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NASONEX' PRODUCT INFORMATION
(mometasone furoate monohydrate)
Nasal Spray, 50 meg*
FOR INTRANASAL USE ONLY
’calculated on the anhydrous basis
BRIEF SUMMARY (For lull Prescribing Information, see package insert)
INDICATIONS AND USAGE NASONEX Masai Spray 5G meg s mdcatec tor the
treatment of the nasal symptoms ot seasonal allergic and perennial aileron: minu
te m adults anc pediatnt patiems 2 vea-s ot age and outer NASONtX Nasal
Soray. 50 meg b Seated tor the propnvtaxis of the nasai symptoms of season
al allergic rhtnms m adult and adolescent patients 12 -/ears anc Okie- ir patterns
wth a known season* allergen that preapiates nasai symptoms o' seasonal
allergic rhinitis, initiation of prophylaxis with NASONEX Nasal Spray. 50 meg is
-ecommenoec 2 to 4 weeks prior to the anticipated start of the poller season.
Safety arc effectiveness ot NASONEX Nasal Spray 50 megm pediatnc patients
less than 2 yea" of age nave net ceen established
NASONEX Nasal Spray. 50 meg. i$ ndeded for the treatment of nasai potvps
m patients *8 years cf age and oide- Safety anc effectiveness of NASONEX
Nasal Spray 50 meg tor me treatment ot rasa! polyps m pediatnc patients less
than *8 years o* age nave not teen estaWisnec
CONTRAINDICATIONS Hypersensitivity to any of the ingredients of ths prepara
tion contraindicates its use
WARNINGS The replacement ot a systemic corticosteroid with a topical con -
costeroic can be accompanied by signs ot adrena* insufficiency and. m addi
tion some patients may- experience symptoms of withdrawal ie joint and or
muscutar pain lassitude anc depression Careful attention must be given
when patients previously treated for prolonged periods with systemic cortico
steroids are transferred to topical corticosteroids .vitn careful monitoring for
acute acrenai insufficiency m response to stress "his is particularly important
in those patients who have associated asthma or other clinical conditions
where too rapid a decrease m systemic corticosteroid desmg may cause a
severe exacerbation of ther symptoms
ft recommendec doses of intranasal corticosteroids are exceeded or if mdMduais
are partcuiartv sensitive or predisposed by virtue of recent system: stereo thera
py symptoms of hypercortcsm may occur. mcJudmg very rare cases of menstrual
regularities acreftorr- lesions and cushmgc-d features’ K such changes occur
teptea corticosteroids should oe ascontmuec sioMy. consistent with acceptec pro
cedures tor fliscohbnur; oral stemid therapy
Persons who are on drugs when suppress the immune system am more sus
ceptoie to infections than neafthy mawifluals. Chickenpox arc measles tor exam
ine an have a more senous or even fata: course m rorammune children or adults
on cortcoflßtefls Ir such children or adults who have not had these diseases
particular cate should be taken to avoid exposure How the dose route, ana dura
tor. of corticosteroid admmstra&on affects the risk of developing a disseminated
infection is net known Tne contribution of the undertymg disease and/or prior
corticosteroid treatment to the risk is also not known it exposed tc chickenpox.
prophylaxis with vanceaa zoster >nmune gioom (VZIG) may be inflated. i f
ecosec to measles, prophylaxis with pooled intramuscular immunqgloDJHn riG i
may be inflated .See the respective package inserts for complete VZiG and iG
prescribing information i if cruckenpox develops treatment with antiviral agents
may be cons,aered
PRECAUTIONS General Irtranasai corticosteroids may cause a reduction m
growth velocity when admimsterec tc pediatric patients isee PRECAUTIONS
Pediatnc Use sectioni in omcai studies with NASONEX Nasal Spray. 50 meg. the
development ot localized infections of the nose arc pnarynx with CanMaatocans
has occurred only rarefy When such ar infection develops, use of NASONEX Nasai
Sp-ay 50 meg snoiXd be discontinued and appropriate loc* or systemic therapy
msKutec if needed
Nasa : corticosteracs should be used with caution if at all m patents with active
or qwescen' tjtertukxis infection of the respiratory tract, or n jntreatec fungai.
