WILLIAM W. K. ZUNG, M.D.

A self-rating pain and

distress scale
ABSTRACf: The author used the most commonly agreed-upon We describe below the develop-
characteristics of pain and accompanying distress to construct a ment of a scale for assessing pain
2D-item Pain and Distress (PAD) scale and administered it to 122 and distress intended to (I) be in-
clusive with respect to the various
pain patients and 195 normal controls. The pain patients scored
aspects of dysfunction that pain
significantly higher on the overall index (indicating more pain)
patients experience; (2) be short
than did the controls, regardless of sex, race, and age. They also and simple; (3) be quantitative so
scored significantly higher than did controls on all 20 individual that the results can be treated sta-
items. Based on results from statistical validation, use of the scale tistically; and (4) be self-adminis-
correctly classified 99.5% of normal controls and 84.4% of pain tered to indicate the patient's own
patients, who had been previously so identified clinically. response at the time of use.
Review of previous authors' ap-
proaches demonstrated that to ad- .
The need for evaluating pain and At the other extreme, eXlstmg equately rate pain it cannot be
associated distress is obvious from pain scales such as the McGill pain viewed as a unidimensional com-
the numerous studies I-S on pain and questionnaire 7 were thought diffi- plaint of sensory quality that varies
its relief, but this has not been cult and cumbersome for the ma- only in intensity. Instead, pain and
matched by the available methods. jority of our patients to compre- its associated distress need to be
We thought that the general ap- hend and complete. Another ap- examined in a multidimensional
proach to pain measurement, such proach to measuring pain has been framework, and evaluated quanti-
as use of the visual analog scale, 6 with patient self-evaluation, using a tatively on the basis of multiaxial
was insufficient in content validity global impression for the severity of constructs.
to describe the varied manifesta- pain and its relief. Other methods Considerable attention has been
tions of the pain and distress com- of assessing pain as a noxious sen- directed toward construction of
plaints, and insufficient in logical sory input use physical measure- models for assessing acute and
validity in grouping into categories ments such as a pressure algometer chronic pain, based on operational
those specific dysfunctions affected and provide a different framework definitions, as well as for evaluating
by the pain. for the evaluation. 8 the therapeutic efficacy of various
forms of pain treatment. One in-
Dr. Zung is professor ofpsychiatry at the Duke University Medical Center. Reprint vestigator l proposed a model that
requests to him at the VA Medical Center, Durham, NC 27705. comprises the primary factors of

OCTOBER 1983 • VOL 24 • NO 10 887

Pain and distress scale
the pain syndrome proper, physical
disability including activities of
daily living, and psychological dys-
functions that are associated with
the pain syndrome, such as depres-
sion and anxiety. Such an approach
avoids the common fallacy of ex-
cluding one factor if another is
present, eg, that "psychogenic"
pain has no physical component.
Bonica9 in a comprehensive re-
view conceptualizes acute pain
provoked by injury or disease as the
Table 1-Profile of Clinical Diagnostic Criteria
Associated with Items for Pain and Distress
Clinical diagnostic criteria
Presence of somatosensory pain
Mood changes
Specific mood changes
Feeling low and down
Feeling nervous, lense
General mood changes
Dissatisfaction
Increased irritability
Decreased personal Interests
Decreased SOCial actiVities
Behavioral changes
Increased fatigue
Decreased work output
Decreased work efficiency
Sleep disturbances
Difficulty falling asleep
Difficulty maintaining sleep
Early awakening
Not feeling rested alter sleep
Psychomotor disturbances
Agitation
Retardation
Decreased alertness
Difficulty With memory
DiffiCUlty With concentration
Difficulty maintaining alertness
Increased effort
888
net effect of many interacting bio- of anxiety and depression as con-
chemical, physiologic, and psycho- tributory factors. In addition, non-
logical mechanisms that involve addictive agents for the relief of
activity of most parts of the nervous pain and its associated distress in
system concerned with sensory, clinically useful dosages are with-
motivational, and cognitive pro- out psychotropic activity except for
cesses, and with psychodynamic changes in affective behavior con-
mechanisms. comitant with the pain relief.
Other models of pain are treat-
ment-oriented. An extensive re- Our scale
view 10 of analgesic drugs in pain In our self-rating Pain and Distress
management points out that pain (PAD) scale, the profile of clinical
assessment must include the degree diagnostic criteria comprised the
.-~
Items for pain and distress
,
I have aches and pains tha bother me
I feel miserable, low, and down
I
I feel nervous, lense, and keyed up
I
I still enjoy the things I used to
I am more Irritable than usual !
I enjoy listening to Ihe radiO or watching TV
I enjoy VISI 109 friends and relatives
I
I
I get tired for no reason
I can work for as long as I usually do
I am as efficient in my work as usual
I have trouble falling asleep
I have trouble sleepmg Ihrough the night
I wake up earlier than I want to
I feel rested when I get out of bed
!
I am restless and can't keep still
I find It hard to do the things I usually do
I find It hard 10 Ihink and remember things
I
My mind IS foggy and I can't concentrate
.
I am as alert as I could be
Everything I do is an effort
-
PSYCHOSOMATICS
most commonly found characteris-
tics when pain and associated dis-
tress are present. These criteria are
listed in Table I, under the catego-
ries for pain and for mood and
behavioral changes. These criteria
are matched with 20 corresponding
items for pain and distress.
Table 2 shows the self-rating
PAD scale devised on the basis of
the profile. The scale was devised so
that of the 20 pain, mood, and
behavioral changes used, the word-
ing of the items appropriately re-
flects the fact that 13 of them are
symptomatically positive and seven
are symptomatically negative. In
addition, the two types of responses
were scattered in the scale so that
no more than four items are scored
consecutively in the same direction.
The patient is asked to rate each
of the items according to the four
quantitative measures shown in
Table 2. Patients with less or no
pain and distress will have lower
scores, and those with more pain

