Volume 17, Number 3 March 1991

MMypertenstonTh» R. W. Johnson

PMmwe*utlMl Sastarch InttKute

MAR I 2 1991

Spring HQUW uorarv

American Heart Association

73-2085 ISSN 0194-911X

Kindhearted Lozol is notassociated with adverse lipid changes*— unlike hydrochlorothiazide. Infact, both short- and long-term stud-ies demonstrate that Lozol reduceshypertension without compromisingcholesterol.1"3 For patients at highercardiovascular risk because of highblood pressure and lipid concerns,Kindhearted Lozol offers safe,effective diuretic therapy.

ONE A DAY

UJZOLINDAPAMDE 2.5mgThe duretic that doesntcompromise cholesterol

Please sec brief summary of prescribing infomutHHi below*Lo7o) is not a cholesterol-lowering agcru. nor has it beenshown to reduce existing atherosclerotic plaque

LOZOL* (Indipamtdel Z.9 mg MMMB«£F SUMMARY

* )y p , atom Of in cofntwbon wMb OMMT mtiiypertensw drugs, aid for lie

uutiient of sal aid hid mtnto) w * " * ^ witti conpetov heal o t f tftap n Prtgnanr S " PRECAUTIONS

CWTAMBCATVM: Amra, riyperwstrty to IndapamJe or cither stflonmfc-demad drags.

WAMMGS: Hypokavna occurs commonly rth (k i r ta , and Btectrolytt roaratamc.a m * * * H omrt , cfcjioa start not in tfwn wti i t t i mPEftMJTTMtt Perform scrum atetroftti deanrutos a appropnaO raemfttsoiclaty In ptttrts who n wntong raessMy or nctmig parantera' U s , inpjbertt subjaetto t*c«r*r» Imbataoct, or n pabena on i stf-restnded Art Intddbon, patcnQ shoati be observed lor caicJ signs of U or dectro^ti irtrianct,sud c tJjrpOTBtrgBtt, hypodJownt * t o , or hypololeina. The rat of

ondvy itdunss md lut i l icu orcrustd rti brger dom, wtttf h f t l *t tart f h l f r f t

yp ybrist cfcjrtsts, wtfi tyvare crrhoft, n l i*ti coxomtart uACTH ttErtftnct rtti tdequtie ori r M v of etectnriyta * i * o ortrtwtetDhypobtomo. Hypobiema on sensfca or caqggjgi the rcyona of tti hurt to thetoxic fftedi of rtjrtiii. tucti a rauud MntriuLir rnbbfltyDirtonJ hyponj&ona rwy ocar r sdenudus pabmtc jppopriMi tisitment austaty w t e rtstnOoa In ictuj u l o^etnuuroproli raptamert sibeliUiucri ofcWct, ChtorUs deiatb o n l y rnki, pdrepwrQ specific tmtrocntexcept i extmnfeury crcsntstno (Wv, rerai dhttse).Hyperuncsmn my occur, md frank gout mty bi prtcbtSBd n certvi prtentt

W d i d S n concsWiKiu of ixc too shodd be frontondf

Use wtt dudon k\ pjocntt nth wven rtntf d m i conoder wtthhottno ordbconkuiQ rf progrosve r v d i rp jnwr t is obserwd Rirui toncton M s shouldbt performed periodalyUs* witbcadOD in pttenBoMh impared tHptifc hnctonor proqreunv i w dscse,m i mnof j tc i i taB of u d n ) shctnriyti tubnee rnty p^^Mtir heptt conu.Lficrt dabttss rmy become (nanfeti aid fesfti requrcmentt n dnbetc pattenfirmy be tfved d u i x liiude idmrtstrOQT Senm cuunttfeuns of yiucose shouldbi monNored roobroy d frrtrt tt k & d

Cacun cjcrrton s dBCrusid by dunKi phamcoloojcily retard to no^pvnide.Senm concmtutDns of calcium ncrnsed only sajnly wti iretajnmoi n tono-tarmstudn of oyperttntiw pajants. hJnanrt n a y f r a n c anni PB t M h wttnrt9Qra of feyroij OBttrbaid CotTpfcafionj of hyperpvjfryrQJdBm hive not beenseen Dtscontiu bttoro tests of paifeyrod hncton n penornisdTkaaJBtwi racertfltid or ic tmM systemic lapos irythcrntosus. Consder tMspoubfty wfli ndajmte,

mU6 Pr rBWTOt t LOZOL may add to or potvtte the acton of otwrtrtypirtBniJw drupjt. Tht jndhyveiWvi enect of N drug nuy bt artwncaJ nthe potisymptfiectonuK) patierl htapamde may decrcm artenai rcponmnessto norcpnephme, but tfu does not prtdude tn use of nDrcpreohm.In mouH ud m iNkne carcboojenaty stocfes, there n n no sqnttcait dArencesn the iiddmce of • n o n bttwon Iw indapanvh-tiuled anifnali and the controlgnwps.

ftipnaKy Cttegory ft Ctarcto O O B h i phcenU barntf and appear n cord btoodkxlaotmldc should bt used doing preonaxy only If ctoaiy needed. Use rmy btB H X U M wffi tetaJ or neoruti1 funict, thrombocytopna, and pottby oth*fadvent sflects that h M occurred n atatts. ft B not known utiethsr ths drug ufiiQited In hmun m i If U H d ths drug H dnmed nwil i^ the pxtent sho^d Jfijpnnng.

