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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 iFortull Prescribing Information, see package insert.)
INDICATIONS AND USAGE NASONEX Nasal Spray. 50 meg is inffcatec for the peatmen: of the nasal symptoms of seasonal aller
gic and perennai anergic toutis. m adults and peffatnc paherts 2 years of age and o'oe NASONEX Nasal Spray. 50 meg is indi
cated for the prophylaxis of the nasal symptoms of seasonal aiiergsc rhinitis m adult and adolescent patients 12 years and older
in patents with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, initiation of prophylax
is with NASONEX Nasal Spray. 50 meg is recommended 2 to 4 weeks prior to the anticipated stai of the pollen season Safety
and effectiveness of NASONEX Nasal Spray 50 meg m pediatnc patients itss than 2 years of age have not been est3oiishec
NASONEX Nasai Spray. 50 meg. is indicated for the treatment of nasai polyps m patients f 8 years of age and older Safety
and effectiveness of NASONEX Nasa' Spray. 50 meg. for the treatment o' nasai polyps m pediatric patients :ess than 13 years
of age have not been established
CONTRAINDICATIONS Hypersensitivity to any of the ingredients of this preparation contraindicates its use
[nasonexj
(mometasone furoate monohydrate)
Nasal Spray,somcg*
WARNINGS T ne replacement of a systemic corticosteroid with a topical corticcsteroic can be accompanied by signs of adre
nal insufficiency and. in addition some patients may experience symptoms of withdrawal ie joint anchor muscular pan las
situde anc depression Careful attention must be given when patients previously treated to/ prolonged periods with svstemic
cortcosteroics are transfemeO to topical corticosterwas with careful monitoring for acute adrenal insufficiency m response
to stress. This $ pameuterty important m these patents who nave associated asthma o' other chrocai cone tions where too
rap'd a decrease m system* comccsteroia dosing may cause a severe exacerbation of their symptoms
if recommendec doses o' ntranasal cortidosterotos are exceeded or if HXtiwduals are particularly sensitive pr predisposed by
virtue of recent systemic steroid therapy, symptoms of hypercortesm may occur including very rare tases or menstrual irreg
ularities acneifomr iesions. and cusnmgoia features, if such changes occur. too*ca‘ cortcosteroiffs should be discontinued slow-
V consistent with accepted procedures for discontinuing oral steroid therapy
Persons who are on drugs when suppress the immune system are more susceptible to mteebons than healthy individuals
Chictenpcx and meas’es for examp e can have a more senous or even fatal course in nommmune children or adults on cor
tcosteroios n such children or adults who have no? had these diseases particute' care snouki ce taken to avoid exposure
How the dose route, and duration of corticoste'oid administration affects the risk o' developing a disseminated infection is
not known. The contribution o' the underlying disease and/or poor corticosteroid treatment tc the risk is also not known, ft
exposed to chckenpcx. prophylaxis with vancefla zoster immune gloom i V'ZIG j may be indicated if exposed to measles pre
pnyiaxis with pooieo intramuscular .nnunogsobuiir :iGi may be indicated .;See the respective packaoe inserts for complete
VZIG and IG prescribing information.) if chickenpc* develops ireatmert with antiviral agents may be considered
PRECAUTIONS General: intranasai corticosteroids may cause a in growth velocity when administered tc pedatnc
patients (see PRECAUTIONS. Pediatric Use section: in clinical studies with NASONEX Nasa: Sprav 50 meg. the development
of localized infections of the nose and pharynx with Cams alters has occurred only rarefy When' such an infection cevefops.