Table 2-Self-Rating Pain and Distress (PAD) Scale

None or
alltlle Some Good part Most or all
of the time of the time of the time of the time
-
1. I feel mIserable, low, and down

2 I eel nervous. tense. and keyed up

-3. -
I get tired for no reason
-
4. I can work for as long as I usually do
.- - - -
5 I am as efficient In my work as usual
.-
6. I have trouble falling asleep

7. I have trouble sleeping through the night

8. I wake up earlier than I wan to

--
9. I feel rested when I get out of bed

10, I am restless and can't keep still

11, I find It hard to do the things I usually do

-- _.
12. I Ind It hard to think and remember hings
13 My mind IS foggy and I can't concentrate

4 I am as alert as I could be

5 I stili enJoy the things I used 0

16 I enJoy listening to he radiO or watching TV

,-, .- - -
17 I enJoy visiting friends and relatives

18. I have aches and pains that bo her me

'- '--

.-
19. I am more Irritable than usual
,~
- -
20 Everything I do IS an effort
._,-
- -
1982 Zun AI r hIS re 'IV d

OCTOBER 1983 • VOL 24 • NO 10 889

Pain and distress scale

will have higher scores. A value of or ache. Table 3 shows the distribu- servable pain and were asked not to
I, 2, 3, or 4 or of 4, 3, 2, or I is tion of pain complaints by area of fill out the scale if pain was present.
assigned to a response, depending the body. Almost 40% of the com-
on whether the item was worded plaints pertained to the back, 20% Scale results
positively or negatively. to the neck, and about 10% each to and validation
An index for the PAD scale was the head and shoulders. Table 4 shows the scores on the
derived by dividing the sum of the The PAD scale was also com- PAD index (means and standard
values (raw scores) obtained for the pleted by a control group of 195 deviations) for the 195 normal con-
20 items by the maximum possible normal individuals. They consisted trols and the 122 pain patients by
score of 80, with the result ex- of an approximately equal number sex, race, and age by decades.
pressed as a percentage. Thus, the of professionals, semiprofessionals, Within the control and patient
PAD index indicates how much of and skilled and unskilled workers. groups very little difference existed
the mood and behavioral changes a These individuals were free of ob- in the means when compared for
particular patient has as a percent (continued)
of the total profile.
The PAD scale was completed by
Table 4-Mean Scores on PAD Index
122 patients seen in a clinic over a
for Normal Controls and Pain Patients
four-month period for treatment of
by Sex, Race, and Age Group
acute (less than four weeks) pain
complaints resulting from trauma
(90%) or from exacerbation of pre- PAD index (%)
vious conditions (postural strains, Group N Mean (SO)
musculoskeletal deformities). In
Sex
addition, the patients were asked to controls 127 35.3 ( 6.7)
circle on a checklist the parts of the Male
patients 59 54 6 (11.8)
body that bothered them with pain
controls 68 35.7 ( 6.3)
Female
patients 63 55.9 (11.7)
Race
Table 3-Distribution con rols 181 353 ( 65)
of Pain Complaints White
patients 102 549 (1 1 7)
by Area
controls 11 359 ( 8.0)
(each patient Black
patients 20 586(10.7)
can have more than
Age (yr)
one complaint)
controls 3 360 ( 3.5)
<20
patients 6 54.0 (10.8)
Complaints controls 46 36,2 ( 6.5)
20-29
N % patients 22 574(116)
Area
con rots 60 350 ( 68)
Head 21 10 30-39
patients 25 524(100)
Neck 43 20
10 4 controls 42 33,3 ( 6,2)
Arm. hand 40-49
25 11 patients 29 562 (14 1)
Shoulder
Back 85 39 controls 25 37.0 ( 6.0)
50-59
Stomach 2 1 patients 20 547(106)
Chest 2 1 controls 14 36.9 ( 6.5)
Leg. 100 16 7 60-69
pallents 17 545(121)
HIp 15 7
con rols 5 40.2 ( 8.2)
70
Total 219 100 patients 3 653 ( 8 1)

