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The Measured Response ofOnce-a-Day

ProcardiaXL(nifedipine) Extended Release

Tablets 30 mg, 60 mg and 90 mg GITS

HANDLES THEIR PRESSURE,WHATEVERTHE LEVELWhatever Their Baseline Elevations,Start Your Hypertensive Patients onConvenient, Once-a-Day PROCARDIA XL

Start patients on a single 30-mg or 60-mgPROCARDIAXL Extended Release Tablet, swallowedwhole, once a day, and titrate as clinically warranted

t- In hypertension, doses above 120 mg are notrecommended

I Side effects include peripheral edema, which is notassociated with fluid retention, and headache

PROCARDIA XL Also Provides 24-HourControl of Angina2

In angina, doses above 90 mg should be used withcaution and only when clinically warranted

References 1. Data on file. Pfizer Inc, New Yoffc, NY. 2. Bittar N. Usefulnessof nifedipine for myocardlal ischemia and the nifedipine gastrointestinaltherapeutic system. AmICardiol. 1989;64:31F-J4F.

alone, •fth low dotes of ttntar^rf. In other surgical proceclurw, or wfth other narcotic anaignica cannot bt rtaadtrw-trwfwt prttnti whnn rirgfry in^g Wph fow V ^ ^ V Wfttwtta fr *f*%'"r*ffari, ft™ phyf t rb" •h n"w *»potential problems md tf tht patients condbon ptrmtts, s u f l k M t ^ (at least 38 rtoun) stouU bt ato*od tor

to be of less otrwft to thostr j

P1trXARnAXL«(ataQBba)E _ __COWnuiracmOWTKnown hypenensfttvfty reaction to nttocipine,WAfWMGS: EDteshn Hyaotetsua: Atthough In most angina patiana the hypotoraJve tflect of rtfedfc*w it modest and weltoieratsd, occasional pitionti have had txcasaVa and poorty tolerated hypotension. Then responses have usuaty OCOTTWJdaring Intitt tttration or at the ttme of subsequent upward dosage adjustment, and may bt mom Bksty In patients on concomttant

Severe hypotension andrtn increesad (Md volume rtoutwients have bean reported In patients receiving nttecflpint togetherwtth a bota-Uocting agent who underwent coronary artery bypass sorpary tahg hicjh doao tantany) aresthesi The InteractionvrtthWghdosefrtawappearetotoduttotwcomblnatOT

out LnnJI raware of those potential problems anrttdlpint B be washed out of tht body prior to surgery

The foaowing WonnetJon should bt taken Into account tn thost petiertt who are being treated for hypertension as wel asangina:lamina" Aarjlaa anaVrw BtwuanBalhrftiTitfrT Ranly. patients, particularly thost who havt w a n obttructht coronary arterydtsees*. havt developed wel documented Incnesod frequency, duration and/or sovertty of angina or acula myocaroU Infarctiononstajfcu nt'soTptnt or at tht time ol docagt Increase The roocimikju rt tfiit effect is not otta WishedBeta Btscttr W t i M x m t rt ts Important to taper beta btoefctrs tf possible, rather than stopping them abruptly before beginningntfadlpint Pauenta rocaiidy wtthdiawn from btti btocktrt m y dovetop a withdrawal syndrome wtth Ljujoued hh^iL probablyrelated to tncrecstd sonsHMJy to catechotamines- Initiation of ntfaOpJne trettment wH not pravant this occurrence and on occa-sion has been reported to hicruse ILCoagcsttva Heart F a j a n Ranly, patients usoafly rtceMng a beta Mocker, heva dtwlopod hurt taSure aftar beginning ntftoi-ptna. Patients wtth tigri aortic stenosis may btaf greater risk forsoch an tvert as tht u n k a ^ efleti of nitaiPpirtf would bt

" vtM^^^^\rt^Mn»yii^Knmtmw^yit^cause r#tfttr4"f decrease! peripheral yatciftr resistance, careful monitoring of

blood preside daring tw intttal adut'iituition and tUjitiui of iUuOykM m sugutited Close observation is wpsctrty recom-ny^f f 1 fr* rtttflffl anfanV tating roffflrittpftt Thai an fry*1fo t r y ^**M1 prrnTrTt (SeaWARMWGS.)PerleJwal canoe: M H to moderate perlphnJ tdema occun in a dost deptndent manner with an incidence ranging fromtpcrodrnatarY 10% to about 30% at tht highest dost stapled (180 mg) It It a bcafeed phenomenon fought to ba asaoctatBdwith vasodjbtion of dependent artBrioles aod smal IAH.HI vesaets and not due to left vtnfiictaar uysiuuetion or oantraced fluidretention. With patients whose angina or hypertraion it compAcatad by conpsstivt heart taiort, care should ba taken to dUJar-f^tjt f this ptrtplieral edema from tht tracts of Increasing Ion 'i^tfiVirtaJ nyiiL^^irjn.OOxr. As wiOi any otto non-dolormabto metenaL caution should bt used when adiniiista^ij PHOCARMA XL h patients wtthpnwristingttvere gastrointestinal narrowing (patholor>c or latrogonic) Then rave b e m n r t n p o ^pttionts witB known strictures In moriition wBi tht Ingastlon of PWOCAROIA XLI tftpfitWT Ttt tr Ran, nsuaty tramtent, bat occattonasV sioniacant ettvattons of jnzyrnos such as ataane pr *TT*Hn* . r s H