Bacterial. svsteow vial infections or ocular herpes simplex
Rarely immediate hypersensitivity reactions may occur atter me mtranasai
administration of mometasone furoate monohydrate Extremely rare instances of
wheezing nave been reported
3 are instances cf nasai septum oertoration anc increased intraocular pressure
nave aisc been reported fotowng me ntranasai aopi-catior of aemsoiized cortico
sfera-cs As win any long-ferm topeai treatment ot the nasal cavitv patents using
NASO»€X Nas* Spray 50 meg ove' several months or longer snouto be examinee
IMhodcaly to- oossce Ganges n the nasai muccsa
Because of me rhCitc'y effect of corticosteroids or wound heakng patients
who have experienced recent nasa ; sepr.'um, mcere nasai surgery or nasa- 'rauma
should net use a nasal ccrtcoste r oid until heating "as occurred
Glaucoma anc cataract formation was evaluated « one controlled study ot
12 weeks' duration and one uncontrolled study of 12 months duration in
patients treated with NASONEX Nasai Spray 50 meg at 200 mcgttiy using
intraocular pressure measurements and slit lamp examination No significant
change from baseline was noted m the mean intraocular pressure measure
ments tor the f4i NASONEX-treated patients m the 12-week study as com
pared with 141 piaceoc-treated patients No individual NASONEX-treated
patient was noted to have developed a significant eievation in intraocular pres
sure O' cataracts in this 12-week study Likewise no significant change from
baseline was noted m the mean intraocular pressure measurements tor me 139
NASONEX-treated patients m the 12-month study and again no cataracts were
detected in these patients Nonetheless nasal and mhaied corticosteroids have
been associated with the deveiopnent of glaucoma and/or cataracts
Therefore close follow-up s warranted m patients with a change m vision and
with a history cf giaucoma tnd'or cataracts
When nasal corticosteroids are used at excessive doses systemic cort*-
coste'CHd effects such as hvpercorticisn and adrena' suopressior mav
appear If such changes occur NASONEX Nasal Spray 50 meg should be dis
continued stovry consistent with accepted procedures for discontinuing oral
steroid therapy
Information tor Patients Pawns De«g treated w*h NASONEX Nas» Spray
50 meg shouc be given the tokowng mtonratwr and instructions Tas information
s rtendedteaem the safe and effective use of toemedation ttsrw a disclosure
of a -mended or posstte adverse effects s aoents show: use NASONEX Nasai
Spray. 50 meg at regular mfertiats isee DOSAGE AND ADMMISTRATION s rr x its
effectiveness depends or regular use improvement r nasal symptoms of anergic
mms has been snowr tc occur with* 11 hours after the first dose based or one
smgtetoose paratei-gmup study of patients man outdoor part setting iparvstextv*
anc one environmental exposure umt (EEU) studv anc witen 2 days after the first
dose m twe randomized dcudfe-oknc pfacebc-cortrofled parafcj-grouc seasonal
allergic mirets studies Maximum benefe-s usualv achieved'.-rthin Ito 2 weeks after
initiator of aosmg Patients should take me medcabor as tweeted anc should not
increase toe prescribed dosage«an attempt to increase its effectiveness Patents
should contact their physician if symptoms dc not improve, or if the condition wors
ens. To assure proper use of this nasai spray anc to attain maxanum benefit, patients
should read and Mow the accompanying Patents instructions to- Use carefully
Administration to young chidren should Oe wed bv an adult
Patients should be cautiorec not to spray NASONEX Nasai Spray 50 meg into
the eyes or directly onto tne rasai septum
Persons who are on immunosuppressant doses of corticosteroids should
be warned to avoid exposure to chickenpox or measles and patients should
also be advised that if they are exposed, medical advice should be sought
without delay
Carcinogenesis Mutagenesis Impairment ot Fertility In a 2-year carcino
genicity study ip Sprague Dawiev rats mometasone ‘uroate demonstrated no
statistically significant increase m the incidence of tumors at inhalation doses up
to 6" meg. kg (approximately 1 and 2 times the maximum recommended daily
mtranasai dose iMBDiD] in adults ;400 meg.' and children (i 00 meg; respec
twefy on a meg'n basis) in a 19-montn carcinogenicity study m Swtss CD-1
mice mometasone furoate demonstrated no statistically significant increase m
the incidence of tumors at inhalation ooses up tc ’6O meg kg (approximately
2 times the MRDC'-r. adults arc cni c-e- respectively onamCQMl basil
Mometasone furoate increased chromosomal aoerrations in an ■ . •- • Chinese
hamster cvary-ceii assay but did not increase chrcmoscma: aberrations m an
- . Chinese ramste- lung ceil assay Mometasone furoate was not mutagenic
n the Ames test or mouse-lvmphoma assay anc was not ciasfogenic .n ar ...
