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p •’W '-ail ’ft s summa'i ca f etu ty ana then 3s* ,00' Doctor anoul NtXUM No advertisement car orovide all the
'yvy ?n needed 'c oresc-De a amq It s affyert-sement Does no: lane the place o' carefu' discussions »itn your doctor
Only you? doct?' "js 'he training :c «eiqh tne :, siis and benefits ot a arescription drug lor you
NEXIUM* (esomeprazole magnesium)
20-mg, 40-mg Delayed-Release Capsules
•*® SUMMARY Before msatong NEXIUM. olease see M Prescnomfl Intomabon NDtCAHONS AND USAGE NEXIUM s mOcateO
tor tht slwt-ttrm treatment (4 to 8 weeks) hi the healing and symptomatic resolution of (taQnosticaliy confirmed erosive esophagitis, the mainte
nance of symptom resolution and heabng of erosive esophagitis (controlled studies do not extend beyond 6 months); and for the treatment of
heartburn and other symptoms associated with GERC CONTRAINDICATIONS NEXIUM s contraindicated in patients with known hypersen
sitivity to any component of the formulation or to substituted benzimidazoles PRECAUTIONS Symptomatic response to therapy with NEXIUM
does not preclude the presence of gastnc malignancy Atrophic gastritis has been noted occasionally in gastnc corpus biopsies from patients
treated tong-term with omeprazole ot which NEXIUM is an enantiomer Information for Patients NEXIUM Delayed-Release Capsules should
be swallowed whole and taken at least one hour before meals For patients who have difficulty swallowing capsules, one tablespoon of applesauce
can be added to an empty bowl and the NEXIUM Deiayed-Release Capsule can be opened and the pellets carefully emptied onto the applesauce
The pellets should be mixed with the applesauce and then swallowed immediately The appiesauce used should not be hot and should be soft
enough to be swallowed without chewing The pellets should not be chewed or crushed The pellet/applesauce mixture should not be stored for
future use Antacids may be used while taking NEXIUM Drug Inkeroctions Esomeprazole is extensively metabolized in the liver by CYP2CI9
and CYP3A4. In vrtroand in vtvo studies have shown that esomeprazole is not likely to inhibit CYPs 1A2.2A6.2C9.206,2E1 and 3A4 No ckmcally
relevant interactions with drugs metabolized by these CYP enzymes would be expected Drug interaction studies have shown that esomeprazole
does not have airy clinically significant interactons with phenytom. warfann. qumidine. clarithromycin or amoxicillin Post-marketmg reports of
changes in prothrombin measures have been received among patients on concomitant warfann and esomeprazole therapy Increases in INR and
prothrombin time may lead to abnormal bleeding and even death Patients treated with proton pump inhibitors and warfann concomitantly may
need to be monitored f or increases in INR and prothrombin time Esomeprazole may potentially interfere with CYP2CI9, the major esomeprazole
metabolizing enzyme Coadmmistration ot esomeprazole 30 mg and diazepam a CYP2CI9 substrate resulted in a 45% decrease in clearance of
diazepam. Increased plasma levels of diazepam were observed 12 hours after dosing and onwards However, at that time, the plasma levels of
d«2epam were below the therapeutic interval, and thus this interaction is unlikely to be of cfemcal relevance Esomeprazole inhibits gastnc acid
secretion Therefore, esomeprazole may interfere with the absorption of drugs where gastnc pH is an important determinant of bioavailabil'ty (eg.