LDH, SGOT, and SGPT I m bean notad. Tht relationship to flirttlphie therapy b) uncertain hi moat cases, bot probaMt in stxnt.ThetoLt^bon^atowyriJtiesravtraTilybtenasMc^has boon reported- A smtfl (5 4%) incroue In mom alulne pbosphetast was noted in patients treated wtth PROCARDIA XL. Thiswas an ^f^tfd fining not asaocutad wtfli ctkaca) tymptomsand tt nnty "tttatarl In vataes which tel ootsidt ttienormel rings.Ran instances ofzlcrgic hepiUUt have been reported. Lncontrofled stiots, PROCARDiA XLdU not adwtety aflsct servn artadd, otacosa, or choaisteroL Stram potatdm was tvichengod In pstiarcs rectMng PROCARDIA XL In the sbsanct of concool'tant cflujstic therapy, and sightly decrpaaed ai patianta rooMng concomitant oTonfflcs. t

Mftdtpine, ate otiw calcnm chanoei HfrT^fn. decnasos plstolet aggreulon In t4tro. UmttBd dnteaJ studies hnv deraoo-strattd a modcrati but i l i lhtlri ly tigntQcant decrease in ptfarist aggregation and increase in bajedbig time In somt nteflpinepatients. This ts thooobtto baa btvoon of inhibition of catciom tnosport across the p*il^*tt mambraoe- NocflricaJ sigreScmce(or thesa flnfliys hai oeen demoostiated

Positfrt drtct Coombt tact wtthMthoat hemofytic anemb has bean rtporttd bat a causa) lehtionahip betwaan neafipine, I I I Tf , 1,1 I . f »^J^ . J ^»»* f • M L • I I I l lh • ! • ' * - L ^ • - I .

aDmnssBion and potsmty OJ mtt laooiany. test, raurjng ncmcfysn, CODU not ot OBrarmanLAlhooph nifedipine tm been used saJehr in patients wtth renal dysfunction and has been reported totxsrt a berwflcU effect In

certain cases, ran revertO* eitvations in BUN tod strum cnatiraw have bean reported in pati^wthpre-«dstingchrortcror^etntos ^ a

ffimgjIcbfatlngilfcal trtaJ has sho

fy pgigmB: (8w W A H O T ^ £>wr>wa In M 14gl pekna » B i P r o a i a r gp -

p J has shown that tutuiia'^iiiadn^iislialkinofnttadtointand bt&^socldng agents Is osoar*(y wel Mtratad but thera havt been occaiional iatratm reports soggedng tfut tht contoindion t n ^ irexona tht KaBuod ofcongestiw heart tasurt, sawrB hypotension, or cxacortuiion of uiulua.

Long Acting Httratar HOtdpInt may bt saftfr co-adnanisiartd wtih ntoaOa, bet thers havt bean no controlled andtes to r>#-a ^ t i ^ f l t h { O h ^ ^

p o s t a t o o e d p v o ^ J ^ c s j i vMla D rene of twarvs nonnari voainteers. Tht avecagetocraast was 45%, Anoflwf tmtiigitof toend no incriasa ho dlgoni lenit in thirteen patitrcswitb coronary arttrydsoass. In andncontfofltd stddy d o w two bondnd UAUBIIII wtth congetfive heart tafcn daring wMcb dtaoidn btoodteMts were not mea-sured, iHyiiiti tuiiUly W D not observed Snct thort have boon tiijttfcl reports of IMHUMS wfla olevattd dLgcoJn tewJa, it is rsc-onmsendtd thd d^o^jn Isirts ot OMMIUMBU when EnBDng* aopsong, and j ^y i^^" |"Tj inttilrttJut to void poaslblt O^QT' or

Coumarln Anticoaguiants, Thars have been fart reports of jrcrtents to whom niftrfpirw a ainii'^ifiurt Hoever tho rctaHon

CknetUku: A t d tniftrfpirw wat ainii^irfiurt However, tho rctaHonstwp to ntferjpirie thsnpy is uncertain.A study tn six healthy volunteers has shown a ttantlcant tncretst In peak ri-todiptat plasnw

(74%),aneraorwweefccourMofc*n*btt^ Ranokflnep, non-signrncant Incrsascs. Tht effect may bt mtdbttd by tha known Inhibttfon of dmtodtnt on hepa450 th t b^^[*kfolkntilMlti)\k H tfdlint therap

. . . . . . . . . ,_ otniontti femt In patents taking coumarin anticoagn-HowBvor, the lelalkHttnp to laterjpine therapy is uncertain.

