A method of evaluating efficiency in theoperating roomDEBRA MILICZKI WEIMER, CRNA, MSNPittsburgh, Pennsylvania

A scientific four-step approach to evaluatingefficiency in the operating room (OR) isdescribed. These steps include identificationof sequential work activities (SWAs) that arecritical to the timely progression of surgicalcases through the OR, identification of a timestandard for completion of SWAs, directobservations of the amount of time requiredfor completion of SWAs, and analysis ofresults. Two strategies to improve ORefficiency are described. Intergroup strategiesrequire coordination of work among variousspecialty groups involved with the progressof cases through the OR. Interpersonalstrategies necessitate coordination of workbetween two or more people within the samespecialty group.

Key words: Coordination strategies, delayfactors, operating room efficiency,time study.

IntroductionIn an age when insurers, employers, and consumersare demanding that hospitals utilize cost and qual-ity control measures, hospital survival depends onefficient, high-quality patient care.1 According toCharns' and Schaefer's model for management ofhealthcare organizations, quality patient care canbe determined simply by asking how well thehealthcare organization delivers the services it says

it provides. Efficiency concerns containing the costsof producing those services.2 Faced with the need tocontain costs, hospital managers must be able toevaluate the efficiency of departments and imple-ment strategies to improve their efficiency. Thisarticle offers an approach to evaluating efficiency inthe operating room (OR) and recommends strate-gies for improving OR efficiency.

Evaluation of operating room efficiencyIn order to acquire dependable and useful in-

formation, a scientific approach should be utilizedwhen evaluating the efficiency of the OR.3 Themajor steps in this approach are listed in Table I.

* Step 1. Identification of work activities thatare critical to the timely progression of surgicalcases through the OR is needed. In order to provide

Table IMajor steps in evaluating operating room efficiency

1. Identify sequential work activities critical to thetimely progression of surgical cases through theoperating room.

2. Establish a time standard for completion of sequen-tial work activities.

3. Conduct direct observations:Design record-keeping form.Design demographic data form.Obtain institutional review board approval.Conduct pilot study.Determine observational sampling criteria.

4. Analyze results.

June 1993/ Vol. 61/No. 3 287

quality patient care in an age of highly complexand technological healthcare, a division of work bydepartments or specialty groups occurs. These spe-cialty groups include anesthesia, escort, generalsurgical nursing, OR nursing, postanesthesia careunit (PACU) nursing, respiratory therapy, andx-ray for patients undergoing surgical procedures.

Each specialty group is responsible for per-forming particular elements of work, allowing formaximum depth of knowledge in each specialtygroup. Although particular elements of work areperformed by different specialty groups, the workfrequently is performed sequentially or simulta-neously so that it can be done effectively andefficiently.2 An example of elements of work thatare performed sequentially is induction of anesthe-sia prior to skin incision. Examples of elements ofwork that are performed simultaneously includemaintenance of anesthesia and performance ofsurgery.

When evaluating the efficiency of the OR, onlythose elements of work that are performed sequen-tially and are critical to the progression of surgicalcases through the OR need to be identified. Thesesequential work activities (SWAs) can be identifiedfrom the job description of each healthcare workerinvolved with moving cases through the OR. 4 Ex-amples of the SWAs performed by anesthesiacaregivers that are critical to the progression ofcases through the OR are included in Table II.

Table IISequential work activities required for theprogression of surgical cases through theoperating room (OR)*

Anesthesia specialty group*** Preoperative anesthesia assessment* Patient transported from the OR holding area to the

OR table* Anesthesia monitors applied* Intravenous preparation* Anesthesia induction/intubation* Anesthesia emergence (after surgical dressing

applied)

* Transport of patient to the postanesthesia careunit (PACU)

* Stabilization of patient in the PACU* Next patient seen by primary anesthesia caregiver

* Simultaneous work activities are not included.** Sequential work activities for escort, general surgical nurs-

ing, OR nursing, PACU nursing, respiratory therapy, and x-raydepartments also need to be identified when evaluating theefficiency of the OR. These work activities may vary witheach organization.

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* Step 2. A time standard for the completionof the SWAs identified in Step 1 is needed so that ananalysis of the amount of time each specialty grouptakes to perform its work activities can be accom-plished. Such an analysis can reveal whether toomuch time was taken to perform a particular activ-ity or whether a delay between SWAs had occurred.

According to the literature, one method of es-tablishing time standards for completion of workactivities is to utilize expert opinion. 5 For example,a listing of the work activities identified in Table IIcan be distributed to randomly selected anesthesiacaregivers in the population of anesthesia caregiversemployed by the healthcare organization. A tablecan be used to determine the sample size from thepopulation. 6 A lottery method can be utilized to se-lect the random sample.3 The participants shouldbe instructed to estimate the minimum and themaximum amounts of time required to completeeach activity listed. Means for the responses to boththe minimum and the maximum amounts of timerequired to complete each activity should be deter-mined using the following formula: 5

Mean =The sum of each participant's response

The number of participants

If five participants' responses to the minimumamount of time required to perform the preopera-tive assessment were 4, 5, 5, 5, and 6, the meanminimum time would be determined as follows:

4+5+5+5+655 =55

If the participants' responses to the maximumamount of time were 6, 6, 7, 7, and 9, the meanmaximum time would be determined as follows:

6+6+7+7+975

The mean minimum and maximum times couldthen be used to determine a standard time range forcompletion of each activity, such as 5-15 minutes forcompletion of the preoperative anesthesia assess-ment. An example of the standard time range forcompletion of activities presented in Table II isshown in Table III.

* Step 3. Direct observation of the actualamount of time required for completion of the SWAsidentified in Step 1 is needed, as well as of the delayfactors that contributed to an increase in the timerequired for cases to progress through the OR. Priorto conducting observations, the following activitiesshould be performed:

Journal of the American Association of Nurse Anesthetists

1

Table IIIStandard time range for completion of anesthesiawork activities

Standard time range*Sequential work activities Minimum Maximum

Preoperative anesthesiaassessment 5 15

Patient transported to theoperating room (OR) tablefrom OR holding area 5 10

Monitors applied 2 5Intravenous preparation 5 15Induction/intubation 6 18Anesthesia emergence (after

dressing applied) 4 15

Transport of patient topostanesthesia care unit(PACU) 5 10

Stabilization of patientin PACU 5 15

Next patient seen byprimary anesthesiacaregiver 1 3

* Time range is expressed in minutes and represents a calcu-lated mean determined by the method presented in the text.

1. Develop a method for recording observa-tions.

2. Obtain institutional review board approval.3. Conduct a pilot study.4. Determine observational sampling criteria.A form for recording the time required for

completion of work activities and for encoding thedelay factors observed and the time consumed bythese delay factors is needed. A sample record-keeping form for anesthesia work activities is pre-sented in Table IV. Possible delay factors that couldincrease the amount of time required to performdirect work activities are presented in Table V. Thedelay factors are grouped into the following fivecategories: environment, equipment/supplies, per-sonnel, information, and patient. Each factor isgiven a code number which is recorded in the delayfactor code column found in Table IV.

A demographic data form is needed to identifythe influence that variations in the individual per-forming the work, in the patient, or in the workenvironment could have on the actual time requiredto perform the activities. For example, a variablein the individual performing the work is the num-ber of years of work experience he or she has. Avariable in the patient is his or her physical status.A variable in the work environment is the numberof cases scheduled in the OR suite.

Permission to conduct the observations shouldbe obtained from the internal review board of thehealthcare organization. A pilot study can then beconducted to assess the adequacy of the data collec-tion instrument.) Direct observations for the pilotstudy could include all of the cases assigned to oneOR suite on a particular day.

Criteria regarding observational samplingshould be determined so that representative obser-vations are obtained. The OR suite in which obser-vations are conducted should be randomly selectedby the lottery method. Decisions regarding thenumber of days, hours per day, and cases requiringobservations should be made prior to data collec-tion. Observations should be performed by some-one who is familiar with the aims of the project, thedelay factors to be observed, the sampling strategyused, and the data collection forms utilized.

Step 4. An analysis of the results is needed.Means and standard deviations can be calculatedfor the total amount of time involved in the ob-served delays, relative to the specialty groups in-volved. An analysis of the estimated and actual timerequired by personnel from each specialty group toperform their work activity can be performed.Means and standard deviations can be tabulated fordirect work activities.

Pearson's product-moment correlations can betabulated to show correlations between variablesand the amount of time required to complete workactivities.'-" This analysis can be performed by man-agers who are familiar with statistics or by hospital-employed statisticians. Once the results have beeninterpreted, a committee composed of membersfrom each of the specialty groups should be utilizedto recommend strategies to improve OR efficiency.

Recommended strategiesThe cooperation of all personnel involved in

the progress of cases through the OR is needed forthe successful and efficient care of surgical patients.Many of the observed delays cannot be resolved,simply because of the factors causing the delays. Forexample, it is difficult to resolve the delays thatoccur when a patient cannot be intubated becauseof anatomical abnormalities or when intravenousaccess cannot be obtained because of prolongedchemotherapy. However, many observed delays canbe resolved through coordination of the work.

