredofmost space, interest to the readership will be listed. All notices and changes must be received no later than two months before date ofpublication (for example,June 1 for August publication). Correspondence should be addressed to Calendar, Psychiatric Services, American PsychiatricAssociation, 1400 K Street, N.W., Washington, D.C. 20005. November November seminar 29-December 1, national on creating employment opportunities for persons with serious psychiatric disorders, sponsored by Matrix Reasearch Institute, Radisson Plaza Hotel, Orlando, Florida. Contact Barbara Granger, MRI, 6008 Wayne Avenue, Philadelphia, 19144; 215-438-8200, 1506, flux 215-438-8337. Pennsylvania TDD 215-438- November 29-December conference, National the Dually Diagnosed, Towers Hotel, Orlando, Georgi M. Hockaday, ment Excellence, Inc., Dayton, Ohio 45401; &x 513-223-6307. 2, annual Association for Radisson Twin Florida. Contact CAE, Manage- P.O. Box 2307, 513-223-8008, November 30-December 1, conference on integrating in-home psychiatric care with partial hospitalization and outpatient services, sponsored by Global Business Research, the Fontainebleau 1112 Hilton, Miami Beach. Con- tact Conference 151 West 19th York,NewYork fax 212-645-4490. Administrator, GBR, Street, 8th Floor, New 1001 1;800-868-7 188, versity, 1823 nessee 37235; 327-7078. Station B, Nashville, Ten615-327-7200, fax 615- December 1 3-17, fill meeting, Amencan Psychoanalytic Association, the Waldorf-Astoria Hotel, New York City. Contact APA, 309 East49th Street, New York, NewYork 10017; 212-752-9450, extension 28. December December tion deficit cycle, 1-2, conference on attendisorders across the life sponsored by the Cambridge Hospital and Harvard Medical School, Cambridge, Massachusetts. Contact Judy Reiner Platt, Ed.D., Cambridge Hospital Professional Services, 1 30 Bishop Allen Drive, Cambridge, Massachusetts 02139; 617-864-6165. December 1-3, annual meeting, American Academy of Psychiatrists in Alcoholism and Addictions, Ritz Canton Hotel, Amelia Island, Florida. ContactJeanne G. Trumble, M.S.W., Executive Director, AAPAA, 8340 Mission Road, Suite B-4, Prairie Village, Kansas 66206; 913-341-6680, fax 913-6422431. 7-8, conference on disease management in behavioral health care, sponsored by the Instinote for Behavioral Healthcare and CentraLink, Ritz Carlton Phoenix, December Phoenix, Arizona. rail, CentraLink, Suite 108, Portola Contact Tim Har4370 Alpine Road, Valley, California 415-851-8411, fax 415-851- 94028; 0406, e-mail [email protected]. December 7-10, behavioral therapy institute on clinical consultation, sponsored by the Obsessive-Compulsive Foundation, Interlaken Inn, Lakeville, Connecticut. Contact Institute Planner, OCF, P.O. Box 70, Milford, Connecticut 06460; 203-878-5669. December American 11-15, annual meeting, of Neuropsychopharmacology, Caribe Hilton, San Juan, Puerto Rico. Contact Oaldye Ray, Ph.D., Secretary,ACN, Vanderbilt UniCollege Psychiatric Services 1996 January January 8-10, international conven- iion of biological psychiatry, sponsored by the World Psychiatric Association and the Indian Psychiatric Society, Bombay, India. Contact Amnesh K. Shrivastava, Convenon, Biological Psychiatry Section, IPS, Silver Mind Hospital, Shivknipa Complex, Gokhale Road, Thane, Bombay 400 602, India; 91-22-539-1734, fx 91-22-533-1084. January 18-20, havioral healthcare conference outcomes on agement, sponsored by the for Behavioral Healthcare traLink, Red Lion Hotel, be- manInstitute and Cen- Costa Mesa, California. Contact Tim Harrall, CentraLink, 4370 Alpine Road, Suite 108, Portola Valley, California 94028; 415851-8411, fax 415-851-0406, e-mail [email protected]. 18-2 1, midwinter meeting on the psychobiology of personality disorders, sponsored by the American Psychiatric Association and the Colorado Psychiatric Society, Sonnenalp Hotel, Vail, Colorado. Contact Meetings Department, Colorado Psychi- January atric Society, 4596 East Suite B, Denver, Colorado 759-6045, fax 303-759-6041. huff Avenue, 80222; 303- January 23-26, winter Royal College of Psychiatrists, meeting, Harno- gate, England. Contact Confrence (Continued November 1995 on page Vol.46 Sec1126) No. 11 4. Sharpley cally related to trazodone, nefazodone has not been associated with side effects such as priapism and sig- Drug nificant with drugs metabolized by that system. Coadministration of nefazodone with terfenadine or astemizole is contraindicated, because carditoxicity may result (6). The clinician may need to reduce the dose ofother drugs orthostasis, associated which with have trazodone. been There is of no evidence of potential for abuse nefazodone. Overdosage with tion ofup not to 11,200 proved life inges- mg perday threatening has or fatal. Three areas in which nefazodone may be distinguished from the tricyclics and SSRIs are its low incidence ofsexual side effects, its normalizing effects on effects. sleep, The sexual its antianxiety reported side gasmia, and incidence effects, of including impaired anor- erection, and im- ejaculation, associated with tricyclic antidepressants and SSRIs ranges from 1 0 percent to 60 percent. paired The incidence of sexual side reported with less than Many 5 percent. patients treated report sleep increased nefazodone continuation for additional tion. Use of often with decreased medication Therefore, nefazodone sleep or the is sleep helps among and awakenings not being with depression an admixture The pear to effects have and well zodone as antidepressant established in toms. the reducing In a study using Rating Scale for Depression, of the scaleвЂ™s anxiety revealed toms may ment of the with another nefazodone study effect until ment (2). of anxiety, need pine 1114 did the depression sufficient first not third patients who also neflizodone therapy, an adjunctive or other for anxiolytic. MAOIs with of ne- should be potentia- An Nefazodone with is a new a dual HT2 reuptake. inhibition The efficacy nefazodone are over of they in A the Unlike antidepressants, not appear treat- mild many nefazodone to impair sexual and it does not impair sleep. As a result of its novel and selective mode of action, its antidepressant efficacy, and its favorable side effect significant profile, nefazodone potential of major although show such for the an benzodiaze- within the U.S. U.S. tional be is included The one-year $95 one-year student rate be will and see U.S. subscrip- $33.50 within outside the subscriptions For more Business on page circulation the the $22.50 Longer-term tion, $45 institu- outside tion U.S. be $65 outside and be $7 5 within rate will and will The the if 31. individual rate are available. informa- Information 1106 or call department at 1-800-368-5777. Group