AWEME BBCTOtt Most tfitra efteO haw been mW and transet FromPhase I ptacebo-coDtroUd tfedcaod bng-tBrm controM dnca1 studei advenereactora wth > 5% cumuUn rodena headache, tarcn, taagw, weafcrnstloss of energy, Wharpj, tndness or nuttse, njsck cranpi or spasm or nvnbntssof the Edronas, nenonmss, tonsnn, annety, ntaSty or apjtaoon; < 5%cumuiafeve nddoncc igMhuMncst, dnwviesi, wbgo, vBonm, depisstion,bkned won, coratpaWi rausst, wnrtnj, darhn, jut ic rrtiion, abdominalnaVi or crimps, n m t t , orthosta c tivpotsrson, prsnuatrB witnoria* contnetnns,rogutar head beat, patotifcns, fnquency of urnttoa noctira, ptfyir^ fBh, hh«,prurtes, >J^v^^^, tnpjtonu or reducid BBdo, rhHutwA, fcshng, hyperunceina,t j r t h hU h BUN Up p g yptryperpjycorta, hyponatnna, hypocUDremo, ncrese h senm BUN or craUm,ojycostra, nght to, dry raoath, tngla^ of utiaiitev CHca1 hwciArniiocaned m 3% and 7% oi pOents p wn nboamde 2 i mg aid 5 o mg, resph i long-terns study (157 fadertij potassui ^^teminiitaiwisgwntoi27%ripa)entsonlnla^mdi25ri^and50rT^respicMly Other advirse

reacbom reported itf i afttvptrtBrnnt/oTureta an nti jhepatic cnuluUk ftundce,B**drOi arthocsi phofctenttMJy. parpun. wcrotang angata, tevy, ryatorydstrtsi pncNdng pneurBonts), nprrytacDC ructora, apjvutocytesis, Imiopintj,thromoocytopenb, iptsac amenb.

OUmot Federa" 1USAJ taw prohbts dspensiBg ttthort prescTTOonKeap bghty doted. Store at roon tcmpKiltf e. Arad wiTfT*** huL[ B w o t n tgN a n a m B M u d In USPSei product c r a i i In M praaOnj rtrmltn M a d . J i n 1990

El HajariJH,OUonmanA,T»KK.EdiocantognphcniattnofWt«rlnoi» lunctm n peots i » « m n jrtiiytmoisiye n l becrtmial ratorat BnScam* PoO)r» t M J 1991 S/ftra* ?1 64-67 L Bdro S, V * » * ( W , Nn>ES. d ir Lorfrtrm nrnima rtfi ndtandi /(m/fcnj « 3 W l . PJI ?)L25<-262 S Y t t P V ^ W t e f t O t

f » W l , S 3 4 3 - 3 «4 Utye-SlbeUW. GoOm R. HeCJ, H i Smm Ipoprowi ta*dtmtment ol t w n r a m rtti [ w a r m tffpertmui 19S 7:ioJ II) 170-1745 Sci*r(»A.S*oreF, (krtoiF, a * CSnof nwstigsbononlonMirmefltcso(

dlenpDgnt!withrananypertnsfcn Qrfteffles 1964.35(1) 17-22

*#V RHQNE-POULENC RORERRORCR PHAHMACEUnCAlJ MC

Product ol Servier Research Institute© 1991 Rhone-Poutenc Roref Pharmaceuticals IncPrinted n i l S ALZ06291A 2/91 FC

Information may beobtained through:American Heart

AssociationNational CenterScientific Conference on

Cellular Mechanisms ofRenal, Cardiac andSmooth MuscleHypertrophy

7320 Greenville AvenueDallas, TX 75231(214)706-1772Fax: (214) 373-3406

AmericanHeart

Association

(doxazosin mesylate)Scored Tablets 1 mg, 2 mg, 4 mg, 8 mg

RoerigA division of Pfizer Pharmaceuticals

O1991, Pfizer Inc RDCOWA91

Call for Abstracts

45th AnnualFall Conferenceand ScientificSessions of theCouncil for HighBlood PressureResearch

September 24-27. 1991

The Palmer House

Chicago. Illinois

Sponsored by the

Council for High Blood

Pressure Research

Physicians and researchinvestigators are invited tosubmit abstracts on basicand clinical research inhypertension. Abstractsaccepted for presentationwill be published in theSeptember issue ofHypertension, a journal ofthe American HeartAssociation.

Abstract deadline:April 26, 1991

Further information may beobtained through:American Heart

Association45th Annual Fall Conference

and Scientific Sessions7320 Greenville AvenueDallas, TX 75231Phone: 214/706-1511Fax: 214/373-3406

AmericanHeart

Association

Call for Abstracts

ScientificConference onHeart Failure:Adaptive andMaladaptiveProcesses

August-1-7. 1991

Sheraton Portsmouth

Hotel and

Conference Center

Portsmouth.

New Hampshire

Sponsored by the

Councils on

Clinical Cardiology

and Basic Science

Basic and clinical scientistsare encouraged to submitabstracts for posterpresentation at thisconference.

Abstract deadline:May 17, 1991

Further information may beobtained through:American Heart

AssociationScientific Conference

on Heart Failure:Adaptive andMaladaptive Processes

7320 Greenville AvenueDallas, TX 75231Phone: 214/706-1511Fax: 214/373-3406

AmericanHeart

Association

CARDIAC OUTPUT COMPUTER+ IBM-PCFOR HUMANS AND RATS

'CARDIOMAX' plui IBM-PC Computer measures, prints on printerand stores on the disc for future recall: *Cardiac Output 'StrokeVolume 'Heart Rate 'Systolic, Diastolic, Mean Blood Pressures•Blood and Injectate Temperatures 'Graphic pictures of DilutionCurve, 'Blood Pressure and ECG waveforms 'Calculates and printsDilution Curve's Appearance, Elevation, Mean Concentration andMean Dilution Times.

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Multi-lane animal exerciser for rats andmice.Separate airtight chambers and exercisebelts for each animal.Very quiet operationAdjustable tilt, speed etc.Programmed exercise schedule withautomatic measurements of animalbehavior.