There are two basic types of work coordinationneeded in order to resolve delays. The first,intergroup coordination, requires coordination ofwork between the various specialty groups involvedwith the progress of cases through the OR. Thesecond, interpersonal coordination, required coor-

June 1993/Vol. 61/No. 3 289

Table IVSample record-keeping form for anesthesia work activities1

Totaltime

Sequential Recorded involvedwork activities time (minutes)2

Observeddelayfactorcode 3

Totaltime

Recorded involvedtime (minutes)2

Patient arrives inoperating room(OR)

Preoperativeassessment(5-15)4

Patient enroute toOR suite

Patient on OR table(5-10)4

Monitors applied(2-5)4

Intravenouspreparation (5-15)4

7:00 SC

S 7:15 15 1PE SC

C 7:30 15

S 7:40

C 7:43 3

S 7:43

C 7:45 2

111 SC

9PT SC

SC

SC

SC

S 7:45 SC

C 8:10 25 4PT SC

Induction/intubation(6-18)4

S 8:10 SC

C 8:34 24 3PT SC

7:007:15

7:217:30

7:307:40

7:488:10

8:128:30

15

9

10

22

18

S-StartedC-Completed1. Recorded times and observed delay factors are examples of how the record-keeping form is utilized.2. Calculated from the recorded time column.3. Delay factors listed in Table V are assigned a code number, which is recorded in this column.4. Represents the standard time range from Table Ill.

dination between two or more people within thespecialty group.9

Application of intergroup coordination strategiesManagers can utilize intergroup coordination

strategies to resolve the delays that frequently occurin surgery, for example, the scheduled OR time orthe need for additional OR supplies.

* Scheduled operting room time. A uniformdefinition for the scheduled OR time which ap-

290

pears on the printed OR schedule is needed. Delaysfrequently occur when a variety of interpretationsexist. Possible interpretations of the printed timeon the OR schedule could include:

1. The time in which a patient should be en-route to the OR suite.

2. The time in which a patient should be readyfor the surgeon.

3. The time at which a skin incision should bemade.

Journal of the American Association of Nurse Anesthetists

Table VDelay factors that can increase the amount of time required for surgical cases to progress throughthe operating room (OR)

EnvironmentCode # Delay factor

1EN Add-on case2EN Case postponed;

Case cancelled3EN Contaminated room (i.e., hepatitis, AIDS, etc.)4EN Delay from the patient care unit5EN Elevators not available6EN Order of cases rearranged7EN OR room being cleaned, set up8EN Recovery room full

Equipment/suppliesCode # Delay factor

1ES Additional equipment needed2ES Additional instruments needed3ES Additional supplies needed4ES Additional equipment not available5ES Additional instruments not available6ES Additional supplies not available7ES Autoclave not available8ES Blood, blood products not available9ES Drapes/instruments contaminated

10ES Equipment not functioning11ES Instruments not functioning12ES Lost suture13ES OR bed needed changing14ES Transport bed late15ES Transport oxygen, ambu bag not available16ES Routine equipment not available17ES Routine instruments not available18ES Routine supplies not available

PersonnelCode # Delay factor

1PE2PE3PE4PE5PE6PE

InformationCode # Delay factor

112131

4151617181

91101111121

Abnormal laboratory resultsAdditional x-rays neededAnesthesia assessment not

completed/recordedChart being completedChart being reviewedConsent not signedConsult not completedHistory and physical examination

not on chartRepeat blood work neededResults from pathology not availableTest results not on chartWriting orders

PatientCode # Delay factor

1PT2PT3PT4PT5PT6PT7PT8PT9PT

10PT

Additional IVs, monitoring lines neededAdditional procedures performedDifficult intubationDifficult IV accessFailed regional techniqueNail polish needs removalPatient not availablePatient being repositionedPatient's conditionShave preparation not completed

Anesthesia not availableEscort not availableHousekeeping not availableOR nurse not availableSurgeon not availableX-ray not available

The various interpretations usually result indelays involving personnel. For example, when per-sonnel are not available until 7 AM, the printed timeof 7 AM does not represent a time when a patient canbe ready for the surgeon or a true time for making askin incision. Once a uniform definition of theprinted time has been made, then cooperation fromeach of the specialty groups is needed so that theavailability of personnel can be ensured.

a Need for additional operating room supplies.When changes in the surgical procedure requireadditional OR supplies, the OR nurse should benotified by the surgeon prior to the scheduled starttime in order to avoid delays.

Application of interpersonal coordinationstrategies

Managers can utilize interpersonal coordina-tion strategies to resolve many of the delays thatfrequently occur regarding such matters as the co-ordination of personnel within the specialty groupsinvolved with the progression of cases through theOR.

* Anesthesia personnel. Interpersonal coordi-nation can be utilized to resolve the delays thatoccur when the OR room is not properly equippedwith anesthesia supplies, transport oxygen, or anambu bag. In certain geographical areas, these workactivities are frequently performed by the anesthe-

June 1993/ Vol. 61/No. 3 291

sia instrument technician or aide. The primaryanesthesia caregiver should be responsible for in-forming the anesthesia technician or aide of theanticipated time for patient transport to the PACU.

* Surgeons. Interpersonal coordination canbe utilized to resolve the delays that occur betweenpositioning the patient and making the surgicalincision. Surgeons perform the following activitiesin sequence: position patient, hand scrub, gownand glove, skin preparation, drape, and surgicalincision. Coordination of efforts so that one sur-geon positions the patient while another surgeondoes the skin preparation can avoid such a delay.

Following its recommendation of strategies toimprove OR efficiency, the committee would thenimplement the strategies and evaluate the resultsof the interventions.

ConclusionThis article describes an approach which can

be utilized by hospital managers to evaluate ORefficiency and suggest possible strategies to improveit. The strategies mentioned are just a few of thosewhich can be utilized to decrease the number ofdelays encountered in the progression of surgicalcases through the OR. Regardless of which strate-gies are implemented, the cooperation of all con-cerned is essential so that the best use is made ofpersonnel, time, and supplies to maximize cost-efficiency.

REFERENCES(1) Johnson M. Perspectives on costing nursing. NursingA dministrationQuarterly. 1989;14:65-71.(2) Charns MP, Schaefer MJ. Health Care Organizations: A Model forManagement. Englewood Cliffs, New Jersey: Prentice-Hall. 1983.(3) Polit DF, Hungler BP. Nursing Research: Principles and Methods. 3rded. Philadelphia, Pennsylvania: J.B. Lippincott. 1987.(4) Ignatavicius D, Griffith J. Job analysis: The basis of effective ap-praisal. Journal of Nursing Administration. 1982;12:37-41.(5) Linder CA. Work measurement and nursing time standards. Nurs-ing Management. 1989;20:44-49.(6) Krejcie RV, Margan DW. Determining sample size for researchactivities. Educational and Psychological Measurement. 1970;30:607-610.(7) Bruning JL, Kintz BL. Computational Handbook of Statistics. Glen-view, Illinois: Scott, Foresman and Company. 1977.(8) Phillips JS, Thompson RE Statistics for Nurses. New York: Macmil-lan Co. 1967.(9) Margulies N, Adams J. Organizational Development in Health CareOrganizations. Reading, Massachusetts: Addison-Wesley Publishing.1982.

AUTHORDebra Miliczki Weimer, CRNA, MSN, is a staff nurse anesthetist/

clinical instructor/clinical preceptor at the University of PittsburghMedical Center, Presbyterian Hospital, Pittsburgh, Pennsylvania. She isalso adjunct faculty at the Anesthesia Nursing Program, University ofPittsburgh, Pittsburgh, Pennsylvania. Ms. Weimer earned a BSN andMSN at the University of Pittsburgh and a certificate of anesthesia atMcKeesport Hospital School of Anesthesia. She completed a residencyin Nursing Administration at Presbyterian Hospital, Pittsburgh,Pennsylvania.

ACKNOWLEDGMENTSThe author would like to acknowledge Marguerite Birkenstock,

RN, PhD; Sue Hanna, RN, MPH; Sandy Sell, CRNA, MSN; JosephWeimer, JD; and the administrative staff at Presbyterian Hospital fortheir encouragement, expertise, and participation in the developmentof this article. She also expresses special thanks and appreciation toLinda Sherbinski, CRNA, MSN, and Dennis Stroup, CRNA, MSN, fortheir editing efforts.