Eison AS, Eison MS, Torrente JR, et a!: Nefazodone: preclinical pharmacology of a new antidepressant. Psychopharmacology Bulletin 26:311-315, 1990 2. FeighnerJP, Pambakian R, Fowler RC, et al: A comparison of nefzodone, imipramine, and placebo in patients with moderate to severe depression. Psychopharmacology Bulletin 25:219-221, 1989 major the card 1 996 one-year The U.S. Read- increase issue. subscription the 1996. , rate by December subscription in this holds depression. the subscribe rates will become 1 avoid treat- 1. symptoms may in subscription U.S. References of treat- eliminating ers can medicationвЂ™s generally time. increase effectivejanuary ofaction-5and ment of major depressive disorder appears comparable to that of imipramine. Adverse effects associated of treat- (5), alone Increase to PsychiatricServices antidepressant mechanism antagonism serotonin decreased with Notice of Subscription Rate activity. to symp- week show potentiated for Readers factor week For not APAвЂ™s related be significantly end Pharmacogenetics and drug of newer antidepressant Journal of Clinical Psychiatry suppl):38-45, 1994 metabolism meta- symp- anxiety CL: the Hamilton items 1994 DeVane is not affected. psychomotor ef- ofpossible ofserotonin ment medicationвЂ™s the that ef- of nefa- anxiety analysis by the ap- antianxiety studies However, are because 234-241, 6. carbamaz- is taken together The combination with avoided 5. Fontaine R, Ontiveros A, Elie R, et a!: A double-blind comparison of nefazodone, imipramine, and placebo in major depression. Journal of Clinical Psychiatry 55: agents. 55(Dec function, symp- SSRIs significant Premarketing efficacy of alcohol when alcohol nefazodone. Psychiatry 1992 medications blockers, and cisapride. fects system triazolam, bolism of lorazepam The cognitive and other often of anxiety tricyclics as fects. channel does Patients toms. calcium 31:1070-1073, together AES, Cowen PJ: Neantidepressant-may REM sleep. Biological increase interact P4503A4 These alprazolam, and decrease treated for depression. have nefazodone. epine, P4503A4 may prescribed include with surprising to normalize patients the are antidepressant is associated of it in- medica- light-stage by they with and Conclusions and hypnotic frequency metabolized when the system AL, Walsh novel fazodone-a SSRIs awakenings. result in dis- of nefazodone decreased that sleep ofthe need (4). with inhibits isoenzyme fazodone been including light-stage Nefazodone tion disturbances, creased frequency These side effects effects has interactions 3. Rickels K, Schweizer E, Clary C, et a!: Nefazodone and imipramine in major depression: a placebo-controlled trial. British Journal of Psychiatry 164:802-805, subscriptions to PsyServices are available at greatly discounted rates through APAвЂ™s Psychiatric Services Rechiatric source Center, which also offers a number of other benefits for mental health facilitiesand organizations. For more information, see page 1201 of this issue or contact Mary Ward at 202682-6173. 1994 Psychiatric Services November 1995 Vol.46 No. 11 VENLAFAX/NE HCI A Serotonin and Norepinephrine Reuptake Inhibitor вЂњInvestigations of the action mechanisms of antidepressants have provided support for the importance of fserotonin and norepinephrinej interactions in the patho physiology of depression.вЂќ -reported Pharmacologic Uptake Inhibition Compound NE 5HT TCAs23 , 1.##* = strong Muscarinic Affinities Histaminergic Adrenergic affinity. norepinephrine; 5HT = serotonin; TCA The clinical significance *Serotonin Receptor 4# i,## EFFEXOR5 = activity / SSRIs4 NE in Kalus et al reuptake inhibition tricyclicantidepressant; SSRI of these in vitro data varies #{149}Like SSRIs and TCAs, #{149}As with = among = selective serotonin reuptake inhibitor. is unknown. TCAs. EFFEXOR SSRIs, anticholinergic-like is a weak inhibitor side effects #{149}EFFEXOR is a structurally novel antidepressant, to any other available antidepressant5 of dopamine may occur with reuptake EFFEXOR and is chemically unrelated EXPAND TREATMENT YOUR POSSIBILITIES An effective first-line depressed patients Response depressed in #{149} EFFEXOP. n #{149} Imipramine n = #{149} Placebo n Baseline I therapy = = for outpatientsвЂ™ 39 33 47 2 3 4 6 Time (weeks) No significant difference between EFFEXOR and imipramine was observed. Significant difference *Response (P < 0.05); venlafaxine and imipramine> placebo at week 6. to treatment was defined as CGI improvement score of I (very much improved) 2 (much improved). In one randomized, on venlafaxine double-blind, or imipramine placebo-controlled study of depressed at 75 mg to 2.25 mg daily in divided The effectiveness of EFFEXOR in long-term cally evaluated in controlled trials. patients initiated/maintained doses (observed use (>6 weeks) or cases at week 6).вЂ™ has not been systemati- EFFEXOR Is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs). EFFEXOR should not be used in combination with an MAOI or within at least 4 days of discontinuing treatmont with an MAOI because of potential for serious adverse reactions. Based on the half-ilk of EFFEXOR, at least 7 days should be allowed after stopping EFFEXOR before starting an MAOI. Treatment with EFFEXOR is associated with sustained increases in blood pressure (BP) in some patients. These appear to be dose dependent and were seen at an incidence of >5% at dosages above 200 mg/day. Regular monitoring of BP is recommended. As with any psychotropic drug, EFFEXOR may impair judgment, thinking, should be advised to exercise caution until they have adapted to therapy. The most common adverse events reported in EFFEXOR placebo) were: nausea, somnolence, dry mouth, dizziness, abnormal ejaculation/orgasm, and anorexia.