ketoconazote ron salts and digoxin) Coadmmistration of oral contraceptives, diazepam, phenytom, or qumidine did not seem to change the
pharmacokinetic profile of esomeprazole Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of
esomeprazole was assessed using omeprazole studies, in two 24-month oral carcinogenicity studies m rats, omeprazole at daily doses of 17.3 4
13.8.44 0 and 140 8 mg/Vg/oay (about 07 to 57 times the human dose of 20 mg/day expressed on a body surface area basis) produced gastnc
ECL cell carcinoids m a dose-related manner in both male and female rats the incidence of this effect was markedly higher m female rats which
had higher blood levels of omeprazole Gastric carcinoids seldom occur in the untreated rat. In addition. ECL cell hyperptasa was present in all
treated groups of both sexes in one of these studies, female rats were treated with 13 Bmg omeprazoie/kg,day (about 5 6 times the human dose
on a body surface area basis) for 1 year, then followed for an additional year without the drug No carcinoids we r e seen in these rats An increased
incidence of treatment-related ECL cell hyperplasia was 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 still showed more hyperplasia in tne treated group Gastnc adeno
carcinoma nos seen m one rat (2%). No similar tumor was seen in male or female rats treated for 2 years For this strain of rat no similar tumor
has been notec historically, but a finding involving only one tumor is difficult to interpret A 78-week mouse carcinogenicity study of omeprazole
did not show increased tumor occurrence, but the study was not conclusive Esomeprazole was negative m the Ames mutation test in the m wo
rat bone marrow cell chromosome aberration test, and the m mo mouse rracronudtus test Esomeprazole however was positive in the m vitro
human lymphocyte chromosome aberration rest Omeprazole was positive in ttie in vitro human lymphocyte chromosome aberration test the in
vivo mouse bone marrow cell chromosome aberration test, and the in vrvo mouse micronucleus test The potenta l effects of esomeprazole on
fertility and reproductive performance were assessed using omeprazole stucies Omeprazole a: oral doses up to 138 mg/kg, day in rats (about 56
times the human dose on a body surface area basis) was found to nave no effect on reproductive performance of parental animals Pregnancy
Teratogenic Effects Pregnancy Category 6 Teratology studies have been performed m rats at ora! doses up to 280 mg/kg/day (about 57 times tne
human dose on a body surface area basis) and m rabbits at oral doses up to 86 rog/tyday (about 35 times the human dose on a booy surface area
basis) and have revealed no evidence of impaired fertility or harm to ttie fetus due to esomeprazole There are, however, no adequate and weli
controiled studies in pregnant women Because animal reproduction studies are not always predictive of human response this drug should be used
during pregnancy only if clearly needed Teratology studies conducted with omeprazole in rats at oral doses up to 138 mg/kg/day (about 56 times
the numar dose on a body surface area basis) and in rabbits at doses up to 69 mg/kg/day (about 56 times the human dose on a body surface area
basis) did not disclose any evidence for a teratogenic potential of omeprazole In rabbits, omeprazole in a dose range of 69 to 691 mg/kg/day
(about 5.5 to 56 times the human dose on a body surface area basis) produced dose-related increases in embryo-iethality. fetal resorptions, and
pregnancy disruptions in rats dose-reiated embryo/fetai toxicity and postnatal developmental toxicity were observed in oftspnng resulting from
parents treated with omeprazole at 13 8 to 138 0 mg/kg/day (about 5 6 to 56 times the human doses on a body surface area basis) There are no
adequate and wen-controlled studies in pregnant women Sporadic reports nave been received ol congenital abnormalities occurring in infants born
to women who have received omeprazole during pregnancy Nursing Mofhers ’he excretion of esomeprazole m milk has not been studied
Hoiwver. omeprazole concentrations nave beer measured m breast milk of a woman following oral administration of 20 mg Because esomeprazole
is likely to be excreted in human milk, because of the potential for serious adverse reactions in nursing infants from esomeprazole, and because of
the potential for tumongemcity shown tor omeprazole in rat carcinogenicity studies a decision should be made whether to discontinue nursing or
to discontinue the drug, taking into account the importance of the drug to the mother Pediatric Use Safety and effectiveness in pediatric patients
have not been established ADVERSE REACTIONS T he safety of NEXIUM was evaluated in over 10,000 patients (agec 18-84 years) in clinical
trials worldwide including over 7.400 patients in the United States and over 2,600 patients in Europe and Canada. Over 2.900 patients were treated
m long-term studies for up to 6-12 months In general NEXIUM was well tolerated m both short- and long-term clinical trials The safety m the
treatment of healing of erosive esophagitis was assessed in four randomized comparative clinical trials which included 1.240 patients on NEXIUM
20 mg. 2,434 patients on NEXIUM 40 mg, and 3.008 patients on omeprazo* 20 mg daily The most frequently occurring adverse events (21%) in
all three groups was headache (5.5.5.0. and 3 8 respectively) and diarrhea (no difference among tne three groups) Nausea flatulence abdominal
pain, constipation and dry mouth occurred at similar rates among patients taking NEXIUM or omeprazole Additional adverse events that were
reported as possibly or probably related to NEXIUM with an incidence < 1% are listed below by body system Body as a Whole abdomen enlarged
allergic reaction, asthenia, back pam chest pain, chest pain substemai. facial edema, peripheral edema hot flushes fatigue fever hu-like disorder
generalized edema >eg edema malaise pain rigors Cardiovascular flushing, hypertension tachycardia Endocrine: goiter Gastrointestinal
bowel irregularity constipation aggravated dyspepsia, dysphagia dysplasia Gl epigastric pan. eructation esophageal disorder, ‘requent stools,
gastroenteritis Gl hemorrhage. Gl symptoms not otherwise specifed hiccup, meiena mouth disorder, pharynx disorder, rectal disorder serum
gastrin increased tongue disorder tongue edema utcerative stomatitis vomiting Hearing: earache tinnitus. Hematologic: anemia anemia
hypochromic cervical lymphoadenooatny epistaxis eukocytosis leukopenia thrombocytopenia Hepatic biimibmemia. hepatic function
abnormal SCOT increased SGPT increase: Metabolic/Hutntionsl. glycosuria hyperuricemia hyponatremia, increased alkaline pnosphatase.