890 PSYCHOSOMATICS
 'S!!'~"~o\"'''
'Jj:ff'\'I>
a.~. .'.I> ~
r!-'e~,,- ~",.- ...
~'I>~a. ,,~
~1! Pain and distress scale
'\~'I>~':iF" ..A
...

f>'1> ....

~~
().'J.. BrIef au......., of "'-1IlII'II1nlonnIIlIon.

,~~ IndaIIoM ... UNgr. Management of anxiety

sex, race, or age by decade (except
L.t::J'
N
disorde<s or shofI-term relief of symptoms of anxiety
or anxiety aaaoclated _ depres8i\/e symptoms. Anxiety
for the two 70-and-over groups,

~
Q or lenslon aaaocIated _ strMs of 8\I8lYd8y life usually does which, like the under-20 group, had
not require treatment _ an anxiolytic.
comparatively few subjects in
~
E~ in long-term use. I.... _than 4 months. has not
~, been asaessed by systematic cliniCal studies. Reassess periodically them). However, statistical analy-
- "' usefulness of the drug lor the individual patient.
.At\ ConhIncIIc8lIon Known MnsiIMIy to berlzodiazepiMs or acute narrow-angle ses using unpaired t tests showed
~~' - glaucoma. that the mean PAD indices for all
W8rr*lga: Not recommended in primary depres8i\/e disorde<s or peychoses. As _ aft
CNS-acting drugs. warn patients not to operate machinefy or motor vehiCles. and of dimin- groups of pain patients were signif-
ished tolerance tor alcohol and other CNS~.
Physical and PsychologiCal Dependence: Withdrawal ayrnpIoms Iilce those noted _ ~
icantly (P<.OI) higher than those
rates and alcohol have occurred following abrupt discontinuance of benzodIaz8pines (including
conwlsiOns. tremor. abdominal and muscle crampe. vomiting and -..g). AddiCtlon-prone
for the comparable control groups.
individuals. e.g. drug addicts and alcoholiCs. should be under carefullUlWillance when on ben- Table 5 compares the mean PAD
zodlazepines because ollheir predisPOSition to habiluallon and dependence. Withdrawal symp-
toms have also been repOrted following abrupt discontinuanc. of benzodiazepines taken scores for each of the 20 items and
continuously at therapeutic Ievets tor several months.
the mean PAD indices for the nor-
I'Ncaltlona: In depression accompanying anxiety. consider possibility for suiCide.
For eIderty or debilitated patients. initial daily dosage should not exceed 2mg to avoid 0V8rll&' mal control subjects and the pain
dation. Terminate dosage gradually Ilince abrupt wiIhdrawal of any antianxiety agent may resuK in
symptoms lik. thoae being treated: anxiety. agitation. iniIabitiIy. tension. insomnia and occasional patients. The mean scores for the
convulsions. Observe U8UaI precautions _ impaired _ or hepetic function. Wher. gastroin-
testinal or cardiOvascular diSOrders coexist _ anxiety. note that Iorazllpem has not been shown
items are based on a possible range
of significant benefit in treating gastrointestinal or cardiovasculer component. Esophageal di1a- of 1 to 4, while the PAp index is
tion occurred in rats treated _ Iorazllpem lor _ than 1 year at 6mg/kg/day. No eIfec1 dose
was 1.25mg/kg/day (about 6 times maximum human therapeutic dose of lOrng/day). Effect was shown in percent of the total possi-
reversible only when treatment was withdrawn _in 2 months of finll ob8eMIIion. Clinical sig-
nificance is unknown: but use of Iorazllpem tor prolonged periods and in geriatrics requires cau-
ble score of 80 for all 20 items.
tion and 'requent monitoring lor symptoms of upper G.I. diseaM. Safely and ~ in Statistical analyses using unpaired t
children under 12 years have not been established.
ESSENTIAL LABORATORY TESTS: Some patients have ~ leukopenia: some have had tests and corrected for multiple
elevations of LDH. As _ other benzodlazepines. periodiC blood counts and I~ function _
are recommended during long-term therapy.
testing against spurious significant
CLINICALLY SIGNIFICANT DRUG INTERACTIONS: Benzodiazepines produce CNS depressant results showed that the normal