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"Oxymax" multi-channel metaboliccomputers for 1,2,4,8 andl6 animals.Can operate in conjunction withexercisers.Systems for very small and largeanimals available.Superior accuracy and ease ofoperation:

'American Heart AssociationNational Research Program

EstablishedInvestigator

1992-1993stipend support in the field of cardio-vascular disease and stroke, Includingrelated basic science and publichealth problems

To support promising scientists who haverecently acquired independent statusto ensure their continued success asinvestigators.

Application DeadlineReceipt June 1, 1991for award activation July, 1992

Information: Division of Research AdministrationAmerican Heart Association7320 Greenville AvenueDallas, Texas 75231

(214) 706-1453

Participation by minority candidates isencouraged 4002

1 American Heart AssociationNational Research Program

Grant-in-Aid

1992-1993

To support research activities broadlyrelated to cardiovascular function anddisease, stroke, or to related basicscience, clinical, and public healthproblems. Support is available for allbasic disciplines as well as for epidemi-ological and clinical investigations thatbear on cardiovascular problems.

Application DeadlineReceipt July 1, 1991for award activation July, 1992

Information: Division of Research AdministrationAmerican Heart Association7320 Greenville AvenueDallas, Texas 75231

(214) 706-1453

Participation by minority candidates isencouraged 4003

MStfB

WN SAFE

i

(diltiazemHCI)^nufedsrelease

For hypertension

Hypertension control,not complaints

Please see brief summary of prescribing information on back page.

For hypertension

LOWERSBLOOD PRESSURESAFELY

Convenient bid dosa

I6ds»«4« bTfe^*um/iary of prestribing Information o/ - . i

Hypertension control,not complaints

CARDIZEM SR(diltiazem HCI)sustained

releasecapsules

For hypertension

HYPERTENSION CONTROL,NOT COMPLAINTS

HIEFOMIUT

SastaMMus*Ca»iatnconuamuTHK

CARDCEM u cortrmnicited In (1) patent] wih nc* saws syndrome excepta tin presence of I fancboning verrtncuiir pacemaker, (2) patents witb second-cr tfurd-defree AV block etept n the presence of a funcnomni ventnatirpacemaker (31 patients with hypotension ( las than 90 mm Hg systolic).(4) patents who haw demonstrated liypersensrUvtty to the drag, and (5) pa-tients with acute myocaroiil mfarcboo and pulmonary congestion documentedbyi-ray on tdmissai

wuoots

may require adoistmerrl when starnnt or stoppmi conconutmtly adrmnsteredCARDIZEM to msintHi optimum therapeutic HxJlevers.

Brt-btockirs: CorrtrolM ind uncontrolled domestic studies suggest thatconcomrtant use ol CARDIZEM and beta-Uockers or difrl»ki a usualy wedtoktrated. but avuable data are not sufficient to predict tm effects of roncoroJ-

rtttlthWi*4)abnormal iocs

Administration of CARDtZEM (dlbamn hydmcMonde) corcomrttrrtty withpropramU m five normal volunteers resulted in rawed propnnoW levels m

l U d d l * ^ * W J W 5 0 %If combuutm therapy rs nrtuttd or withdrawn in contunchon wrtti m x m W ,an adjustment in the propranolol dose may be warranted (See WARMIGSJ

| p y pp y p g g sums node recovery Brae, e«cept in patents with sick

smus syndrome. Thrs effect may rarely result m abnormal* stow heart rates( f i ^ l ^ t h t d O d t t M( p ^ p s t s y n B l d r o O c r i e a m d c t t m M e s T MAV Ucck(nineo< 2,111 patients or 0 43%) Concomitant use of dttjuem witjibett-bbckers or digitals may resutt In additve effects on c a r d * conduc-tion. A patient wrth PmumetaTs angma developed periods of asystole (2 to5 stands! after a mjk dose of 60 mt of diuanm.

2. Caapstivf Hur t Fafere. Although d f taam has a netatiw irotropic effectin s i l t e d an mil tissue preparations, hemodynamic studies in humans withnormal ventricular firocton w e not shown a reduction in cardiac Indo norconsistat negative effects on cootnctUy (dp/dt) An acute study of orald t t n m B patents witb impairad verrtncufar Tuncbon (ejection fncbon24% ± 6%) showed improvement in unices of ventricular function withoutsjmrficiiit decrease m contractile function (dp/dt) Experience with the use ofCttDIZEM (oirtaem hydrochionde) <i combination with beta-blocken inpatents wrth impand ventricular funcbon a llmttBd Cautai should beewastd when using this animation.

I HnnttssiM. Dtaeases in blood pressure associated wit* CARDIZEM therapymay occasouQy result in symptomatic hypoteism

4. A o t t K j j r t c h * r j . Mid elevttJons of transamnases with and withoutconcomitant elevation «i afcaine phosprujtise and brkrubm have beenobserved in dm t i l studies. Such elevators were usually transient andfrequerrtly resolved even wrth continued tfrtluem treatment In rare in-stances, snprfiart elevations in eruymes such as alkabne phospbatse,LDH, SGOT.SGPT, and other phenomena consistent with acute hepatic injuryhave been noted. These reactions tended to occur eufy after therapy notationII to 8 weeks) and have been reversible upon dBcontmiaton d drug therapyDie relationship to CARDIZEM a uncertain in some cases, but probable insome. (See PRECAUTIONS.)