Journal of the American Association of Nurse Anesthetists292

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CLNICAL PARMACOG Y- laddula fsaag: Ganani: DIPRPVAN Injectionosa potentlsedativehtypeelc agent whichprovides clinically usehil anesthetic and sedative actions depending upon the dose and techniqse o adinistration. Imporantlactorsto consider include the types of preiduction and concomitant medications, age, ASA physical classification and level odebilitationo the patient, and ultimately, the dose and rated administration of DIPRPAN Injection. Indvidualization o1 dose andltechniquewilprovide a smooth inducteen and stable maintenance while reducing potential unwanted side efects. Patients with hypovlemia shouldhave fluid-volume deficits corrected prior toadministraton of DiPRIVAN ijectio ntdueluuatAnnuute: Most adult patients under55 years ofage and classified ASA IlorlI1 require 2.0o25 mg/kg of1DIPRPIANIneto forminductionuwhen unpremedicated or whenpremedicatna with oral benssdiaanpines or Intramuscular opinids. For Induction. DIPRPAN Injecton should be terated (appnromately40 mgnevery 10 secoeds) against themreponse of the patientuod the ctnicalosigns showthe onset d anesthesia. Aowith other sedatvehypnoticuagents, the amount ofintravenous optoid and/or benssdiazepine premedcatin wilinfluence the response of the patenttoan iuction dse of DiPRPAN injection t is importantto bebendiiar with andirperieced with the intraenos use o DPRN Ninjectionbeore treating elderly, debloitated and ASlt Ilor N patients. Dseto the reduced clearance and higher blood levels, most elderty patientsreqire apprximately .0 o 15mgfl prg) dm ately 20 mg every 10second)o1DPRIVAN k> onfadutin nhaac igtostheircondition and responses. Arapid bols shouldsot beusedas this willrcrease the fkelhodofaundesirable cardiorespiratorydepression including hypotension, apnea, arway obstruction and/or osygen desaturation. (See DOSAGE AND ADMINISTRATION.)Mlutuaaaeaat Asraaua: Anesthesia can be maintainedhbyadministerng DPRP AN Injection hy infusion or intermittent lV bolusinjectio. The patients clinicalmepose will determine theinfusion rate or the amount and frequency of incremental nis .Whenadministerng DPRPAIN Injection hy infusion, syringe pumpsaor volumeric pumpsmust beesed to provide controiled infasion rates.Contnuosuatusleu: DIPRIVAN Injecton 10010o 200p g/kg/miradmininteredinaa riable rate infusin with 60%-70% nitrous oxideand oxygen provides anesthesia far patients undergoing general surgery. Maintenance hy infusion 01 DIPRPAN Injection shouldimmediately folow the induction dose in orderlto povide satisfactory or continuous anshsduring the induction phase. Deringthis initial periodfollowing the induction dose higher rates of infusion ame general eqie (15010o 200 pgkgmi) for the first 1010 15 minutes. Infusion ratesohhould suibsequenty be decreased 30%- 50% duringth firs halt-oto maintenance. Changes in vitalsigns (increses in pulse rate, blood pressure, sweating and/or tearing) that indicate a respnse to surgical stimulation or g'erringof anesthesia maybe conrolledhbythe admnistration of DPRVANlInjection 25 mg (25 ml)to 50mg 5)0OmL) incremental bolusesand/orhy increasing the infusion rate itl sign changesare not controlled after a five minute period, other mearo such asan opinid,barbturate, vasodlator or inhalation agent therapy should be intiated to control these responses. For minor surgical procedures (le,body surface) 60%-70)% nitrous oxide can be combined with a variable silo DIPRPJAN infusion to proide satisfactory anesthesia.With more stimuating surgical pcedures (e, rtra-abdominpsupplementatowith anagesic agents shouldbe considered toprovidea satisfactory anesthetic and recowery pofi When supplementaton with rthnus oxdeis not rovided, administration raes)ofDiPRAInjection and/or opeaidsshould be increased in orderto provide adequate anesthesia. Infusion raes should always be ttruted downwardin theabsenceof clinical signsof lightanesthesia until anmdepnse to surgical stimuations obtanedn order toaoid admiistrationof DIPRIVAN Injection at raeslhigher thanuameclinicallysnecessary. Generally, raes o50 to100p g/kg/nnisshould be achieved duringmaintenance in orderlto optirmize recoveryftimes. Ilnntlnut ulaic Icrements ofDlPRPAN Injection 25 mg (25 mL)to 50 mg (50mL) maybe administered withnitrousmoade inpatients underging geeral surgery. The incremenal boluses should be administeredwhen changes in vital signs indicate a men se to surgical stimulator orfitgh anesthesia. DIPRIVA Injection has been used witha aniety otagent commonlysused in aethsasuch as atmpine, scopolane, gyoprla diazepam, doplabigand nndpolarzn ucerlxns n podaagsca ela ihihlto n einlaetei gns nteedry ai ours

dosesoshould nidhbeusoedas this wilicrease cardiorespiraloryffects including ypotension, apnea, aiway obstructionand/or osygendesaturation. Most elderly patients requimea reducton d the recommended maintenance raesfor healthy adults)(< 55years) 10 50Io 100 pg/kg/mis (3 to 6 mg/kg/h). MAC SEDfITON: When DIPRPAN Injection is admnmsteredlfor sedation, rates oadminsrutionshould be individualized and ttrated to clinical response. In most patients the rates o1 DIPRPVAN Injection administration will beapprondmately 2% ofthosesed for mantenance ofgeral anesthesia. Diang Inititioncof MACsedation, sowinfuson or sowqedlontechniques arepreferable over rapid bolus administratior. Duing mainteance of MAC sedation, auvariable rateolnfusionrispreferableoveintrmittent bolusodoseoadministraton. Isthe elderly, deblitated and ASA IllorlN patients, rapid (single or repeated) bolus doseadministrator should not be used for MAC sedation. (See WARNINGS.) A nspid bousa I-Ouete e snumB In muduinsblueardlurasplnsuury deprusslOa laludIng hqpaumsloaa, Msas, alewsy ebstuetloa randlw sr ygan ustuatn.l yts a ASeaionu: Fornitton ofsedaton, either aninfusion or aslow injection method may beuizd whilecleymhongarieskoyfunction. Wth the infusion method, sedation may be intiated hy infusing DIPRPAN Injectoatl100ltol50p gkg/min (6 to 9 mg/kg/h)fora perodof 3lto 5 mnutes and tiratisgltothe deired level osedation while closely monitoringsparaory function. Wth the slowinjector methodfor initiation, patoents will require upproimately 05 mg/kg administered ower 310o5 minutes and itraled to clinicalresponses. When DIPRIVAN Injector is administered slowly over 3to 5 minutes, most patoenswitl be adequately sedated and thepeak drug effect can be achieved while minimizing undesirable caidiorspiratory eflectseoccurrn at highr plasma levels. In the eldery,debilitatod, and ASAlllIorIV patients, rapd(sgle or repeated) bolus doseadnsistration should not be used for MAC sedation. (SeeWARNINGS)(The rate of administration should be over 3-5 minutes and the dosage o1 DIPRIVAN Injector should be reduced toapprssumatel 80% o1 the adutidosage in these patients according to their condition, responses, and changes in vital signs. (SeeDOSAGE ANDADMINISTRATION.) Manaanaat MAC Sedatian: For mainenance of sedation, aarariable raeninfusion method ispreferable oweran etermittent bolus dose method. With the variable rateninfuslon method, patient wilgenerally reqiam maintenancesales 01 25101 5 pg/hg/ran (1.5 to 4.5 mg/kg/h) during the first 10 to 15 rmnutes o1 sedation maintenance. Infusion rates shouldsubsequently be decreased over time to0251050 pdkmir and adjusted to cinical responses. In itlrating to cinical effect, allowapprosimately 2 minutes far onset 01 peak drop effect. Infusion rates should always be fitraled downward in the absence o1 clinicalsigns of lightlsedation until mild responses to stimulationrare obtained in ordero avid sedative administration of DIPRIVAN Injectionat rules higher than ame cinically necessary Ifthe intermittent bolusose method is used, increments of DIPRIVAN Injection 10mrg(10 mL( or 20mg (2.0OmLcan be administered andltrutedto desired level of sedation. With themtermittenlbolus method ofsedationmaintenance there is the potentiallor respiratory depression, transent increases in sedation depth, and/or prolongation of recovery.In the elderly, debiliated, and ASA III orIV patients, rapid (singl or repeated) bolusriose administration should not be used for MACsedation. )SeeOWARNINGS)The rated adminisrationandlthe dosage of Dl PAN Injecton should be reducedto approimately 80%of thn adult dosae in these patients according to their condition, responses, and changes in vital signs. (See DOSAGE ANDADMINISTRATK)N. DIPRFIAN lnjeciocasbe admnistered as the soleagentlfor maintenance ofMAC sedation during sorgicalldiogeostcprocedures. When DIPRIVAN sedation is supplemented with oploid and/or benssdiozeplne medications, these agonts increase thesedative andmrspiratory effects of DIPRPAN and may also resultmna slower recovnery profile. (See PRECAUTONS Drug Interactions.)INDICATIONS AND USAGE: DIPRIVAN Injection inanIV anesthetic agent that can be used for bth inductor and/or mainenance ofanesthesaas part ota balanced anesthetic techniqelor inpatent and outpatient sorgry. DIPRPVAN Injection, when administeredN as directed, car be usedto initiate and meiamn monitored anesthesia care (MAC sedation during diagnostic procedures. DIPRIVANInjector may also be used for MAC sedation in conjunction with iscallmpgional anesthesia in patients underging surgical procedures.(See PRECAUTIONS.) DIPRIVAN Injectinis not recommeded forse atthistitme inpatients with increased intracranial pressure orimpaired cerebral circulation, in obstetrics including cesarean section deliveries, in nursing mothers, and in pediatric patients.CONTRAINDICAIONS: DIPRVAN Injection is contraindicated in patiens with a known hypersensitivityto DIPRIVAN Injection orits