вЂ™ Please see brief summary or motor skills, and patients clinical trials (incidence >10% and 2x that of constipation, nervousness, sweating, asthenia, of prescribing information on last page of this advertisement. VENLAFAXINE HCI 25 mg, 37.5 mg, SO mg, 75 mg, and 100 mg Brief Summary See package need for full prescribing information. Clinical Pharmacology: The antidepressant action of venlafaxine is believed to be associated with potentiation of neurotransmitter activity in the CNS. In preclinical studies, venlafaxine and its active metabolite, 0-desmethylvenlafaxine (ODV). were potent inhibitors of neuronat serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptakeVenlafaxine and ODV have no significant aftinity for muscarinic, histaminergic, or a-i adrenergic receptors in vitro. Pharmacologic activity at these receptors is hypothesized to be associated with the various anticholinergic, sedative, and cardiovascular effects seen with other psychotropic drugs. Venlafaxine and ODV do not possess monoamine oxidase (MAO) inhibitory activity. indications and Usage: Effexor is indicated for the treatment of depression. Contraindicatlons: Contraindicated in patients with known hypersensitivity. Concomitant use in patients taking monoamine oxidase inhibitors (MAOI5) is contraindicated (see вЂњWarningsвЂќ). Warnings: POTENTIAL FOR INTERACTION WITH MONOAMINE OXIDASE INHIBITORS (MAOIs)Adverse reactions, some serious, have been reported when veniafaxine therapy is initiated soon after discontinuation of an MAO1 and when an MAO1 Is initiated soon after discontlnuation of veniafaxine. Reactions have Included tremor, myocionus, diaphoresis, nausea, vomlt ing, flushing, dizziness, hyperthermia with features resembling neuroieptic malignant syn drome, seizures, and death. Given these reactions as well as the serious, sometimes fatal interactions reported with concomitant or immediately consecutive administration of MAOIs and other antidepressants with pharmacological properties similar to Effexor, do not use Effexor in combination with an MAOI or within at least 14 days of discontinuing MAOI treatment. Allow at least 7 days after stopping Effexor before starting an MAOI. Hyperthermia, rigidity, myocionus, autonomic instability, mental status changes including extreme agitation progreasing to delirium and coma, and features resembling neuroleptic malignant syndrome have been reported with concomitant selective serotonln reuptake inhlbitor/MAOI therapy. Severe hyperthermia and seizures, sometimes fatal, have been reported with concomitant tricyclic antidepressants/MAOI therapy. SUSTAINED HYPERTENSION-Effexor treatment is associated with dose-related sustained increases in supine diastolic blood pressure. Regular monitoring of blood pressure is recommended, and, when appropriate, consider dose reduction or discontinuation. Precautions: GENERAL-Anxiety and Insomnia: Anxiety, nervousness, and insomnia have been reported in short-term studies. Changes in Appetite/weight: Anorexia has been reported in short-term studies, and a dose-dependent weight loss has been reported in patients taking Effexor for several weeks. Activation of Mania/Hypomania: Hypomania or mania has been reported; as with all antidepressants, use cautiously in patients with a history of mania. Seizures: Seizures were reported in premarketing testing (0.26%). Use cautiously in patients with a history of seizures. Discontinue it in any patient who develops seizures. Suicide: The possibility of suicide attempt is inherent in depression and may persist until significant remission occurs. Closely supervise high-risk patients during initial drug therapy. Write Effexor prescriptions for the smallest quantity consistent with good patient managementto reduce risk of overdose. Use in Patients with Concomitant Illness: Clinical experience with Eflexor in patients with concomitant systemic illness is limited. Use cautiously in patients with diseases or conditions that could affect metabolism or hemodynamic responses. In patients with renal impairment (GFR=1O7OmL/min) or liver cirrhosis, clearance of venlafaxine and its active metabolite were decreased, resulting in prolonged elimination half-lives. A lower dose may be necessary; use with caution in such patients. INFORMATION FOR PATIENTS-Clinical studies revealed no clinically significant impairment of psychomotor, cognitive, or complex behavior performance. However, caution patients about operating hazardous machinery, including automobiles, until they are reasonably sure that Effexor does not adversely affect their ability to engage in such activities. Tell patients to 1) notify their physician if they become pregnant or intend to become pregnant during therapy, or ifthey are nursing; 2) inform physicians about other medications they are taking or plan to take; 3) avoid alcohol while taking Effexor; 4) notify their physicians if they develop a rash, hives, or related allergic phenomena. DRUG INTERACTIONS-Cimetidine: Use caution when administering Effexor with cimetidine to patients with pre-existing hypertension or hepatic dysfunction, and the elderly. Drugs Inhibiting Cytochrome P,IID, Metabolism: In vitro, venlafaxine is metabolized to its active metabolite, 0-desmethylvenlafaxine (ODV), via cytochrome P4,lID,. Therefore drugs inhibiting this isoenzyme could potentially increase plasma concentrations of venlafaxine and decrease concentrations of ODV. Drugs Metabolized by Cytochrome PlID6: In vitro, venlafaxine is a relatively weak inhibitor of this isoenzyme; clinical significance is unknown. Monoamine Oxidase Inhibitors: See ContraindicationsвЂќ and вЂњWarnings.вЂќ CNS-Active Drugs: Use of venlafaxine with CNS-active drugs has not been systematically evaluated; therefore, use caution when administering Effexor with such drugs. CARCINOGENESIS. MUTAGENESIS, IMPAIRMENT OF FERTILITY-Carcinogenesis: In 18-month studies, there was no evidence of carcinogenicity in mice given 120mg/kg/day (16 times the maximum recommended human dose (MRHD)]. In 24-month studies, there was no evidence of carcinogenicity in rats given 120mg/kg/day. Mutagenicity: In male rats receiving 200 times (on a mg/kg basis) the MRHD, chromosomal aberrations were found in the bone marrow in vivo. Impairment ofFertiity: No impaired reproductive function was found in rats given 8 times (mg/kg) the MRHD. PREGNANCY-Teratogenic Effects-Pregnancy Category C. Reproduction studies in rats given 11 times, and rabbits given 12 times the MRHD (on a mg/kg basis) revealed no malformations of offspring. However, in rats given 10 times the MRHD, there was a decrease in pup weight, increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation when dosing began during pregnancy and continued until weaning. There are no adequate and well-controlled studies in pregnant women; use Effexor during pregnancy only if clearly needed. LABOR, DELIVERY, NURSING-The effect on labor and delivery in humans is unknown. It is also not known whether Eftexor or its metabolites are excreted in human milk; exercise caution when administering to a nursing woman. PEDIATRIC USE-Safety and effectiveness in children (<18 years) have not been established. GERIATRIC USE-In clinical trials, 12% of Effexor-treated patients were 65 years of age. Overall differences in efficacy or safety in the elderly have not been demonstrated, however, greater sensitivity of older patients should not be ruled out. Adverse Reactions: ASSOCIATED WITH DISCONTINUATION OF TREATMENT-Nineteen percent (537/2897) of Effexor patients in clinical trials discontinued treatment due to an adverse event. The more common events (1% associated with discontinuation and considered to be drug-related included: