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Pie3se reafl thts lucnTnaryicaretuiiy a'o~d'4h!en.ask your tiodnr about No trte.. ’
information netdefl foprestribea drug. This advertisement floes.Mtfike'ttie place of careful discussions wVtn your doctor
' . ...Only your doctor has the !raimn(jlp tlie. r'isi<V3n(J befldits trt a prescnpfion cruif.ior yi>ii ..
NEXIIIM *(esomeprazole magnesium)
20-mg, 40-mg Delayed-Release Capsules
BMP SUMMARY of Presenting informabon INDICATIONS AND USAGE Treatment of GERD NEXIUM b indicated tor the short-term treatment (4 to 8 weeks)
m die heabng and symptomatic resolution of dragnosdcatty confirmed erosive esophagus: die maintenance of symptom resolution and healing of erosive
esophagitis icontroßed studies do not extend beyond 6 months) the treatment of heartburn and other symptoms associated wdh GERO. to* Redaction et Hs#D-
Arociam Gastric Ulcer: H.pfkri EradicaUait to Reduce fee Rife of Duodenal Ulcer Receneace. CONTRAINDICATIONS NEXJUM is contram&cateC in
patterns with known rrypersenstovny to any component of the formulation or to substituted benzirradazoles PRECAUTIONS General Symptomatic response to
therapy with NEXIUM does not preclude the presence of gastric makgnancy Atrophic gastritis has been noted occasionally in gastric corpus Dtocsies from patients
treated long-term with omeprazole of v/h»ch NEXIUM is an enantiomer Informotion for Pohenn NEXIUM Detayed-Rttease Capsules should be swallowed v.-ho*e
and taken at least one hour before meals For patients who h»e difficulty swadowng capsules, one taoiespoon of applesauce can he added to an empty bowl and
the NEXIUM Deiayed-Reiease Capsule can be opened, and the pellets carefully emptied onto the applesauce The octets should be muted v/ift the applesauce and
then swatonedimmedatety. The applesauce used should not be hot and should be soft enough to be svaHtwed without chewng The peitets should not be chewd
or crushed. The pebet/applesauce mixture should not be stored for future use. Antaads may be used whde taking NEXIUM Drug Inieraciiora Esomeprazote is
extensive* metabolized m the Iwer by CYP2CI9 and CYP3M to m and « wvostude nave shown that esomeprazole is not bkely to rtuM CYPs 1A2.2A6.2C9
206.2E1 am) 3M. No ctmcalyretevam interactions vnfe drugs metabofczed by these CYP enzymes would be expected Orug interaction stuttes have shown mat
esomeprazote does not have any clinically significant interactions with phenytoin vartawi qumtdme. danthromycm or amoxioin Post-marketing reports of
cnanges m prothrombin measures have been received among patients on concomitant warfcmn and esomeprazole therapy, increases it INR and prothrombin time
may lead to abnormal bleeding and even death Patients treated with proton pump inhibitors and vrarlann concomitant* may need to be monitored tor increases m
iNR and prothrombin time. Esomeprazole may potent** interfere yh»CYP2CI9 the mapr esomeprazote metabohzmg enzyme CoadnwKtr&on of esomeprazote
30 mg and diazepam a CYP2CI9 substrate resulted m a 45S> decrease n clearance of diazepam Increased plasma levels of dazepam were observed 12 hours alter
oosmg and onwards However, a that time, the plasma levels of dazepam were below the therapeutic interval aw thus tm interaction is untta* to be ot cfmcai
relevance. Coadmmistratwn of oral contraceptives, dazepam. phenytoin or qumtome dW not seem to change the pharmacokinetic prohd of esomeprazole
Concomitant administration ot esomeprazole may reduce the plasma tertls of atazanaw Studcs evaluating concomitant admwstratioo of esomeprazole and effhnr
naproxen inon-seiectwe NSAIO) ot mtecox* (COX-2 selective NSWO) did not identify any ckmcaßy relevant changes in the pharmacotonebc orohles of
esomeprazole or these NSAIOs Esomeprazole nhitws oastnc acid secrehor Therefore esomeprazole may interfere with the absorption otorugsvvheregastnc pH
is an important determinant ot btoavadabdity (eg. kotoconazoic iron sate and digoxwi Corcmogmem, Mutogmeus, Impomwnt of FerhMy The carono
gemc potential ot esomeprazole was assessed usrng omeprazole studies in two 24-month oral carcinogen city studes m rats, omeprazole at dady doses ot 1 7 34.