' " ' peak naUUnt ptasrna levels (80%) and are*-- • ^ ^ - • ~ ^Tnopio-

ducad smaller, noo-signrncant Incrsasas. Tht effect may bt medattd by 'tht known' Wilbrtton of dmefldtnt on hepaticcytochrome P-450, the anzymt system probably rtspondWe for tht first-paai matttMatni ot nbedlputt. If ntfadlpint therapy BJI [>i • j r^ -t ^ ^ ^ ^ i ^ i i #i—-^^LaL^* ^ ^ i iJu l ia ifi i • il ^ *

r • *

M^jTffli QI a |m*ffn currarK p rtctmng omoaow, rai 11 H n i a onvoon 9 ac*nsoo.Cartiaeejesesai, Hataoaaests, lui^aliwesl tf FaiuUI). NUsdUji was admlrdstend orasyto rats, tor two yean and was notshown to ba caidnogeric. Whtncj^toratiprloftonrMtinanbtOaplritcaittodramo madrruiri recomrnended human docs, ki rfwrrtutagerncity ttudiei were negattoPneaaacr Pregnancy CatagoryC MJedpine has been snownbbaantogenic in rats when o>van in d o a « X tines the rraDomumrecommended human dote. NbeoTptrit was tmbryotoidc ( renand fatal resorptions, decrenad tetH wqlgW, incnesed stuntedforms, tncreesed fs£d deaths, decreased neonatal survtvzf) n ratt, mice, and rabbits at dotes of from 3 to 10 times tie radmomrecommended lumendoae. tn pregnant monfcays, doses Z/3 and twlcttieuujilJiUTi rec&iimiJMltiJ htuiiaji does residted inwitiflptacantas and underdeveloped chononic v C In rats, dotes throe times maximum human dott and higher caused protangation ofpraonency Than an rw adequate and wet corwof l tdat i^ In p n g ^ w o m e r L p ^ ^tiijlgu should be uaad during pregnancy orty If the potential boneffl pstiQes tht potentiaJ risk to tu idnt,ADVBaEEXFHnBsCa: O w IQOOpatisrtb) from both controfled and opentrtahwBiPROCARDWXLExtarirJtdna'iaiHTaUotstn hyptrtentlon and angina wen Induded In tht evaluation of a *«rw experiences. MstotftoctBreportsddonngrcExtsriW R«ltaK Tablet t r«rapy wan tabdttsd Indeporaltinreportad wtth PROCARDIA XL was edema wnch was dote related and ranged tifrequori^fromapprorfmat8*y10%toabout30%atthara>vstdoststtxled(180mg) Other common advenjtaxperitnett reported In plactiKHMrtroitd trim Include: headache(15J%, compared to 9.8% ptacebo exidtneo), tatigue (5 9%, con«nKlto4 1%placobofaiddonce),olzzirBw(4 IVcomparedto 42% ptacebo incidence), mnsiiuaiMJii (33%, compared to 13% ptacabo axldenct), and ranee (33%, compared to 1.0%placate Irciderce) Ofthest.orty edtrra aril raedacra wan fTwnconwrion In FTCICAR^ XL pattern

Tha foflowlngaovtnt reactions occurred wtih m iricktonct of last than 3 0%. WUh the exarton of leg crampt, thelnddonctol thest side eflects was simaar to that of ptacebo ekxifc tjotyagwhotofsytttrric tsthorit, ftidhing, paan canflpwenafrf ptl-pttttJons; centra/ntmussyttwn trtifrmnU. naPiTHfantTt. frSfTttfwnia. innnrrtttnnr ffarmair'frTprV" pfTrTthw. m h . QPtt'v^^wf-n*l abdominal pain,tfarrhet,dry[rnootfudyspepsia, flattened mfartemlr^^ chestpain(noneptciDc), dyspnea: ofo^tnUm impotence, pOMjrta.

Other adverse reactions were reported aporaoicaBy wtth m incidenct of 1 ^ % or less, Thettindurt: txxfytst <Hhot6^yttomictact tdema, revet, hot Bathes, malaise, periorbttal tdema, rigors; ctrdkntscultf arrhythmit, hypotensioQ, increased angina,taarad ia , syncope; caa&af ntnoa sytttm. arodtty. ataxla, decreased feidc% depress^ hypertort^paroitti~tnmorvwtloa darm«tt*tfr star ' ' ' " J ' ' " - '

g x . p ^ p p p y a ^ ^m l ^slon, &stt perwaton, Uuiiuts, orppsn'&B^qprDdbctfnr brtast pain, dysorta, hamaturia, noctLrrta.