use of NASONEX Nasa; Spray 50 meg shouid be d*scontmuec 3nd appropriate :oca or systemic therapy instituted if needed
Nasa: corticosteroids shouid be usee with caution if at ail in patients with active or Quiescent tuberculous infection of the
respiratory tract, or in untreated fungal. Oactenai. system:: -viral infections cr ocular herpes simplex
Rarely immedote hypersensitivity reactions mav occur after the mtranasai administration of mometasone furcate mononv
drate Extremely instances o' wheeang have been reported
Rare instances of nasai septum perforation and increased intraocular pressure have also beer; reported following the mtranasai
application of aerosolized corticosteroids As with any long-term topica. treatment of the nasai cavity, patients using NASONEX
Nasal Spray. 50 meg over severa months or longer should be examinee periodically tor poss.bie charges >n the nasai mucosa
Because of the inhibitory effect o' corticosteroids or; wound heating patients who nave experienced -ecent nasai septum
ulcers nasai surgery- or nasal trauma should net use a nasal corticosteroid until neaitng has occurred
Glaucoma and cataract formation was evaluated m ore controlled study of 12 weeks 'duration an; cne uncontrolled study
of 12 months duration m patients treated .-nth NASONEX Nasal Spray 50 meg at 200 megtoav. using intraocular pressure
nwsuwnents and slit amp examination. No sionificant change from baseline was noted m the mean intraocular pressure
measurements for the 141 NASONEX-treated patients m the 12-week stuff: as compared with ui pacebo-treatec patients
Nc morviduai NASONEX-treated patient was noted to have developed a significant elevation m mtraocuar pressure or cataracts
m this 12*\veek stuffy Likewise, nc significant charge from baseline was noted in the mean mtraocuia r pressure measure
ments for the '39 NASONEX-seated patients n the 12-month stuffy anc again, nc cataracts were detected m these patients
Nonetheless nasai and inhaled cort-costemids have been associated with the development of giauccna ancor cataracts
close follow-up ;$ warrantee m patients with a change m visior anc with a history of gaucoma and or cataracts
When nasai ccrticcstercids are used at excessive doses systemic corticosteroid effects suer as hypereorticism and
aorenai supp'ession may appear if such changes occur NASONEX Nasa Sprav 50 meg should be discontinue: slowfv.
consistent with accepted procedures for discontinuing ora! steroid therapy
Information for Patients: Patients being treated with NASONEX Nasai Spray. 5C meg should be gw the following ntormabon
and instructions This rtormation is intended to ®d m the sa‘e anc effective jse of this medication it is not a o sclosure o' an
mtencec o- cossibie adverse effects Patems should use NASONEX Nasai Sprav 50 mega: reguar intervals ;see DOSAGE AND
ADMINISTRATION, since its effectiveness depends or; regular use Improvement r nasai symptoms of allergic rhinitis nas oee"
shown to occur within 1 f hou’s aner the first cose cased on are singfe-dose oa'aHei-gmup stuffy of sanems nan cutcoor sb'K
setting (part study) and cne environmental exposure unit (EEU) study an: within 2 days arter tne first cose e two randomized
doubte-Dima ptecefxxonttoiec parafiel-group seasonal aierg.c rhrttis stjffies Maximum pene'it is jsua tv achieved wittiin i to
2 weeks after initiation of dosing Patients should lake tne medication as directed an: should nc: increase ‘he prasc'-bed dosage
man attempt to increase its effectiveness Patients should contact their physical if svmptons do net improve. c r if me condition
worsens To assura proper use of this nasa 1 spray and to ara n maximum benefit patients should read an: follow the accompa
nying Patterns instructions tor Use arefuKy. Administration to young children shouid be aided by an acult
Patients should be cautioned not to spray NASONEX Nasai Spray 50 meg mtc the eyes or directly onto the nasa. septum
Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to cfuckenpo*
oi measies anc patients should also be advised that if they are exposes medical advice shouid be sought -without oetay
Carcinogenesis. Mutagenesis. Impairment of Fertility: In a 2-year carcinogenicity study in Sprague Dawfey rats
mometasone furoate demonstrated no statistically significant increase m the incidence o' tumors at inha alien coses up to
67 meg-kg (approximately 1 and 2 times the maximum recommended daily intranasal dose 'MRDiD] m adults 1400 megj
and children [IOO meg), respectively on a mea n- oasis) In a 19-month carcinogenicity study in Swiss CD-1 mice, mometa
sone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation coses up to 160
mcQ/kg (approximately 2 times the MRDID in adults anc children resoective y on a meg/m oasis
Mometasone furoate increased chromosomal aberrations man - Chinese hamster ovary-ceii assay but did no:
increase chromosomal aberrations m an m vr. Chinese hamster ;ung ceil assav Mometasone furcate was not mutagenic m
the Ames test or mouse-iymphoma assa, an: was no: dastogemc man ••.mouse microrucieus assay anc a rat bone
marrow chromosomal aberration assa, cr a mouse male germ-cell efromosoma 1 aoerrat on assav. Mometasone furcate also
did no: induce unscheouiec DMA synthesis " • .. m rat nepatoevtes
in reproductive studies m rats impairment of fertility was not produced by subcutaneous ooses up to 15 meg kg dess than
the MRDiD m adults on a meg/m basis).