mouse mcronucieus assay anc a rat bone marrow chromosomal abemation
assay or a mouse male germ-ceil chromosomal abe"atioc assay Mometasone
furcate also did not mcuce unscheduled DNA synthesis ' ■ w m rat heoatocvtes
Ir, reproductive studies n rats, impairment of fertility was not produced by
subcutaneous doses up to : 5 meg'kg ness than the MRDID m adults on a
meg/m basis)
[NASONExj
(mometasone furoate monohydrate)
Nasal Spray,somcg*
Pregnancy Teratogenic Effects Pregnancy Category C When admtnstefed to
pregnant mice rats and rabbits mometasone furcate increased fetal malforma
tions The doses that produced malformations aisc dec'eased fetal growth, as
measured by lower feta neghts anc ex deayec cssrticancr Mometasone furcate
also caused dystocia anc rested implications v/nen administered tc rats during
the er: of pregnane.
ir mice mometasone furoate caused cief? paiate a: subcutaneous acses of
60 mcgkg and above (less than the MRDID m adults on a megm basis,- fetal sur
vival was mcucec at 180 mcgAg (approximately 2 times the MRDID n adults on a
meg'm basis) No texoty was observed at 2d mcgkg (less than the MRDID n
adults or amegrm bass-
In rats mometasone furoate produced umbilical nern.a at topical dermal
doses o* 600 meg/kg and above 'approximately 10 times the MROIO in
acufts on a meg/m basis i A dose of 300 meg/kg iapproximately 6 times
the MROIO m adults on a meg’m oasis' produced delays in ossification,
but no malformations
in rabbits, mometasone furoate caused multiple malformations eg flexed
‘-ont paws gallbladder agenesis umbilical hernia hvdrocepnatv- at topical
oemiai doses of 150 mcgkg and above (approximately 5 times the MRDID in
adults or a mcg/m- basis) in an oral study mometasone ‘uroate increased
reso'ptions anc caused cleft paiate anchor head malformations i hydrocephaly
or domed head) at TOO meg/kg (approximately 30 times .he MPD’iD in adults
on a meg.m basisi At 2800 mcg'kg (approximately i l O times the MRDID in
adults on a meg m basis) most litters were aborted or 'esorbec No toxicity
was observed at 140 mcg'kg i approximately 6 times the MRDID in adults on a
meg m basiSi
When rats rece-vec subcutaneous coses ol mometasone furoate throughout
pregnancy or during the ater stages of pregnane. l 15 mcg'kg -'less than me
MRDID m acufts or a meg'm- oasis i caused prolonged anc difficult labor and
reduced me number of live births, birth weight anc earn pup survival Similar
effects were not observed a 7 5 mcgixg (less than the MRDID in adults on a
megm- oasis i
There a*e no adequate and wrt-controled studies m pregrant v/omen.
NASONEX Nasal Spray 53 meg. -like other corticosteroids, should be used dur
ing pregnancy omy it the potential benefits justify the potential risk tc the fetus
Experience with oral corticostertucs since meir introduction -r pnamacciogic
as opposec to physiwogic doses suggests mat rodents are more prone to
teratogenic ertects iron comcostemics man humans In addition because
there s a natural 'ncrease in corticosteroid production curing oregnanev most
women will require a tower exogenous corticcste'oid dose and many will not
need corticosteroid treatment curing pregnane..