and nt lavalvd Intheueeaduatfthe aeglealldlagnuslleproaar durt shauld haeantaunusly maatosnnd anaties~foe nlutuus inoea apa laEuIl eildn, ad yguenitebsntrand deltr~yreusullan emudt loosu dlinmyavailable. n the eldey, dbditalod and ASA Ilor IV patents, rappd(single or repeated) bolus administraton shouldoat beusoeddurnsggeneral anesthesia or MAC sedaton irorderto minimize undesirable cardiorespvratory depressonincluding hypotension, apnea, airayobistruction and/or oygen desaturaton. MAC sedation patents should be continanusly monitored hy persons notinhonved in the conductof the surgical ordagnostic procedure; seygen supplementation should be immedioteyaly bead viedweeciialyidctdand oxygen saturationrshould be monitored in all patents. Patets should be continuously monitored for eadyigns d hypotesion,apnea, arwaysobstruction and/or osygen desaturaton. Thesocardiorospiratoryneffectsame more Wikely to occurfokeg rapid initiator(loading) boluses or during supplemental maintenance boluses. especially inthe elderly, deblitated and ASA III or N patents. DIPRPANInjection should not be coadmimustered through the same N/catheter wth blood or plasmaubecause comrpatbilty has notbeen estabinhed.Inviro rtests have show tha agrgtes0 the globular component of the emulion vehicle haveuoccurred withblod/plasma/serum

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baadllngpneeadunusmu nasltn mla nbianlatlaneu~islng sIdelalmopsls ndh )thadaarnueeonsequnceswhiob neuld land toe Iluhnnuunalng Illam. PRECAUTIONS: innid: Akwer induction dose and a sowr maintenance rate 01administration should be used in eldedly, debilitated and ASA III or IV paients. (See CLINICAL PHARMACOOGY-Individualizationof Dosage.)(Patents should be continuously monitoedfor eadlysigns ofsignificant hypotension and/or bradycardio. Treatment mayinclude incmeasing the rate o1 intravenous fluid, elevation of lower extrmmities, use otpressor agents, or administration 01 atropine.Apnea often occurs during inductor and may pesist for more than 60 seconds, Ventilatorysupr maybe required. Because DIPRFANInjection ioar emulsion, cauton should beowiecised in patents with disordersof lipid metabolism scas prmary pei~nei n n ais heciia rtrafrdshrefrmtercwr/a u rraw oroteinito

WIPRIWP (nsedul) I*nfise

DIPRIWI Inection when decreases in mean arterial and cerebral pertusion are prevented byappropriate measures. Infrm tilsfoPMlumb: atentsmhud beadvied tatpeormance ofactiviies requiring mental alertness, such as operating a motoervehicle, orhazardous machinery or gniplegaldouenrs may be ipredor somem ater general anestheia orsedtion. Dru lbmebuoThe induction dose requirements of00iPRIW htjactionay rdced in patients wilthIntamuscular or itrvenous premedication,pariclary it nacoic (e, orhin, epedieandfertrry) ndcombinions ofopioids and sedalires (g benadaeiebabiurts.h a eaiv feto epA N ltc,

c hllhyrate, dropenidol, etc). These agents may increase the anesthetic or sdtvefcsofDPRM4 InKand may also result in more pronounced decreases inRoc diastoic and mean arterial pressures and cardiac output Dunnmantnance oanesthesuaor sedaion, tire rate o IPcdD W Injection administion should be adjusted according tothe desiem eeo anestheaaor sedation and maybe reduced in the presence ofsupplemental anlesic agents (eg ntrmusmaxde or opkeds) Theconcurmit adninistration of potient inhalational agents (eg, in01urane, enflurane, ndhablhane) during mantenance with DPANInjection has sot been extensively evauated. These inhalational agents can also be espected to increase the anesthetic or sedativeand cardiorespralmy effects ofDlPRPANW Injection. DIPRPDN hjecion does nt cause aclnicalysigiflcant change in onset, intensityor duration ofaction ofthe commonly used neumomuscular boinng agents (ag, succinytcholne aed nondepladazing musclemrlaxants).No algnicant aseiteractions wth commronyused premedicaionor dapgs sed during anesthesia or sedaion (mcdlding amgot muscle relasunts, inhalational agents, analgesic agents, and local anstec Dts) have bees observed. Cwelegmte

M b luhriagbuiotr fFe .llrAnimnalcacse ,studies bavent been edwith propoir. Inovitro and in viv animaltess File t shw ay ptetia fo muagni tyc bypr Testtfor mtapenlcity included tie Ames (using Sainonela sp) mutationtest, gene mutaion/gene conversion usng Saclwomnyvescwaws&e, in vitro cytogenetic studies in Chinese hamsters and a mousemicronucleusltest. Stde in fnmale rats at intravenous doses up to 15 mg/k/day (6times the maalmum recommended humanindctiodose)or 2mebefore preganyo day 7 gestation didohow imparedfertilty.Malefetlity inrats was notaltectedn adominant lethal study aintravenous doses up to 15 mg/tn/daytor 5days. Pruguancy Cuau S : Reproduction stediesbhavebeer performed in rats and rabbits atintravenous doses o115 mg/lc/day (6 times the recommended huan induction dose) andhave revealed no evidence ofimpaired fertility or harmeto thelfetus dse to propotol. Propotol, however, has been shown to causematenmal deathsoin ras and rabbis and docreased pup survival duringthe lactating perod in dams treated with 15 mg/kg/day (or6 times Vie recommended human induction dmae). The pharmacological actviy(anesthesa) othe drugsen te mother isprobablyresponsibletforthe adverse effects seen in the offspring. Thereare. howver, no adequate and well-contmolled studies in pregnantwonmen. Because animal reproduction studies are notalways predicive ofhuman responses, ths inre should be usedduring pregnancyonl iclesaty needed. Lbor ad DlanyDIPRA Injection is notrecomrneededtfor obstetrics, including cesarean section deliveries.DIPRIVAN Injection crosses Vie placenta, andeas with other general anesthetic agents, thenadministration of DIPRIVAN Injectionmaybe associated with nesnatal depression. Nusn others: DIPRPA4N Injections not recommendedtfor use innursing mothersbecause DlPRlVAN has been repotedto be escretedlon human nilk and the effects oforal absorption ofsmall amounts o1 propoflamenot known. Pudaic Us: DIPRVAN nje ction is not recommended for use in pediatric patients because safety and effectivenesshave not bennestabisahed. ADVERSE REAflS: Adverse event inormation is derived from controlledctinical trials and wordwidemarketing espeience. In Ve description below, rates otthe mare common events represent US/Canadian clinical stady results.Lesslfrequent eventsoamrderved prnipally romnpubications and matretingexperience in overt8 miltion patients; thereare insufficientdaa to support an accurate estimate o1 ther incidence rates. The adverse esprrience profile 1mom reports 01 150 patients in VieUS/Canadian MAC sedation cinical trials issimndar tothe profle established wi DIPRPAN Injection duing anesthesiaa(see below).During MAC sedation clinical trials, significant respiratory eventslincluded cough, upper alrway obstruction, apnea, hypoventilation,and dyspnea. The most common adverse evnnts whicheoccurred in morelthan 3%nofthe patients receiving DIPRIVAN InectonlforMAC sedation included hypotension, nausea, headache, and injection site painor hotnes.The ollwing estimates ofadverseneventsfor DIPRIVAN Injection are deivedtfrmmreports of2588ltpatientslincluded inthe US/Canadian studes. These studies werecnductedusng avanetynofpremedicants, varying lengths ofsurgicaldagnostic procedures and various other anesthetic/sedative agents.Most adverse events were mild and transient. The folowng adverse events were reported in patients treated with DIPRIVANlInjection.They are presented within each bedy system in oder ofdocreasing frequency. luelduen b lsu thus 1%-Al I I s ergardlesof ateamlt, duvd rm clnlutals.ted" ad aaWhole: Fever. Cardovascular: Hypotenson' (see asouCLINICAL PHARMA-COLOGY), Bradordia, Hypertension, Anrhythma. CnralNki~n., Syiu: Movement*, Headache, Dmneswitching. Ogulles:Nausea" (1596), 'Vlmiting' Abdonunal Cramping. lunellaa Situ: Pain', gaming/Stinging'. Rusplealuryv:Hiccough, Cough (seealsouCLINICAL PHARMACOLOGY). Skiuand Appendage: Rash. Incidence0ofunmarked events is 1%-3%; '3tzo 9%; "*10% orgreater luclduan Leaathan 1%-Causal Relattashlp Probable, derived hemcliuicalltrilt. (Adverse events reported in thelierature, not seen in cinical trials, areirtalkcied) Bdy asa Whole: PedinataloDisorder, Extremities Pain, Awareneso, Chest Pain,Increased Drag Effect, Neck RigIdity/Stiftnoso, Trunk Pain. Aropaiy1ass/Aeaph1acad Reactkn. Cmrdoasular: Tachycardia,Premature Ulntrclar Contractons, Syncope, Premature Atilal Contractions, Abnormral ECG, Sr SegmnitDepression, Bundle BranchBlock, Etrasystole, Myocardial Infarction, Heart Block, Atrieventricuhir Block, Second Degee A" Block. Ceutral NervusSvusBucing/Je dong/Thraslring, Clonic/Myoclonic Movement, Hypertonia/Dystoni, Chills/Shivering, Somnolence, Tremor, AgtaioConfuion, Delirium, Paresthesia, Abnormal Dreams, Euphesa, Fatigue, Moaning, Rigidity Combativeness, Depression.Hypersalivation, Dry Mouth, Swallowing, Enlarged Parotid. Iuneton ltu: Tingling/Numbness, Coldness, Discomfort, Plebitis,Hines/Inching, Redness/Discoloration. klelNubhtloai: Hywperilpema. Muuealushuelet: Myalgia. Rauphaluny: Apnea (seealso CLINICAL PHARMACOLOGY), Upper Aia Obstruction, Weezing, Dyspota, Hpoventilahion, Bmonchospasm, Bumning inThroat, Sneezing, Tactypna, Hyperventilation, Hypoia, PhnnItis U aud podau:Flushing, Urticaria, Pruritus. Spacialeuss: Amblyopia, Dplopia, Taste Perversion, Eyn Pain, linnitu. I:Aeaa"AormUrine, Urine Retention, Green Urine. Ind-daaceaLastthal%- Caal Rlatiushp U knw, dervdfrom liunal ut(Adverse events reported in the literature, notseen in clnicaltrials, are lahlzed)UBodus aWhe: Ashesia. Cadoaauuelar: Atrial Fibritlation, Bigemninj, Hemmorrhage, Edema,Ventricular Fibrillation, Supranentricular Tachycardia, Myocardiu//scfieniu. Cuatral NervousSystuem: Emotional Lability, Anxiety,Hsnria, Insomnia, Generalzed andtLocalized Seizures, Opfltonurc fypoonia, Halucinatlions, Neurnpary, Phenlo invenalOlgauttvuDiarhe.Diarrhea. c Hausals Coaulatoneisorer. ehablic: Coagulation Disorder. Mutaba andlleld NutriphorsisClHyereia.:peHiyperhaslEemia.n N Rusplnu U tuny:al