somnolence, insomnia, dizziness, nervousness, dry mouth, anxiety, nausea, abnormal ejaculation (male), headache, asthenia, and sweating. INCIDENCE IN CONTROLLED TRIALS-Commonly Observed Adverse Events in Controlled Clinical Trials: The most commonly observed adverse events associated with the use of Effexor incidence of 5% or greater and incidence for Effexor at least twice that for placebo): asthenia 12% vs. 6%), sweating (12% vs. 3%), nausea (37% vs. 11%), constipation (15% vs. 7%), anorexia (11% vs. 2%), vomiting (6% vs. 2#{176}!.), somnolence (23% vs. 9%), dry mouth (22% vs. 11%), dizziness (19% vs. 7%), nervousness (13% vs. 6%), anxiety (6% vs. 3%), tremor (5% vs. 1%), blurred vision (6% vs. 2%), abnormal elaculation/orgasm male (12% vs. <1%), and male impotence (6% vs. <1%). Adverse Events Occurring atan Incidence of 1% or More Among Effexor-Treated Patients: The following occurred in 4- to 8- week placebo-controlled trials, with doses of 75 to 375 mg/day, at a frequency of 1% or more. This includes patients with at least one episode of an event at some time during treatment. Body as a Whole: headache, asthenia, infection, chills, chest pain, trauma. Cardiovascular: vasodilatation, increased blood pressure! hypertension, tachycardia, postural hypotension. Dermatological: sweating, rash, pruritus. Gastrointestinal: nausea, constipation, anorexia, diarrhea, vomiting, dyspepsia, flatulence. Metabolic: weight loss. Nervous System: somnolence, dry mouth, dizziness, insomnia, nervousness, anxiety, tremor, abnormal dreams, hypertonia, paresthesia, libido decreased, agitation, confusion, thinking abnormal, depersonalizalion, depression, urinary retention, twitching. Respiration: yawn. Special Senses: blurred vision, taste perversion, tinnitus, mydriasis. urogenital System: abnormal ejaculation/orgasm, impotence, urinary frequency, urination impaired, orgasm disturbance, menstrual disorder. Studies indicate a dose dependency for some ofthe more common adverse events associated with Effexor use. There also was evidence of adaptation to some adverse events with continued Effexor therapy over a 6-week period. Vital Sign Changes: In clinical trials, Effexor was associated with a mean increase in pulse rate of about 3 beats/mm, and a dose-dependent increase in mean diastolic blood pressure of 0.7 to 2.5 mmHg. Laboratory Changes: During clinical trials, only serum cholesterol exhibited statistically significant differences from placebo (increases of 3 mg/dL from baseline); clinical significance is unknown. ECG Changes: Only heart rate exhibited a statistically significant difference, with mean increases of 4 beats per minute from baseline. OTHER EVENTS OBSERVED DURING THE PREMARKETING EVALUATION OF EFFEXOR-During premarketing assessment, multiple doses of Effexor were administered to 2,181 patients, and the following adverse events were reported. Note: вЂњfrequentвЂќ = events occurring in at least 1/100 patients; вЂњinfrequentвЂќ = 1/100 to 1/1000 patients; вЂњrareвЂќ = less than 1/1000 patients. Events are classified within body system categories and enumerated in order of decreasing frequency using the definitions above. It is important to emphasize that although the events occurred during Effexor treatment, they were not necessarily caused by it. Body as a Whole - Frequent: accidental injury, malaise, neck pain; Infrequent: abdomen enlarged, allergic reaction, cyst, face edema, generalized edema, hangover effect, hernia, intentional injury, moniliasis, neck rigidity, overdose, chest pain substernal, pelvic pain, photosensitivity reaction, suicide attempt; Rare: appendicitis, body odor, carcinoma, cellulitis, halitosis, ulcer, withdrawal syndrome. Cardiovascular system - Frequent: migraine; Infrequent: angina pectoris, extrasystoles, hypotension, peripheral vascular disorder (mainly cold feet and/or cold hands), syncope, thrombophlebitis; Rare: arrhythmia, first-degree atrioventricular block, bradycardia, bundle branch block, mitral valve disorder, mucocutaneous hemorrhage, sinus bradycardia, varicose vein. Di#{231}estive system - Frequent: dysphagia, eructation; Infrequent: colitis, tongue edema, esophagitis, gastritis, gastroenteritis, gingivitis, glossitis, rectal hemorrhage, hemorrhoids, melena, stomatitis, stomach ulcer, mouth ulceration; Rare: cheilitis, cholecystitis, cholelithiasis, hematemesis, gum hemorrhage, hepatitis, ileitis, jaundice, oral moniliasis, intestinal obstruction, proctitis, increased salivation, soft stools, tongue discoloration, esophageal ulcer, peptic ulcer syndrome. Endocrine system - Rare: goiter, hyperthyroidism, hypothyroidism. Hemic and lymphatic system - Frequent: ecchymosis; Infrequent: anemia, leukocytosis, leukopenia, lymphadenopathy, lymphocytosis, thrombocythemia, thrombocytopenia, WBC abnormal; Rare: basophilia, cyanosis, eosinophilia, erythrocytes abnormal. Metabolic and nutritional - Frequent peripheral edema, weight gain; Infrequent: alkaline phosphatase increased, creatinine increased, diabetes mellitus, edema, glycosuria, hypercholesteremia, hyperglycemia, hyperlipemia, hyperuricemia, hypoglycemia, hypokalemia, SGOT increased, thirst; Rare: alcohol intolerance, bilirubinemia, BUN increased, gout, hemochromatosis, hyperkalemia, hyperphosphatemia, hypoglycemic reaction, hyponatremia, hypophosphatemia, hypoproteinemia, SGPT increased, uremia. Musculoskeletal system - Infrequent arthritis, arthrosis, bone pain, bone spurs, bursitis, joint disorder, myasthenia, tenosynovitis; Rare: osteoporosis. Nervous system - Frequent: emotional lability, trismus, vertigo; Infrequent apathy, ataxia, circumoral paresthesia, CNS stimulation, euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia, hypertonia, hypotonia, incoordination, libido increased, myoclonus, neuralgia, neuropathy, paranoid reaction, psychosis, psychotic depression, sleep disturbance, abnormal speech, stupor, torticollis; Rare:akathisia, akinesia, alcohol abuse, aphasia, bradykinesia, cerebrovascular accident, loss of consciousness, delusions, dementia, dystonia, hypokinesia, neuritis, nystagmus, reflexes increased. Respiratory system Frequent bronchitis, dyspnea; Infrequent asthma, chest congestion, epistaxis, hyperventilation, laryngismus, laryngitis, pneumonia, voice alteration; Rare: atelectasis, hemoptysis, hypoxia, pleurisy, pulmonary embolus, sleep apnea, sputum increased. Skin and appendages - Infrequent acne, alopecia, brittle nails, contact dermatitis, dry skin, herpes simplex, herpes zoster, maculopapular rash, urticaria; Rare:skin atrophy, exfoliative dermatitis, fungal dermatitis, lichenoid dermatitis, hair discoloration, eczema, furunculosis, hirsutism, skin hypertrophy, leukoderma, psoriasis, pustular rash, vesiculobullous