3
alert awakening c 1; , 15mg 30mg caPSUles (temazepam) A more appropriatehalf-life One 3O-mg capsule. h.S -usual adultdosage. One 15-mg capsule. h.S.-recommendedinitialdosage lor elderly and/or debilitatedpatients. INDICATIONS AND USAO.: Restoril 8 (lemaze- pam) is indicated for the reliel of insomnia associaled wifh complaints of diHiculty in lalling asleep. frequent nocturnal awakenings. and/or early morning awaken- ings. Since insomnia is olten transient and intermit- tent. the prolonged administration of Restoril is gen- erally not necessary or recommended. Restoril has been employed lor sleep maintenance lor up to 35 consecutive nights 01 drug administration in sleep lab- oratory studies. The possibility that the insomnia may be related to a condition lor which there is more specific treatment should be considered CONTRAINDICATIONS: Benzodiazepines may cause tetal damage when administered during preg- nancy. An increased risk 01 congenital malformations associated with the use 01 diazepam and chlordiaz- epoxide during the first trimester 01 pregnancy has been suggested in several studies. Also. ingestion of therapeutic doses of benzodiazepine hypnotics during the last weeks of pregnancy has resulted in neonatal CNS depression. Restoril is contraindicated in preg- nant women. Consider a possibility of pregnancy when instituting therapy or whether patient intends to become pregnant. WARNINOS: Patients receiving Restoril (temaze- pam) should be cautioned about possible combined eHects with alcohol and other CNS depressants. PR.CAUTIONS: In elderly and/or debilitated patients. it is recommended that initial dosage be lim- ited to 15 mg. The usual precautions are indicated for severely depressed patients or those in whom there is any evidence of latent depression; it should be recog- nized that suicidal tendencies may be present and pro- tective measures may be necessary. If Restoril is to be combined with other drugs hav- ing known hypnotic properties or CNS-depressant eHeets. due consideration should be given to potential additive eHects. Inlormation lor Patients: Patients receiving Restoril should be cautioned about possible combined eHects with alcohol and other CNS depressants. Patients should be cautioned not to operate machinery or drive a motor vehicle. They should be advised ot the possi- bility of disturbed nocturnal sleep for the first or sec- ond night alterdiscontinuing thedrug. Laboratory Tests: The usual precautions should be observed in patients with impaired renal or hepatic lunction. Abnormal liver lunction tests as well as blood dyscrasias have been reported with benzodiazepines. Pregnancy: Pregnancy Category X. see Contraindica- tions. Pediatric Use: Safety and eHectiveness in children below the age ot 18 years have not been established. ADV.RS. R.ACTIONS: The most common adverse reactions were drowsiness. dizziness and leth- argy. Other side eHects include contusion. euphoria and relaxed feeling. Less commonly reported were weakness. anorexia and diarrhea. Rarely reported were tremor. ataxia. lack of concentration. loss 01 equilibrium. falling and palpitations. And rarely reported were hallucinations. horizontal nystagmus and paradoxical reactions. inCluding excitement. stim- ulation and hyperactivity. Restoril is a confrolied substance in Schedule IV. Caution must be exercised in addiction-prone individ- ualsorthosewho might increase dosage. DOSAO. AND ADMINISTRATION: Adults: 30 mg usual dosage betore retiring; 15 mg may suHice in some. Elderly and/or debilitated: 15 mg recommended initially until individual response isdetermined. SUPPLI.D: Resforil (temazepam) capsules-15 mg maroon and pink. imprinted "RESTORIL 15 mg"; 30 mg. maroon and blue. imprinfed "RESTORIL 30 mg" Packages 01100. 500 and ControlPak e pack. ages ot 25 capsules (continuous reverse-numbered roll otsealed blisters) (RES-Z2 1111/81) 8elore prescrIbing. see peclcage insert lor lull product information. ABSTRACTS Treatment of depression inadequate, study finds Keller MB. Klerman GL. Lavori PW. et al: Treatment received by depressed patients. lAMA 248:1848-1855.1982. The authors report a multi- center study of 217 patients re- ferred to five different university psychiatric centers for treatment of depression. All patients met RDC for major depression and had been ill for at least a month. The princi- pal finding is that the patients had received a very low level of somatic antidepressant therapy prior to re- ferral. Only one third of the sample was treated with antidepressant medication for four consecutive weeks, as contrasted with two thirds who had received psychotherapy and 55% who had received an- tianxiety drugs. In fact, the authors estimate that only II % of the total sample had had a truly adequate trial of antidepressant treatment or ECT prior to referral. There were no particular demographic or clini- cal variables that defined a popUla- tion of patients who received more adequate therapy. For instance. even among patients with long- standing depressive symptoms or the endogenous syndrome, less than 20% received what the authors felt to be an adequate trial of so- matic treatment. The authors point out that their patients were not randomly selected, but they argue that their results nevertheless indi- cated a real inadequacy in the treatment practices of physicians in the community. In this regard, the findings are in agreement with pre- vious studies. The authors specu- late that the deficiencies noted are due to a combination of patient resistance and faulty treatment practices on the part of clinicians. In an accompanying editorial, Dr. Uhlenhuth argues in reply that the treatment practices observed by the authors reflect the difficulties asso- ciated with adminstering high dose antidepressant treatment. Yet these difficulties, such as cardiac toxicity and anticholinergic side effects, are notably absent with the antianxiety drugs used most commonly by the referring physicians. The question remains open, therefore, whether patients fail to receive maximum doses of antidepressant treatment because of their own resistance to taking such medication, or because of physician ignorance or reluc- tance to prescribe such medication because of its toxicity. Francis P. LeBuffe Georgetown University The physician-patient encounter Siegler M: The physician-patient accommo- dation: A central event in clinical medicine. Arch Inlern Med 142:1899-1902.1982. There is as yet no definitive the- oretical description of the nature of clinical medicine, in particular in the light of the growing interest in the biopsychosocial treatment ap- proach. This article provides a clear exposition of what occurs in daily clinical medicine when physicians treat patients. The nature and nuances of the patient-physician interaction determine the essence of medical treatment. A patient ap- pears at the office or clinic, partici- pates in a diagnostic process, and agrees to proceed with further ac- tion. These steps are referred to as RES·183·2 A Pharmaceutical Division SANDOZ, INC. East Hanover. NJ 07936 860 PSYCHOSOMATICS