Oliun. I aditonto hoe avese vets ised bo eloowng adverse eent has been reported asoaaulof postmarhetingexpenience: amorousbehavior. OOSAGE ANDADMINISTRATION: Dosage and rate ofadministration should be individualized andtilrated tnlthesdesired effect according to clinically relevat facors includin prinduction and concomitant medications, age, ASAphysical classification and level of debilitation 01 the patient. TMublluwung ls sbbnuatalud d asa t aadmslntbllan hdusnaltanwbhhstonlytetuadud eus general gulddenathea mat fDIPRIMN lajactoa. Priornto admtlaluutg DIPRtIVAN Injection, 11 teImperatethtihe ph etu lw and ba euelutlyteiualtth usullticdosagand adIlinhttn reinlnsudtald11uthaCONICALPIAMCLOY- adduallsulteuu geusaua aeta..Inuthauelderly, dubitld and ASAIIllorIV patieats,rapid blusadosasushauld satbeausued lunthu stthods at sdmlntetrattuu dueribed belaw. (Saa WARNINS.)

Inducton ef Dosage should be individualized and irated.Anstheia Adults': Most patiens require 2.0to 2.5 mg/kg (approximaely 40rmgoevery 10 seconds until induction

onset)Elderly, OublltatadadASAllII urlV Pattasts: Most patients require 1.0is 1.5 mg/kg (approximately20 mg every 10 seconds until induction onset).For comolete dosage information, see CLINICAL PHARMACOLOGY- Individualization of Dosage.

Mantenancael Vaiableab nasion -titrated to the desired clinical effect.Anesthesia: Inusuiou Adults': Most patients require lO0 ts 200 pg/kg/mis (610o12 mg/kg/b).

Eldurly, Debiltted and ASA III an IV Patiunts: Most patients require 50 In 100 pg/kg/mis(31to6 mg/kg/h).

Mantuaanceaat Increments of 25 mg to 50 mg as needed.Anesthesia: For complete dosage information, see CLINICAL PHARMACOLOGY-Intensittuat Balsa Indvidualization of Dosage.Initiattan at Dosage and ran should be individualized.MAC Sadation AdlWs: Slow infusion or slow injecthen techniques are p referable over rapid bolos administration. Muss

patients require an infusion 0 10010o150 pg/gmis (610o9 mg/kg/h) or a slow injection 01 0.5 mg/kgseer 310o5 minutes.Elderly, Dabllt tudand ASAllIIlurIV Patieats: Mos paients require dosages similar toadults, belmustbe given us a slow infusion or slow injection and soles a rapid bolus. (See WARNINGS.)

Malutunanca at Dosage and ratn should be thtrated 10 clinical effect.MAC Badation Adul s': A variable rate infusion technpue isprelerable owr anmitermittentbolosltechmque. Most ptet

requime as ifusion 01 2510o75 pg/hg/mis (1.510o4.5 mg/kg/h) or incremental bolus doses o01g or

Elderly, DablIald and ASA Ilor IV Pit: Most patients require a20% reduction of the adult dose.A rapid (single or repealed) bolos dose should not be used. (See WARNINGS.) For complete dosagenformation, sen CLINICAL PHARMACOLOGY- Individualization 01 Dosage.

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Safe, Proven ReliefEffective Analgesia for Moderate Acute Pain* Rapid, dependable pre- and post-op analgesia.* Established safety for mother and child during labor

and delivery.'* Indicated as an adjunct to regional anesthesia. 2

For any questions, call 1-800-541-1733Please see following page for a Brief Summary of the Prescribing Informations.

1. Hunt CO. Naulty JS, Malanow AM et al Eidural butorphuanol-bupivacaine for analgesia during labor and delivery.lAnAnd 1989;68:323-327.

2. Palacios Q7; Jones MM, Hawkins JL et al. Post-caesarean section analgesia: a comparison of epidural butorphanoland morphine. Ca JAnaeu. 1991:38:24-30.

Stadol®;(ibJpLnoI tartrate,Um9

DAPOTHECON°A BRISTOL-MYERS SQUIBB COMPANY

The name that assures confidence.

01993 Bristol-Myers Squibb Company 5092-802/Issued: January 1993

STADOL*(butorphanol tartrate) InjectableBefore prescribing, see complete prescribing information in Apothecon* literature. The following is abrief summary.INDICATIONS AND USAGESTADOL* (butorphanol tartrate) Injectable is indicated for the management of pain when the use ofan opioid analgesic is appropriate.STADOL Injectable is also indicated as a preoperative or preanesthetic medication, as a supplementto balanced anesthesia, and for the relief of pain during labor.CONTRAINDICATIONSSTADOL Injectable is contraindicated in patients hypersensitive to butorphanol tartrate or the preser-vative benzethonium chloride in STADOL Injectable in the multi-dose vial.WARNINGSPATIENTS DEPENDENT ON NARCOTICSBecause of its opioid antagonist properties, butorphanol is not recommended for use in patientsdependent on narcotics. Such patients should have an adequate period of withdrawal from opioiddrugs prior to beginning butorphanol therapy. In patients taking opioid analgesics chronically, butor-phanol has precipitated withdrawal symptoms such as anxiety, agitation, mood changes, hallucina-tions, dysphoria, weakness and diarrhea.Because of the difficulty in assessing opioid tolerance in patients who have recently received repeateddoses of narcotic analgesic medication, caution should be used in the administration of butorphanolto such patients.PRECAUTIONSHEAD INJURY AND INCREASED INTRACRANIAL PRESSUREAs with other opioids, the use of butorphanol in patients with head injury may be associated with car-bon dioxide retention and secondary elevation of cerebrospinal fluid pressure, drug-induced miosis,and alterations in mental state that would obscure the interpretation of the clinical course of patientswith head injuries. In such patients, butorphanol should be used only if the benefits of use outweighthe potential risks.DISORDERS OF RESPIRATORY FUNCTION OR CONTROLButorphanol may produce respiratory depression, especially in patients receiving other CNS activeagents, or patients suffering from CNS diseases or respiratory impairment.HEPATIC AND RENAL DISEASEIn patients with severe hepatic or renal disease the initial dosage interval for STADOL Injectableshould be increased to 6-8 hours until the response has been well characterized. Subsequent dosesshould be determined by patient response rather than being scheduled at fixed intervals (see INDI-VIDUALIZATION OF DOSAGE in full prescribing information).CARDIOVASCULAR EFFECTSBecause butorphanol may increase the work of the heart, especially the pulmonary circuit (see CLINI-CAL PHARMACOLOGY in full prescribing information), the use of butorphanol in patients with acutemyocardial infarction, ventricular dysfunction or coronary insufficiency should be limited to those sit-uations where the benefits clearly outweigh the risk.Severe hypertension has been reported rarely during butorphanol therapy. In such cases, butor-phanol should be discontinued and the hypertension treated with antihypertensive drugs. In patientswho are not opioid dependent, naloxone has also been reported to be effective.INFORMATION FOR PATIENTS1. Drowsiness and dizziness related to the use of butorphanol may impair mental and/or physical