rash. Special senses - Frequent abnormal vision, ear pain; Infrequent cataract, conjunctivitis, corneal lesion, diplopia, dry eyes, exophthalmos, eye pain, otitis media, parosmia, photophobia, subconjunctival hemorrhage, taste loss, visual field defect; Rare: blepharitis, chromatopsia, conjunctival edema, deafness, glaucoma, hyperacusis, keratitis, labyrinthitis, miosis, papilledema, decreased pupillary reflex, scleritis. Urogenital system Frequent: anorgasmia, dysuria, hematuria, metrorrhagia , urination impaired, vaginitisвЂќ; Infrequent albuminuria, amenorrheaвЂќ , kidney calculus, cystitis, leukorrhea, menorrhagiaвЂќ, noctuna, bladder pain, breast pain, kidney pain, polyuria, prostatitisвЂќ , pyelonephritis, pyuria, urinary incontinence, urinary urgency. uterine fibroids enlargedвЂќ, uterine hemorrhageвЂќ , vaginal hemorrhageвЂќ, vaginal moniliasisвЂќ; Rare: abortionвЂќ , breast engorgement, breast enlargement, calcium crystalluria, female lactationвЂќ, hypomenorrhea, menopauseвЂќ , prolonged erectionвЂќ, uterine spasm. (вЂњBased on the number of male or female patients as appropriate.) Drug Abuse And Dependence: CONTROLLED SUBSTANCE CLASS-Effexor is not a controlled substance. In a retrospective survey of new events occurring during taper or following discontinuation, the following occurred at an incidence of5%, with incidence for Effexor at least twice that for placebo: asthenia, dizziness, headache, insomnia, nausea, and nervousness. Taper the dose gradually and monitor the patient. Evaluate patients carefully for history of drug abuse and observe such patients closely for signs of Effexor misuse or abuse (e.g. development of tolerance, incrementations of dose, drug-seeking behavior). Dosage and Administration: The recommended starting dose is 75mg/day in 2 or 3 divided doses, taken with food. If needed, dose increments of up to 75mg/day should be made at intervals of no less than 4 days. Maximum recommended dose, for use in severely depressed patients, is 375mg/day, in 3 divided doses. When discontinuing Effexor after more than 1 week of therapy, the dose should be tapered to minimize the risk of discontinuation symptoms. SWITCHING PATIENTS TO OR FROM A MONOAMINE OXIDASE INHIBITOR At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with Effexor. In addition, at least 7 days should be allowed after stopping Effexor before starting an MAOI (see вЂњContraindicationsвЂќ and вЂњWarningsвЂќ). Please consult full prescribing information for detailed dosing instructions. This brief summary is based on CI 4193-2, issued May 23, 1994. References: 1 Kalus 0, Asnis GM, van Praag HM. The role of serotonin in depression. Psychiatric Annals. 1989;19:348-353. 2. Preskorn SH, Burke M. Somatic therapy for major depressive disorder: selection of an antidepressant. J C/in Psychiatry. 1992;53(suppl):5-18. 3. Richelson E. Synaptic pharmacology of ant/depressants: an update. McLean Hosp J. 1988;8:67-88. 4. PhysiciansвЂ™ Desk ReferenceвЂ™. 48th ed. Montvale, NJ: Medical Economics Co Inc; 1994; ProzacвЂ™:877-880; ZoloftвЂ™:2000-2003; Paxil#{176}вЂќ:2267-2270.5. EFFEXOR#{176} prescribing information, Wyeth-Ayerst Laboratories, Philadelphia, PA. 6. Data on file, Wyeth-Ayerst Laboratories. WYETH-AYERSF a В© 1994, Wyeth-Ayerst Laboratories 83561 LABORATORIES August 1994 ]IRIEALTIH[ NEWINPAPERBAO( AFFAIS вЂњ[A] compelling phy of an acute psychiatric coln1d1}r unit. A fascinating account that describes how the staff of such a unit managed briefly to treat and then вЂ�placeвЂ™ the often poor and destitute . Mceiniftai IRleatllth in th age ethnogra- f . . emergency Miia#{236}gcd1 C&ur patients.вЂќ -Contemporaty вЂњRhodesвЂ™ Sociology observations are I _.j couched in the theoretical formulations of Michel Foucault. The description of the unitвЂ™s activities are bloodcurdling and funny and precisely accurate. A readable, accurate, and aвЂ™arming work of -; - Philip Boyle ethical and Daniel on the Callahan ramifications. Susan states Essocic and Howard Goldman on how are catching up with the marketplace. Roger Meyer and Stuart care and the training Mary Jane England can improve mental Anthony of life. Lehman - . Journal of Psychiatry MP1YING BEDS of psychiatrists. The Work of an Emergency and Robert Cole on how we health care for children. on improving . - anthropology.вЂќ-American on managed Sotsky . Psychiatric Unit LORNA A. RHODES Comparative Studies of Health Systems & Medical Care $12.95 paper at bookstores or order tolL-free 1-800-822-6657. the quality Lt1IVRSITY OfCAVIORNIA PR(SS Richard Frank, Tom McGuire, Nwhouse on risk contracting. and Joe Barbara Burns and colleagues on the Great Smoky Mountains Study: ChildrenвЂ™s Mental Health Service Use Across Sectors. U Order your copy today! I Call 1-800-765-7514. 7y a new can easily ofyour clienL Why einvetU die wheel? gtvup approach thoiyou adjust to meet die needs S U and improves competence Staff or clients can be instant teachers Flexible format for all mental health settings Inexpensive and fun Raises self-esteem HEALTH AFFAIRS 22i:iiiiiвЂ™ Fall 1995, 288 pgs. In the U.S. and )вЂњ, Canada, .#{176}-Mai вЂ�a $25 each. Bulk discounts available: - inquire. please Ask about subscriptions to Sa1 Instructr Innwathne and Student Roleplaylng 11 ABCвЂ™s Courses: #{149} Keeping #{149} Handling in Shape Medication Decisions #{149} Making Games. #{149} Handling Hassles a Friend #{149} Managing Money #{149} Being #{149} Handling for Children #{149} Understanding #{149} Caring #{149} Preventing Guides. Card Anger #{149} Being Creative Mental Accidents illness and Crimes HEALTH AFFAIRS, and 1 stay informed health about Please policy issues call orse,sd for afree brochure. Each Course is $45.00 Telephones : 718-430.3353 1-800.925-8025 FAX: 718-931-7307 year-round. ABCвЂ™S SKILLS P.O. Box 148, Congers, Tel: 800-765-7514. NY 10920. Fax: 914-267-3479. ACURRICULUM FOR LIVING Jack F. Wilder, Mental Health Albert Eiftstein 1300 Bmnx, MorrIs New M.D. Education College Park York Pmgram of Medicine Avenue 10461-1602 VIIeвЂ™ve changed our name and our video collection! expanded he APAвЂ™s Psychiatric Services Resource Center Video Library you knew us as the H&CP Service Video Rental Library now has a collection of close to 250 videos on mental health and related issues. Check them out! j - !J New titles include: ADHO in Adults Building Bridges: Hispanics A Guide for Interviewing The Drop-In Group DSM IV: New Diagnostic Family Assessment . Issues Hospital Without Walls The Psychoeducational Profile Stressfullssues for Clinical Clerks The Touching Tree Winner ofthe 1994 H&CP Institute Video Award! - Understanding and Communicating with a Person Who is Hallucinating . What is Schizophrenia? All videos have been