Nonteratogemc Effects: Hypcad'enaasm may occur m infants bom to
v/omen receiving corticosteroids during pregnancy Such infants shotHC be
carefully monitored
Nursing Mothers ft is net known if mometasone ‘uroate is exemtec in human
milk Because other corticoste'cics are excreted m human milk, caution snouic be
usee when NASONEX Nasal Spray 50 meg is admimsterec tc nursing women
Pediatric Use: Controlled clmical studies have shown mtranasai cortico
steroids may cause a reduction m growth velocity m pediatric patients This effect
has been observed m the absence of laboratory evidence of hvcothaiamic-piiu
nary-adrenal (HPA) axis suppression suggesting that growth velocity -s a more
sensitive indicator of systemic corticosteroid exposure m pediatric patients tnar
some commonly used tests of HPA axis function ’he tong-tem effects ot this
reduction in growth velocity associated with mtranasai corticasteroids including
the impact on fin* aduf? height, are unknown ’he potential 'or catch up
growth toftowmg discontinuation of treatment with intranasal corticoste r o«Js has
not been aoequatetv studied ’ne growth of pediatnc patients receiving mtranasai
. corticosteroids mdudmg NASDNtx Nasai Spray 5C meg should be monitorec
routtnety (eg. via stadtometry) The potential grov/to effects ot prolonged treat
mem shouic be weighed against cfcncal benefits obtained and the avaiiaoikty of
sate and effective noncorticcsteroid treatment alternatives Tc minimize the sys
temic effects of -ntranasai cortostero;os including NASONEX Nasai Spray
50 meg each patient should be titrated to hivher wrest effective dose
Seven hunpred and twenty (720) patients 3 to 11 years ot age with alfergic
rhinitis were heated with mometasone furoate nasal spray 50 meg ’OO meg
fotai daily dose- m controlled cimcai trials see CLINICAL PHARMACOLOGY
Clinical Studies section) Twenty-eight .28- salients 2 to 5 years of age with
anergic rhinitis were treated with mometasone furoate nasai spray 50 meg
HOG meg total daily dose) m a controlled trial tc evaluate safer -see CLINICAL
PHARMACOLOGY. Pharmacokinetics section- Safety and effect'veness m chil
dren less than 2 years of age with allergic rhinitis and in children less than
’8 years o? age with nasai polyps nave not been established
A clinical study has been conducted tor f year m pediatnc patients with allergic
rhinitis i ages 3 to 9 years i tc assess the effect of NASONEX Nasal Sprav. 5G meg
-t 00 meg total daily dose) on growth velocity No statistical significant effect on
growth vetoaty was observed tor NASONEX Nasai Spray. 50 meg comparec to
piacehc No e*vicence or clinically relevant HPA axis suppression was observed
following a 30-minute cosyntropm intuswn
’he potential of NASONtX Nasai Spray 50 meg to cause growth suppression
in susceptible patients or when given at ingner dcses cannot oe luiec out
Geriatric Use A total of 28C patients above 64 years ot age with allergic -hmitis
or nasai ootyps -age range 64 tc 86 years: nave been treated with NASONEX *iasai
Spray 50 meg for up to 3or 4 months, respectively r he adverse reactions report
ed m this population were similar m type and incidence to those reported by
younger patients
ADVERSE REACTIONS Allergic Rhinitis. Ir. controlled US and international clin
ical studies a rot* ot 321 C adurt and adolescent patients ages 12 years and oider
with aHercic rtuntis received treatment '.-nth NASONEX Nasal Sprav. 50 meg at
doses ot 5C ic 80G meg-day ’he maionty of patients r = 21C3'- were treated with
200 meg-day in controlled US and international studies a total of 990 pediatnc
patients iaaes 3 to 11 years) with afergic rhinitis received treatment with
NASONEX Nasai Spray. 50 meg. at doses at 25 to 200 meg/oay ’he majority of
pediatnc patients (720) were treated with fOO meg/da. A total ot 513 aoult. ano
•escent and pediatric patients nave peer treated lor ‘ rear cr longer 'he overa'i
incidence of adverse events 'cr patients treated with NASONEX Nasai Spray
50 meg was comparable to patients treated with the vehicle placebo Also adverse
events cid not differ significantly based or age sex or race Three pecen: cr less
of patients in ciimcai trials discontinued treatment because o' adverse everts this
mte was similar for the 'vehicle and active comparator.