Pregnancy Teratogenic Effects Pregnancy Category C When administered to pregnant m:e rats anc rabbits mometasone
furoate increased feta naifo-mations The doses that produced maKonnaticns also decreased 'eta growth as neast'ec by
tower fetal .'/eights anew delayed ossification. Mometasone furoate also causes ffvstoca an: related complications when aom n
stereo to rats ounng me end ff pregnancy
in mice mometasone furoate caused deft caiate at subcutaneous coses of 60 mcgfcg ana above (less than tne MRDiD m
adults an a megm bass) survival was reduced at *SO mcc-kg (approximately 2 times the MRDID m adults on a megm
bass; No toxicity was observed at 20 ncgkg (less than the MRDiD m adults on a meg m pass:
in rats, mometasone furoate produced umbilical hema at topical derma: doses of 60C meg-'kg an: above (approximate
ly 10 times the MRDiD in adults on a meg/nr basis) A dose o‘ 300 meg/kg approximately 5 times the MRDiD m adults
on a meg rr bass) produced deteys in ossification but no malformations.
in rabbits mometasone furoate caused multiple malformations (eg. ficxea front paws, gallbladder agenesis umbilicz
herma. hydrocepnaiyi at topical dermal doses of 150 meg/kg anc above (approximately 6 times the MRDiD in adults oi
a megm basis! In an oral study, mometasone furoate increased resorptions and caused cleft palate snd or head mal
formations (hydrocephaly or domed head at 700 meg/ta (approximately 30 times the MRDID in adults on a meg m
oasis* At 2500 mcg'kg (approximately 110 times the MRDiD m aduits on a megtor basis), most litters were aborted o
resorbed. No toxicity was observed at 140 meg kg (approximately 6 times the MRDID in adults or a meg/nr basis)
When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of preg
nancy. 15 meg/kg fiess than the MRDID m aouits on a megm basis* caused prolonged and difficult labor and reduced th
number o' live births, oirth weight and eariv pup survival Similar effects were not observed at 7 5 meg/kg (less than th
MRDID m adults on a meg/m basis)
There are no adequate an: v/eH-controled studies m pregrant women NASONEX Nasa' Spray. 50 meg. like other corticosteroid*
should be used durog pregnancy only if the potential benefits justify the potential risk to the fetus Expeneoce wih oral comcosteroe
since their ntmauction m prarmacoiogc. as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effect
from corticoste’oicrs than humans. In addition because there is a natural increase m corticosteixc production dunng c’egnancy. mos
women wi require a lower exogenous comcosteroia dose an: many- wi’i not need corticosteroid treatment dunng pregnancy
Nonteratogenic Effects: Hypoadrenatism mav occur in intents bom to women recetving corticosteroids during pregnancy
Such infants should be carefully monitored.