reviewed and selected for their usefulness in stafftraining, patient support, family education, Yes! Send our facility a FREE COPY of the 1995 Video Rental Library Catalog. Also send information Psychiatric Services about how our facility Resource can join the and community service. If your facilityвЂ™s Psychiatric not yet a member Services 1400k Po u Stunt 310 30- 3)0 D uonuutuu 005 u Cutour D7Sr/u31? DC 20005 iPirune Center, nowвЂ™s the time to join. Center. In addition to discounted A 13110 Resource of the PS) ufriatoc 2026826173, Fan Association 202-682-6348) facility will receive group subscriptions fees for video rentals, your to the journal Psychiatric Services Facility Psychiatric Practice & Managed Care, a bimonthly newsletter APAS Practice Guidelines series Discounts for the Institute on Psychiatric Services, APA Library Literature Searches, Address publications. Name Psychiatric PS1195 - Services Resource Center isaprogram of the American Psychiatric Association APA ference March Calendar Department, 6000 Executive Suite 5 13, Rockville, Mary20853; 301-231-5484, fax 301- Boulevard, land 1112) (Continuedfrompage 231-7392. March retary, RCP, 1 7 Belgrave Square, don SW1X 8PG, England; 2351, fax 11-071-245-1231. Lon- 1 1-07 1-235- 24-26, national seminar on creating employment opportunities for persons with serious psychiatric disorders, sponsored by Matrix Research Institute, Holiday Inn IndeMall, Barbara Avenue, Philadelphia. Granger, MRI, Philadelphia, 19144; 215-438-8200, 1506, fax 215-438-8337. Contact 6008 Wayne Pennsylvania TDD treating seminar 215-438- on guidelines addictions, Cambridge January pendence 1-2, for sponsored Hospital and by the Harvard Medical School, Boston. Contact Reiner Platt, Ed.D., Cambridge pital Professional Services, 1 30 Allen Drive, Cambridge, 02139; 617-864-6165. March ciation 6-9, Hyatt Regency for Judy HosBishop Massachusetts annual meeting, AssoAcademic Psychiatry, Westshore, 02238; Tampa, 617-499-5198, March 7-10, biennial meeting, Society for Research on Adolescence, Westin Hotel, Boston. Contact Maryse Richards, Ph.D., SRA, Loyola Univer- February sity of Chicago, Department of Psy- self-destructive behavior in children and adolescents, sponsored by Harvard Medical School and the Cambridge chology, Chicago, Hospital, March 7-10, third annual conference on using behavioral information services and advanced tech- February Platt, 2-3, seminar Boston. Ed.D., Contact Judy Cambridge fessional Services, Drive, Cambridge, 02139; on Reiner Hospital 1 30 Pro- Bishop Allen nologies, Massachusetts February 12-17, American Group Psychotherapy meeting, As- sociation, Hyatt Regency San Hotel, Franciso. Contact Karen OвЂ™Brien, Education and Meetings Director, AGPA, 25 East 21st Street, 6th Floor, New York, New York 10010; 212-477-2677, fax 212-979-6627. 26-28, on February conference service health national childrenвЂ™s research mental sponsored by systems, the Research and Training Center for ChildrenвЂ™s Mental Health, Tampa, Florida. Contact Krista Kutash, Ph.D., Deputy Director, Mental Health South Florida, Boulevard, 974-4661, RTCMH, Institute, 13301 Tampa, Bruce fax 813-974-4406, of B. Downs 33612; 813- e-mail [email protected]. 28-March 2, first international conference on philosophy and mental health, sponsored by the Royal College of Physicians, Marbella, Spain. Contact Mrs. Jean Wales, RCP, February 17 Belgrave Square, London SW1X 11-071-235-2351, fax 11-071-235-1231. 8PG, 1126 England; fax 312-508-8317. sponsored by the Institute traLink, 4370 Alpine Road, Suite 108, Portola Valley, California 94028; 415851-8411, fax 415-851-0406, e-mail [email protected]. March 9-10, international workshop on cross-cultural epidemiology, phenomenology, and nosology in psychogeriatrics, sponsored by the International Psychogeriatric Association, India International Centre, New Dehli. Contact IPA Secretariat, 1-3, 14th annual 3127 and on leisure skills, sponsored by the Medical College of Pennsylvania and Hahnemann University, Adams Mark Hotel, Philadelphia. Contact Pat Lewis, Medical College of Pennsylvania, 3200 Henry Avenue, Philadelphia, Pennsylvania 19129; 9028. 215-842-4380; fax 215-843- April 24-26, seminar on creating employment opportunities for persons with serious psychiatric disorders, sponsored by Matrix Research Instinate, Executive Tower Inn, Denver, Colorado. Contact Barbara Granger, MRI, 6008 Wayne Avenue, Philadelphia, Pennsylvania 19144; 215-438-8200, fax 215-438-8337. May May 1-2, symposium on excellence in the implementation of computerbased patient record systems, sponsored by the Computer-Based Patient Record Institute and the Managed Health Care Technology Institute, Washington Convention Center, Washington, D.C. 70 Blanchard lington, 270-6000, Contact Road, CPR/Healthlnfo, Suite 4000, Bur- Massachusetts 0 1803; 617fax 617-270-6004, e-mail [email protected]. Greenleaf 60091; 708- March 2 1-24, 14th annual symposium in forensic psychiatry, sponsored by the American College of Forensic Psychiatry, Chateau Sonesta Hotel, New Orleans. Contact Conference Planner, ACFP, P.O. Box 5870, Balboa Island, California 92662; 714-8310236, fax 714-675-1107. March 28-31, national conference on the impact of stress, trauma, and anxiety on the family, sponsored by the Anxiety Disorders Association of America, Hyatt Orlando, Orlando, Florida. Contact Jan Ross, ADAA Con- Psychiatric conference activities TDD 215-438-1506, Avenue, Wilmette, Illinois 966-0063, fax 708-966-9418. Florida University Florida 6525 North Sheridan Road, Illinois 60626; 312-508- for Behavioral Healthcare and CentraLink, New Orleans Macriot, New Orleans. Contact Tim Harrall, Cen- 617-864-6165. annual 3007, April therapeutic Florida. Contact AAP Executive Office, Department of Psychiatry, Wyman 2, Mount Auburn Hospital, Cambridge, Massachusetts fax 617-499-5498. April Services **May 4-9, annual meeting, Amencan Psychiatric Association, Jacob Javits Convention Center, New York City. Contact George Campbell, Director, Meetings Management, APA, 1400 K Street, N.W., Washington, D.C. 20005; 202-682-6000; fax 202-682-6114. May 13-17, meeting on current developments in psychiatry in France and North America, sponsored by the Federation Francaise de Psychiatnie in collaboration with the American Psychiatric Association, Paris, France. Contact John A. Talbott, M.D., 645 West Redwood Street, Baltimore, Maryland 21201; fax 410-328-3693, email [email protected]. November 1995 Vol.46 No. 11 MEDICAL The American manage APA and Psychiatric the operation currently the day-to-day of the is seeking oldest medical has approximately direction plans psychiatric and care, communication international Candidates strong of the administration