PSFXAfTMB

t a m L CARDIZEM (dStiuem rrvdrochlonde) is extensively raetabotaed bythe Over and erereted by the kidneys and m bfe. As wrth any drug given overprrJonged penods, laboratory parameters should be monitored at regular inter-vals. The dni | should be used wrth caution in patents with unpaired renal orhtpatK functim In subacute and chrome dog and rat studies designed toproduce taocrrr, hlfb doses of fitatrc were associated wrth hepatc damage.In spedal subacute hepatic studies, oral doses of 125 rig/kg and wgber m ratswen associated with hatdogical chanies m IS* Intr which ware reversili whenthe drug was discorrtmued. m dogs, (tees of 20 mg/lg were also tssoctattd wrthhepatic chanies; however, these change were reversible wrth continued dosing.

Dermatoktlcal events (see ADVERSE REACTIONS section) may be transientand may disappear desprte continued use of CARDIZEM. However, skin eruptionsf r o t t J J n i t ^ l t d / r f U l d I l t o

in peak drtbam plismi levels (58%) and area-under-tht-curve (53%) aftar a1-weak course of amebdme at 1,200 m| per day and dittnam 60 m| per dayRamtidine rjoduced smalie; nonsignrficaiTt increases. The effect may be me-diated by cuneudine's known inhibition of hepatic cvtochrome P-450, the euymesystem probably responsible for the first-pass metabolsm of drttiaam. Patientscurrently recemng datJuem therapy should be carefully rmdored for a change

4 * * W r t t J d ^ l t 'p j i |dlne. An tdiustment in the cBtiawi dose may be warranted

Datfafa Admnstnnon of CARDIZEM wrth digram in 24 healthy male sub-jects increased plasma digoun concentrations appronmately 20% AnotherKTvestigator found no increase in dream levels m 12 patents wrth coronaryartery rJseast. Since there havi been conflicbnt results refining the eftact ofdifuuu levels, it is recommeoded thit uijpMin levels bt rionitoied wncn mtiit-ing. adjustmt and discontinmng CARDIZEM therapy to avoid possible over- orunder-digitalization (See WWNNGS)

t m l W l u . The depression of cardiac corrrnctjlrty. condudmty. tnd auto-matKity as w d as the vascular ddatnn assocuted wrih anesthetics may bepotentiated by calcium channel Mockers. When used concomtantly, anesthebesand calcium bkxters should be titrated carefut/

C a i c k n i a i i i l i . l l n t a i m t h , lnp i f r»Mtol FertWt. A 24-month study Innts and a 21-month study m mice showed no evidence of caronotencitv Therewas also no mutagenc response m m vitro bacterial tests, tin intrinsic effect onfertjity was observed in rats.

P l U m c i . Category C Reproduchon studies have ben conducted m mce,rats, and rabbrti Admmistratjon of doses ranging from f w to ten times greater(on a m| / t | basis) than the daily recommended therapeubc dose has resulted inembryo and fetal lethality These doses, in some studies, have been reported tocause skeletal abnormalities In the pennatal/postnatal studies, there was somereduction m earty individual pup weights and survival rates. There was anincreased incidence of stStwths at doses of 20 tiroes the human dose or greater.

There are no well-controlled studies in pregnant women, therefore, useCARDIZEM m pregnant women only if the potential benefit fustrties the potentialnsk to the fetus.

l m h | Natttrs. Diltuuem is eneted m human mi l . One report suggest!that concentrations m breast mi* may approumate serum levels. If use ofCARDIZEM is deemed essential, an alternative method of infant ftedmg shouldbe nstrtuted

nmti turn PUCOD CufnouiDnraTBBXPiTiuu

Advmt

beadacbe

AV block first degree

dizsness

edema

bradycardui

ECG abnormalrty

asthenu

constiparjM

dyspepsia

nausea

patprtatons

polyima

somnolence

a Ik phos increase

hypotension

insomnia

rash

AV block second degree

Mtfcna•.-US

#ptJ(%)3S(12%)24 (7.6%)22(7%)19(6%)19(6%)13 (4 1%)10(32%)5(1.6%)4 (13%)4(1.3%)4(U%)4(1.3%)4(1J%)3(1%)3(1%)3(1%)3(1%)2 (0.6%)

Ptatta11=111

#*> (%)17IW)4(19%)6(18%)2(09%)3(14%)3 (14%)1(05%)2(0.9%)1(0 5%)2(09%)2(0 9%)2(0.9%)

1(0 5%)1 (0.5%)

1(0 5%)

1(0.5%)

-

In nWrteri, the toiownj emits were reportid infrequently (ten than 1%) ortvne been observed tn ingkn tnth. In mtny c « « , the rcUtno to dni| ti

t

Anpna, inrirthma, bunde branch block, tactyunUa, ven-tricular edrasystdts, congestive heart lulum, syncope.

• a r m s S f t t m Amnesia, depressi», gar! abnormality, hallucinations, ner-vousness, paresthesu, ptrsonaUty chanfe, tinnitus, I r a n *abnormal dream.

tmr«kUastkilt Anomu. riarrhea, dysgtosia, mM efnatjons of SCOT, SCPT,and LDH (see hepatic warnings), vomrbng. weqfrt increase,thirst

l n a i a t i l m k t l Petechiae, pruritus, photosenstlvity, urtiana.Ottw. AmUyopia, CJK increase, dyspnea, eptstnis, lye rrttiDon,

hyperglycenua, semal drrMcurbes, nasal congestion, noctuna,osteoarbcular pain, impotence, dry mouth.

Tru foaowmg postnurketmg events havt been reportad nfrequentry

and Itukopenia Definrtrve cause and effect relationship between these eventsand CARDIZEM therapy cannot vet be established

Issued VJ9

discontinued.B n | krtanctta. Due to the potential for addrtrve effects, caution and careful

trtration are wamrrted in patients recemng CARDIZEM ixncomrtanrjY with anyagtrrts known to affect cardiac contnctiHy and/or conducboa (Set WARNKGS.)Pharmacotofic studes indicate ttut there may be addrhve effects n prokngmiAV conduction whtn min i beti-blockers or digitalis concomrtantty wrthCARNZEM.(SeeWAf!Kr1GS.)

