1. health and fitness
2. disorders

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 month’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 patient’s daily oral dose*2
on oral doses
to oral medication,
(
Initial month’s dose is 20 times patient’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 month’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 Dysuinesia”except 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 i94”. 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;
1’
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
%
4’
She’s
anxious.
She’s
agitated.
She can’t sleep.
She’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.
‘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
_____________________________
© 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 they’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,
hos-
tility, 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.
Bescham
Fma;eu
Philadelphia, PA 19101
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November
1995
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No.
11
Because lives
complicated by
psychosis
further
complicated by EPS.
are
‘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.
©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 RISPEROAL’
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 $yVI#{231}IOmSOIIanM dysidnesis pserm
a pei1cn
R1SPERDAI.,
iMig deconinuion
alocid be conideret
I4omar, acne pilents may reqwre
ItsWieci ciii RISPERDAL’W*ptsssnc.
cite ayr#{243}cme.
Potential for Proarrliythmlc
Efbcts:
Riaperidon.
and/or 9.hydroxy.
IdoM
3pS$
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 RISPERDAL’ 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.’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
m’), 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 RISP8hDAL’ 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
urypmscr’
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 ss’
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
RISPERDAL’Vurapyie wmmmat
RISPEIAL’&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 ‘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
FISPDAL’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. fleproahsctls’. orisrs,
Fssseho Frequent msnordsaa’,
-
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.’.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.’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 RISPERDAL’ Is not a controlled sststance.
sirosid be evalulad carefully or a hIstory ci demahsup, sal such
shard be ctsssved dossly ho shins ci Rlth’ERDA[’ 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.’(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
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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
‘extrepyrernidi symplairu does not sppsw hr dINer or Vu ‘ 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 RISPERDAL’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 the’
dona
Wsknsst Asrse sisal die dialled by a chsduat for Ida dads
po
msulbng Es an enWacedillsd(SseaJNICAL
PHARMACOLOGY).
1mm alsge*idycoss#{231}stngshssaddosssci
RISP8bAL’(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.’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
RISPERDAL’ 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.
©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.
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(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
scale’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
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see
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the
if
31.
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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
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The
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Read-
increase
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subscription
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References
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ers can
medication’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
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Pharmacogenetics
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Journal
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suppl):38-45,
1994
metabolism
meta-
symp-
anxiety
CL:
the
Hamilton
items
1994
DeVane
is not affected.
psychomotor
ef-
ofpossible
ofserotonin
ment
medication’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
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APA’s Psychiatric Services Rechiatric
source Center, which also
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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
“Investigations of the action mechanisms of antidepressants
have provided support for the importance of fserotonin
and norepinephrinej
interactions in the patho physiology
of depression.”
-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
outpatients’
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).’
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.’
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 “Warnings”).
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
Contraindications” and “Warnings.” 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: “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 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, vaginitis”;
Infrequent albuminuria, amenorrhea” , kidney calculus, cystitis, leukorrhea, menorrhagia”,
noctuna, bladder pain, breast pain, kidney pain, polyuria, prostatitis” , pyelonephritis, pyuria, urinary
incontinence, urinary urgency. uterine fibroids enlarged”, uterine hemorrhage” , vaginal hemorrhage”, vaginal moniliasis”;
Rare: abortion” , breast engorgement, breast enlargement, calcium
crystalluria,
female lactation”,
hypomenorrhea,
menopause” , prolonged erection”,
uterine
spasm. (“Based 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 “Contraindications”
and “Warnings”).
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. Physicians’ Desk Reference’. 48th ed. Montvale, NJ: Medical Economics Co Inc; 1994;
Prozac’:877-880;
Zoloft’:2000-2003;
Paxil#{176}”:2267-2270.5. EFFEXOR#{176}
prescribing information,
Wyeth-Ayerst Laboratories, Philadelphia, PA. 6. Data on file, Wyeth-Ayerst Laboratories.
WYETH-AYERSF
a
© 1994, Wyeth-Ayerst Laboratories
83561
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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
tharrall@ix.netcom.com.
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
hlthinfo@nmhcc.com.
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
jtalbott@umpsy.ab.umd.edu.
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
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SEROTONIN
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IN RELIEVING
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IMPRISON
PATIENTS’
DEMONSTRATED
COMPULSIONS
RAPIDLY
ACHIEVES
SHORT
HALF-LIFE’
LOW
INCIDENCE
FAVORABLE
BLOOD
STEADY-STATE
OF AGITATION
SAFETY
OBSESSIONS
MINDSI*
AND
LEVELS;
(2% vs 1% for placebo)’
PROFILE
#{149}:#{149}
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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%’
#{149}:#{149}
Concomitant
FLEXIBLE
use of LUVOXTMTablets
monoamine
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is not recommended’
DOSING
Dose: 50 mg once a day
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HS
50-mg tablet
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and
Dose Range: 100 to 300
mg/day
#{149}Increaseby 50 mg increments
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100 mg/day
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COMPREHENSiVE
DATABASE
SAFETY
(Worldde
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40 countries
+
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+
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+
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trials
treated
LUVOXTM
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TARGETED
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Prescriben
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TREATMENT
not established
beyond 10 weeks in controlled
should write the smalkst
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COMPULSIONS
trials.
tablet quantity consistent
of prescribing
AND
information
with good
patient management toreduce
on adjacent page.
overdose
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for
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PHARMACEUTICALS
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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 staff’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 patients’
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
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Care
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Success
Managed
Stories
Psychiatric
Servicer would
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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. Talbott,
M.D., Editor, PsychiatricSenrces,
Amencan Psychiatric
Association,
1400 K
Street,
N.W.,
Washington,
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20005.
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1991
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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
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Revolution
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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
Life”
series
Your
and
actual
scenarios
families
dealing
with
Panelists
include
physicians,
through
a woman’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.
APA’s
State
Newsletter
a copy
Money
and
Seminars,
ism and
Update
purchased
the “Your
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Graduate
(60 minutes)
no
for initiating
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Update,
me more
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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 California”
August
reports
in its first column
that the change
in health care
for the vast
name
a bill
to patients’
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 “The
27-3 1, 1995.
The Times
delivery
has been positive
California
as having
Maryland
(36.2%),
series took seven
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