Newspaper Page Text
NASONEX® PROOUCT INFORMATION
(mometasone furoate monohydrate)
Nasal Spray, 50 meg*
FOR INTRANASAL USE ONLY
* calculated on the anhydrous basis
BRIEF SUMMARY (For hill Prescribing Information, see package insert.)
INDICATIONS AND USAGE NASONEX Nasal Spray. 50 meg is indicated for the
treatment ot the nasal symptoms of seasonal allergic and perennial allergic rhini
tis. m adults and pediatric patients 2 years of age ana older. NASONtX Nasal
Spray. 50 meg is indicated for the prophylaxis of the nasal symptoms of season
al allergic rhinitis in adult and adolescent patients 12 years and older. In patients
with a known seasonal allergen that precipitates nasal symptoms of seasonal
allergic rhinitis, initiation ot prophylaxis with NASONEX Nasal Spray. 50 meg is
recommended 2 to 4 weeks prior to the anticipated start ot the poller season
Safety and effectiveness of NASONEX Nasal Soray. 50 meg m pediatric patients
less than 2 years of age have not been established
NASONEX Nasal Spray. 50 meg is indicated for the treatment of nasal polyps
m patients 18 years of age and older Satetv and effectiveness of NASONEX
Nasal Spray. 50 meg. for the treatment of nasal polyps m pediatric patients less
than 18 years of age have not been established
CONTRAINDICATIONS Hypersensitivity to any of the ingredients of this prepara
tion contraindicates its use.
WARNINGS Tne replacement of a systemic corticosteroid with a topical corti
costeroid can be accompanied by signs of adrenal insufficiency and. in addi
tion some patients may experience symptoms o' withdrawal: ie. joint ano or
muscular pam lassitude and depression Carefui attention must be giver
when patients previously treated for prolonged periods with systemic cortico
steroids are transferred to topical corticosteroids, with careful monitoring for
acute adrenal insufficiency in response to stress This is oarticulariy important
in those patients who nave associated asthma or other clinical conditions
where too rapid a decrease in systemic corticosteroid dosing mav cause a
seveie exacerbation of their symptoms
If recommended ooses of intranasal corticosteroids are exceeded or if individuals
are particularly sensitive or predisposed by virtue of recent systemic steroid thera
py. symptoms of hypercolicism may occur, including very rare cases of menstrual
irregularities acneilorm lesions and cushtngod features' if suen changes occur
topical corticosteroids should be discontinued slowly consistent with accepted pro
cedures tor discontinuing oral steroid therapy
Persons who are on drugs which suppress the immune system are more sus
ceptible to infections than healthy individuals Chickenpox anc measles for exam
ple. can have a more serious or even lata! course m nommmune children or adults
on corticosteroids in such children or adults who nave not hac these diseases
particular care should be taxen to avoid exposure How tne dose route, and dura
tion ot corticosteroid administration affects the nsk of developing a disseminated
infection t$ not known The contribution of the underlying disease andror prior
corticosteroid treatment to the risk is also not known it exposed to chickenpox
prophylaxis with varicella zoster immune globin (VZIGi mav be indicated if
exposed to measies, prophylaxis with pooled intramuscular immunoglobulin ;iG)
may be indicated (See the respective package inserts fo r complete VZIG and lG
prescribing information.) h chickenpox develops, treatment with antiviral agents
may be considered
PRECAUTIONS General: intranasal corticosteroids may cause a reduction m
Sowth velocity- when administered to pediatrc patients isee PRECAUTIONS.