As with a l dreg], care should be enrosed when rjeatjii pauents wrthmultiple mtdKauoni CARDIZEM undergoes botrlitrtrmiUm by cytodmneP-450 mbad funcbon oddase. CoKtminlstratai ot CARDIZEM wrth other anrtswrack fouow the same route tt brtransfomation may result <i the cmpetrlivecribrtM of metabolism. Dosttes of simlarty metabolinl drugs, pardctilarryrJns> of low therapeutic ratio or n patients wrtn renal and/or hepatic impairment,

CSRAB976

AUTOS ( L O W SSenous adverse reactions have been rare m studies earned out to date, but rt

should be iccotrncod that patients wrih mpafed mi l imiv fmebon and mfiiwconducuon abrurmarrbes have usually been eduded from these studies.

The adverse everts deserted below represent events observed in ctncsl sturjesof hypertensM pabents recavmf etfher CAROCEM Tablets or CARDIZEM SRCapsules as well as openences observed m studes of angiu md during market-ng. The most common events n hypertensm studn ire shown in i table wrtnrates m placebo patients shown tor companson. Less common events are fated bybody system; these Include any adverse reactions seen m angina studies that werenot observed m hvpertensnn stude. In a l hypertensve pabents studied (over900), the most common adverse events were edema (9%), headache (!%),dramss (6%), asthena (5%). sous bradycardia (3%). ftetdnt (3%1 and 1* AVblock 13%) Only edema a«l perhaps bradrcardo and dinmess ware dost related.The most common everts observed n canical stufes (over 2,100 patients) ofaniinapabents and hypertensive patients receiving CARDIZEM Tablets orCAHDIZEM SR Capsules were 0 , gnatar than 1%) edema (5.4%), headache(4 5%). dmness 0.4%), asthena QJX), fast-degree AV D t e M l . m fbstuntII 7%). nausea (16%). braoyardia (15%), and rash (15%).

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TREATHYPERTENSIONAT ITS SOURCE \

1 WITHVASCULOACTION

NEWONCE-A-DAY

(doxazosin mesylate) {Please see brief summary of prescribing information on last page of this advertisement.

Scored Tabletsmg, 2mg,4mg,8mg

VASCULOACTIONTREATS HYPERTENSIONAT ITS SOURCE...THE PERIPHERAL _ ^VASCULATURE....INSTEAD OF THE KIDNEY....INSTEAD OF THE CNS....INSTEAD OF THE HEART.

k SITE OF ACTION-S'THE PERIPHERAL

VASCULATURE. -

Plea! information on last page of this advertisement.

ft New vasculoactive CARDURAlowers blood pressure regardlessof age or race1

]ft Typically lowers systolic blood

pressure 10 mm Hg and diastoliipressure 8 mm Hg, with minimaleffect on heart rate12

Mean change in standing bloodpressure: CARDURA vs placebo1

(n-73) (n-74)

Systolic Diastolic Systolic Diastolic

Dota available on request from Roerig.1

><0.001 vs placebo.

Results of a randomized, double-blind, plocebo<ontrolled study to assess theantihypertensive efficacy of CARDURA: 147 patients received CARDURA (meandaily dose: 13.9 mg) or placebo for 10 weeks. Mean standing baseline BP:CARDURA.153/105; placebo, 153/106.

Smooth 24-hour efficacy1

03

0 —

7 E "5

& ~ I Q CARDURA (0=82)

i.E -15 — -

| - 20 -

-25-Time (h) 0

Systolic blood pressureDiastolic blood pressure

Day 724

Data available on request from Roerig.Pooled analysis of double-blind, plocebcxonlrolled, multicenter studies of CARDURA.A total of 165 patients received CARDURA (mean daily dose range: 12.5 to 13.9 mg|or placebo for 11 to 16 weeks. Hourly measurements of blood pressure were taken at24 hours postdose and then hourly for the next 12 hours following drug administration.

on mean standin

L

CO

c

I?ii

+5"

-5-

-10"

-15"

•20

Systolic blood pressunDiastolic blood pressu

irepressure

Baseline Year 1 Year 2 Year 3(n=76) (n=77) (n-80)

| p Q ~r Adapted from Tolseth.3

Eighty patients treated with doxazosin in an extended, open-label treatment periodfollowing a 1-year double-blind study; over the 3-year study period, 76.3% (61) wereconsidered a therapeutic success on a mean doily dose of 4.8 mg. Therapeutic success:reduction in sitting diostolic blood pressure by £10 mm Hg, or to 90 mm Hg with a fallof 25 mm Hg.

NEW, ONCE-A-DAY

doxazosin mesylate) S S ' i ^Vasculoactive at the

Source of Hypertension©1990, Pfizer Inc

NEW, ONCE-A-DAY ^ _

CARMJRA©(doxazosin mesylate] ^ ^ ! %(doxazosin mesylate] 1^2^!%. 8mg

^* Convenient once-a-day dosageMost retponttve patient* arecontrolled with one daily dote of4to8mg'—recommended initial dose it

I mg, with dotage range of I 1119to 76 mg per day.

Begin all patientswith CARDURA 1 mgonce daily to mini-

mize side effects. Evaluatesupine and standing bloodpressure. PrescribeCARDURA 2 mg once daily,if necessary.

0 Evaluate for bloodpressure control.Prescribe 4 mg once

daily, if necessary.

4mg

Evaluate for bloodpressure control.Prescribe 8 mg once

daily, if necessary.Maximum recommendeddosage is 16 mg oncedaily.