document

  • Upload
    duongtu

  • View
    212

  • Download
    0

Embed Size (px)

Citation preview

RestfuI~alert awakening c

1;,15mg

30mgcaPSUles

(temazepam)A more appropriatehalf-life

One 3O-mg capsule. h.S -usualadultdosage.One 15-mgcapsule. h.S.-recommended initialdosagelor elderlyand/ordebilitatedpatients.INDICATIONS AND USAO.: Restoril8 (lemaze­pam) is indicated for the reliel of insomnia associaledwifh complaints of diHiculty in lalling asleep. frequentnocturnal awakenings. and/or early morning awaken­ings. Since insomnia is olten transient and intermit­tent. the prolonged administration of Restoril is gen­erally not necessary or recommended. Restoril hasbeen employed lor sleep maintenance lor up to 35consecutive nights 01 drug administration in sleep lab­oratory studies.

The possibility that the insomnia may be related to acondition lor which there is more specific treatmentshould beconsideredCONTRAINDICATIONS: Benzodiazepines maycause tetal damage when administered during preg­nancy. An increased risk 01 congenital malformationsassociated with the use 01 diazepam and chlordiaz­epoxide during the first trimester 01 pregnancy hasbeen suggested in several studies. Also. ingestion oftherapeutic doses of benzodiazepine hypnotics duringthe last weeks of pregnancy has resulted in neonatalCNS depression. Restoril is contraindicated in preg­nant women. Consider a possibility of pregnancywhen instituting therapy or whether patient intends tobecome pregnant.WARNINOS: Patients receiving Restoril (temaze­pam) should be cautioned about possible combinedeHects with alcohol and other CNS depressants.PR.CAUTIONS: In elderly and/or debilitatedpatients. it is recommended that initial dosage be lim­ited to 15 mg. The usual precautions are indicated forseverely depressed patients or those in whom there isany evidence of latent depression; it should be recog­nized that suicidal tendencies may be present and pro­tectivemeasures may be necessary.