effects when administered _ such mediCations as barbiturates or alcohol.
subjects had significantly lower
CARCINOGENESIS AND MUTAGENESIS: No evidence 01 carcinogeniC potential_gad in rats
during an llknonth study. No studies regarding mutagenesis have been petformed. mean scores than did pain patients
PREGNANCY: Reproductive studies were performed in miC•. rats. and 2 strains of rabbits.
Occasional anomalies (reduction of tarsals. tibia. metatarsals. malrotated limbs. gastroschisis.
on all 20 items (P<.OI for every
maKormed skull and miCrophthalmia) - . - . in drug-treated rabbits without relationship to item).
dosage. Although all ' - anomalies were not."..,t in the concurrent control group. they have
been reported to occur randomly in historical conlrOIo. At .amg/kg and ~ . lhere _ evi- Statistical analysis using the a-
denc. of lelal resorption and increased tetaI loss in rabbits whiCh _ not - . at _ doses.
C~niCal sign~ieance of ' - findings is not known. Howewr. increased rilIk Of congenital malfor-
coefficient calculation for reliability
mations associated with us. of minor tranquilizers (chlordiaz.poxide. diaz.pam and analysis yielded a coefficient
m.probamat.) during first trimester of pregnancy has been suggested in several studies.
Because use 01 ' - drugs is rarely a mafter of urgency.... of Iorazllpem during thiS period a = .89, indicating highly reliable
should almost always be avoided. Possibility that a woman of child-beering pOtential may be preg-
nant at institution of therapy sIloold ba considered. Advise palienl8 ~ they become pregnant to
internal consistency for the profile
communiCate _ their physician about desirability of diSContinuing the drug. In humans. blood of pain measured by the PAD.
Ievets from umbilical cord blood indiCa1e placental transfer of Iorazepem and its glucuronide.
NURSING MOTHERS: K is not known ~ oraIlorazllpem is exeteted in human milk Iik. other ben- To examine further the psycho-
zodIazepines. As a general rule. nursing should not be underta.... while on a drug Ilince many
drugs are excreted in milk.
metric properties of the PAD scale
AIMrM IINctIona, ~ they occur. are usually obll8Mld at beginning of thenIpy and generally dill- with respect to its ability to distin-
appear on continued mediCation or on decreasing dose. In a -..pIe of about 3.500 anxloua
patients. most frequent acMIrse reaction is sedation (15.9%). toIIowed by ~ (6.9%). -'<-
guish normal subjects and pain pa-
ness (4.2'1(,) and unateadiness (3.4'11.). Less frequent are dilorientalion. depression........ tients, a multivariate statistical
change in appeti1e. headache. sleeP disIurbance. agiIatIon. dermatolOgical symptoms. eye tunc-
tion disturbance. various gastrointestinal symptoms and autonomic m8nilestations. Incidence of analysis (stepwise discriminant
sedation and unsteadiness increased _ age. Small ~ in blOOd pressure have been
noted but are not clinically significant. probably being related to relief of anxiety. function) was performed. All sub-
Overdosage: In management 01 OIIerdosage _ any drug. bear In mind multiple agents may jects were reclassified as normal or
have been taken. Manifestations of overdosage include somnolence. confusion and coma.
Induce vomiting and/or undertake gastriC lavage tollowed by general supporti\Ie care. monitoring as pain patients, based on results of
vital signs and close observation. Hypotension. though unlikely. usually may be controlled _
Levarterenol Bitartrate Injection U.S.I' Usefulness of dialysis has not been determined.
the new weight given to each item.
The 11 PAD items that best dis-
e-~tlvan·@ criminated between the two groups
were, in rank order: Have aches

