RESPIRATORY CARE CERTIFICATION GUIDE

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(mefEprorereno!sulfate)

InhIIItianAeroooI10 mL' '10 mL; 15 mg per mL(eechmOlenKl dolO delivers0.65 mgmeteproterenol.ulfete) Bronchodiletor Briel Summary 01 Prescribing Inlormatlon

;~~:~~~~~?a~II~~~aY;~i~l:,uents wrth cardiac arrhythmias associated Although rare . immediate hypersensrtivity reactions can occu r. Therefore, Alupen" (metaproterenol su~ate USP1'nhalation Aerosol is contraindicated in patients wrth a history of hypersensrtivity to any 01 rts components. WARNINGS FataliUes have been re~orted fOllowin~ excessive use of Alupent'

&':'eeJ~~~?;~~:,n~~~~~;t:x~~i&.~s:1s~~~~~~m~trdc:a~i'.::ti~:~~~~ in

several cases .

Alupent, like other beta adrenergic agonists, can produce a significant ca rdiovascular effect in sOmetcatients, as measured b~ pulse rate , blood

~~~g~~r:: .:.r~~~~na;'W~ce~~~~~~'~~o~~:m~~hf~h~~~ Iffethreateningl ' Ifrt occurs, the preparation should be discontinued immediately and anernaive therapy instituted . Alupent should not be used more onen than prescribed. Patients should be advised to contact their physician in the event that they do not respond to the ir usual dose of a sympathomimetic amine aerosol. PRECAUTIONS General Extreme care must be exercised wrth respect to the administ ration of addrtional sympathomimetic egents. Since metaproterenol is a sympathomimeUc amine, rtshould be used with caution in patients wrth cardiovascular disorders, including isc hemic heart disease, hypertension or card iac arrhythm ias , in patients With hyperthyroidism or diabetes mellrtus, and in pat ients who are unusually responsive to sympathomimetic amines or who have convulsive disorders. Significant changes ~a~i~~\~Ii~n".:;~~~agl~~yb~~fJ~:~:~i~~~~~~edto occur in some

Inlormatlon tor Patlenta Appropriate care should be exerciSed when

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sympathomimetic age nt. Drug Interact,lona Other beta adrenergic aerosol bronchodilators should not be

~~~en~~~i~0~'~~7~~ ~~U~~ug:~d=~~e~':Jrt~~~~ rodg~rr:nr:=gBeta treated wrth monoamine oxidase inhibrtors or tricYclic antidepressants, since the act ion of beta adrenergic agonists on the vascular system may be potentiated. Carclnogene.IIIIMutagene"llllmpalrment 01 Fertility In an 18-month study in mice. Alupent produced an increase in benign ovarian tumors in females at doses corres~,"dingto 320 and 640 times the maximum recommended dose

I~~~g;~ be~~:,n,~~~~~~~7aao~-rheea:.,~~~~~~~tsW:s~~~~T~~timesthe maximum recommended dose. The relevance of these findings to man is not known. Mutagen ic studies wrth Alupent have not been conducted. Reproduction studies in rats revealed no evidence of impaired fertility. PregnencylTeratogenlc Effect. PREGNANCY CATEGORY C Alupent has been ~~~:~~n~nt~rl~m':ii;'~~~~:~z.y,;;>~~~~~~:1'3;;':'~+'I.=~ects

included skeletal abnormalrties, hydrocephalus and skull bone separation. Results of olher studies in rabbrts, rats or mice have not revealed any teratogenic. embryocidal or fetoloxic effects . There are no adequate and wellcon trolled sludies in pregnant women . Alupent should be used during pregnancy only d Ihe polenUal benefrt justifies the potential risk 10the fetus . Nurelng Mathe.. It is not known whether Alupent is excreted in human milk; therefore. Alupent should be used during nursing only d the potenlial benefit /ustffies the possible risk to the newbom. Pedlelrlc Use Safety and effecUveness in children below Ihe age of 12 have not been established. Stud ies are currenlly unde r way in Ihis age group. ADVERSE REACTIONS Adverse react ions are similar to Ihose noted wrth other sympathomimetic agenls. The most frequent adverse reaction to Alupent3 (metaproterenol su~ate USP) administered by metered-dose inhater among 251 patients in 9O-day controlled clinical trials was nervousness. This was reported In 6.8% of patients. Less frequen t adverse experiences, occurring in 1% 10 4% 01 patients were headache, diZZiness, palprtations . gastrointestinal distress, tremor. throat irrrtalion. nausea. vomiting. cough and asthma exacerbation. Tachycardia occurred in less then 1% of patients. HOW SUPPUED Each 200 inhalations of Alupent3 (metaproterenol su~ate USP) Inhalation Aeroso l contains 150 mg of metaprolerenol su~te as a micronized powder in inert propellants. Each metered dose delivers through the mouthpiece 0.65 mg metaproterenol su~ate (each mL contains 15 mg). Alupenl Inhalation Aerosol wrth Mouthpiece (NDC 0597·0070-17). nel contents 14 g (10 mL). The mouthpiece is whrte wrth a clear , colorless sleeve and a blue prolective cap. Alupentlnhalation Aerosol Refill(NDC 0597-0070-18), net conlents 14 g (10 mL). Store between 59"F (15°C) and 77"F (25°C). Avoid excessive humidity. Consult package Insert before prescribing. AL-BS-319O