Nursing Mothers: it i$ not known if mometasone furoate is excreted m human milk Because other corticosteroids ar
excreted in human milk, caution should be used when NASONEX Nasal Spray 50 meg is administered to nursing women
Pediatric Use: Controlled cimica studies have shown mtranasai corticosteroids may cause a reduction in growth velocity h
pedatnc patients This effect nas been ccserved in the absence of laboratory evidence of hypothalamic-pituitary-adrenai iHPA
axis suppression suggesting that growth -velocity' is a more sensitive indicator ot systemic corticosteroid exposure in peoatri
patients man some commonly used tests of HPA axis function. The long-term effects of this reduction m growth velocity asso
cated with mtranasai corticosteroids, including the impact on final adult height are unknown Tne potential for' catch up
growth following discontinuation of treatment with mtranasai corticosteroids has not been adequately studied The growth c
pedatnc patients receiving mtranasai corticosteroids, including NASONEX Nasa' Sprav 50 meg. should oe monitored routine
ty (eg. vta stadtomety) Tne potential growth effects o* prolonged treatment should be weighed against cun cal benefits obtain*
and the availability of safe and effective noncorticosteroid treatment alternatives To minimize the systemic effects of intranasf
corticosteroids, including NASONEX Nasai Spray. 50 meg. each patient should be titrated to his tier lowest effective dcse
Seven hundred and twenty (720) patients 3 tc 11 years of age with allergic rhinitis were treated with mometasone furoat
nasai spray 50 meg dOO meg totai daily dose! in controlled clinical trials (see CLINICAL PHARMACOLOGY. Clinical Studie
section) Twenty-eight (23: patients 2 to 5 years of age with allergic rhinitis were treated with mometasone furoate nasa! spray
50 meg itOC meg total daily- cosei in a controlled trial tc evaluate safety isee CLINICAL PHARMACOLOGY Pharmacokinetic
section-. Safer* and effectiveness m children less than 2 years of aoe with allergic rhinitis and n children less than is year
of age with nasal polyps have not been established
A cjimcai study nas been conducted 'or 1 year in pedatnc patients with allergic rhinitis (ages 3tc 9 vea r s) to assess th
effect of NASDNEx Nasal Sera;,. 50 meg ;fOO meg total daily dose) on growth velocity Nc statistically significant ehect o>
growth velocity vas observed for NASONEX Nasal Spray 50 meg compared to placebo No evidence of clinically relevant HP/
axis suppression was observed following a 30-minute cosyntropm infusion.
The potential of NASONEX Nasa! Spray. 50 meg to cause growth suppression m susceptible patients or when given at high
er doses cannot be ruled out
Geriatric Use: A totai of 2SO caiients above 64 years cf age with akerg e rhinitis or nasal polyps (age range 64 to 86 years
have been treated with NASONEX Nasa: Spray 50 meg tor up to 3 or 4 months, tespectivety The adverse reactions 'eponed«
this population were similar m type and incidence to those 'eponed by younger patients
ADVERSE REACTIONS Allergic Rhinitis n controlled US and international dinicai studies, a total of 3210 adult and adoles
cent patients ages 1 2 years anc Oder with allergic rhinitis received treatment with NASONEX Nasa Sprav 50 mco at dose
of 50 tc 80G meg/fla-,- Tne maionty o? patients (n = 2103! were treated with 200 meg/day. in controlled US an; internation;
studies, a total of 99-3 pedatnc patients (ages 3 to V- years) with allergic rhinitis received treatment with NASONEX Nas;
Spray. 50 meg at doses of 25 to 200 meg/day Tne majority of pediatric patients (720) were treated with 100 meg-day A tot;
ot 513 adult adolescent and pedatnc patients have been treated for 1 year o f longer The overall incidence of adverse event
for patients neate: with NASDNEX Nasal Spray. 50 meg was comparable to patients treated with the vehicle placebo Alsc
adve r se events did not differ significantly based on age sex. or race Three oercent or less of patients in clinical tnals discon
tmue: treatment because of adverse events this rate was similar for the vehicle and active comparators
Ail adverse events regard-ess of relationship to treatment ; reported by 5% or more of adult and adoiescent patients age
12 years and older who received NASONEX Nasal Spray. 50 meg. 200 meg/day and by pedatnc patients ages 3 to r year
who received NASONEX Nasal Spray 50 meg 100 meg/day m clinical tnais vs placebo and that were more common witt
NASONEX Nasa: Spray. 50 meg than placebo are displayed in the table below
ADVERSE EVENTS FROM CONTROLLED CLINICAL TRIALS IN SEASONAL ALLERGIC AND PERENNIAL ALLERGIC RHINITIS