If Restoril is to be combined with other drugs hav­ing known hypnotic properties or CNS-depressanteHeets. due consideration should be given to potentialadditiveeHects.Inlormation lor Patients: Patients receiving Restorilshould be cautioned about possible combined eHectswith alcohol and other CNS depressants. Patientsshould be cautioned not to operate machinery or drivea motor vehicle. They should be advised ot the possi­bility of disturbed nocturnal sleep for the first or sec­ond night alterdiscontinuing thedrug.Laboratory Tests: The usual precautions should beobserved in patients with impaired renal or hepaticlunction. Abnormal liver lunction tests as well as blooddyscrasias have been reported with benzodiazepines.Pregnancy: Pregnancy Category X. see Contraindica­tions.Pediatric Use: Safety and eHectiveness in childrenbelow the ageot 18years havenot been established.ADV.RS. R.ACTIONS: The most commonadverse reactions were drowsiness. dizziness and leth­argy. Other side eHects include contusion. euphoriaand relaxed feeling. Less commonly reported wereweakness. anorexia and diarrhea. Rarely reportedwere tremor. ataxia. lack of concentration. loss 01equilibrium. falling and palpitations. And rarelyreported were hallucinations. horizontal nystagmusand paradoxical reactions. inCluding excitement. stim­ulation and hyperactivity.

Restoril is a confrolied substance in Schedule IV.Caution must be exercised in addiction-prone individ­ualsorthosewho might increase dosage.DOSAO. AND ADMINISTRATION: Adults: 30 mgusual dosage betore retiring; 15 mg may suHice insome. Elderly and/or debilitated: 15 mg recommendedinitially until individual response isdetermined.SUPPLI.D: Resforil (temazepam) capsules-15 mgmaroon and pink. imprinted "RESTORIL 15 mg";30 mg. maroon and blue. imprinfed "RESTORIL30 mg" Packages 01100. 500 and ControlPake pack.ages ot 25 capsules (continuous reverse-numbered rollotsealed blisters) (RES-Z2 1111/81)8elore prescrIbing. see peclcage insert lor lull productinformation.

ABSTRACTS

Treatment of depressioninadequate, study findsKeller MB. Klerman GL. Lavori PW. et al:Treatment received by depressed patients.lAMA 248:1848-1855.1982.

• The authors report a multi­center study of 217 patients re­ferred to five different universitypsychiatric centers for treatment ofdepression. All patients met RDCfor major depression and had beenill for at least a month. The princi­pal finding is that the patients hadreceived a very low level of somaticantidepressant therapy prior to re­ferral. Only one third of the samplewas treated with antidepressantmedication for four consecutiveweeks, as contrasted with two thirdswho had received psychotherapyand 55% who had received an­tianxiety drugs. In fact, the authorsestimate that only II % of the totalsample had had a truly adequatetrial of antidepressant treatment orECT prior to referral. There wereno particular demographic or clini­cal variables that defined a popUla­tion of patients who received moreadequate therapy. For instance.even among patients with long­standing depressive symptoms orthe endogenous syndrome, lessthan 20% received what the authorsfelt to be an adequate trial of so­matic treatment. The authors pointout that their patients were notrandomly selected, but they arguethat their results nevertheless indi­cated a real inadequacy in thetreatment practices of physicians inthe community. In this regard, thefindings are in agreement with pre­vious studies. The authors specu­late that the deficiencies noted aredue to a combination of patient

resistance and faulty treatmentpractices on the part of clinicians.In an accompanying editorial, Dr.Uhlenhuth argues in reply that thetreatment practices observed by theauthors reflect the difficulties asso­ciated with adminstering high doseantidepressant treatment. Yet thesedifficulties, such as cardiac toxicityand anticholinergic side effects, arenotably absent with the antianxietydrugs used most commonly by thereferring physicians. The questionremains open, therefore, whetherpatients fail to receive maximumdoses of antidepressant treatmentbecause of their own resistance totaking such medication, or becauseof physician ignorance or reluc­tance to prescribe such medicationbecause of its toxicity.

Francis P. LeBuffeGeorgetown University

The physician-patientencounterSiegler M: The physician-patient accommo­dation: A central event in clinical medicine.Arch Inlern Med 142:1899-1902.1982.

