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Pluse reed Bus summary carefully and thee ask your doctor about CRESTOR. No advertisement can provide all tne information needed to determine it a drug is nght tor you.
This advertisement does nef take the place ot careful discussions with your doctor Only your doctor has the training to weigh the risks end benefits of a prescription drug
SUMMARY: Present intormtfion see pactlQe insert INDICATIONS
AND USAGC CRESTOR s mooied 1 is an adjunct to d* to 'eouce eteviieo totar-C
LOl-C. Aqoo nonHOl-C. W) TG *vt* and to increase HOL-C <n pai*flß v»Rt> pnmiry hyperChO
wsteroiemu (heterozygous tammai ano nontimihaii and mute ovsupioema (Fredrickson T/oe iia
Md Hbi 2. is an admnet to d*t ta tt>e treatment of patients wdh etevateo swum TG levels
(Fftflucksoo Type IVI. 3 to 'text LOL-C. iobW. anc Apo6 in DitiMtt m homozygous Um**
hyotfdtoiestwoiWTM is an adjunct to other Ipo-lowtnng treatments \t g . LOL aoneresrsi or if
suen treatments are unavauat* CONTRAINDICATIONS CRESTOR s cornu nfltateo n
outfits win a Known nypersensitwify to any comoonem o» ties product. Rosuvtttatm «
cootumcutefl m patients win active liver disease or with unexpiatneo persistent elevations
of swum transammases .see WARNINGS Leer Enzymesi Pregnoncy and Lociatw
Ainerosderosts • a chrome process and discontinuation o! hbkHowenug orugs during pregnane,
shomo n*t wife impact on the outcome oi long-frm nwapy ot pnmr. hyperchofestefoiemia
Chdesteroi and outer procucts of choestew biosyWma art essentia; components tor tet*
development imdwJmg synthesis ot draft ana cel memounes, Since HMG-CoA reouctase
mftiMors decrease chofesteroi synthesis and possiOK- the Synthes# of other MogcaMy active
substances derived from choiesieioi they may cause fetal harm when adminstered to pregnant
women. Thwwore HMG-CoA reductase mmators are contramcianeo dunng pregnane. 1 and m
nursing mottle's RCSUVASTATIN SHOULD Bf ADMINISTERED TC WOMEN Of CHILDBEARING
AGE ONLY WHEN SUCH PATIENTS ARE HIGHLY UNLIKELY TO CONCEIVE AND HAVE BEEN
INFORMED OF Th£ POTENTIAL HAZARDS it the pahent becomes piegnam while taking this drug
therapy should be discontinued immediately and the patient aoonseo ot the potential haard to the
lew WARNINGS Livwr Enzymes HMG-CoA reouctase nhiWors '** some Other
Kpo-roy/ermg therap* nave been associated antn oocnemica abnormakbet of liver function
The mooence of persistent elevations i >3 times the uppr imw or normal ju.N) occurring on 2 or
more consecutive occasions i m serum transaminases hi hod dose studies .vas C 4 0.0 anc
0 IS m patients who received :osuvasiarm 5 10 20 and 40 mg resoective.-y in most cases the
elevations were transient and resolved or improved on continued therapy or afte* a one* interrup
tion m therapv There were two cases ot jaunOce ’or aheh a reatonship to rosuvastatm therap.