abilities required for the performance of potentially hazardous tasks (e.g., driving, operatingmachinery, etc.).

2. Alcohol should not be consumed while using butorphanol. Concurrent use of butorphanol withdrugs that affect the central nervous system (e.g., alcohol, barbiturates, tranquilizers, and antihist-amines) may result in increased central nervous system depressant effects such as drowsiness,dizziness and impaired mental function.

DRUG INTERACTIONSConcurrent use of butorphanol with central nervous system depressants (e.g., alcohol, barbiturates,tranquilizers, and antihistamines) may result in increased central nervous system depressant effects.When used concurrently with such drugs, the dose of butorphanol should be the smallest effectivedose and the frequency of dosing reduced as much as possible when administered concomitantlywith drugs that potentiate the action of opioids.It is not known if the effects of butorphanol are altered by concomitant medications that affect hepaticmetabolism of drugs (cimetidine, erythromycin, theophylline, etc.), but physicians should be alert tothe possibility that a smaller initial dose and longer intervals between doses may be needed.No information is available about the use of butorphanol concurrently with MAO inhibitors.USE IN AMBULATORY PATIENTSDrowsiness and dizziness related to the use of butorphanol may impair mental and/or physical abili-ties required for the performance of potentially hazardous tasks (e.g., driving, operating machinery,etc.). Patients should be told to use caution in such activities until their individual responses tobutorphanol have been well characterized.Alcohol should not be consumed while using butorphanol. Concurrent use of butorphanol with cen-tral nervous system depressants (e.g., alcohol, barbiturates, tranquilizers, and antihistamines) mayresult in increased central nervous system depressant effects.CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITYThe carcinogenic potential of butorphanol has not been adequately evaluated.Butorphanol was not genotoxic in Salmonella typhimurium or Escherichia collassays or in unsched-uled DNA synthesis and repair assays conducted in cultured human fibroblast cells.Rats treated orally with 160 mg/kg/day (944 mg/sq. m.) had a reduced pregnancy rate. However, asimilar effect was not observed with a 2.5 mg/kg/day (14.75 mg/sq. m.) subcutaneous dose.PREGNANCYPregnancy Category CReproduction studies in mice, rats and rabbits during organogenesis did not reveal any teratogenicpotential to butorphanol. However, pregnant rats treated subcutaneously with butorphanol at 1 mg/kg(5.9 mg/sq. m.) had a higher frequency of stillbirths than controls. Butorphanol at 30 mg/kg/oral(5.1 mg/sq. m. and 60 mg/kg/oral (10.2 mg/sq. m.) also showed higher incidences of post-implanta-tion loss in rabbits.There are no adequate and well-controlled studies of STADOL (butorphanol tartrate) in pregnantwomen before 37 weeks of gestation. STADOL should be used during pregnancy only if the potentialbenefit justifies the potential risk to the infant.LABOR AND DELIVERYAlthough there have been rare reports of infant respiratory distress/apnea following administration ofSTADOL* (butorphanol tartrate) Injectable during labor, this adverse effect was not attributed toSTADOL Injectable as used during controlled clinical trials. The reports of respiratory distress/apneahave been associated with administration of a dose within two hours of delivery, use of multipledoses, use with additional analgesic or sedative drugs, or use in preterm pregnancies.In a study of 119 patients, the administration of 1 mg of IV STADOL Injectable during labor was asso-ciated with transient (10-90 minutes) sinusoidal fetal heart rate patterns, but was not associated withadverse neonatal outcomes. In the presence of an abnormal fetal heart rate pattern, STADOLInjectable should be used with caution.NURSING MOTHERSButorphanol has been detected in milk following administration of STADOL (butorphanol tartrate)Injectable to nursing mothers. The amount an infant would receive is probably clinically insignificant(estimated 4 microgram/liter of milk in a mother receiving 2 mg IM four times a day).PEDIATRIC USEButorphanol is not recommended for use in patients below 18 years of age because safety and effi-cacy have not been established in this population.GERIATRIC USEThe initial dose of STADOL (butorphanol tartrate) Injectable reccnmended for elderly patients is halfthe usual dose at twice the usual interval. Subsequent doses and intervals should be based on thepatient response (see INDIVIDUALIZATION OF DOSAGE in full prescribing information).Due to changes in clearance, the mean half-life of butorphanol is increased by 25% (to over 6 hours)in patients over the age of 65. Elderly patients may be more sensitive to its side effects.ADVERSE REACTIONS

A total of 2446 patients were studied in butorphanol clinical trials. Approximately half receivedSTADOL (butorphanol tartrate) Injectable with the remainder receiving STADOL" NS

T (butorphanol

tartrate) Nasal Spray. In nearly all cases the type and incidence of side effects with butorphanol byany route were those commonly observed with opioid analgesics.The adverse experiences described below are based on data from short- and long-term clinical trialsin patients receiving butorphanol by any route and from post-marketing experience with STADOLInjectable. There has been no attempt to correct for placebo effect or to subtract frequenciesreported by placebo treated patients in controlled trials.

The most frequently reported adverse experiences across all clinical trials with STADOL Injectableand STADOL NS were somnolence (43%), dizziness (19%), nausea and/or vomiting (13%). In long-term trials with STADOL NS only, nasal congestion (13%) and insomnia (11%) were frequentlyreported.The following adverse experiences were reported at a frequency of 1% or greater, and were consid-ered to be probably related to the use of butorphanol.BODY AS A WHOLE: asthenia/lethargy', headache', sensation of heatCARDIOVASCULAR: VASODILATION, PALPITATIONSDIGESTIVE: ANOREXIA', CONSTIPATION*, dry mouth', nausea and/or vomiting (13%), stomachpain

NERVOUS: anxiety, confusion*, dizziness (19%), euphoria, floating feeling, INSOMNIA (11%), ner-vousness, paresthesia, somnolence (43%), TREMORRESPIRATORY: BRONCHITIS, COUGH, DYSPNEA', EPISTAXIS*, NASAL CONGESTION (13%),NASAL IRRITATION*, PHARYNGITIS*, RHINITIS*, SINUS CONGESTION', SINUSITIS, UPPER RES-PIRATORY INFECTION'SKIN AND APPENDAGES: sweating/clammy*, pruritusSPECIAL SENSES: blurred vision, EAR PAIN, TINNITUS', UNPLEASANT TASTE*(also seen in short-term trials with STADOL* NS

T [butorphanol tartrate] Nasal Spray)