idiatric Use section). In dmo studies with NASONEX Nasal Spray. 50 meg. the
development of localized infections of the nose and pharynx with CaW a&can
has occurred only rarely When such an infection develops, use of NASONEX Nasal
Spray 50 meg should be discontinued and appropriate local or systemic tnerapy
instituted, if needed
Nasal corticosteroids snouid be used with caution if at all in patients with acbve
or quiescent tuberculous infection of the respiratory tract or in untreated fungal
oactenai systemic viral infections or ocular herpes simplex
Rarefy immediate hypersensitivity reactions may occur after tne intranasal
administration of mometasone furoate monchydrate Extremes ra r e instances of
wheezing have been reported
Rare instances of nasal septum perforation and increased intraocular pressure
have also Deer reported following the intranasal application ot aerosofzed cortico
steroids As witn any iong-term topical treatment of the nasa: cavity, patients using
NASONEX Nasal Spray 5C meg over several months or longer should be examined
periodically for possible changes in the nasal mucosa
Because of the inhibitory effect of corticosteroids on wound healing patients
who have experienced recent nasal septum ulcers nasal surgery, or nasal trauma
should not use a nasal corticosteroid until healing has occurred
Glaucoma and cataract formation was evaluated in one controlled study of
12 weeks' duration and one uncontrolled study of 12 months duration in
patients treated witn NASONEX Nasal Spray 50 meg at 200 meg/day using
intraocular pressure measurements ana slit lamp examination No significant
change from baseline was noted in the mean intraocular pressure measure
ments for the 141 NASONEX-treated patients in the 12-week study as com
pared with 141 placebo-treated patients No individual NASONEX-treated
patient was noted tc have developed a significant elevation in intraocular pres
sure oi cataracts m this 12-week study Likewise no significant change from
baseline was noted in the mean intraocular pressure measurements tor the 139
NASONEX-treated patients m the 12-month study anc again, no cataracts were
detected in these patients Nonetheless nasal and inhaled corticosteroids have
been associated with the development of glaucoma ana/or cataracts
Therefore close follow-up is warranted m patients with a change in vision and
with a history of glaucoma and/or cataracts
When nasal corticosteroids are used at excessive doses, systemic corti
costeroid effects such as hypercortiosm and adrenal supp-ession mav
appear If such changes occur. NASONEX Nasai Spray 50 meg should be dis
continued slowly, consistent with accepted procedures for discontinuing oral
steroid therapy
Information for Patients: Patients being treated with NASONEX Nasa' Spray
50 meg should be given the following information and instructions T his information
is intended to aid in the safe and effective use of this medcat on It is not a disclosure
of ail intended or possible adverse effects Patients should use NASONEX Nasai
Spray. 50 meg at regular intervals (see DOSAGE AND ADMINISTRATION since its
effectiveness depends on regular use Improvement m nasal symptoms of allergc
rhinitis has been shown to occur within 11 hours after the first dose based on one
sinole-dose. parallel-group study of patients in an outdoor park' setting (park study)
and one environmental exposure unit (EEU) study and within 2 days after tne first
dose in two randomized double-blind piacebo-controiied. paraiie l -group seascnai
allergic rhinitis studies. Maximum benefit is usually achieved within 1 to 2 weeks after
initiation of dosing. Patients should take the medication as directed and should not
increase the prescribed dosage n an attempt to increase its effectiveness Patients
should contact their physician if symptoms do not improve, or if the condition 'wors
ens Tc assure proper use of this nasai spray ana to attain maximum benefit, patients
should read and follow the accompanying Patients instructions fo r Use carefully
Administration to young children should be aided by an adult
Patients should be cautioned not to spray NASONEX Nasal Spray. 50 meg into
the eyes or directly onto the nasal 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 it they are exposed medical advice should be sought
without delay
Carcinogenesis. Mutagenesis. Impairment of Fertility: In a 2-year carcino
genicity study in Sprague Dawfey rats, mometasone furoate demonstrated no
statistically significant increase in the incidence of tumors at inhalation doses up
to 67 mcglrg (approximately 1 and 2 bmes the maximum recommended daily
intranasal dose [MRDfD] in adults (400 mcgl and children (100 meg) respec
tively on a meg/m' basis) In a 19-month carcinogenicity study m Swiss CD-1
mice mometasone furoate demonstrated no statistically significant increase m
the incidence of tumors at inhalation ooses up to 160 meg/kg (approximately
2 bmes the MRDID in adults and children respectively on a meg/m' basis)
Mometasone furoate increased chromosomal aberrations m an m vitro Chinese
hamster ovary-cell assay, but did not increase chromosomal aberrations in an
•n v!rc Chinese hamster lung ceil assay Mometasone furoate was not mutagenic
m the Ames test or mouse-lymphoma assay, and was not clastogemc in an in mo
mouse micronucieus assay and a rat bone marrow chromosomal aberration
assay or a mouse male germ-cell chromosomal aberration assav Mometasone
furoate also did not induce unscheduled DNA synthesis m me in rat hepatocytes
In reproductive studies m rats impairment of fertility was not produced by
subcutaneous doses up to 15 meg/kg (less than the MRDID in adults on a
meg/m basis)
[nasqnexj
(mometasone furoate monohydrate)
Nasal Spray, 50mcg*
' r.i : os s
Pregnancy Teratogenic Effects: Pregnancy Category C: When administered to