couKJ not be determined wtuch resolved after dWCOMHian ot therap. Tnere were no cases of
:tvtr taewe or rarabie t-ve o#eise m these tra# n # return meobeb that In* hmetroa tests
be pertermed before >M at 12 weeks following both At mitielion of therapy and aoy elevation
of dose and periodically It | somiamwallyi thereafter .ner enzyme changes genewY occur
m the krst 3 months of treatment wdh rosuvastatm Patents who develop ncreased transaminase
levels snouic be monitored until tne abnormalities nave -esofvec Should an increase n AIT
oi AST ot >3 tunes ULN pervst recuction ot ocse O' adhdnw V rosuvaswn s recommence:
Rosuvastatm snouic be used with cauhon m patens woo consume subsum* Quantities
of aicond anc or nave a mstory of me- disease >see CLINICAL PHARMACCLOG v
Special Populations Hepatic msudicencyi Active kver oisease o< unepa-ned persistent
transaminase ewvafcoro are contraindications to tie use ot rosu.astatm see CONTRAiNDICA
T 'CNSi MyopoiNy/Rhobdomyoiyvs Rare cases oi rtiiboomyolysis with Kate renal
tailor* secondary to nyegMnoana have been reported with rosueattata and with other drugs
• Hus class uncomplicated myaiga nas been reported m rosuvastatm treated parents see
ADVERSE REACTIONS) Creative unase CK| eevaiens >lO times upoe - Km.t ot norma)-
occurred m 0 2\ to 0.4 S ot patients rating rosuvastatm. at ooses up to 40 mg m cwtieai staOres
Treatment-related myopathy oetmed as muscle aches or muse* wtakness «conjunction vvitrr
octanes m CK values >lO times upper urn# ot normal was 'eponec m uptoO T*e ot patients
taking rosuvastatm ooses of up to 40 mg m cwucai studies in cunts flats the ncPence o' i
myopathy anc rtabdomyo<yt« keened at doses cl rosuvastatm ass* the recommended dosage
range sto 40 mgi in oostmaiketmgaftertax* effects on s«e<eia: muse* eg uncompncatec
myalgia, myopathy and rarefy rtiaboomyotyw have beer- reported m patients seated with HMG- .
CoA reouctase nmbitors mduOmg rosuvastatm As with other HMG-CoA reductase inhibito's
•eports ct rnibdomyoi-.'S# with rosuvastatm are rare but n-ghe- a: the highest marketed dose
140 mg- Factors that may predispose patents tc myopathy with HMG-CoA reductase uMtfors
-nuide advanced age -B5 years: hypathyropism and renal msufaency Consecuent.y
1 Rosuvastatm should be prescribed with aufion m patents with preo<sposirg factors tor
myopathy such as renai .impairment -see DOSAGE AND ADMINISTRATION; advanced age anc
-nadeouawv healed hypothy*oid*m 2 Patents snomc be advised to promptly report unexplained
musce pam tenderness or woakness part&tarty it accompaned by maiase v 'e.r
RosuvasUtm the'apy snouid be discontinue: 4 ma'xech elevate: CK evert occur cr myocath. is
oagnosec or suspected 3 Tne 40 mg :ose of rosuvastatm is reserved only tor those patents who
have not acntveo men LDL-C goal utiiizmg me 20 mg dose o' rosuvasatm once daily isee
DOSAGE AND AOMiNiSTRATiONi 4 Tbensi of myopathy oumg lre«ment wdh rosuvastatm may
be .ncreasec with concuirent administration pi other bpuMowermg therapies or cydOSporme st?
CLINICAL PHARMACOLOGY Drug mteract-ors PRECAI' CNS Orug mteracticns aro DOSAGE
AND The benelii of farther aheraiiors m lipid levels by the cembmed use bf
rosamtatin with tibrates or macm should be carefally weighed against the potential ns«s at
this combmahon Combination therapy with rosavastilin and gemfibrozil should generally be
mmed (See 00SAGE ANO ADMINISTRATION and PRECAUTIONS Drug interactions; 5 The
rtsfc ot myopathy baring treatment with rosuvastatm may be increased m circumstances which
increase rosivasatm drug levels (see CLINICAL PHARMACOLOGY Special Populations Race
and Renal Insalficiency and PRECAUTIONS Generali 5 Rosuvastatm therapy should also he
temporarily withheld m any salient with an acute seriavs condition suggestive ot myopathy or
predisposing to the development ot renal dilate secondary to rhabdomyoiysis <e g sepsis
hypotension, dehydration major surgery, trauma, severe medbolic. endocrine and elec
irotyte drsoeders or uncontrolled tauares) PRECAUTIONS Gwnwrol Before mwutmg
therap-. wdh rosuvastatm an anempt snouid be made to contrc; hyperchoiesieroiema with appre
rnate diet ano exercise weight 'eductw m obese patients ano treatment o? uMirtying meow,
problems (see INDICATIONS AND USAGE- Admauanbpr. c* rosuvasutm 20 mg to patents with
severe 'ena- -moairment
concentrations of wuvutaim compareo .-..in meartn, volunteers -see WARNINGS Mvopainv
RtilMomyolys# ana DOSAGE AND ADMINISTRATION 'v resui* o' a argt prarmatcxmetic
stud-, conducted m tne US oemonstrateo a-, approximate Z-'okj efevatwn m meaian exposure -
As«n sudjects lhavmg either Fwpmc Chinese jaca-ese Korean Vietnamese or AMmiodr
origin, wmpa'ec wdn a Caucas.an contrc group This ryease should be consioered when
making rosuvasut-n cos-ng dec-sions 'or Asian patients (See WARNINGS Myopathy
Rhaodomyoiysis CLINICAL PHARMACOLOGY Soecia Populafions Race ano DOSAGE AND
ADMINISTRATION Informohon for Pahwntj Patients sr-Ouid be aa-rrteo to rebOfl
promptly une<pamec mused pam tenderness or eainess parttuiarn -f accompanec b.