(Reactions occurring with a frequency of 3-9% are marked with an asterisk.* Reactions reportedpredominantly from long-term trials with STADOL NS are CAPITALIZED.)The following adverse experiences were reported with a frequency of less than 1%, in clinical trials orfrom post-marketing experience, and were considered to be probably related to butorphanol.CARDIOVASCULAR: hypotension, syncopeNERVOUS: abnormal dreams, agitation, drug dependence, dysphoria, hallucinations, hostilitySKIN AND APPENDAGES: rash/hivesUROGENITAL impaired urination(Reactions reported only from post-marketing experience are italicized)The following infrequent additional adverse experiences were reported in a frequency of less than 1%of the patients studied in short-term STADOL NS trials and from post-marketing experiences undercircumstances where the association between these events and butorphanol administration isunknown. They are being listed as alerting information for the physician.BODY AS A WHOLE: edemaCARDIOVASCULAR: hypertensionNERVOUS: convulsion, delusions, depressionRESPIRATORY: apnea, shallow breathing(Reactions reported only from post-marketing experience are italicized.)bRUG ABUSE AND DEPENDENCEAlthough the mixed agonist-antagonist opioid analgesics, as a class, have lower abuse potential thanmorphine, all such drugs can be and have been reported to be abused.Chronic use of STADOL* (butorphanol tartrate) Injectable has been reported to result in mild with-drawal syndromes, and reports of overuse and self-reported addiction have been received.Among 161 patients who used STADOL NS for 2 months or longer, approximately 3% had behavioralsymptoms suggestive of possible abuse. Approximately 1% of these patients reported significantoveruse. Symptoms such as anxiety, agitation, and diarrhea were observed. Symptoms suggestiveof opioid withdrawal occurred in 2 patients who stopped the drug abruptly after using 16 mg a day ormore for longer than 3 months.Special care should be exercised in administering butorphanol to emotionally unstable patients and tothose with a history of drug misuse. When long-term therapy is necessary, such patients should beclosely supervised.OVERDOSAGECLINICAL MANIFESTATIONSThe clinical manifestations of overdose are those of opioid drugs, the most serious of which arehypoventilation, cardiovascular insufficiency and/or coma.Overdose can occur due to accidental or intentional misuse of butorphanol, especially in young chil-dren who may gain access to the drug in the home.TREATMENTThe management of suspected butorphanol overdosage includes maintenance of adequate ventila-tion, peripheral perfusion, normal body temperature, and protection of the airway. Patients should beunder continuous observation with adequate serial measures of mental state, responsiveness andvital signs. Oxygen and ventilatory assistance should be available with continual monitoring by pulseoximetry if indicated. In the presence of coma, placement of an artificial airway may be required. Anadequate intravenous portal should be maintained to facilitate treatment of hypotension associatedwith vasodilation.The use of a specific opioid antagonist such as naloxone should be considered. As the duration ofbutorphanol action usually exceeds the duration of action of naloxone, repeated dosing with naloxonemay be required.DOSAGE AND ADMINISTRATIONFactors to be considered in determining the dose are age, body weight, physical status, underlyingpathological condition, use of other drugs, type of anesthesia to be used, and surgical procedureinvolved. Use in the elderly, patients with hepatic or renal disease or in labor requires extra caution(see PRECAUTIONS and INDIVIDUALIZATION OF DOSAGE in full prescribing information). The fol-lowing doses are for patients who do not have impaired hepatic or renal function and who are not onCNS active agents.USE FOR PAINIntravenous: The usual recommended single dose for IV administration is 1 mg repeated every threeto four hours as necessary. The effective dosage range, depending on the severity of pain, is 0.5 to2 mg repeated every three to four hours.Intramuscular: The usual recommended single dose for IM administration is 2 mg in patients whowill be able to remain recumbent, in the event drowsiness or dizziness occurs. This may be repeatedevery three to four hours, as necessary. The effective dosage range depending on the severity of painis 1 to 4 mg repeated every three to four hours. There are insufficient clinical data to recommendsingle doses above 4 mg.USE AS PREOPERATIVE/PREANESTHETIC MEDICATIONThe preoperative medication dosage of STADOL* (butorphanol tartrate) Injectable should be individu-alized (see INDIVIDUALIZATION OF DOSAGE in full prescribing information). The usual adult dose is2 mg IM, administered 60-90 minutes before surgery. This is approximately equivalent in sedativeeffect to 10 mg morphine or 80 mg meperidine.USE IN BALANCED ANESTHESIAThe usual dose of STADOL Injectable is 2 mg IV shortly before induction and/or 0.5 to 1.0 mg IV inincrements during anesthesia. The increment may be higher, up to 0.06 mg/kg (4 mg/70 kg),depending on previous sedative, analgesic, and hypnotic drugs administered. The total dose ofSTADOL Injectable will vary; however, patients seldom require less than 4 mg or more than 12.5 mg(proximately 0.06 to 0.18 mg/kg).

In patients at full term in early labor a 1-2 mg dose of STADOL Injectable IV or IM may be adminis-tered and repeated after 4 hours. Alternative analgesia should be used for pain associated with deliv-ery or if delivery is expected to occur within 4 hours.If concomitant use of STADOL with drugs that may potentiate its effects is deemed necessary (seeDrug Interactions in PRECAUTIONS section) the lowest effective dose should be employed.SAFETY AND HANDUNGSTADOL Injectable is supplied in sealed delivery systems that have a low risk of accidental exposureto health care workers. Ordinary care should be taken to avoid aerosol generation while preparing asyringe for use. Following skin contact, rinsing with cool water is recommended.HOW SUPPLIEDSTADOL Injectable for IM or IV use is available as follows:NDC 0015-5644-20-2 mg per mL, 2-mL vialNDC 0015-5645-20--1 mg per mL, 1-mL vialNDC 0015-5646-20--2 mg per mL, 1-mL vialNDC 0015-5648-20-2 mg per mL, 10-mL multi-dose vialSTORAGE CONDITIONSStore below 86°F (30°C). Parenteral drug products should be inspected visually for particulate mat-ter and discoloration prior to administration, whenever solution and container permitCAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

BIAPOTHECON

APOTHECON*A Bristol-Myers Squibb CompanyPrinceton, New Jersey 08540 USA

Dermik #20201 p4Prepared by Ted Thomas Associates Inc.Date:1/11/93 Proof #1 Page 1

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MEETING THEDEMANDSOF TODAY'SAMBULATORYSURGERY

?RAPI EECOVERY

(alfentanil HCI) Injection (

Please see following page for brief summary of Prescribing Information.

Alfenta(alfentanil HCI) Injection GBefore prescribing, please censlt complete prescribing lnformation, of which the fellowila isa brief summary.

CAUTION: Federal Law Prohibits Dispensing Without PrescriptionDESCRIPTION: ALFENTA is a sterile, non-pyrogenic, preservative free aqueous solution containing alfentanilhydrochloride equivalent to 500 pg per ml of alfentanil base for intravenous injection. The solution, which contains