~
and pains, enjoy visiting friends
and relatives, trouble sleeping
DOSAGE: IndIvlcIu8IIIe tor maximum beneIcIIII elIecta. IncreMe doN"""'" through the night, am as alert as
when ...... gIvlnghlghef-*'ldoNbefcn~.,..... ..... ~ could be, work as long as usual,
ely. usuen, 2·3mg/d8y gl¥wI b.I.d. or tid.; doNge m., .-r from 1 to 1Clmg/d8y
In divided doNs. For elderly or cIlIblIltllted. InIU8IIJ 1~2mg/dllr, InI-* due to
anxiety or tr-'ent altuaUonaI . . . . . 2-4mg h.s.
HOW SUPPLIED: 0.5, 1.0 and 2.CImg tabIeta. 892 PSYCHOSOMATICS

Wyeth laboratories
Philaclelptlia. PA 19101 ~'M
 hard to do usual things, wake up
Table 5-Mean Scores (Possible Range of 1 to 4) earlier, more irritable than usual,
by PAD Item for Normal Controls and Pain Patients restless and can't keep still, trouble
falling asleep, and feeling nervous
and tense.
Normal Pain Table 6 summarizes the reclas-
controls patients sification of all subjects using these
=
(N 195) =
(N 122) results. We see from it that only one
PAD items Mean (SO) Mean (SO) of the clinically observed 195 nor-
1 Feeling low and down 1.3 (0.4) 1.9 (0.9) mal controls was wrongly reclassi-
2 Feeling nervous and ense 1.6 (0.6) 2.1 (0.9) fied as a "pain patient," with the
3 Tired for no reason 1.4 (0.6) 2.0 (1 0) correct reclassification rate being
4 Work as long as usual 1 6 (10) 2.7 (1 1) 99 .5%. Of the clinically observed
5 As effiCient In my work as usual 1.7 (1 0) 2.6 (1.1) 122 pain patients, 103 were correct-
6 Trouble failing asleep 1.2 (05) 2.0 (1 0) ly reclassified as pain patients
7 Trouble sleeping through the nrght 1.3 (0.5) 2.2 (1 0) (84.4%), and 19 (15.6%) were mis-
8. Wake up earlier 1.4 (0.7) 1.9 (1 .1 )
classified as "normal controls."
9 Feel rested on getting out of bed 2.0 (0.9) 2.8 (1. 1)
Lastly, a factor analysis using a
10 Res less and can't keep still 1.5 (0.7) 2.0 (1 0)
11 Hard to do usual things 1 2 (0.5) 2.3 (1 0) varimax orthogonal rotation was
12 Hard to think and remember 1 3 (0 5) 1.6 (08) performed on the PAD results ob-
13 MInd foggy and can t concentrate 1.1 (0.3) 1.5 (07) tained from the pain patients. The
14 Am as aler as could be 1 5 (0.8) 25 (1 1) results of the analysis showed the
15 Still enjoy usual things 1 5 (0 8) 2.3 (1.1) importance of using a multiaxial
16 EnjOy listening to radio model for measuring pain, with
or watching TV 1.5 (0.8) 2.3 (1 2) each of the six factors obtained
17. EnJOy VISlling fnends clearly reflecting distinct and clini-
and relatives 15 (0.8) 2.6 (1 2) cally meaningful item clusters.
18 Have aches and pains 13 (0.5) 2.8 (08)
Factor I consisted of the items
19 More Irritable than usual 1.4 (0.6) 21 (0.9)
20 Everything IS an effort
feeling low and down, feeling ner-
12 (0.4) 21 (1.0)
vous and tense, tired for no reason,
PAD Index 35.6 (6.6) 553 (11.7) and have aches and pains; Factor 2
of feel rested on getting out of bed,
am as alert as could be, still enjoy
things, enjoy listening to radio or
watching TV, and enjoy visiting
friends and relatives; Factor 3 of
Table 6-Validation of the PAD Scale* hard to think and remember, and
I
mind foggy and can't concentrate;
Factor 4 of trouble falling asleep,
Clinically Predicted group trouble sleeping through the night,
observed "Normal "Pain and restless and can't keep still;
group controls" paUents" Factor 5 of work as long as usual, as
efficient in my work as usual, hard
195 Normal (N) 194 1 to do usual things, and enjoy lis-
controls (%) (99.5) (0 5)
tening to radio and watching TV;
122 Pain (N) 19 103 and Factor 6 of more irritable than
patients (%) (15.6) (844) usual, and everything is an effort.
II Classlflcatlon of subjects by clinIcal obs Nation In 0 normal controls and paIn pa 1 nrs These various analyses taken to-
II compared With he pred,cled classl lca Ion utiliZing results on he PAD scale
gether indicate that the PAD scale
- - has sufficient sensitivity and speci-