tur antacid tne amac-C sno-uic be ta«en at east 2 hours liter ipsuvaswm ttmnstiafton see
CLINICAL PHARMACOLOG V Drug interactions. Loborotory Tests in tne rosuvastatm
cfmicai tnai program dipsticx-posT-.f profemuna anc mic'oscopi: hemituna were obsen.-ed
among rosuvastatm-treatec patients predonwnanitjr n catiems dosed above tne 'ecommrdec
ocse tinge . e 80 mgi Ho-.ve.r tr s tmftng was more tieauent m patients tak-n; 'osuvastatm
40 mg when comoa'ed tc iov.fr coses o' -osuvasatm or ccmparato' statms ’nougn t ..as gerer
ally transient anc -.-. as not associated with worsening rera- tunct-on Aiitioug" the dmcai
stgnrtance ct this tmding .s unknown a dose 'eduction should be considered tor oatients on
'Osuvastabr 40 mg therap-. .vrth unexpa ned oers#tent protemuna curing routine urmarys#
testing Drug Inferoctions Cywcsponne: .‘.hen rosuvasatm 13 mg -.-. as '.oacm ms’eiec
.-.ith c’/dosporme m urdac t'anscant patients rosuvastatm mean tv mean kIC wee
mreased 11-Wfl and 7-toM respecti.e:. compared with health, volunteers Tr«e ncreasesar*
cors-oerec to be cmwiky significant ana reoune soeca; consKteratior m tne dosi"g ot rosuva-
Statm to patients taxing concomitant CyClOSOOrine -see WARNINGS Myopathy Rhaoflomyolysis
and DOSAGE AND ADMINISTRATION) Wertenrr Coadmmistration of rosuvastatm to patients on
staoie wartarm therapy resulted -n ckmcaßy significant uses m !NR - >4 baseline 2-3> in patients
taxing coumane anticoagulants and rosuvastatm concomitantly iNR shoum be determined betorn
starling rosuvastatm and treouentiy enougn out mg early therapy to ensure that no significant
alteration of iNR occurs Once a staoie INR time has been oocumentec iNR can be monitored at
the intervals usually recommended tor patents on common anticoagulants H the dose ot rosuva
statm is clanged the same procedure snouic be repeated Rosuvasutm therapy nas not been
associated with Weeding or with changes a INR m batems not ukmg anhcoaguanis Gemfibrozil:
Coadmmistration ot a single rosuvasiahn oost to healthy -volunteers on gemlibrozii <6OO mg twice
dairy) resulted ma 22- and 1,9-fotc respectively, increase m mean Cm»« ano mean AUC of rosuva
statm isee DOSAGE AND ADMINISTRATION) Endocrine Function Aimougn c:meal studies
have shown that •osuvasatm alone does not reduce basal ptasma cortisoi concentiabon o r impair
acrena reser-.f cauion should be exercised it am- HMG-CoA reductase mndMot or other agent
useo to lower cnotestroi «vtrt -s aommistered cancomitartty win orugs mat may decrease the
levels or activity o' endogenous steroid hormones such as bMoconazofe. spironottetone. and
cimetidme CNS Toxicity CNS vascular lesions chaiactrized by oenvasculai hemorrhages
eoema and mononuclear cell mtirafton o' oenvascuiar spaces nave been observed m cogs
treated with several otner members o' ths drug class A cnemicaif'/ similar drug m m# :ass
prooucea dbSMjeotnoem opbc nerve degeneration Wattenan degeneration ot retinogemculMe
hoe’s- m cegs at a dose mat b’oouced plasma drug e.-eis about 30 times higrtr than the mean
drug wve m numans taking the highest 'ecommenoec dose Edema hemorrhage ana oartiai
necross m the mterstitium ot me choroid oiexus was ooser-.fd m a female oog sacnlicec mori
bund at day 24 at 90 mg ngoav by ora ga-.»ge 'systemic exposures 'OO times the ruman
exoosure a; 40 mg oar base: on AUC compar-sons Cornea- opactfy was seen -it cogs treated tor
52 weeks at 6 mg kg oa> by ora- garage (systemic exposures 2C times tne human exoosure at