13.8.44 omo 140.8 mgfleg/day (about 0.7 to 57 times the human dose of 20 mgrday expressed on a body surface area toast produced gastric Ed cel caranoWs
m a dose-related manner m both male and female rats: the mewence ot this effect was markedly togher m female rats, whch had mgiwr blood levels of omeprazole
Gastnc caionoWs sewom occur infee untreated rat In addition ECL cel hyperpfasa was present max treated groups of both sexes, in one ot these stuoes temate
rats were treated wife 13.8 mg omeprazole/ kyday (about 5.6 tones the human dose on a body surface area baas) fort year, then followed tor an atttbonal year
without the drug No carcinoids were seen m these rats An increased mcWence ot treatment-related ECL ceil hvpemasa vras observed at the end of 1 year (94%
treated vs 10% controls). By the second year the difference between treated and control rats was much smaller <46% vs 26%) but stfl showed mote hyperplasia in
the treated group Gastric adenocarcinoma was seen in one rat(2%j No sunttrtumorvras seen m male or female rats treated for 2 years For this straw of rat no
sumiar tumor has been noted tostorcaby. but a fmdwg involving only one tumor s difficult to interpret. A 78-week mouse cardnogeracdy study ot omeprazole dW
not show increased tumor occurrence, but the study was not conclusive Esomeprazole was negative m the Ames muanon test, in the mvwor* bone marrow cell
enromosome aberration test, and the m wo mouse nucronudeus test Esomeprazole. however, vras positive m the ip tv human lymphocyte chromosome
aberration test Omeprazole was positive m the« vnro human lymphocyte chromosome aberration test the in m mouse marrow cell chromosome aberration
test and the m wvo mouse nucronuaeus test The potential effects ot esomeprazole on fertility and reproductive performance were assessed using omeprazole
studies Omeprazole at oral doses up to 138 mg/kgrday m rats (about 56 times the human dose on a body surface area oasis) was found to have no effect on
reproductive performance of parental annnais Pregnoncy Tentogemc Effects Cattgory fi Teratology stueMes nave been penormed si rats at oral doses
up to 280 mg/kg/day (about 57 tunes the human dose on a body surface area bass) and m rabbits at oral doses up to 88 mgikgtoay (about 35 tunes the human oose
on a body surface area basis! and have revealed no evidence ot impaired ferttoy or harm to the fetus due to esomeprazole There are. however no adequate and
weft-controfed studies m pregnant women. Because annual reproduction studies are not always pretbttve ot (man response the drug should be used dunng
pregnancy only it dearly needed. Teratology studies conducteo with omeprazole m rats at oral doses up to 138 mgikgidav (about 56 times the human dose on a body
surface area bass) and in rabbits at doses uo to 69 mq/kg/oay (about 56 tones the human dose on a body surface area bassidd not disclose any evidence tor a
teratogenic potential ot omeprazole in rabbits omeprazole m a dose range oi 6.9 lo 89.1 (about 5.5 to 56 times the human dose on a boov surface area
bass) produced dose-related increases in fetal resorptions and pregnancy Disruptions in rats dose-related embryo-fetal toxicity and postnatal
oevewpmentai towitv were observed in offspring resulting from parents treated vmh omeprazole at 13J to 138 0 mg/kgrcay (about 5.6 to 56 times the numan
doses on a body surface area basis) There are no adequate and wee-controled studts m pregnant women. Sporadic reports have been received ot congenita
abnormalities occurring m infants bom to women who haw received omeprazole during pregnancy Nunmg Moinrs The excretion of esomeprazole m mft
has not been studed. However, lynywe concentrations hue been measured n brent mft of a woman ipup—g oral admmretrauon of 20 mg
tsomewaa* is mti to be aatm n tamt mil Maust ot w pouM lor wans «timt «ckn «i «jot( rtvts lr» aomnaoc. w txast ol B*
aoteiial tpf luinonaencf i«o— lor omamate w»«raennomw Muit«s.»d«oßn «IwbM tt« i»ia« «n««i«r lo *aconliniie iwoana Of to oacoimiie Hit
When you’re in the know, you can better manage your acid reflux disease.
For more information on t
Purple Plus u
PROGRAM
NEXIUM* 7-Day Free Trial Offer I
(esomeprazole magnesium)' I
If your doctor prescribes NEXIUM, you can try it free for 7 days with this offer. W
Here's how. w
l Call or visit your doctor or health care professional to find out if NEXIUM is right
for you. NEXIUM is available by prescription only.
2. Present both your prescription for 7 NEXIUM capsules and this certificate to your
pharmacist to receive your free trial of NEXIUM.
If you're interested in more information about NEXIUM plus more
money-saving offers, visit purplepill.com or call 1-877-97-NEXIUM.