(PERCENT OF PATIENTS REPORTING)
Adult and Adolescent Patients 12 years and older Pediatric Patients Ages 3to 11 years
NASONEX 200 meg VEHICLE PLACEBO NASONEX 100 meg VEHICLE PLACEBC
(n = 2103) (n s 1671) (n = 374) (n = 376)
neacache 26 22 17 15
V'3i mfeacp 14 it 8 9
Pna'vncrtis 12 to 10 10
Epistaxis-Btood-Tinged Mucus 11 6 8 9
CouchmQ 7 6 13 15
Upper Respiratory Tract Infection 6 2 5 4
Dysmenorrhea 5 3 1 Q
Muscuioskeietai 5 3 i 1
Vcmitmo 1 ] 5 4
othe r acve'se e.enc. wrach occurred m less than 5-'-. but g-eate - ran c' ecua to 2°- o‘ mometasone tu'oate adu* anc adoescent caber:
-ages 12 .-ears an: offer; treated :.t doses iregartfess of to treatment, and mo r e frequent:/ than m the ptaceoc you
msudec arthrags astrma bronclte. chest oar; conuneMis camea c.-soepsa earacne. symptoms nr,alga, nausea rtumtc
Other adverse events which occurred n :»ss than 5% but greater than or equal tc 2 : -o of mometasone furoate pedatn
patients ages 3 to 11 years treated with 1 00-mcg doses vs oteeebc (regardless of relationship to treatmenti arc mere frequent
•y than m tne piacebo group included- diarrhea nasai irritation otitis media and wheezing
T r? adverse event 'regardless of reiationsmp tc treatment! reported by 5“-. of pedatnc patients ages 2to 5 years wfn
rece ved NASONEX Nasa: Spray. 50 meg. 100 meg day in a cfimcai tnat vs piacebo including 55 subjects «28 eacn NASONE
Nasai Spa;, 53 meg 3i: o acebo) ana tnat was more common with NASONEX Nasai Spray 5C meg than piacebo include:
-bper respiratory tract infection ;7°c vs o*l-8. respectively: The other adverse event which occurred in less than s®c but greate
than or ecua: to 2*? of mometasone furoate pedatnc patients ages 2 to; years treated with 100-mcg doses vs placed
'eoaroiess o' relationship to treatment) and moa frequently than m the places: group included skin trauma
Nasal Polyps in controlled clinical stuc.es tne types of adverse events ccse r ;ed in patients with nasai polyps were sum
iar to these observed for patients with allergic rhinitis. A total of 594 adult patients (ages 18 to 36 years) received NASONS;
Nasai Spray. 5C meg. at doses of 200 meg once cr twice daily tor up to 4 months to' treatment of nasal polyps. The overa
incidence of adverse events for patients treated with NASONEX Nasai Spray 50 meg was comparab’e tc patients treated witt
the piacebo except for eoistaxis which was 9% tor 200 meg once daily ?3 a c for 200 mco twice daily and s°o for placebo
Rare cases of nasal ulcers and nasai and ora candidiasis were aiso reported in patients treated with NASONEX Nasai Spra
50 meg primarily in patients treated tor -onger than 4 weeks
in postma'ketmg surveillance of this product cases of nasai Durning anc irritation, anaphylaxis and angioedema. am
ra'e cases of nasai septai oerforation have been reported Disturbances of taste and smell have been reported very rarely
OVERDOSAGE Tne r e are no oata available on the effects of acute or chrome overdosage with NASONEX Nasal Spray 50 meg
3ecai.se of low systemic, tkoavaiUMir/ aid an absence o' acute drug-related systemic findings in clinical studies overdose is un ike
- to leouire any therapy other than observation, ntanassi administration of 1600 meg i 4 times the recommended dose c
NASONEX hiasa'. Spray 50 meg daily- for 29 days to healthy human volunteers, was we:i tolerated with no increased incidence c
adverse events Singe ntranasa 1 coses up to 4000 meg rave been studied m human volunteers with nc adverse effects -eportec
Single c’a! doses up to 8900 meg have been studied m human volunteers with np adverse ejects reported Chronic overoosage witl
any corticosteroid ma> result r signs or symptoms of hy-percortic-sm. see PRECAUTIONS» Acute overoosage with this dosage tom
is unkkely since cne bottle of NASONEX Nasa Spray 50 meg contains approximately 3503 meg cf mometasone 'ornate
C
Schering Corporation
Kenilworth, til 07033 USA
Copyright £• 1997 2003.2005 Schenng Corporation All riohts reserved Rev 9/Of
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Grapevines at Jessie’s Grove Winery are the
oldest in the Lodi region, dating to the 1890 s.
(Continued from page 5)
fidence that the legacy of their vineyards
and winery will be in the hands of their
children, who will continue to elevate the
stature of Lodi's wines.
“Lodi doesn’t want to be Napa,” Marissa
explains. “Lodi just wants to be Lodi
because it's a generational town.”
Jeanne Lauj Walpole is a freelance writer
based in Reno. Nev.
To comment or to access the Lodi
Grape Festival website, click on this
story at americanprofile.com.
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