40 mg day based on AoC ccmparsonsi Cataracts were seen m oogs ueatec for 12 weeks by cni
gavage at 3C mg kg oay rsvstenuc exposures 60 times the numan exposuie at 40 mg cay based
on AJC comparisons- Retinal dvspiasia and -etinai loss were seen n oogs treateo for 4 weeks by
ora gavage at 90 mgkgcav -systemic exoosures 100 times the numar exposuie at
40 mg oav bisec on AuC i Doses - 30 mg kg oay i systemic exposures <6O times the human
exposure at 40 mg oav based on AUC comoansonsi 'oilowmg treatment up to one year did not
reveal retmai tinomgs Carcinogenesis, Mutagenesis, Impairment of Fertility in
a 104-week carcnigencdy study m rats at nose levels of 2 20 60 or 80 mg kg cav by
ora gavage the incidence o' uterine stromal polyps was significantly increased m females at
SOS
CRESTOR
rosuvastatin calcium
80 mg-ng oav at systemic exposure 20 times the numan exoosure at 40 mg oay oaseo on AUC
increases ocoence oi polyps was not seen at lower ooses in a 107-week carcinogenicity stud.-
m mice given '0 60 200 mg kg or.- by ora. gavage ar increased incidence o’ neptfocoNulat
aderoma carcinoma was observed ai 200 mg kg oa/ ai systemic exposures 20 times human expo
sure at 40 mg oav based on AUC An increased .ncroence ct nepatcceiiuai tumors was not seer at
lower doses Rosuvastatm was not mutagenic or ciastogemc with or without metabolic actrvjt*or
m tne Ames test wdh Sunoneiu lypfmunum ano ftcftenrte u»> the mouse lymphoma assa,
and thecMonmona aerrabon -issa. - CMnese hamster lung :ei)s RowaßaUi .-.as negatne
m tne m wvo mouse micronucleus test n 'at fertiWv stuoies wih oral gavage ooses ot 5 ‘.5
50 mg <Q ca. mares were treateo tor 9 v,*e*s prior to ano throughout mating ano females were
treat*: 2 weeks pr-or so mating ano tmougtwut mating until gestation oay 7 No adverse efect or.
fertility was observed at 50 mg xg day s.-siemic exposures ud to 10 times human exoosure at
40 mg pay tasec on AUC comparisons n testicles ot oogs treateo win rosuvastatm at
30 mg kg da-; tor one north spe-natioic gart cr# -were seen Spe-maticc gant cells we
observed n nonkeys after 6-mortn treatment at 30 mg xg day in adoitioo to vacuoation oi semi
niferous tubu-ar epithef-un Exposures in the oog we 20 times ano m the monkey 10 times
human exposure at 40 mg oay based on bod-, surface area ccmpausons. Similar '.ndmgs have
wr seen with other orugs -r this class Pregnancy Pregnancy Cittgory X See CONTRA
INDICATIONS Rosuvastatm ma, cause teal narm when aomirste , ed tc a regnant woman
Rosuvastatm s conuamdicate: m -women who a-e or may become pregnant Safety ® pregnant
-omen -as not been established T nere are no aoequete ano weu-contre-eo stuo-es o f rosuva
statm m pregnant women Rosuvastatm crosses tne placenta and i$ found m fetal tissue ano
ammofic fluid at anc 2T> respectively oi in* maternal c asma cpncentral.an following l
sng-e 25 mg kg era- gavage dose on gestation day *6 n rats A higher fetal tissue dstnouiicn
i2s*« matemai dasrna ccncenratipr.i .-.as obsei.to -n rabbits after a single oral gavage ocse of
i mg kg on gestat-or oay '8 it this drug is administered to a woman with reproductive potential,
tne patient sncuic be apprised ot me potential nazaid tc a 'etus in temaie rats given o>ai ga.agc
doses ot 5 '5 5C mg xg cay rosuvastatm oetore mating and continuing through day 7 oostcoitus
results m oec-easec fetal body weigh! female puosi and delayed ossiticafcn at tne high dose
'system.; exposures 10 times numan exoosure a: 40 mg-oa. based on AUC compar sons, in