Terms and Conditions: Limit one 7-day free trial certificate per person for the duration of the program.
Valid ONLY at retail pharmacies, no mail order. Please see eligibility restrictions and other terms and
conditions on the back of this certificate.
RxBIN # RxGRP # Identification # Suffix
610415 NEXIOO72 721278709 01
This offer is good through September 30,2006.
drug, taking mto account Ok rmoortance ol tto drug lo the mower. Pedtaric Um ust ot NEXKJM m adoMsett talents 12 to 0 yen ol agt tv snofl.wir
trtatmeffl ot G£RC is swooned by at ntracoasw of reset. Jittaoy nduder X* c*ne#t wtxcvtfl Isoong (ran uauM md sues lilt
suowxtst me jwrovai ol NEXIUM lor uuns and b) safety mi Dtanracounttc sm« ptrtjfmefl in Mnesant oxMne {So CUK4L RIMMCfIUNY.
Pluinm>iwlin Pesainc xh phannacoiunetic intonnaion) The saety vxl ettectmncss o> NEXIUM tot nte treatment ot syragKmaiic G£RO si ciMnts <!2
/tanoDgetiMnotaewaatttM
in a mwtiamr. landoaun. <kxit>lH*M. itudr. 149 antscta nuns 02 bl 7 -/tan ol ut» kmc 124 Cjucawn 15 hd 10 o**) m*
dnaty eognisco GEflO net «Wd <«i Mw NEXIUU 20 mg or NEXIUM <0 ng onx My ki nID I MM to nttac sIMt M 4 OttaMt. Pains »M
m turn pants tm naOOt HV UXBrnal mb 12.7 V. aarnn 12V) at nausea (2%L Mm Mu cmwu am MM Gmfek Uto 0 l»U»
nixntw ot nuns t*> rKswdItKHJM «cktoi nils. 1459 tm 55 k 74 yan oi *)t M 354 pM tin £75 ton Hat Me trm* mannas «i ut*»
and erticacy t vt oout*o Mtnwi me tiddly ,nc njunflp mdmAaft and tang upomd canal tinpiaicaaaiiidtalCTwndddMlpwcßWfWddmw (Wan
me Vdel. and yomgar Dawns tad gitaw sraMy ol Sdme oldat mnuaß enw K nad« ADVBBt KACDONS Tin sa«Ry dl KSUH na nanoH
m m 15.000 patents laged H-W yeni m Oral male wdtlmde reward out «jffl gun <i me UMd Sam and ow SJOO naM n inm and
Canada. Ow 2.900 ganeieaim raid mlddd«in makes kx on to 6-12 mdieni mjmeni WXll»lM!««l(e»aiedritan!Wl»»>fk!nno«a!
mail A Studr ties twfomed enduing tne satet, ot KtXOI at nedatnc naneno aged 12-U tor me treatment ot wnwooiaK 6ERO iie« rKCMimd-
PediatneUai The safe* in me neammoineikigolemsiveaoisigftsvas assessed in to tantotaaed cannaiaM (Mat tms. Men »MU 1.200
patterns on NEXIUM 20 mg. 2.434 caneits on NEXIUM <0 mj. and 3.000 pattens on umegexsate 20 mg My Tbe moa neqdMty ocamm advene mnß (al%l
■iaitnieegtdi«scasneadictie{ss.6o.and3l.te)«etMiyianldanlieaindddleieKeainongtnetnieegneps!.llagseiitaiiMce.aoddmmiiew ceon
panon and #y mouth ocoxted at Hint* rates among weens mug NEXIUM ot omeontoli Addmonai ad«ene neno mat rnn reoofed as coaeiy or gummy
netaled la NEXIUM men an incidence < 1% are ksted tteloa bir taody system ledraia Wear itdwen innya merge macnon asthenia hack mat. cneaoaet
aw nan suttstemjt teat edema, penonea edema, not tones mngue. tenee. fluHae doaeder edema, eq edema maaei m •qm
CiUitmalr nitsnmo nypettetiMX! iactnfcanha: fedeemee. goeer Oaitremaeineit; nonet inegmanty. consetMUt aootavaad. dvsoensa. trspnarni
dysptssa Gl. pan evuenbon. wophagoi dsontor. frequere sttoH
mouth dander, pnarm msoroer. -eeta ersonter. serum gasmn increased totgue Poonter. rnngee edema nlcnm setmabs. roneeng; Hmwf anon
tinnitus HemttitofK: anema anema hypochromc. cervc* wmoftoadenooatny jprstaxjs. leukocytosis, ifirtpyug NqNk: DNubncina.