OCTOBER 1983 • VOL 24 • NO 10 893

Pain and distress scale
ficity to be used as a measure of pain
and distress, and provides informa-
tion that can be treated statistically.
Used in conjunction with an in-
terviewer-rated scale, the PAD
self-report scale can provide the
objective and subjective data nec-
essary to document pain and dis-
tress as a presenting chief com-
plaint. Thus the PAD can be used
in research and clinical settings to
( I) provide an overall index of the
pain and distress present; (2) deter-
mine a pain profile in terms of the
associated dysfunctions experi-
enced by the patient as measured
by the clinical diagnostic criteria,
REFERENCES
1. Balzer 0: Chronic pain: A multiaxial approach
to psychological assessment and interven-
tion South Med J 74:203-208. 1981.
2. Kocher R: The use of psychotropic drugs in
the treatment of chronic severe pain. Eur
Neurol 14:458-464.1976.
3. Lindsay PG. Wyckoff M: The depression·pain
syndrome and its response to antidepres·
sants. Psychosomatics 22:517-577.1981.
4. Moertel CG. Ahmann DL. Taylor WF. et al: A
comparative evaluation of marketed analge-
sic drugs. N Engl J Med 286:813-815.1972.
5. Pilowsky I. Bassett DL: Pain and depression.
Br J Psychiatry 141 :30-36. 1982.
Letter to Editor Invited
Brief len r. c mmenling n publi hed ani Ie or
ther ubject of inter trader of Psycho 0-
maties ar in ited. omment on publi h d ani Ie
will be forwarded to the author ~ r r pI
di cretion of th editor orre pondence rna b
edit d and publi hed.
Write to: Wilfred 0 rfm n. M.D.. ditor in hi f.
P )'ehosomatic, 55 Holl H ill Lane, Box 40 IO.
Greenwi h T 06 30.
894
which would help in formulating
treatment plans; and (3) evaluate
the therapeutic efficacy of various
forms of pain treatment by its use
as a repeat measure over time and
with intervention.
Further work on the scale will
include obtaining data from pa-
tients with depression, since the
general preval~nce of pain and de-
pression, and their frequent coexis-
tence, has been recognized for some
time, but the exact nature of this
association is unclear. 0 reduction of dosage or the addition of amajor tranquilizer to the
Research support from Whitehall Labo-
ratories is gratefully acknowledged.
6. Revill 51. Robinson JO. Rosen M. et al: The
reliability of a linear analogue for evaluating
pain. Anaesthesia 31 :1191-1198. 1976.
7. Melzack R: The McGill pain questionnaire:
Major properties and scoring methods. Pain
1:277-299. 1975.
8. Merskey H. Evans PR: Variations in pain com-
plaint threshold in psychiatric and neurolog·
ical palienls with pain. Pain 1:73-79.1975.
9. Bonica JJ: Neurophysiologic and pathologic
aspects of acute and chronic pain. Arch Surg
112:750-761.1977.
10. Halpern LM: Analgesic drugs in the manage-
ment of pain. Arch Surg 112:86HI69. 1977.
t the
PSYCHOSOMATICS
....
(trimipamirerraeae)
..,." ,,,..'I~I••• 'I.... a.. c••,I••• ,,,II.c' I.,,,·
••,1 "., wlIld ,.11 :
CHTUI. .CATI_: Contraindicated in cases of known
hypersensitivity to the drug. and during the acute recovery
period alter myocardial infarction. The possibility of cross·sen·
sitivity to other dibenzazepine compounds should be kept in
mind. Surmontil (trimipramine maleate) should not be given in
conjunction with drugs of the monoamine oxidase inhibitor
(MAOI) class. At least two weeks should elapse between cessa·
tion of therapy with an MAOI and institution of therapy with
SUrmontil (trimipramine maleate).
WAU''': C~III1".: This drug is not recommended for use in
children. since safety and eltectiveness in the pediatric age
group have not been established. AII,"a: Use extreme caution
in giving the drug to patients with evidence of cardiovascular
disease. Caution is advised in patients with: increased intra·
ocular pressure. history 01 urinary retention. narrow·angle
glaucoma. seizure disorder. hyperthyroidism. a need for thyroid
medication. In patienls receiving guanethidine or similar agents.