8 mg

c 1 . DaBwItolB on request tram Roef* 2. GUn A C J J t t w PJ,HuviOi JS, ot tl Comparison ol otaazostn aid itenolol In mid hypertan-sion jndoflectt on * ' f f ***'' 1 ** ^y. hemodynamcs 2nd tot railjmitf function Am JCan** 19W 61950-954 I T t a t i T Lang-Cmi conpvtian ol doxarah n <t a x W m patents wtth mild or moderate esstntta hypertervslon, abstractP y i d f c ^ b » « t t l d t o > r f CfastDts$Bt Rtst f-Kton In IfypstoHsln Ptfidity CSnai£JQBI0M WffjOosKWh. London, UK, January 26,1990 4. Schean AJ, Castillo M, Sarvaore T,e m Ljck^dtMertousrlkcBrithealph^-adnmosaplDrWoddnonnldoxazosin on Insulin lecralion md Insulin sensitivity In haaftw men QjmrtfasqrjMcteotrrt 1989; 46.200-209 I Winer KD, Zkgkr MG Effects ol•tphji Inrdbrtion on reral blood flow md sympafttic nervous activity in systtmchypertension AnJCnSoim.smM!,CMDUIU* (dtnztsfa mm/tot) TaMtctIllll tlMMII) It Tllll ll>ll| htlllBlillMMCATtOM H O USMECAROUBA (drjazosin mesyWe) Is Incicated lor the Mtnent ol hypertension.CAROURA may be used atone or in rambtnaton with dkietics or beta-xtrenerglcbtattngagerrs. There Is llmtadexperience wffli CARDURA IricornMnakm «W)angkitsrsin converting eiuyiiie InNotton or calcium dumal btockars.C(SfmA«DICAT10JB

(co pnzosin, Rnzosln).WMHBStfwcoai at "FM-ttotr EIHctDam*!, Ma I t * att*t-4*Mtnli IMdjg HUB, CM• a t * arMtmiM, •MtcMhr I" »V MrifM eatrlM. »•»Md mm wtttwil uatwtuiai wet n tbitma. W d ttwuteifltcb m • « ) CMIBM wta at Int K M baft CM tin gear i t *tan b • tatf UCTMM, or It I m k honaatod •» non am aImr oyi. Ti MKrMt* tM MoMood ol OCMSM kffoaotoa Mdtnc*ot, •It ttSMtW M tnaaat M Wttattd wt» On1 at torn.TW 1,4, tod I ag tabus m Ml to tarthl t u n . OM*M snoeMraw ta^jtisM ttowty ( S M DOJAflt AOT ADWMrnWTIM t»cttt»)wta IncrNin ui doM f w f two w t t o AnflttoMl utlfeywfwjnshM• M r t t M c M M a M t d w f t t C M l l a i .rltHUU MtBf UuBltd Wftb * " " " 1 ' " ttatU M CWttOMd to ItOld

ittMtlaM w M n tafay covU nmlt tkosU lyBupt ICCST.In an etrty imnBiMDo™! ttudy of lt» s^ely and toteorce o( Inmtslng daBy

dosts ol doozosin ti nomHenilvn beginning a 1 mg/Jjy. only 2 of 6 subjectscould totaae mm Hen 2 mgytw "WmJ exptrtsnctarj symplorrallc posturalh^ntonston In mother skjdy of 24 tattiy nonnotensM msJe suo]tcts rsceivinQIn Hal doses ol 2 mr/tay ol Anaaatn, sem f29%) ol the juCfco enperkmcedsymptonvtlc postural hypotBnslon between 0.5 and 6 hours after the flrst dosenecesstednrj termination ol the study In l ib study 2 ol the normamsrw subjectsexperienced syncope Subsequent tmls In hypsrttnsrn panne always beganooxaztnjn dosing a 1 mrjtiay resulting In a 4% incidence ol postura side effects a1 iiiuyiliy with no cases of syncope

In miHple dose cinlcal triab nvoMng c w 1500 patents witn dose Unboneiwy one to No weeks, syncope was reported In 0 7% ol patients. None ol Ihoeewno occurred at the starting dos« ol 1 mg and 12% (WB4) occurred a16mrjAUr

« M C O M occai, tl» Hf lK atootd M ilaad • a n i a h n lH I M M Md t t l rttPWCAUTIOMtownt

p f W xd lowered blood pressure, such as dtotness, llghtheadedness, or nrtJgo, canoccur, especfely a InrrJaion ol therapy or a ft ttme ot dose increases. These werecommon In dfneal trtjts, occurring In up B 2 3 * ol all patents treaed and causingdiscontinuation ol therapy In about 2%

In placebo control ltd tUnHon trials orthostttlc aflects m « mlnlmiad bybeginning therapy at 1 mg per day and rJHatng ewy l w waeks to 2,4, or 8 mg perdsy Tt i i j » n in mossrt (Ttqutrey o* attio5l«x » * s In paranc jrvm 8 mgor more. 10%, compared Io5%ai-4mgand3%inrhe p m b o group.

Patents In occupatons in which orthosutc hypotnlon could be riingerousshould be meted wtti parttcular caution.