neoanc timcnor anttorma. SCOT increased. SOFT increases: aeiekiitiratiiliiiii shcdseia. nvtmwtema increased atame mtoseeasase
must mamm 612 deltcieacy riergm mcreaa. riagni decrease: anmeuaam armotga enlwtis aggnmed. arsmuoanr cramps nneomtama smdmme
nesma. oohmyalga rMumana Htrms Hmamat anonu. ananagsmetme ncreased. contusion, rtettressron aggrauakd. dnzmess nmeflaua.
nervousness, ffypoeslhesa. ireootoHce msorma nugraae Tyyypf aggravaseb oaresthesa. disorder tremor, verhgo. wsuai hckO | re*ff l '
RepreddfOw nyffinf|i dHrydef. vagtruf’S fyffntf'y asthma iggravitfyl coughs dyspnei (arynx edema gta>yiigtos.matos.snstos:ftii
gat iffrreryrt acne angnedena. bemabbs. pruritus, prurtus an. rash, rash erythematous, rash rnacuto-papular, skn mtawnabon.«
uriicana Sptcal Stmt ootrs meda parovne. tassetoss. tasie pervemon UrupunW-ionormUunne cysbbs.dysma.tungartKbon.he«iaiuna.
metunbon frequency, montoss. gendal monkasis. polyuns: contundMbs. vwon abnormal. Endoscorec hndngt that were reported as adverse evewß
and mucosal dtscoorabon T wo pacebo-controlled were conducM in 710 paHNs tor the Hitr"ft ol r vl rr v hr 'jirffhtnumhfgti 1 relux
disease The most common adverse events that were reported as posstoly or probably retaled to NEXIUM were danhea (4.35) headKta (3 8V and abdommai
pan (3.8%). °ostmartabng Reports - There ftwe been spontaneeus repons ol adverse events wdh postnariatoig use el esomepraMii Theto reports occvred
rarely and are listed below by body system: IM ml lyapMe Sok» ftswderr agonuiocytose pancytopena Est Gaerdeir Mirred wwn
ugstrofutastmi Disvitn: pancreatitis ffitfiktiilrvy Omrdeiy hepatitis v/dti or wdhout gureKt bnaae syi4ww AMvddnr yaphyatlff reacborvshocx
itosatostiietii aatf Cmtdm hsae Oaarderr nrvaiya Hfdohe Doarttrr. depression Sim and Stfnomm Tam Dtsmtoz aioocoa. eiytnema
muttitorme. Stevens-Johnson syndrome, toxx epidermal necrolysis (TEN. some fatal). Other advene events not observed wtfh NEXIUM bat occurring writ
omeprazoie can be found m the omeprazole package msert. ADVERSE REACTIOKS section OVBtDOSAGE A vet# oral dose ol esomeprazole at 510 reykg
(about 103 times the human dose on a body surface area basis), was lethal to ran The maior signs of acute toooty were reduced motor acbvdy. changes m
respiratory frequency, tremor, ataxa. and intermittent ctomc convulsions There haw been some reports ot overoosage with esomeprazote. Reports tare been
received iff overrtotogernteomeorazoler humans Dose ranged up to 2.400 mg (120 bmes the usual recommended chmamosci Mamtestiuons were ranabte
Put mduoed conluson. drtnfseiess otorred wsfon. tachycarca nausea dapnoresis. husftmg headache, dry mouth, and other adverse reactions sxmtar to those
seen m normal ebneat experience tsee omeprazole package msert-AOVBBE FACTIONS) No speoheanboote tor esomeprazole skaowiScce esomeprazole a
extensively proiem bound, it 5 not expected to be removed by dialysis, in tne event ot overdosage, ireatment should be symptomabc and supportive. As wdi the
management ot any overdose, the possfrhty ot mulbpie drug mgesbon should be considered. For current irtformabon on treatment ot any dniQ overdose, a certrhefl
Regoiai Person Control Cater should be contacted. Teiepaone numbers are ksted m the Physoans Desk ftelerence fPOR) or local telephone boot DOSAGE
AND ADMiNeTIAnCN PleaK see ton Prescnbmg Wormaoon for recommended dosages and dosage adiusimeats tor Spec*! PppoUen tor NEXIUM
NEXIUM and me emor purple as appfeed to the catsuit are registered trademarks ot the AstraZeneca group ot compamei
S AstraZeneca 2006. .A* rights reserved
Distributed by AstraZeneca IP Wrfmmgton. DE19850 Product of France 31026-02 Rev. 044)6 240613
-
fmm 1
# of
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Nexium,
(esomeprazDiemagnesun)