sodium chloride for isotonicity, has a pH range of 4.0-6.0.CONTRAINDICATIONS: ALFENTA (alfentanil hydrochloride) is contraindicated in patients with known hyper-sensitivity to the drug.WARNINGS: ALFENTA SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OFINTRAVENOUS AND GENERAL ANESTHETIC AGENTS AND IN THE MANAGEMENT OF RESPIRATORY EFFECTS OFPOTENT OPIOIDS. AN OPIOID ANTAGONIST, RESUSCITATIVE AND INTUBATION EQUIPMENT AND OXYGEN SHOULDBE READILY AVAILABLE. BECAUSE OF THE POSSIBILITY OF DELAYED RESPIRATORY DEPRESSION, MONITORINGOF THE PATIENT MUST CONTINUE WELL AFTER SURGERY. ALFENTA (alfentanil hydrochloride) administered ininitial dosages up to 20 pg/kg may cause skeletal muscle rigidity, particularly of the truncal muscles. The incidenceand severity of muscle rigidity is usually dose-related. Administration of ALFENTA at anesthetic induction dosages(above 130 pg/kg) will consistently produce muscular rigidity with an immediate onset. The onset of muscularrigidity occurs earlier than with other opioids. ALFENTA may produce muscular rigidity that involves all skeletalmuscles, including those of the neck and extremities. Th e incidence maybereduced by: 1) routine methods ofadministration of neuromuscular blocking agents for balanced opioid anesthesia; 2) administration of up to /V4 of thefull paralyzing dose of a neuromuscular blocking agent just prior to administration of ALFENTA at dosages up to130 pg/kg; following loss of consciousness, a full parahlzing dose of a neuromuscular blocking agent should beadministered; or 3) simultaneous administration of ALFENTA and a full paralyzing dose of a neuromuscular blockingagent when ALFENTA is used in rapidly administered anesthetic dosages (above 130 pg/kg). The neuromuscularblocking agent used should be appropriate for the patient's cardiovascular status. Adequate facilities should beavailable for postoperative monitoring and ventilation of patients administered ALFENTA. It is essential that thesefacilities be fully equipped to handle all degrees of respiratory depression.PRECUTIONS: ELAYED RESPIRATORYDEPRESSION, RESPIRATORY ARREST, BRADYCARDIA, ASYSTOLE,ARRHYTHMIAS AND HYPOTENSION HAVE ALSO BEEN REPORTED. THEREFORE, VITAL SIGNS MUST BE MONITOREDCONTINUOUSLY.Beaeral: The initial dose of ALFENTA (alfentanil hydrochloride) should be appropriately reduced in elderly anddebilitated patients. The effect of the initial dose should be considered in determining supplemental doses. In obesepatients (more than 20% above ideal total body weight), the dosage of ALFENTA should be determined on the basisof lean body weight. In one clinical trial, the dose of ALFENTA required to produce anesthesia, as determined byappearance of delta waves in EEG, was 40% lower in geriatric patients than that needed in healthy young patients.In patients with compromised liver function and in geriatric patients, the plasma clearance of ALFENTA may bereduced and postoperative recovery may be prolonged. Induction doses of ALFENTA should be administered slowly(over three minutes). Administration may produce loss of vascular tone and hypotension. Consideration should begiven to fluid replacement prior to induction. Diazepam administered immediately prior to or in conjunction withhigh doses of ALFENTA may produce vasodilation, hypotension and result in delayed recovery. Bradycardia producedby ALFENTA may be treated with atropine Severe bradycardia and asystole have been successfully treated withatropine and conventional resuscitative methods. The hemodynamic effects of a particular muscle relaxant and thedegree of skeletal muscle relaxation required should be considered in the selection of a neuromuscular blockingagent. Following an anesthetic induction dose of ALFENTA, requirements for volatile inhalation anesthetics orALFENTA infusion are reduced by 30 to 50% for the first hour of maintenance. Administration of ALFENTA infusionshould be discontinued at leas 10-15 minutes prior to the end of surgery. Respiratory depression caused by opioidanalgesics can be reversed by opioid antagonists such as naloxone Because the duration of respiratory depressionproduced by ALFENTA may last longer than the duration of the opioid antagonist action, appropriate surveillanceshould be maintained. As with all potent opioids, profound analgesia is accompanied by respiratory depression anddiminished sensitivity to CO2 stimulation which may persist into or recur in the postoperative period. Intraoperativehyperventilation may further alter postoperative response to CO. ppropriate postoperative monitoring should beemployed, particularly after infusions and large doses of ALFENA, to ensure that adequate spontaneous breathingis established and maintained in the absence of stimulation prior to discharging the patient from the recovery area.Nead Injuries: ALFENTA may obscure the clinical course of patients with head injuries.Impaired lespiratle: ALFENTA should be used with cautionini patients with pulmonary disease, decreasedrespiratory reserve or potentially compromised respiration. In such patients, opioids may additionally decreaserespiratory drive and increase airway resistance. During anesthesia, this can be managed by assisted or controlledrespiration.Impaired Nepatlc ar ellna Functied: In patients with liver or kidney dysfunction, ALFENTA should beadministered with caution due to the importance of these organs in the metabolism and excretion of ALFENTA.Drug Interactins: Both the magnitude and duration of central nervous system and cardiovascular effects maybe enhanced when ALFENTA is administered in combination with other CNS depressants such as barbiturates,-tranquilizers, opioids, or inhalation general anesthetics. Postoperative respiratory depression may be enhanced orprolonged bythese agents. In such cases of combined treatment, the dose of one or both agents should be reduced.Limited clinical experience indicates that requirements for volatile inhalation anesthetics are reduced by 30 to 50%for the first sixty (60) minutes following ALFENTA induction. The concomitant use of erythromycin with ALFENTAcan significantly inhibit ALFENTA clearance and may increase the risk of prolonged or delayed respiratory depression.Perioperative administration of drugs affecting hepatic blood flow or enzyme function may reduce plasma clearanceand prolong recovery.CarcinRnOsisl Mutageesis and Impairment of Fertility: No long-term animal studies of ALFENTA havebeen performed to evaluate carcinogenic potential. The micronucleus test in female rats and the dominant lethaltest in female and male mice revealed that single intravenous doses of ALFENTA as high as 20 mg/kg (approximately40 times the upper human dose) produced no structural chromosome mutations or induction of dominant lethalmutations. The Ames Salmonella typhimurium metabolic activating test also revealed no mutagenic activity.Pregancy Categery C: ALFENTA has been shown to have an embryocidal effect in rats and rabbits when givenin doses 2.5 times the upper human dose for a period of 10 days to over 30 days. These effects could have been dueto maternal toxicity (decreased food consumption with increased mortality) following prolonged administration ofthe drug. No evidence of teratogenic effects has been observed after administration of ALFENTA in rats or rabbits.There are no adequate and well-controlled studies in pregnant women. ALFENTA should be used during pregnancyonly if the potential benefit justifies the potential risk to the fetus.

Labr and Dellvery: There are insufficient data to support the use of ALFENTA in labor and delivery. Placentaltransfer of the drug has been reported; therefore, use in labor and delivery is not recommended.Nursing Mathers: In one study of nine women undergoing post-partum tubal ligation, significant levels ofALFENTA were detected in colostrum four hours after administration of 60 pg/kg of ALFENTA, with no detectablelevels present after 28 hours. Caution should be exercised when ALFENTA is administered to a nursing woman.Pediatric Uae: Adequate data to support the use of ALFENTA in children under 12 years of age are not presentlyavailableADVERSE REACTIONS: The most common adverse reactions, respiratory depression and skeletal muscle rigidity,are extensions of known pharmacological effects of opioids. See CUNICAL PHARMACOLOGY, WARNINGS andPRECAUTIONS on the management of respiratory depression and skeletal muscle rigidity. Delayed respiratorydepression, respiratory arrest, bradycardia, asystole, arrhythmias and hypotension have also been reported. Thereported incidences of adverse reactions listed in the following table are derived from controlled and open clinicaltrials involving 1183 patients, of whom 785 received ALFENTA. The controlled trials involved treatment comparisonswith fentanyl, thiopental sodium, enflurane, saline placebo and halothane. Incidences are based on disturbing andnondisturbing adverse reactions reported. The comparative incidence of certain side effects is influenced by thetype of use, eg., chest wall rigidity has a higher reported incidence in clinical trials of alfentanil induction, and bythe type of surgery, e.g., nausea and vomiting have a higher incidence in patients undergoing gynecologic surgery.

ALFENTA Fentanyl Thiopental Sodium Enflurane Halothane Saline Placebo'Percent (N=785) (N=243) (N=66) (N=55) (N=18) (N=18)

GastrointestinalNausea 28 44 14 5 0 22Vomiting 18 31 11 9 13 17

CardiovascularBradycardia 14 7 8 0 0 0Tachycardia 12 12 39 36 31 11Hypotension 10 8 7 7 0 0Hypertension 18 13 30 20 6 0Arrhythmia 2 2 5 4 6 0

MusculoskeletalChest Wall 17 12 0 0 0 0

RigiditySkeletal Muscle 6 2 6 2 0 0

MovementsRespiratory

Apnea 7 0 0 0 0 0Postoperative 2 2 0 0 0 0

RespiratoryDepression

CNSDizziness 3 5 0 0 0 0Sleepiness/ 2 8 2 0 0 6

PostoperativeSedation

Blurred Vision 2 2 0 0 0 0

"From two clinical trials, one involving supplemented balanced barbiturate/nitrous oxide anesthesia and one inhealthy volunteers who did not undergo surgery.In addition, other adverse reactions less frequently reported (1% or less) were: Laryngospasm, bronchospasm,postoperative confusion, headache, shivering, postoperative euphoria, hypercarbia, pain on injection, urticaria, anditching. Some degree of skeletal muscle rigidity should be expected with induction doses of ALFENTA.DllU ABUSE AND DEPENDENCE: ALFENTA (alfentanil hydrochloride) is a Schedule II controlled drug substancethat can roduce drug dependence of the morphine type and therefore has the potential for being abused.OEIR E: Overdosage would be manifested by extension of the pharmacological actions f ALFENTA(alfentanil hydrochloride)(see CUNICAL PHARMACOLOGY) as with other potent opioid analgesics. No experience ofoverdosage with ALFENTA was reported during clinical trials. The intravenous LO)e of ALFENTA is 43.0-50.9 mg/kgin rats, 72.2-73.6 mg/kg in mice, 71.8-81.9 mg/kg in guinea pigs and 59.5-87.5 mg/kg in dogs. Intravenous adminis-tration of an opioid antagonist such as naloxone should be employed as a specific antidote to manage respiratorydepression. The duration of respiratory depression following overdosage with ALFENTA may be longer than theduration of action of the opioid antagonist. Administration of an opioid antagonist should not preclude immediateestablishment of a patent airway, administration of oxygen, and assisted or controlled ventilation as indicated forhypoventilation or apnea. If respiratory depression is associated with muscular rigidity, a neuromuscular blockingagent may be required to facilitate assisted or controlled ventilation. Intravenous fluids and vasoactive agents maybe required to manage hemodynamic instability.DBSIE AND rADINlSTRAIrlN: The dosage of ALFENTA (alfentanil hydrochloride) should be individualized ineach patient according to body weight, physical status, underlying pathological condition, use of other drugs, andtype and duration of surgical procedure and anesthesia In obese patients (more than 20% above ideal total bodyweight), the dosage of ALFENTA should be determined on the basis of lean body weight. The dose of ALFENTAshould be reduced in elderly or debilitated patients (see PRECAUTIONS). Vital signs should be monitored routinely.Protect from light. Store at room temperature 15°-30° C (59°-86° F).

JANSSENPHARMACEUTICA

Piscataway, NJ 08855-3998

March 1987 April 1988U.S Patent No. 4,167,57449-7619902-M

© Janssen Pharmaceutica Inc. 1992

Printed in U.SAJPI-AL-063A April 1992

SStandard laryngoscope handles with fittings manufacturedto ASTM standards.

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