Advtrsa esqiortenccs wtrich occurrod in I m than 1 in 1000 patients camol bt distinguished from concurrent d

TM (otowtng idwrM . mpoDDd h l o t Oan ^% of piUenti, mmiaJ unba mnJBtaaltoHXtnix^okmia}*taamvtt<irtetmtbkm*

p e US and foreign controasd studlei wtth itifoJlptwapuM%nooaay, advent «ftadi want tncpent bot generaly not sanooe and rarsly notnan. Uost ware c^ectfld contoquencts of tht w*mJtjLui aflecai ot

l d f c « * l l n m t \ " ^

nporttd^KKltt-dbcondnuatlon of therapy or i

raponad In ptacebo-con-y

i vntHMilm attack ofPnxanlt- Adverst axperitnees raponad In ptaceband giddirieeB (2/%, conpend to 15% nlartriT ^y^rtf^y tY ^ " ^ ^ r j . h**^

Oon f2S%, compared to 0% ptacebo ircidenct), Ittayadie (23%, cuntiand to 20% ptitttM) kndbenct), wtaknesa (12%, com-pared to 10% poctbo bicldtnct); neittse, heartbom (11%, corDpand to 8% ptarehn incidenca): muscit crarape, tremor (8%,compered to 3% ptacebo incideoctb ptrlphenJ tdema(7%, cooi^tJ to 1 % placebo Incidence^ nervouanest, mood changes(7%, compared to 4% nla*tfTft iodDenct^ palpitition (7%, compared to 5% pbcebo inddenca), dyspnea, cougtv and wbesong(6%, compered to 3% ptacebo inddtoce^ and nasal congestion, son B r a t (6%, compand to 8% psacabo tadoenct).

TranisaJsoalvnurcontroladC(parWalnover21Wpa^^ Most of the patients had vatnanestk- orntistartangimpecloris. arid aboot rial had ccficomUan Tha ntatMy commonadvent events wen • r a t e in ntton to thoee teen wtti PflOCAflDtA XL

In addition, more sartocs advert* rants were observed, not rude/ daringutttatai from the MtHral hattory of tht (flatasajbmast patients, tt remains postlblt, howsvet that tome or n e w of tbeet events wen drog ntatad. UyocardU Infarctionocoiiidinab«fl4%ofpatiartaandconpealhiehemMOTorD^^ VwrntoUr antiynrmat or con-duction Disturbances caon occurred ai tiwcr ttun 0-5% of patients.

In a subgroDp of over 1000 patiana rtceMng Procanfia wtth concomttant beta Uockar therapy, frit pattern and taddenct ofadvent experiences was not dmtrtnt from that of the entire gniup of Pnxarth tnMBKl ptflarti ( S M PRtCALTnOKS.)

In a fbgroap of approitaataiy 250 patients with a dagnotis of congestivt heart taaun as wel as angina, <fln*o**» 0/ *PM-beadadnata, perkOhecal tdema, HeaoacDt or fluahirig eecti occurrad in one In tigrt pstitrts. Ht QOteneion occorrtd m SOOIB one m20paatnts Syncope occurred in appnuluutofc one peaant la 250 Uyocardts irt^ccaon or syiii jtiJinsof u i u t t t i w h t **-*-

0/12 In hypertension,

HANDLE THEIR PRESSURE,WHATEVER THE LEVEL

v

The Measured Response ofOnce-a-Day

ProcardiaXL(nifedipine) Extended Release

TMets30mg,60mgand90mgGITS

BLOOD PRESSURE (BP)REDUCTIONS THATCORRELATE WITHBASELINE ELEVATIONSPlease see brief summon of prescribing information on adjacent page

SITTING SYSTOLIC BP

© 1992, Pfizer Inc

Mutticenter. open label stix3y of rne efficacy and safely of PROGARDiA XL mouded ; • 56 patents «ttr> nrna re "Tasrtttr*g iiasroitf BP Detween 9S a>xJ • ' 0 T T . -tg After a / A* tuaretx. p ^ o T PRCX' A f-JtA <. A.;,

nj od arxl titrated to a rnaxtrnun-' oose o( *S0 mg era ove' ' r. A * \C acr«ve gca1 BF •S'ttif-g itavGar»d a >1O mm Hg reOuctKyi from Daseime). 1136 pat»enis w e evaiuatea at me* fw*a= ^i&! fa*1 ^• 30-mg qd ad|us!ment ot PROCARDlA XL was permitted during the 1? ^k efticacy pnase An. •'••? made ?^ r> af'e' r^e sasr * . j g l o w *^ear -Jose a? fin a' visit 8 9 ^ " mg qd iData or *<ie