thirst, vitamin 812 deficiency weight increase weight Decrease Musculoskeletal arthralgia arthritis aggravated arthropathy cramps
hbromyaJgia syndrome hema, qotymyalgia rheumatica. Nervous System,Psychiatric anorexia apatny appetite increased confusion, depression
agg-avated dizziness, hypertonia, nervousness hvpoesthesia. impotence, insomnia migraine migraine aggravated paresthesia, sleep disorder
somnolence tremor vertigo visual field defect Reproductive: 3ysneno"tiea menstrual disorder vaginitis Respiratory asthma aggravated
coughing, dyspnea, larynx edema pharyngitis rhinitis, s nusitis Skin and Appendages acne angioedema. dermatitis pruritus pruritus ah' rash
r ash erythematous rash macutopapuia - skin inflammation sweating increased urticaria Special Senses: otitis media, parosmia taste loss taste
perversion Urogenital: abnormal unne. albuminuria cystitis dysuna. fungal infection hematuria micturition frequency, moniliasis genital monii
asis. DOfyuna: Visual: conjunctivitis vision abnormal Endoscopic findings that were reported as adverse events induce duodenitis esophagitis
esophageal stricture, esophageal ulceration, esophageal vances gastnc ulcer, gastritis hernia benign polyps or nodules Barrett s esophagus and
mucosal discoloration T wo piacebo-contro'ied studies were conducted m 710 oatients for the treatment of symptomatic gastroesophageal reflux
disease The most common adverse events that were reported as possibly or probably related to NExiUM were dia r mea ‘4 3%). headache (3 B%i
and abdominal pain (3.8%) Postmarketing Reports - There have been spontaneous reports of ad-verse events with: postmarking use ot
esomeprazole T hese reports nave mdudec rare cases of anapnyiactic reaction and myalgia, severe demagogic reactions including toxic
epidermal necrolysis (TEN. some fatali Stevens-Jonnson syndrome, and erythema multiforme and pancreatitis Very rarely, hepatitis with or
without jaundice has beer reported Other adverse events not observed with NEXIUM. but occurring with omeprazole can be found in the
omeprazole package insert ADVERSE REACTIONS sector OVERDOSAGE A single oral dose ot esomeprazoie at 51C mg/kg (about 103 times
the human dose on a body surface area basisi was lethal to rats The maior signs of acute toxicity were reduced motor activity changes in
’espiratorv frequency tremor ataxia, and intermittent clonic convulsions. There have been some reports ol overdosage with esomeprazole Reports
have been received of overdosage with omeprazole m humans Doses ranged up to 2.400 mg (120 times the usual recommended clinical dose»
Manifestations were variable but included contusion drowsiness, blurred vision, tachycardia nausea, diaphoresis ‘lushing headache dry mouth
and other adverse reactions similar to those seen in normal clinical experience (see omeprazoie package nsert-ADVERSE REACTIONS No specific
antidote for esomeprazole is known. Since esomeprazole is extensively protein bound. 1 is nor expected to be removed by dialysis in the event of
overocsage treatment should be symptomatic and supportive As with the management of any overdose tne possibility of multiple drug ingestion
snould be considered For current information or treatment of any drug overdose a certified Regional Poison Control Center should oe contacted
Telephone numbers are listed m the Physicians Desk Reference .'PDR> or .ocal telephone book DOSAGE AND ADMINISTRATION : ease
see full Prescribing Information for recom,mended adult dosages for NEXIUM For patients who have a nasogastric tube m place NEXiUM Delayed-
Release Capsules can be opened and the intact granules emptied into a 60 mL syringe and mixed with 50 mL of water Replace the blunge' and
snake lie syringe vigorously for 15 seconds Hold tne syringe with the tip up and check tor granules remaining in the tip Attach ‘he syrnge to a