strategic policies, 40,000 a Medical association members, Director in the a budget presence should and must who country. of $26 will The million, ability Board to develop for quality policy, facilitates a strong leadership and to motivate and implementation, with education member national and curriculum will be handled letter nominations must Medical and private Search P.O. Box 27876 Washington, DC academic issues. of the APA. and/or nominations Please indicate interest Office box vitae. be received Director employees. involvement, members Applications confidentially. to the advocacy research experience, and a strong psychiatrists by a detailed management members prior and Employer. APA the provides efforts maintains Opportunity cover advocacy experience, be Board-certified and with Director Association. clinical familiarity Medical for Association and and setting All communications and major demonstrated include be accompanied Applications works develops skills, is an Equal a CV programs, for the have of budget submitting of APA involvement, knowledge APA the and should Candidates of Trustees, as spokesperson interpersonal background, Board acts Background must Association 1 75 employees. Under The DIRECTOR 20038-7876 Post by January Committee listed 1, 1996. below. by selective serotonin reuptake hThibitor for OCD A fiuvoxamne maeate E&S A SELECTiVE SEROTONIN INHIBITOR REUPTAKE EFFECTiVE IN RELIEVING THAT IMPRISON PATIENTSвЂ™ DEMONSTRATED COMPULSIONS RAPIDLY ACHIEVES SHORT HALF-LIFEвЂ™ LOW INCIDENCE FAVORABLE BLOOD STEADY-STATE OF AGITATION SAFETY OBSESSIONS MINDSI* AND LEVELS; (2% vs 1% for placebo)вЂ™ PROFILE #{149}:#{149} Relatively low incidence of anticholinergic side effects in controlled trials of OCD and depression, LUVOX Tablets vs placeb&: dizziness I 1% vs 6%;constipation 10% vs 8%; dry mouth 14% vs 10% #{149}:#{149} The most commonly observed adverse events compared to placebo were somnolence 22% vs 8%, insomnia 21% vs 10%, nervousness 12% vs 5%, nausea 40% vs 14%, abnormal ejaculation 8% vs 1%, asthenia 14% vs 6%вЂ™ #{149}:#{149} Concomitant FLEXIBLE use of LUVOXTMTablets monoamine oxidase inhibitors is not recommendedвЂ™ DOSING Dose: 50 mg once a day Initial HS 50-mg tablet .вЂ�, .- and Dose Range: 100 to 300 mg/day #{149}Increaseby 50 mg increments вЂ�is needed #{149}BID dosing : for over recommended ever 4 to 7 di s 100 mg/day 100-mg tablet COMPREHENSiVE DATABASE SAFETY (Worldde Eposure 40 countries + Data from + Over 9 millionpatients + More than 37,000patientsstudied inclinical trials treated LUVOXTM fiuvoxamnemaleate TARGETED *Efftjven Prescriben FOR OBSESSIONS TREATMENT not established beyond 10 weeks in controlled should write the smalkst Please see brief summary COMPULSIONS trials. tablet quantity consistent of prescribing AND information with good patient management toreduce on adjacent page. overdose risk. for Reporting Overdose t)1 LUVOXвЂ™ (fluvoxamine m.oteUobhis BiiefStjmmoy (Forh Prescithinghifoimoh #{238}#{227} to pockage inseit.) 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Da61SolvayPhannzeudca1sjnc m#{224}. h#{225} SOLVAY i26tmi)mon na mwintsn ho &*,ss i a mqjm saa#{226}; Reedenc.dnRsOgfl p*n aisd24Oea#{243}maN#{234}6 w oeavsd ma mois misonudeus SOLVAY i vude &&#{149} C 1995, Soay L!JвЂ™ PHARMACEUTICALS 30062 Phanuaceuiica1 Inc MI hgtns resenL 999217 USJ3863.OO Sepenber 1995 charge planning functions to perpetuate homelessness among persons with chronic housing instability. Although the number of subjects in the study was small, the data suggest that inadequacies in discharge planning are most apparent for homeless subjects with the triple disorders of schizophrenia, substance abuse, and antisocial personality disorder. The act ofsigning out ofthe hospital against medical advice appears to undermine the staffвЂ™s efforts to conduct adequate discharge planning. However, more information is needed about the treatment expeniences of homeless men with schizophrenia and concurrent substance abuse and antisocial personality disorder. It is possible that patients who traverse the roads between jails, homeless shelters, and psychiatric hospitals (23-26) are the most difficult to plan for because they have the greatest needs and the fewest options for adequate housing and treatment in the community. These characteristics, combined with such patientsвЂ™ greater likelihood of refusing treatment, can present serious management problems for inpatient staff, who are often compelled by policy mandates to strictly limit length ofhospital stay. The complex interplay between treatment refusal and reduced access to needed care is illustrated by the study finding that antipsychotic medications were less likely to be prescribed for homeless subjects than for never-homeless subjects. Although more information is needed about this important issue, it is plausible that medication was not prescnibed for some homeless subjects because oftheir past history of refusal to comply with medication therapy. Future work on service use and homelessness should focus on the problems of treatment refusal and service access among severely disabled patients, particularly those with comorbid diagnoses of schizophrenia, substance abuse, and antisocial personality disorder. We concur with researchers who have suggested that successful management of such patients in community settings requires specialized supportive housing and treatment services (27). Psychiatric Services November 1995 16. Acknowledgments This work 44705 was supported from the by grant National MH- Institute of Mental Health. The author thanks Patrick E. Shrout, Ph.D., and Boanerges Dominguez, M.S., for their helpful advice on the statistical analysis. 1 . Bassuk EL: The homelessness problem. Scientific American 25 1 :40-45, 1984 2. Hopper K, Hamberg J: The Making of AmericaвЂ™s Homeless: From Skid Row to New Poor, 1945-1984. New York, Community Service Society of New York, 1984 3. Baxter E, Hopper K: Troubled on the streets: the mentally disabled homeless poor, in The Chronic Mental Patient: Five Years Later. Edited by TalbottJA. Orlando, Fla, Grune & Stratton, 1984 4. Lamb HR: Deinstimtionalization and the homeless mentally ill. Hospital and Cornmunity Psychiatry 35:899-907, 1984 5. Lamb HR: Will we save the homeless mentally ill? American Journal of Psychiatry 147:649-65 1, 1990 6. Homeless Mentally Ill: Problems and Options in Estimating Numbers and Trends. Washington, DC, US General Accounting Office, 1988 7. Baxter E, Hopper K: Private Lives/Public Spaces: Homeless Adults on the Streets of New York. New York, Cornmunity Services Society, 1981 8. Cohen NL, PutnamJF, SullivanAM: The mentally ill homeless: isolation and adaptation. chiatty Hospitaland 35:922-924, FischerPJ,BreakeyWR: mental health: 1984 Homelessrssand overview. International Journal ofMental Health 4:6-41, 1986 Sosin MR. 