• There is as yet no definitive the­oretical description of the nature ofclinical medicine, in particular inthe light of the growing interest inthe biopsychosocial treatment ap­proach. This article provides a clearexposition of what occurs in dailyclinical medicine when physicianstreat patients. The nature andnuances of the patient-physicianinteraction determine the essenceof medical treatment. A patient ap­pears at the office or clinic, partici­pates in a diagnostic process, andagrees to proceed with further ac­tion. These steps are referred to as

RES·183·2 A Pharmaceutical DivisionSANDOZ, INC.East Hanover. NJ 07936

860 PSYCHOSOMATICS

the three basic clinical moments inthe patient-physician encounter.With reference to Tolstoy's novel,The Death of Ivan I1ych, the articlefirst depicts the biopsychosocialevent ofdeciding to see a physician.Then the phase of data gathering,data reduction, and tentative diag­nosis as a complex task for both thephysician and patient is delineated.The third essential feature of clini­cal medicine is that the patient andphysician arrive at a mutual rela­tionship and plan of action. Thisaccommodation undergoes furtherdynamic changes. The article'sthesis is that medicine has neverbeen defined solely by its content ofscientific knowledge or by its tech­nologic capabilities. The definingfactor is what the physician andpatient decide will happen at anyparticular moment. Many factorsoutside personal judgment affectthe physician-patient accommoda­tion. Bureaucratic, political, andeconomic influences could changethe delicate physician-patient en­counter into an impersonal con­tract. Effective understanding andcommunication as provided by thisarticle could help prevent this.

Robert E. Holt, M.D.Medical College of Wisconsin

Hyperthyroxinemia andpsychiatric disordersSpran Dl, Pont A, Miller MB. et al: Hy­perthyroxinemia in patients with acute psy­chiatric disorders. Am J Med73:41-48, 1982.

• Thyroid function has long beenimplicated in the pathologicchanges resulting in either thyro­toxicosis or myxedema madness.Several studies in recent months

SEPTEMBER 1983 • VOL 24 • NO 9

have suggested that thyroid func­tioning may playa greater role inthe genesis of acute psychotic dis­orders than had previously beenthought. The investigators in thisstudy sought to elucidate the role ofthe thyroid gland in the naturalhistory of acute psychiatric dis­orders. They measured thyroidfunction tests in 645 patients ad­mitted in an acute state to a psychi­atric unit. Surprisingly, some 33%of the patients admitted had ele­vated serum thyroxine (T4), while18% of the patients had elevatedfree T4. These authors then studied22 such patients showing initialhigh serum thyroxine and notedthat this hyperthyroxinemia wastransient. They point out that onthe basis of their experience serumT4 or free T4 measurements taken atthe time of admission will give alarge number of spuriously elevat­ed values. They conclude that thesevalues are not representative of hy­perthyroidism requiring specifictherapy, but that the values willreturn to normal unaided. Theyrecommend that if thyroid screen­ing is to be done, it is probablymore effectively accomplished bywaiting one week after admission.This allows time for an apparentlynatural rise of serum T4 to return tonormal in those patients who arenot suffering from hyperthyroid­ism. These investigators attemptedto associate the presence of in­creased serum thyroxine or in­creased free T4 with the varioustypes of psychiatric pathology seenin their patient population. Theywere unable to do so. Their conclu­sion is that in most cases the in­creased thyroid hormone levelswere probably an effect rather than

a cause of underlying psychopa­thology. They then offer some pos­sible theories as to why this wouldbe the case. For the purposes of thepracticing clinician, this excellentstudy suggests further restraint inassessing thyroid disorders bymeans of laboratory measurement.For the clinical researcher, the puz­zle as to why transient hyperthy­roxinemia occurs in acute psychoticstates offers a significant challengein further elucidating the biology ofcompensated and noncompensatedego function.

Thomas P. Beresford, M.D.University of Tennessee

Drug treatmentof anxietyRosenbaum JF: The drug treatment of anxi­ety. N Engl J Med 306:401-404. 1982.