It hypotension occurs, the patient should be placed In tie supine position and. Itthis measure Is rradequaH, wtume expansion wltti Wrawnous IruBsorssopressor therapy may be used. A transient hypotsnshu response Is not aaiitiaindtalton to ajrthet doses ol CARDURA.( .bnarndamtne t ton ;CAflOuRAshouH be atnlnistBred with caution to patents wtth nidence olimpaired hepatc ajnetjon or to patients receiving (jugs known to IrAonce hipaicmetabolism (ae» CIMCAL PHAmiACaOGY) There is no control led ctnlalixpertence with CAROURA In padenB » * thesa cond Horn3. Ltanai lWNMlnaaUa:Analysis d hemaotogic daa tram patents receiving CAaoURA In corcoieddMca trtats showed lha the mean WBC 0M7*) and mean mutroprtJ counts()Wig)«md«CTa^rjYZ<%»Td1Cr\TOpWr^ lccrwrrtrawi3to.iphenomenon seen with aher alpte btaddnrj drugs. A search through a data base ol2400 pjUerts revealed 4 In which drug-reiaad neutropenla could not be ruled outTwo tod a single low «Jtu on the last day ol treatment Two had stable, non-prcorasw rairophH counts In the 1000/mm1 range onr periods ot 20 and 40w e n InciseswharaWtow-upwasivallabielheWBCsand neutropnlI countsreturned to normal a t e rJsconrJnuation ol CAROURA. No patients becamesymptomatic.as a rauttenhe low \ « C or neutropt* countsU a w f l o a i lev PaoawtePatients should be made ware ol the posslbffily ol svncopa and otloaancsymptoms, espedaiy a the Wtjakm ot therapy, and urged to avoid 4Mng orhaardous Bsn lor 24 hours i)>» the first dose, atkr a dosage mast and jBerWerruptton ot therapy when treatment is resumed They should be cautioned toavoid stations where injury could resul should syncope occur during Wttatjon oldowpsin therapy. They should also be aoVfeed ol the need to si or I le down whensymptoms of foMred blood pressure occu, ilttnjoh then symptoms ue notways orthostaic, and D be caroful when nsing from a sitting or lying position It

to the physician, so tha dose a4ustrnBnt can be considered. Patients tfnuid alsobe loMBia drowsiness or somnolence can occur wiri doxamsln, requiring cautionIn people who mist drive or operate heavy machineryDiwg W a n c t J o n :Most (96%) ol ptema doxamin Is protein bound, h »*o data In human plasmarndbae M CARDURA las no effect on protein birring ol dnadn, wartartn,phenytoin or Indomethedn There Is no Information on 9u enect ot other highlyptasma protein bound drugs on donmsln bMlng. CARDURA has beanadministered without any evidence of an advene drug interaction to patientsreceiving thtoirje dluretfa, boB blocking agena, and nonslerotdaJ tnh-fnflammarory drugs.D/UMtog/None knownCardte Tedcfl i a MwaSx:

fSpngue-Oawiey rxs afier 6 mull is ol dettry administrauon a ualarMedto provide SOmgtososinAryoay and aier 12 months ol rJetaryadrnrnlstritton a concentrations ctlculalad to provide 40 mg doK&oslnAo>VJay(150 bms the rnaxmum racommended human dose assuring a patJenl woigri ot60 kg). There is no evidence tha similar lesions occur n humans.C a T a t p t M i i l i , I W » M M r t M d h n a i n s M l tt FtrtUttrChronic rJetary trjmmistraton (up to 24 monts) ol domnsln mesytaB a

i h i r t ( h d * O A about ISO bmes themaximum recunmended human dose ol 16 mr>G0 kg) revealed no evidence ofcardnogenbty In rats. There was also no evidence of ctrcinogenlclry In a similarlyconductfld study (LI) to 18 months ot dietary aiiiliiisljaJon) In mka The mousestudy, however, was compromised by the fe*jre to use a rrmimalty Meraed doseof cbxazosln

W ^ n W t y studlesrevealed no drug- or naBrjoue-rsiaod eOects a eitherchromosomal or subefromosome! levels

Studies In rats showed reduced tartjllty In males treated with doxazrjsin a oraldoses of 20 (but not 5 or 10) mgywday, axut 75 times the maximumrecommended human dose This eflect was reversible wBun two weeks ol drugwithdrawal

T n t o p e r k B t t c a , P n f M K | Catagar B. Studies In rabbits and rats adaiy ora dosesotupto40 and 20 rryto, mpocftmy (150 and 75 tjmes themaxorun recommended dtily dose ol 16 mg, assuring a patient wignt ol 60 kg),have revealed no evidence of harm to tie Mis. The rabbt study, however, wiscompromised by ffv taltun) to use a iiiauiially irjieratsd dose of doxizDsn. Thereare no adequate and well-control led studies In pregnant women Because animalreproduction studta are not always prerjetiw ot human response, CAROURAshould be used during pregnancy airy I clearly needed.R j O M t t a r t ^ i t t l f l

labelled donzosm to pregnart raS.• v a a n a t M k EtiKts. In peri-postnaal sturias In ras, postnaal dewlopmtnlat rralemal doses of 40 or 50 mortryoay of doarosm was dsujyed as evidenced byslower body weight gain and a slightly War appearance ol anatomical Mures andreflexeslamlatlMkanD is not known whether this drug Is excreted m human mUc Because meny drugstre excretad In human r r * . caution should be exercised when CAROURA isadminlslered to a nursing motherrWMUSAty and eOacBveness In chUdran haw not been esBPrshedA O V m E R E A C T W MCAROURA has baen aomlrilsteadlOTOroximalery 4000 patents, ot whom 1679ware included in lie drnica' devotapment program. In tha program, mmor adverseariects were tequert but led to atscontinuation of Watmerl In only 7% ot patients,tn placebo-controlled studies alverso effects occurred In 49% and 40% of patientsIn the doxazosin and placebo groups, respectively, and led to dbcatnatxn In 2%ol patents m each group The rra(or raasons tor damnbnuaion were posturaleffects (2%), edema, malaise/laltgue, and some heart rale disturbance, each about07%

In contro*d dWcal trials direcdy compsrrg CAROURA to placebo there was noslgrtifcant rJOerenci In rh» InddMce of side affecB. except tor d t^rna (Includingpostural), wetgril gan, somnoience and tsttgu&^iulalie. Postural etascts and edemaappetredlo be dose related.

| p pcontrolled ^"^* involving once dally auiiiiiistiltlon ol donzosln a doses rangingfrom 1-16 mg. Table 1 summaries luse adverse experiences (possUy/probabtyrelatad) raporttd tor patents In these studies where ttt prevalence r*e in ftd l xi M S a least 05% or w4iere ft reKtion Is ot particular Interest

TAHI1 AOVBKREACT)OI«DURIr«PtJ^CEBOCafm(XliDSTlJfjeS

CAMWVAWULM

UnjAf fEXDMO

MWCUIOMEIET/U.

camuu.ipeuntaui N.I.