pregnant mice rats and rabbits mometasone furoate increased fetal malforma
tions. lie ooses that produced malformations also decreased fetal gw/th. as
measured by lower fetal weights and/or delayed ossification Mometasone furoate
also caused dystocia and related complications when administered to rats dunng
the end of pregnancy
in mice momerasone furoate caused deft palate at subcutaneous doses of
60 meg/kg and above (less than the MRDID in adults on a meg/m basis) Fetal sur
vival was reduced at 180 meg/kg (approximately 2 times the MRDID in adults on a
meg'm bas*s). No toxicity was observed at 20 meg/kg dess than the MRDID in
adults on a megm basis)
In rats mometasone furoate produced umbilical hernia at topical dermal
doses of 600 mcg'kg ana above (approximately 10 times the MRDID in
adults on a meg/m basis) A oose of 3CO meg/kg (approximately 6 times
the MRDID in adults on a meg/nr basis) produced delays in ossification
but no malformations
In rabbits mometasone furoate caused multiple malformations (eg. flexed
front paws gallbladder agenesis, umbilical hernia, hydrocephaly) at topical
derma: doses of 150 mcg'kg and above (approximately 6 times the MRDID m
adults on a megm- basis), in an oral study mometasone furoate increased
resorptions and caused cleft paiate and/or head malformations (hydrocephaly
or domed head! at 700 meg/kg (approximately 30 times the MRDID m adults
on a megm oasis) At 28M mcg y kg iapproximately 110 times the MRDID in
adults on a meg m basis) most liners were aborted or resorbed No toxicity
was observed at 140 mcg.'kg (approximately 6 times the MRDID in adults on a
megm' basis)
When rats 'ecetved subcutaneous doses of mometasone furoate throughout
pregnancy or durng the later stages of pregnancy. 15 mcg'kg (less tnan the
MRD'D m adults on a meg'm basis) caused prolonged and difficult labor and
reduced the number of live births, birth weight and early pup survival Similar
effects were not observed at 7 5 meg/kg dess than tne MRDID m adults or a
megm basis)
There are no adequate and well-controlled studies m pregnant women
NASONEX Nasal Soray 50 meg. like other corticosteroids should be used dur
ing pregnancy only if the potential benefits justify the potential usk to the fetus.
Experience with oral corticosteroids since their introduction in pharmacologic,
as opposed to physiologic, doses suggests that rodents are mere prone to
teratogen c effects from corticosteroids than humans in addition because
there is a natural increase in corticosteroid production during pregnancy most
women will require a lower exogenous corticosteroid dose anc many will not
need corticosteroid traatment during pregnancy
Nonteratogemc Effects. Hypoadrenaksm may occur in infants born to
women receiving corticosteroids dunng pregnancy Such infants should be
carefully monitored
Nursing Mothers. It is not known if mometasone furoate is excreted in human
muk Because other corticosteroids are excreted in human milk caution should be
used when NASONEX Nasal Spray 50 meg is administered tc nursing women
Pediatric Use: Controlled clinical studies have shown intranasal cortico
steroids may cause a reduction m growth velocity m pediatric patients This effect
has been observed .n the absence ot laboratory evidence of hypothalamic-pitu
itary-adrena. (HPA) axis suppression, suggesting that growth velocity is a more
sensitive indicator of systemic corticosteroid exposure in pediatric, patients than
some commonly used tests of HPA axis function. The long-term effects of this
reduction m growth velocity associated with intranasal colcosteroids including
the impact on final adult neignt are unknown. The potential for "catch up'
growth following discontinuation of treatment with intranasal corticosteroids has
not been adequate')- studied T he growth of pediatric patients receiving intranasal
corticosteroids including NASONEX Nasai Spray 50 meg should be monitored
routinely (eg. via stadiometry) The potential growth effects of prolonged treat
ment snouid oe weighed agamst clinical benefits obtained and the availability of
safe and effective noncorocosteroid treatment alternatives To minimize the sys
temic effects of intranasal corticosteroids including NASONEX Nasal Sprav
50 meg each patient should be titrated to htstter owest effective dose
Seven hundred and twenty (720) patients 3 to 11 years of age with allergic
rhinitis were treated with mometasone furoate nasai spray 50 meg (100 meg
total dauy cosei m controlled climca: trials <see CLINICAL PHARMACOLOGY.
Clinical Studies section) Twenty-eight (28) patients 2 to 5 years of age with
allergic rhinitis were treated with mometasone furoate nasal spray. 50 meg
(100 meg total daily dose) in a controlled trial to evaluate safety isee CLINICAL
PHARMACOLOGY, Pharmacokinetics section) Safety and effectiveness in chil
dren less than 2 years o' age with allergic rhinitis ano in children less than
‘8 years of age with nasal polyps have not been established
A clinical study has been conducted for 1 year in pediatric patients with allergic
rhinitis (ages 3 to 9 years) to assess the effect of NASONEX Nasal Spray 50 meg
(100 meg feta daily dose) on growth velocity No statistically significant effect on
growth velocity was observed for NASONEX Nasal Spray. 50 meg compared tc
placebo No evidence o! clinically relevant HPA axis suppression was observed
following a 30-minute cosyntropin infusion
The potential of NASONEX Nasal Spray. 50 meg to cause growth suppression
in susceptible patients or when given at higher Ooses cannot be ruled out
Geriatric Use: A total of 280 patients above 64 years of age with allergic rhinitis
or nasal po<yps (age ranoe 64 to 86 years) have been treated with NASONEX Nasal
Spray. 50 meg for up to a or 4 months respectively The adverse reactions report
ed in this population were similar in type and incidence to those reported by
younger patients.