All adverse events regardless of relationship to treatment -eoGrted by or
more tr adult and adolescent patients ages 12 ./ears anc cider '/ho received
NASONEX Nasai Spray. 5G meg. 200 meg/day ana by pediatnc patients ages 3 to
11 years who received NASGNEx Nasal Spray. 50 meg ’OO meyday n clinical
tnais vs piaceDG and that were more common, with NASCNEx Nasai Spray
50 meg than placebo, are displayed ;n the able below
ADVERSE EVENTS FROM CONTROLLED CLINICAL TRIALS IN SEASONAL
ALLERGIC AND PERENNIAL ALLERGIC RHINITIS
(PERCENT OF PATIENTS REPORTING)
Adult and Aflciescem Patterns Pediatnc Patients Ages
12 years anc ower 3 tc n years
NASCNEX VEHICLE NASCNEX VEHICLE
200 meg PLACEBO ‘OO meg PLACEBO
in = 21031 (ns 1671) n = 374) ,n.- 376)
Heaflache 26 22 i_7 18
rai infection 14 n 8 9
Pharyngitis ]2 10 10 iQ
Epistaxis Bfooc-
Tinqed Mucus 11 6 3 9
Coughing 7 6 13
Upper Respiratory
Tract Infection 6 2 5 4
Dysmenorrhea 5 3 1 G
Musculoskeletal Pam 5 3 1 ’
Sinusitis 5 3 4 4
)mitmg 1 1 5 4
Qthe r adverse events wh“Ch occureo r ess than s°« but greater than or eaua tc 2 : »
of rremetasone tumate adult and adolescent patients -ages 12 years anc omen treated
win 200-ncg acses recarciess of relationship to treatment) and more treouendy than
ir the placet)-: group included arthralgia asthma bronchitis chest par conjunctivitis
danhea. dyspepsia, earacne flu-iike symptoms, mvaigia nausea anc rhinitis
Other adverse events which occurred in less than 5% but greate- than oi eauai
to 2% of mometasone furoate pediatnc patients ages 3to f 1 years treated with
100-mcg coses vs piacehc - regardless of relationship to treatment) and more fre
quently than m the piaceDo group included, darmea. nasai irritation otitis media
and wheezing.