Surmontil may block the pharmacologic enects of these drugs.
Warn patients that the drug may impair the mental or physical
abilities required for driVing or pertorming other potentially haz·
Irdous tasks.
'.ECAlT....: Because of an inherently serious suicide poten·
tial. the nonhospitalized severely depressed patient should be
given the smallest drug amounl feasible. In schizophrenic
patients. activation of the psychosis may occur and require
medication schedule. Manic or hypomanic episodes may occur,
especially in patients with cyclic·type disorders: Surmontil may
have to be discontinued until the episode is relieved and reinsti·
tuted. ilrequired. at lower dosage. Limit concurrent
administration of Surmontil and electroconvulsive therapy to
Ihose patien,s for whom it is essential. When possible. discon·
tinue the drug for several days prior to elective surgery. The use
of alcoholic drinks during therapy may provOke exaggerated
response. Potentiation of eltects has been reported when trio
cyclic antidepressants were administered with sympathomimetic
amines.local decongestants. local anesthetics containing epi·
nephrine. atropine. or drugs with an anticholinergic inKl.
Drugs having aparasympathetic enect. including tricyclic anti·
depressants. may alter ejaculatory response.
..... 1. ,"....c,: Pregnancy Category C. Surmontil has
shown evidence of embryotoxicity and/or increased incidence of
major anomalies in rats or rabbit~ at doses 20 times the human
dose. There are no adequate and well·controlled studies in preg·
nant women. Surmontil should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.
C.rtIl"....III-Hypotension. hypertension. tachycardia.
palpitation. myocardial infarction. arrhythmias. heart block.
stroke.
h,c"",lc-Confusional states (especially in the elderly)
with hallucinations. disorientallon. delusions: anxiety. restless·
ness, agitation; insomnia and nightmares; hypomania:
oxacerbation of psychosis.
..".IIII_Numbness. tingling. paresthesias of extremities:
incoordillation. ataxia. Iremors: periplleral neuropalhy: extra·
pyramidal symptoms; seizures. alterations in EEG palterns:
tinnitus.
Altlchll,,"lc-Ory mouth and. rarely. associated sublin·
gual adenitis: blurred vision. disturbances of accommodation.
mydriasis. constipation. paralytic ileus; urinary retention.
delayed micturition. dilation of the urinary tract.
AII,"lc-Skin rash. petechiae. urticaria. itching. photosensi·
tization. edema of face and tongue.
.........I_80ne·marrow depression including agranulocy-
tosis. eosinophilia: purpura; thrombocytopenia. Leukocyte
and differential counts should be performed in any patient who
develops fever and sore throat during therapy: the drug should
be discontinued if there is evidence of pathologic neutrophil
depression.
..str.I.,..II..I-Nausea and vomiting. anorexia. epigastric
distress. diarrhea. peculiar taste. stomatitis. abdominal
cramps. black tongue.'
EltII"I..-Gynecomastia in the male; breast enlargement and
galactorrhea in the female; increased or decreased libido; impo-
tence: testicular swelling; elevation or depression of blood·sugar
levels. .
It~"-Jaundice (simulating obstructive): altered liver func·
tion: weight gain or loss; perspiration: flushing: urinary
trequency: drowsiness. dizziness. weakness. and fatigue; head-
ache; parotid swelling: alopecia.
W"W,...I',."'1II-Though not indicative of addiction.
abrupt cessalion of treatment alter prolonged therapy may
produce nausea. headache. and malaise.
..'PUEI: 25 mg in bonles of 100 and in Clinipak c cartons of
100 (20 strips ot 5) opaque blueand yellow capsules. 50 mg
in bonl,s of tOO and in ClinipakC cartons Of 100 (2o.strips of 5)
opaque blue and orange capsules. tOO mg in boltles ot 100
opaque blue and white capsules.
IVES LABORATORIES INC.
685 Third Avenue. New York NY 10017(3
Dedlcatld '0 Improving the quality
of 11flJ. through IlIedlcl.,.·