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American Journal of Psychiatry 148: Rossi PH,WrightJD,FisherGA,etal: urban homeless: estimating The composition and size.Science 235:1336-1341, 18. 20. 21 22. 23. . 1987 Susser E, Struening EL, Conover S: Psychiatric problems in homeless men. Archives of General Psychiatry 46:845849, 1989 Caton CLM: The Community Care Schedule. New York, New York State Psychiatric Institute,Jan 1989 First MB, Spitzer RL, Gibbon M, et at: The Structured Clinical Interview for DSM-III-R Personality Disorders, Part I , Description. New York, New York State Psychiatric Institute, 1993 Kay SR. Fiszbein A,Opler LA: The Posinyc and Negative Syndrome Scale (PANSS) for schizophrenia. SchizophreniaBulletin 13:261-275, 1987 HosrnerDW,LemeshowS: Applied Logistic Regression. New York, Wiley, 1989 Abram KM, Teplin LA: Co-occurring disorders among mentally ill jail detainees. American Psychologist 46: 1036-1045, 1991 24. Solomon PL, DraineJN, Marcenko M, et at: Homelessness in a mentally ill urban jail population. Hospital and Commu- 25. Michaels D, Zoloth SR. Alcabes P, et at: Homelessness and indicators of mental illness among inmates in New York City correctional system. Hospital and Cornmunity Psychiatry 43:150-155, 1992 Vitelli R: Thehomeless inmate inamaximum security prison setting. Canadian Journal of Criminology, July 1993, nity Psychiatry 43: 169-1 7 1 , 26. 1992 pp 323-33 1 27. Gelberg L, Linn LS, Leake BD: Mental health, alcohol and drug use, and criminat history among homeless adults. American Journal of Psychiatry 145: 191-196, 1988 J ournal Care Seeks Success Managed Stories Psychiatric Servicer would like to encourage a dialogue among its readers about how to cope successfully with managed mental health care. The journal seeks case examples or descniptions of successful model programs for a possible future section in the journal. Potential contributors should send a one-page letter summarizing the successful experience to John A. 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Medical Care 25(9Xsupp): S37-S41, 1987 Frank impact ment ThompsonJW, 1991 Huber PJ: The behavior of maximum likelihood estimates under nonstandard conditions, in Proceedings of the Fifth Berkeley Symposium on Mathematical 13. Research. 4. Taube CA, 5. LosAngeles, Administna- view, ann supp 1991 , pp 45-77 2. CA, al: Prospective payment discharges from general and without psychiatric References 1 . Coulam prospective appraisal. 148:888-897, 25. Taube 12. of Health design. by grants Financing Ms. Taube ofPsychiatry 1991 of in- the National Institute ofMental (NIMH) assisted with study This canJoumal Essock-Vitale in the development Reviewers Needed Psychiatric Services seeks expert meviewers in the following areas: . Outcome research, particularly in the area of psychopharmacological treatment ofmental disorders S Rating scales for symptoms, outcome, and other aspects of treatment . Dual diagnosis (mental illness and drug abuse and mental illness and mental retardation) . Rural psychiatric services . Patient and consumer perspectives and attitudes Reviewers should be familiar with the literature in their areas of expertise, should have published in peerreviewed journals, and should be familiar with the content and focus of Psychiatric Services. Prospective reviewers should send a curriculum vitae, specifying areas ofinterest, toJohn A. Talbott, M.D., Editor, Psychiatric Services, APA, 1400 K Street, N.W., Washington, D.C. 20005. November 1995 Vol. 46 No. 11 November1995 PSYCHIATRIC SERVICES RESOURCECENTER a program ofthe American Psychiatric for mental health organizations Center AmericaвЂ™s Phone: 202/682-6173 Fax: 202/682-6348 Video Rentals Order The on Catalog PBS. care Psychiatric definitive discussions Practice Managed Care 202/682-6175 and Newsletter on Psychiatric Services Services вЂ�s Managed Care Arthur confronting pregnancy Care Revolution I 570 AP9 Psychiatric 202/682-6173 Institute Managed Number America 202/682-6349 1/800/366-8455 Video Association of the Month Video Services Resource Psychiatric Resources Center Revolution from Miller leads just a group of physicians, patients, hospitals, within a managed care system. executives, advocates, and conclusions are reached, related to the colliding patient the forces panelists of the video LifeвЂќ series Your and actual scenarios families dealing with Panelists include physicians, through a womanвЂ™s managed a syndicated columnist. Although video is an excellent tool of business and medicine. Inc. in association with Columbia Thirteen/WNET New York, 1995. APAвЂ™s State Newsletter a copy Money and Seminars, ism and Update purchased the вЂњYour University Graduate (60 minutes) no for initiating Produced by School of Journal- Reports 202/682-6237 New APPI Books YorkвЂ™s facilities reportedly 1/800/368-5777 [State Subscriptions 202/682-6158 Governor Update, me more on membership Psychiatric Services in the Center Times majority come at a price, or hard-to-diagnose address in July authorizing state psychiatric records. The patients. legislation 1995] published a five-part series ofarticles Revolution: Remaking Medicine in CaliforniaвЂќ August reports in its first column that the change in health care for the vast name a bill to patientsвЂ™ criminal acts of court-committed Update The Los Angeles Resource signed August/September California Please send information Pataki to have computer access was prompted by violent ofpatients. They conclude, however, which has been paid by the sicken conditions and the chronically highest level of HMO highest (35.8%), level and (38.3%) followed by Oregon Massachusetts (35.2%). The enrollment, research and is available delivery, call from reporters Times Health Care that these changes have patients, those with complicated ill. Among the states having the identified (37.5%), exhaustive on Demand, on вЂњThe 27-3 1, 1995. The Times delivery has been positive California as having Maryland (36.2%), series took seven Order No. the Arizona months of 401 5, for $8 plus $3 1-800-440-3441. fax to Mary Return Submission Ward APA Submissions Psychiatric Resource Services Center 1400 K Street, NW Washington, Fax: Psychiatric Deadlines DC November 6237; fax Mary 202/682-6348 Services Contact Submissions 20005 1995 for the 1995. Vol. Ward, 46 APAвЂ™s 1996 Almost Institute Office Here on Psychiatric to Coordinate Services the Annual are due November Meetings, phone January 5, 1995. 15, 202-682- 202-682-6345. for the H&CP phone No. 11 Achievement 202-682-6173; Awards are due Contact fax 202-682-6348. 1201