DizzinessMrttgoPostural HypotensionEdemaPUrtttr,ArrhymmujHypotensionTachycardiaPertpriera Ischemia

RashPruritusAtthnJgia/ArthritisMuscle WeaknessMyalgtaHodacheParesOiesa

DOXAZOSINKW39)

19%2%

03%4%2%1%1%

03%03%

1%1%1%1%1%

14%1%

PLACBO(N-336)

9%1%0%3%3%0%0%1%0%1%1%0%0%0%

16%1%

KMtc DisordersAtoaHyperion laUuscle Cramps

DOXAZOSIN(H-339)

1%1%1%1%

PLACEBO(H-336)

0%0%0%0%

AUTONOMK

IKCULmtES

PSYCMATTUC

Mouth DryRushingVision AbnormalCon|uncfMrJl/Eye PainTinnitusSomnolenceNervousnessDepressionInsormaSexual Dysfunction

2%1%2%1%1%5%2%1%1%2%

2%0%1%1%

03%1%2%1 %1%1%

MsntoanfrrouL NauseaDiarrheaConstipationOyspepsUFlatulenceAMominsI PainVomiting

3%2%1%1%1%0%0%

4%3%1%1%1%2%1%

RW1RATOTY RhinitisDyspnea

3%1%1%

1%1%0%

PotyurlaLrrirwy IncontinenceMlcartton Frequency

2%1%0%

0%0%2%

Ftt)gue/Malal»Chest PainAstheruaFace EdemaPan

12%2%1%1%2%

6%2%1%0%2%

GOHW.

Addtknl adverse reactions have been reported, but these are. In genera, notdtstJngutsnebte Irom s^nptoms tha rrwotit hew occurred In the absence olexposure to doxcosin The lollowing adverse reactions occurred with a frequency otbetween 0 i % and 1% syncope, hypoastjiaslt, increased sweaing, agnation.Increased wafcjhl The M(owing atttjoml adverse reactJons ware reported by<0 5% ol 3960 patents who received doxazosin In controlled or open, short- along-term tfm'al studies. Including knemarjontt studies. CmtomajtvSySsn:angina pectoris, nwocardlal rnrarctjon, cerebrovcscula aeddert tdtomtm:

tymphadenopeOiy, purpurt; fefroOjcftm Syam tms [mn: StvDact&natopeda, dry skin, tczama, Ctml Msrwia Sysktn. paresis, tremor, twtehing,corrkjsion, migraine. Impaired concentration, Psfitmtik: parorwia, amnesia,

earache, B » perversion, pholaphobia, abnorrral racrimaion, SasfrorastMwf

f i bronchospasm, sinusitis, coughino, pharyngitis, UrirwySystom renalcatuteGanoj/BodrS&m:hrJUn, back pain, Infection, lever/rigors,OHJWWI waluil Influenza-Ste syiiiXuns

C A f l C W U a t r t Wroutine tuochemkal lasts. No clinically raievart adverse afcets wart ruled onserum potanun, serum gkjeost, uric add, bkxd urea nitrogen, creattnlne or Irverkmction lasts. CAROURA has been associated wtth decreases in whrfe Wood callcounts (See Precautions)OVEHDOUGE

The oral LDjjOt doxazosin Is greaer than 1000 mgAg In n*e and rats The mostlikely manlletjUon ol owrdosage would be hypotension, lor which the usualtnament would be Intravenous ntuston of Hi Id. At ooxaBalii D highly proteinbound, dWysls wouM not be InJtnMOOSAaE U D A D m M T I U T T O NDOUSE M A T K IMDmoUAUZED. The initial dosage ot CAROURA Inhypertensive paianB Is 1 mg grvan once dally Depending on the Indrviduapattern's standing btood pressure response (based on measurements bkan a 2-6hours postdosa aid 24 hours posatee), dosage may than be increased to 2 mg andthereafter B necessary to 4 mg. 8 mg and 16 mg to acriew the desirad reduction «ibbod pressure, mcraases In dose beyond 4 mg Increasa ft HWinod of excessivepostura Otca Induing syncope, postunl rizzlmsVwrngo, postural hypotension.At t tJtraed dose ol 16 mg once daiy ft frequency of postural effects Is about 12%compared to 3% tor placeboH O W t U P f U E D

CARDURA (doxazosin mesytaB) is available as colored tablets for oralaomlristntton Each tablet cortnts doxcosln mesyWe equivalent to 1 mg (whrte),2 mg (vetiowU mg (oraige) or 8 mg (green) rj me actlw constituent, doxazosin

CAWXJRA* TABLETS are trtllable as 1 mg (white), 2 mg (yellow), 4 mg (oraige)and 8mg (green) scored tablets Bootes of 100 1 mg (NDC 0049-2750-66) 2mg(NOC 0049-2760-66), 4 mg (NDC 0O49-277O-66). 8 mg (NDC 0049-278f>66)Recommendad Storage: Stare below 86"F(3(rC)CAUTXItt Federa law prohMs dispensing wkicu praso^ition65-4538-00-0 Issued Nov 1990

RoerigA dlvuion of PfUrr Ph*muceutic«li

ROC006A91