• A spate of publicity and contro­versy over the use of benzodiaze­pines has called attention to thevolume of prescriptions issued forthese medications, perenniallyamong the nation's most prescribeddrugs. The attitude of individualphysicians toward prescribingmedication for psychic distresscovers a spectrum from "pharma­cologic Calvinism" to "psychotrop­ic hedonism," reflecting a personalmoral stance which, unfortunately,is likely to determine the prescrib­ing patterns of physicians lackingreliable and scientific guidelines fordiagnosing and prescribing. Theauthor suggests that a reasonedtherapeutic strategy in determiningthe choice of antianxiety medica­tions should involve three ques­tions: Is there a condition otherthan generalized anxiety to account

861

ABSTRACTS

for the patient's distress? If not, isthere an appropriate nonpharma­cologie remedy? In a risk-benefitanalysis, is symptomatic anxiolyticpharmacotherapy indicated? As tothe first question, studies indicatethat 9% to 42% of patients referredfor treatment of anxiety and otherpsychiatric disorders have underly­ing medical illness responsible fortheir distress. In patients withknown medical illness, careful at­tention to that condition is the firstconsideration in the effort to ex­plain anxiety symptoms. Particularscrutiny for conditions commonlyassociated with anxiety, eg, caffein­ism, alcohol withdrawal, and thy­roid function abnormalities, is in­dicated. Depressive disorders,panic attacks, and psychoses haveprominent anxiety symptoms, butthe primary treatment is with

agents other than anxiolytics. Thelatter may have some role in treat­ment but are likely to be ineffectivealone. As to the second question,various sorts of psychotherapeuticintervention (individual or grouppsychotherapy, marital counsel­ing), as well as a number of behav­ioral techniques, may prove to beeffectively anxiolytic in the absenceof pharmacotherapy. As to thethird question, risk-benefit analysisshould involve consideration ofspecific classes of agents (benzodi­azepines are clearly superior tobarbiturate and non barbituratesedative and hypnotic agents foranxiolytic treatment). Moreover, aresponse of improved functioning,not only enhanced comfort. isneeded to justify continued treat­ment with such agents. Consider­ations of medical absorption

rate. rapidity ofaction, and half-lifeare also important, as is the obser­vance of various prescribing pre­cautions (potential for suicide,withdrawal symptoms, teratogeniceffects, and paradoxical reactions).Classes of patients likely to be re­sponsive are those with a lifelongpattern of chronic anxiety and fre­quent exacerbations, those with ep­isodic anxiety states lasting days toweeks, usually stress-related, andthose with transient symptoms last­ing minutes or hours associatedwith specific stimuli or specific set­tings. Properly considered, anxio­lytic agents, especially the benzodi­azepines, can be of considerableclinical benefit and, contrary to re­cent publicity. need be regarded asneither panacea nor poison.

Charles R. Tartaglia. M.D.Georgetown University

INDEX TO ADVERTISERSSEPTEMBER 1983

862

ABBOTT LABORATORIES

Tranxene 816-818

elBA PHARMACEUTICAL COMPANY

Ludiomil .. . . . . . . . . . . . .. 832-834

DUPONT PHARMACEUTICALS

Symmetrel EPS 820-821

LEDERLE LABORATORIES

Asendin . . . . . . . . . . . . . . .. 776-778

MERCK SHARP & DOHME

Sinemet . . . . . . . . . . . . . . .. 802-804

MERRELL DOWPHARMACEUTICALS, INC'.

Norpramin. . . . . . . . . . . . .. 806-808

ROCH.E LABOR ATORIES

Val release. . . . . . . . . . . . . .. 850-852Vitamins 843

ROERIG

Navane. . . . . . . . .. 784-786. 838-840Sinequan . . . . . . . . . . . . . .. 798-800

SANDOZ PHARMACEUTICALS

Hydergine third coverMellaril. 794-796.

fourth coverRestoril. . . . . . . . . . . . . . . .. 858-860

SMITH KLINE & FRENCHLABORATORIES

Stelazine second cover-773

E.R. SQUIBB & SONS. INC.

Prolixin 822-824

THE UPJOHN COMPANY

Halcion. . . . . . . . . . . . . . . .. 780-782Xanax. . . . . . . . . . . . . . . . .. 845-846

WYETH LABORATORIES

Ativan 791-792

PSYCHOSOMATICS