nasogastric tube and deliver tne contents of the syringe through the nasogastric tube into the stomach After administering the granules tne
nasogastric tube should be flushed with additional water Do not administer the pellets if they have dissolved or disintegrated The suspension must
be usee immediately atte r preparation Special Populations in adults no dosage adiustments are necessary based on age gender o r rena;
insufficiency For panerns with hepatic insufficiency no dosage adjustment is necessary r patients with mild to moderate liver impairment (Child
°ugh Classes A and B) for patients with sever i-ver impairment 'Child Pugh Class Ci a dose of 20 mg ot NEXIUM should not be exceeded
NEXIUM is a registered trademark of the AstraZeneca group ot companies
9 AstraZeneca 2005 Ail rights reserved
Distributed bv AstraZeneca LP WHmmgton DE19850
Product of France
222226 AStTSZGnGCS 4^
References:
’Castell DO. Kahrilas PJ. Richter JE, et al. Esomeprazole (40 mg)
compared with lansoprazole (30 mg) in the treatment of erosive esophagitis.
Am J Gastroenterol. 2002;97:575-583.
Data on file, DA-NEX-37.
Hometown
Hero_
B Fielding I
a League I
Wired
In 1996, Phillip Deason
was approached by the mother of
Corey Freeman, a spunky 3-year-old
with Down syndrome who desperately
wanted to play baseball. Deason, then
president of the youth sports associa
tion in Moody, Ala. (pop. 8,053), put
the youngster on a non-competitive Cap
Ball team, a precursor to tee-ball.
But after five years, Corey grew too
big to play with the 3- and 4-year-olds,
and Deason considered starting a base
ball league for kids with special needs.
In 2002, he did just that, creating the
Moody Miracle League, which now
boasts 150 players.
“In regular youth associations, par
ents will holler because of a bad call
or a child who didn’t get to play,” says
Deason, 44, a city councilman in charge
of Moody’s parks and recreation depart
ment. “But at a Miracle League game,
you hear them talk of wrenching deci
sions between buying a new automobile
or their child an electric wheelchair.
That puts it all into perspective.”
Deason’s search for a special needs
team led him to the National Mira
cle League Association (NMLA), a
Conyers, Ga.-based organization that
formed after a Georgia coach started a
special needs team in 1999. The NMLA
informed Deason that a Miracle League
field would cost about $400,000.
Fund-raising efforts for Moody’s
field began in July 2002. Deason
teamed up with two Birmingham, Ala.,
deejays, who collected SIO,OOO during a
radiothon. The city donated park space
for the field, while Deason
blitzed local corporations
for donations.
“We raised about
S2OO.(XM) in hinds, the rest
in materials and manpow
er,” Deason says.
The Moody Miracle
League field was completed
in April 2003 and includes
a flat, cushioned, synthetic
Adolphus Evans, 16, heads toward first base
1 1
Phillip Deason created a league for special kids.
playing surface with bases painted on
to eliminate barriers for players with
wheelchairs, walkers or visual impair
ments. The league involves players from
seven Alabama counties that form 10
teams. Every player gets a chance to bat,
every at bat is a home run, and every
game ends in a tie. There are 16 Miracle
League fields nationwide, with 61 under
construction and more planned.
Moody’s league has a regular spring
season and an abbreviated fell season,
the latter ending with a fall festival at
the park. Although the NMLA sets
ages at 3 to 21, many Moody players
are in their 20s and 30s, with two in
their 70s. Some, like Corey Freeman,
have Down syndrome, while others are
autistic or suffer from cerebral palsy.
M'S*; v)
T 1
I I
Page 4
One woman is blind, and her
guide dog leads her around
the bases.
Butch Hallmark, 17, is
one of the “buddies” who
walks bases with players or
stands in the field alongside
them to make sure they don’t
get hurt. “I’ve loved doing
this since opening day,” the
Moody High School senior
•American Profile