pregnant rats given oral gavage doses of 2.20 50 mg xg day from gestation oay 7 rmougn arj
tor oay 2* - weanmgi decreased oup sur.-va occurred n groups g.-.er 50 mg kg day s.-stemx
exoosures -’2 tirres njmam ezoosure at 40 rng ca. based on body surface area comparisons in
ptigninrabMig en -? -,i i-/ coses:;.3l3mgigfd^fromoeWlioi'diy6toaettbon
da, *3 - .'.ean-ng. exposures eauwaient to numan exoosure at 40 mg day oaseo on ooov surface
area comparisons decreases 'eta ao- 1 tv anc maternal mortality vas ooser.-ec Rosuvastatm
was net teratogenic m rats at - 25 mg kg day or m raoc-ts * 3 mg kg day isystem:: exposures
eoui.alent to human exposure at 40 mg oay casec or AJC or body surface comparison respec
tive:.- Nursing Mothers 1 1$ not known wnether rosuvastatm «excreted m human mist.
Stuoies -n lactat.ng rats nave demonstrated that 'osuvastat® # secreted into breast m«k as le-.tis
: 3 times n.gner tnan that obtained ® tne plasma toiiovnng 313. gavage oosmg Because many drugs
rt exc-ete: m huma- m* anc because of tne potential for sreus ac-.trse reactions m itarshg
anams f:om rosuvastabn a oecsor snouid be Taoe wneflter tc discontinue nursng or aommis
- •ration o' rosuvastatm taking mto account the importance o' the drug 10 'he actatirg woman
Pediatric Use T"e safety anc effectiveness m oediatr:; oatients nave not oeen established.
Tmimint experience rrth rosuvastabn • a pedtatnc oboj-avc 1 limited to 8 patients vith
‘omof.-gous f H None o' these patients was below 3 -.-ears o' age Geriatric Use Of the
’0 275 pat ents n ertnteof studies with rosuvastatm 3159 '31%) vere 65 years and omer ano
698 '6B‘*i -were *5 years and omer The ovetar treouency of ao-.t»se e.tnts anc c.-pes ct
aoitrse events :.rt similar in oat.ems abtrve and below 65 years o' age -See WARNINGS
Myopatr Rhaodomyoiysis The efficacy of rosuvastatm® the
: age ..as amparabieto tre efticacy ooser.-ed n the non-eoer-y ADVERSE REACTIONS
: Ros. .astatm is generally well tderafec Aoverse 'eactiors nave usually oeen mna ano fransie:: In
! cwucai studies of f 0275 patients 3 7*. -were discontinued cue tc aoverse experiences attnbutabe
i to rosuvastatm Tne most ‘reouert ao.eise events thcugm to be 'eiate: tc rosuvastatm
■ .ere myalgia constipation asthenia abdominal cam ano nausea Clinical Adverse
Experiences Adverse expt’ences regardless 0! causality assessment reported m o'
patients hi piacebo-contioiied cbnal studies ot rosuvastatm are shown Hi Tab*' oscontmua
lions oue to events m these stuoies ot up to 12 weeks duratior occurred m 3*. of pahents
on rosuvastatm and s*. on piacebc
Table 1. Adverse Events in Placebo-Controlled Studies
Rosuvastabn Placebo
Aoverse event N-744 N=3B2
Pharyngt $ ? 7 76
Headache 55 5.0
Diarrhea 34 29
Dvsoeosia 34 31
Nausea 3.4 31
Myalgia 2.8 13
Asthen-a 2.7 2 6
Bacx pam 2.6 24
Flu syndrome 23 18
Unitary tract Miction 23 16
Rhinitis 2.2 21
Sinusitis 2.0 18
in additior me fodowmg aditrse events were reported regardless ot causal assessor: m
-I°. 01 10 275 patents treated with rosuvastatm m dmtai studies The events in itmcs occurreo
m -2% ot these patients Body as a Whole: AMommtl m KOOtnw injury, rhest ptm infec
tion pam pevic pam anc neck pam Cardiovascular System: Hypertension ang-na pectoris
vasodilatation and palpitation Digestive System Constiut>or gtstroentem vomiting flatu
lence penodomai aoscess. ano gastm-s Endocrine Diabetes meiirtus Hemic and Lymphatic
System Anemia and ecchymosis Metabolic and Nutritional Disorders Penpmn eotir.3