The adverse event regardless of relationship to treatment) reported by s“e
of pediatnc patients ages 2 tc 5 vears who received NASCNEX Nasal Spray
50 meg. *OO mcg'dai m a clinical trial vs piaceoc including 56 subjects (28
each NASONEX Nasal Spit/ 50 meg and piacetoi arc mat was more common
with NASONEX Nasai Sprav SO meg than placebo induced upper respirator
tract -ntection (7% vs 0V respectively) T ie other adverse even: which
occurred ir less than 5% but greater than or equal to 2S of mometasone
furoate pediatnc patients ages 2 tc 5 years treatec with tOC-mcg doses vs
piacehc - regardless of relationship to treatment and more frequently tnar ,n
the piacebc group included skin trauma
tosa/ Polyps n controtlec cmical studies the types ot adverse events
observed in patients with nasai polyps were simitar to those observed 'cr patients
win allergic rhinras A tot* ot 594 adult patients rages '5 tc 36 .ea r s received
NASONEX Nasai Soray 5G meg at coses of 2QG meg once or twice daily for up
tc 4 months lor treatment or rasa poiyps The overall mcioence of acveree events
tor patients treated with NASONEX Nasai Sprav 50 meg was comparable tc
patients treated with the piacebc except 'or epistaxis .when was 9% for 200 meg
once cany 13S tor 200 meg twice oariy ana s°« for placebo
Rare cases cf nasal ulcers ano nasal and ora; candicias;s were also reported m
patients treatec with NASONEX Nasai Spr3y 50 meg. onmarily m patients heated
tor longer than 4 -reeks
in postmarketing surveillance o' this product cases of nasal burning anc
citation, anaphylaxis and angioeoema aid rare cases of nasal septa; per
foration nave been reported Disturbances of taste and snier have been
reported very rareiy
OVERDOSAGE ’here are no data available on the effects of acute or chronic over
oosage witn NASONEX Nasai Spray 50 meg Because ot ow systemic bicavailaoi:-
1y and ar absence of acute drug-reiatec s-zstemic findings m cknical studies over
dose s unimety to require any therapy other than observation .ntranasai adminis
tration of f6OO mm (4 times the recorrnenoed oose of NASONEX Nasal Spray
-50 mcg.i daiiv for 29 cays fc healthy human volunteers, was :ie ß toratea with nc
increased incidence of adverse events S ngie ntranasai doses up to 49X meg
ha-re Deer studies m human volunteers with no adverse elects reported Single
orai ooses up to BCOC meg have been studied m human vo-unteers with nc adverse
effects reported Chronic twraosage with anv comcoste'c.d mav result in signs or
symptoms of hypercortiasm :see PRECAUTIONS -cute overcosage f this
dosage tom $ unlikely since one bottie of NASGNEX Nasai Sprav 50 meg mn
tarns approximately 3500 meg of mometasone 'uroate
CL \‘/u?tSsy
Scnenng Corporation
Kenilworth NJ 07033 USA
Copyright © 1997.2003.2005. Scnenng Corporation All rights reserved
Rev 9/05
26405289TJ8S
Home J
Creating
Gift Wrap
You've bought or made the
perfect gift, but that's only the first step. Wrap
ping your present in a creative and unexpected
way makes a gift even more personal, can be
fun to do and, in todays "disposable" world, is
kinder to the environment when you use materi
als that otherwise would be tossed in die trash.
"Think seasonally," suggests Karen Keenan,
owner of Pamela Loring Gifts in Lee, Mass. (pop.
5,985). “Top your package with an old holiday
ornament, spray of fall leaves, holly, or flow
ers—real or artificial."
If giving homemade breads, casseroles or
other goodies, buy inexpensive plates, dishes
and baskets at yard sales and flea markets for
food containers. Top jars ot your special preserves
with material from your scrap box or by cutting
pieces from a child's outgrown garment. Tag
sales can yield other wrapping materials such as
iinens, fabric scraps, doilies and napkins.
"Get creative with paper," says Keenan,
whose shop wraps dozens of presents daily.
"Blueprints, maps, wallpaper, brown butcher'
paper, sheet music, brown paper bags, alumi
num foil and plastic wrap all work well."
Reuse newspapers, matching the sec
tion to the recipient's interest. Consider the
sports pages for a sport fan, cartoons for a
child, stock listings for a business diehard,
and the food section for someone who loves
to cook. Wrap a graduates gift in the clas
sified job ads, and use the real estate section
to package a housewarming present.
To top it all off, recycle old ribbons in new
ways. Cut them into “confetti" and put them
inside clear plastic wrapping or glue them to the
outside of your package. You can even wash out
empty potato chip bags and cut them into strips,
using the shiny side as a ribbon.
Double your gift by wrapping it in a related
gift item. Tie a baby shower present in a cotton
receiving blanket. Give a book in a reusable
canvas bag; gardening tools in an apron; seed
packets taped to a pitted plant; or a kitchen
gadget wrapped in a new dishcowel.
While gift bags are quick and easy,
a present wrapped with personal flair is
likely to be remembered long after the
occasion, as is the giver. 3^
Man S. Cold is a fretlasia: u riter m Sl-u York.
Page 10
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bv MARI
S. GOLD