References: 1. Reilly EB, AodglllSJM. Bickennan HA. Acomparison oftheonset 01 broncI1odiatoraetMtyof andisoproterenol aerosols. Cw TIler Res. 1974;16(8):759-764. 2. Alupent" (metaproterenol su~ate) InhalationAerosol fullPrescribing Inlormation. 3. Data on file,Boehringer Ingelheim PharrnaceuUcals, Inc. AL-4783 m~

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Boehringer

~ Ingelheim

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Boehringer Ingelheim Pharmaceuticals. Inc. Ridgefield , CT 068n

The Bookshelf Conlinued from page 19 THE LUNG; SCIENTIFIC FOlJNDATIONS. Edited hv Ro 'uw G. CHYS' TAL, JOli N B. WEST, Po:n:H J. B.'HNES, NEI L S. Cm:~N I.\CI( , an d EW.' LJ> R. W O :Jso:L. New York; Raven Press, 1991,2,224 pp , $265.00

Overwhelming. massive , and deci sive - terms ap p lied 10 a recent military conflict - might al so he used to des cri be thi s two-volume tr eatise on IHn~ hiolo~y and dis ease . The ed itor s haw pUI together an int ernational M .D .Ph .D . coalition of more than 300 authors and attempt to "cove r the whole neld of th e scie nn fic foundations of the lung in health and dis eas e ," ind ud inj\ cell hiolo!\}', biocbemtstry, morpholo!-,'y, ph ysiolo!\)', pharmacology, and paIholo!\)·. Thai individual chapters ar e devoted 10 platelet-activuttng Iactor, mucu s rheology, Clara cells, nhmneclins, cartilage, th e bronchial cir cu lation, micrornechantcs ofth e acinus, airway regulation hy prostanoids. neural control of pulmonary circulation , cent ral che morece ptor s, particle depos ition, ~a.~ exchange during sleep, determinants of maximal oxygen uptake, fetnl lu nj\ liquid , ciliar y dysfunction, hyperbaric oxygenation, and the lung aft er transplantation -Iml the briefest sampl ing of the tahle of contents -j\i\'es som e se nse of the depth an d br e adth " f coverage . M"st " f the cha pte rs are succinct . well-illustrated state -of-the -art reviews, with references IhroulUJ 1989 or 1990 . This is a re fe re nce textbook written primarily f"r inve stigators: it will find its greatest use in medical school an d other teaching hospital libraries. Clinicians \\ill want to seek answe rs to patient problems el sewhere . hut can be grateful h" and inspi red bv the elegant presentation "f th e science su pporting th e ir endeavors . These twin volumes suc ce ed in or~anizin~ and deploying megatons of infnrmal inn nn lunj\ hinlo!\).' This new work is, at the sam e lime, a valuable expres sion of current scholar sh ip and a monument to our pre sent iAllor.Ul<:e. Raven Press, the ed itors , and the authors d e se rve congra tulations and praise for their suhslantial efforts.

h ie L Dyer; M.D ., f :C .C.P. ,'IIas/lVille, Tennessee

THE AORTIC \i\LVE . By ROKo:KT\\: EMEHyand KIT \ : AHOM. Philadelphia; Hanle y & Belfus, 1991 , 336 pp, $65 .IKl This con cise text embraces e ve r y aspect of congenital and acquired lef] ventricular outflow tract disease . Basic science and diagnosttc aspe ct s of the majnr hemodynamic lesions are covered in a way that shatt e rs hlind faith (ej\ , in such now too-simple notions as the Corlin fcJnnnla). New hopes are inaugurated fnr aor tic valve balloon dilatatkm-s a topic as ineluctable as the seasonal return of the 17-year locust . (D ilatat ion can actuall y pro\'e useful h" erilieal slennsis in ne
Alan T. Marty, M .D. , FC.C .P.

f:vansville, Indiana

RESPIRATORY C ARE CERTIFICATION GUIDE . By JA"':S R. STILl.S. St. Louis; Moshy-Year Bt• •k. 1991,412 pp, $27 .95 The e volu tio n of Ihe sludy j\uide for respiralory l'are eredenlialinj\ examinalions ("ntinues wilh Ihe puhliealion oflhis re<.'enl text. A s Ihe markel !>e<."mes A<.>
Robert G . McGee , RRT .\lOnist OWII,

Tennessee