Musculoskeletal System Arthritis jntn,vgi3 ano pathological fracture Nervous System
toness. msomnn hvpertm paresthesi3 depression anxrtb-. vertigo ano neuralgia
Respiratory System: Bronchitis, ccvijn measeo dyspnea pneumonia ano asthma Skin and
Appendages Rash ar.o pruritus Laboratory Abnormalities m the rosuvastatm enmear Inal
program. drpstiCk-positr.e proteinur-a ano rmcroscopic hematuna were obser-.td among rosuva
stat-n-treatec patients predominantly m patients dosed above the 'ecommenoed dose rang? 1 e.
80 mg; However tn# tmdmg was more frequent Hi patients taking rosuvastatm 40 mg -when
compared to lower ooses of rosuvastatm or compaiatr.: statins thougn it was generally uansient
and was not associated with worsening renai function !see PRECAUTIONS Laboratory Tests -
Other abnormal laboratory values reported were elated creabrnne pnospnok.nase transam.-
Tases hyperglycemia, gmtamyi transpepbdase amaure phosphatase oiinuom ano tivyroro
function abnormakbes Otner adverse events teooneo ess frequently than 1". m tne rosuvastabn
cimitai study program reqaifliess o' causality assessment mciudeo arrhythmia hepatitis n,-pe'
sensitivity reactions (i.e face edema, thrombocytopenia leukopenia vesiculoounous rash
urticaria anoangioeoemai mane, failure syncope myasthena myositis, pancreatitis pnotosen-
Siwity reaction mvopatnv ano •hanoomvovsc Postmorketing Experience in addition
to 'he everts report*: above as -with otner drugs ® ths cass the following eitnt nas bee"
reported during post-marketing exoe:*nce wih CRESTCR regardless 0? causality assessment
very rare cases of auno.ee OVERDOSAGE ’here -s no specific tieatment in the event of
overdose in the event oi overdose tne patient snouio be treated symptomatically ano sucportive
measures instituted as ’formed Hemodialysis does not siqiuttamiy enhance c eaiance of rosu-.-a
statm DOSAGE AND ADMINISTRATION't patient snouic be o-actc on a stanoaro
cnofste’Oi-ic.-rmg diet before receiving CRESTOR anc shomo continue bn this diet during treat-
ment CRESTOR car oe administered as a single dose ai am- time o< so wih or -without tocc
Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and
Mixed Dyslipidemia (Fredrickson Type lla ond lib) T,i eOOSe range for CRESTOR
#5t040 mg once oai. Therap. with CRESTOR should be mdrvidualued according to goat ot
therapy and resoonse T h* usual recommenced starting cose o' CRESTOR rt 10 mg once da- ,
However, -iw-ation of therap-/ with 5 mg once can/ should be considered for patients requiring less
aggress ve LDL-C 'eductions who have predissos.ng factors tor mvopatnv ano as notes below for
soeca: populations suen as patients tax-ng cyclosporine Asian patients ano patients with se-.-ere
renai insufficiency isee CLINICAL PHARMACOLOGY. Race, an: Renai insufficiency and Drug
interactions ?or patients‘with marked hypercholesterolemia LDL-C >l9O mg aL and aggressive
np-o targets a 20-mg starting dose may oe considered Atte- initiation and O' upon titration of
CRESTOR itpid levels should be analyzed wimm 2 to i weeks ano dosage as;us!eo accordingly
The 40-mg dose ol CRESTOR is reserved only for those paiients who have not achieved their
LOL-C goal utilizing the 20 mg dose ol CRESTOR once duly (set WARNINGS Myopathy/
Rhabdomyoiysis 1. When initiating statm therapy or switching from another statin therapy, the
appropriate CRESTOR starting dose should first be utilized and only then titrated according to
the paiients individualized goal Ol therapy Homozygous Familial Hypercho
lesterolemia Tne 'econmenoejjpiQi doit 4 CRESTOR «2D mg or.ee oa v m oatients
.-nth homozygous FH T- > mush itwimiiihded daffy dose it 40 me CRESTOR should be useo
in these p2i-eis as an adiuncstooiba uom-kwnmg treatments pe g LDL apheres.s- or if such
treatments are unavailable - soots*Tc therapy should be RMMfeit from pre-apneresis LDL-C
-e.es Dosage in Asian Of CKSW lierau
snouc be cois-cered sci As an :neml formats systemic exposures relative to
CauMsans s relevant wner cons oToose in cases where n-.-percfoieste'diema
.-s not adecuate); controlled at doses ct 5 '0 or 20 mg once caiiy tSee WARNINGS
Myopathy. Rhaooomyoiyss. CLINICAL PHARMACOLOG v Soeca; Popuiaiiohs Race and
°RECAbT!ONS General) Dosage in Paiients Taking Cyclosporine m patients tak.ng
r.-cosponr.e therapy should be limited to CRESTOR 5 mg bnce daily isee WARNINGS
Myopathy RhabOpmyCHvSrt and PRECAUTIONS Drug Interactions: Concomitant Lipid-
Lowering Therapy ’te ehec! of CRESTCR on LDL-C anc totai-C may be ennanceo when
used m combination with a bi« acd bmdmg resm If CRESTOR rt used m ccmomation -win
gemlioroz 1 she dose of CRESTOR should De i-mited to 10 mg once daily isee WARNINGS.
Myopafhy Rmaooomyo'vsis and PRECAUTIONS Oiug interactions, Dosage in Patients
With Renal Insufficiency No modification o' dosage -S necessar; fo' pal ents with mud to
mocerate renai insufficiency for patents with se-.tre renai impairment (CL { . <3O mLmm
1 73 m i not on nemodufysrt. dosing 3' DRES’OR snpj.c be started at smg once for/ am not to
exceec 10 mo once daiiy -see PRECAUTIONS General and Clinical PHARMACOLOGY Special
s Renal insutiic-enc.i
NOTE This summary provides important information about CRESTOR. For more information
oiease ask your doctor or health care professional about the full Prescribing Information and
discuss it with them
Rx on>y
CRESTOR :s a traoemaik o' the AstraZeneca group ot companies
2 AstraZe-eca 2005
Licensed from SHIONOGIBCC . LTD Osaxa Japa
fAanufachired for AstraZeneca Pnarmaceuhcais l?
Wumington DE 1985 C
B;. IPR Pharmaceuticals ic
Carolina PR 03954
PCC 630302 30043-01 31028-00 Re.’oß 05 242155
/]
w M
A bronze bust of James Dean is part of a
display of his movie-career memorabilia.
(Continued from page 13)
Fairmount's quiet, laid-back atmosphere
and friendly people that he began visiting
each year beginning in 1983. In 1996, he
moved to Fairmount after retiring as an
optometrist in York, Pa. Today, Zeigler
lives in the house once occupied by Dean's
father next to the family farm north of
town in Jonesboro (pop. 1,887). He earned
that privilege by striking up a friendship
with Dean’s first cousin, Marcus Winslow
Jr., who grew up with the film star-to-be.
"I told him when I retired I wanted to
move out here, and lie said, 'Well, we’ll see if
we can't find a place for you,”’ Zeigler recalls.
Now he helps Winslow and members of the
museum staff organize the town’s annual
events in memory of its most famous citizen.
”1 think it will go on forever," Root
says. As long as there are movies and
people who love them, she says, ’’they'll
come. And we’ll be glad to see ’em.”
Alarum Nash, a contributor to American
Profile, lives in Louisville. Ky.
Visit www.jamesdeanartifacts.com
for more information.
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Alex Beachy, 12, from Nappanee, Ind., soaks
up the sights in the James Dean museum.
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