ADVERSE REACTIONS Allergic Rhinitis. In controlled US and international clin
ical studies a total of 3210 adult and adolescent patients ages 12 years and older
with allergic rhinitis received treatment with NASONEX Nasal Sprav. 50 meg at
doses of 50 to 800 meg/day. The majority of patients (n = 2103) were treated with
200 meg/day. In controlled US and international studies, a total of 990 pediatric
patients (ages 3 to 11 vears) with allergic rhinitis received treatment with
NASONEX Nasal Spray 50 meg at doses of 25 to 200 meg/day. The majority of
pediatric patients (720) were treated with 100 meg/day A total of 513 adult ado
lescent, and pediatric patients have been treated for 1 year or longer The overall
incidence of adverse events foi patients treated with NASONEX Nasal Spray.
50 meg was comparable to patients treated with the vehicle placebo Also adverse
events did not differ significantly based on age. sex. or race. Three pecent or less
of patients in clinical trials discontinued treatment because of adverse events this
rate was similar for the vehicle ano active comparators
All adverse events (regardless of relationship tc treatment) reported by 5% or
more of aduit and adolescent patients ages 12 years and older who received
NASONEX Nasal Spray 50 meg. 200 meg/day and by pediatric patients ages 3 to
11 years who received NASONEX Nasal Spray 50 meg. 100 meg/flay in clinical
trials vs placebo and that were more common with NASONEX Nasal Spray'.
50 meg than piacebc. are displayed in the table Wow
ADVERSE EVENTS FROM CONTROLLED CLINICAL TRIALS IN SEASONAL
ALLERGIC AND PERENNIAL ALLERGIC RHINITIS
(PERCENT OF PATIENTS REPORTING)
Acuit and Adolescent Patients Pediatnc Patients Ages
12 years and older 3 to 11 years
NASONEX VEHICLE NASONEX VEHICLE
200 meg PLACEBO 100 meg PLACEBO
(n = 2103) (n a 1671) (ns 374) (n = 376)
Headache 26 22 17 18
Viral infection 14 11 8 9
Pharyngitis 12 10 10 10
Epistaxis/Biood-
Tmged Mucus I_l 6 8 9
Coughing 7 6 13 15
Upper Respiratory
Tract Infection 6 2 5 4
Dysmenorrhea 5 3 1 p
Musculoskeletal Pam 5 3 1 1
Sinusitis 5 3 4 4
Vomitmo 1 1 5 4
Other adverse events which occurred in less than 5% but greater than or equai to 2%
of mometasone furoate adult and adolescent patients (aoes 12 years and older) treated
with 200-mcg doses (regard'ess of relationship to treatment), and more frequently than
m the placebo group included arthralgia, asthma, bronchitis chest pam. conjunctivitis,
diarrhea dyspepsia earache flu-iike symptoms, myalgia nausea and rhinitis
'Other adverse events which occurred in less than 5% but greater than or equal
to 2% of mometasone furoate pediatnc patients ages 3 to 11 years treated with
100-mcg doses vs placebo (regardless of relationship to treatment) and more fre
quently than in the placebo group included' diarrhea, nasal irritation, otitis media,
and wheezing
The adverse event (regardless of relationship to treatment) reported by 5%
of pediatnc patients ages 2 tc 5 years who received NASONEX Nasai Spray.
50 meg. TOO meg/day in a clinical triai vs placebo including 56 subjects (28
each NASONEX Nasal Spray, 50 meg and placebo) and that was more common
with NASONEX Nasal Spray. 59 meg than placebo included upper respiratory
tract infection (7% vs 0% respectively). The other adverse event which
occurred in less than 5% but greater than or equal to 2% of mometasone
furoate pediatric patients ages 2 to 5 years treated with 100-mcg doses vs
placebo (regardless of relationship to treatment) and more frequently than in
the piacebo group included skin trauma
Nasal Polyps in controlled clinical studies, the types oi adverse events
observed in patients with nasai polyps were similar to those observed for patients
with allergic rhinitis. A total ot 594 adult patients (ages 18 to 86 years) received
NASONEX Nasal Spray 50 meg at doses of 200 meg once or twice daily for up
to 4 months for treatment of nasal polyps The overall incidence of adverse events
for patients treated with NASONEX Nasal Spray. 50 meg was comparable to
patients treated with the placebo except for epistaxis which was 9% for 200 meg
once daily 13% for 200 meg twice daily and 5% tor placebo
Rare cases of nasal ulcers and nasal anc oral candidiasis were aiso reported in
patients treated with NASONEX Nasal Spray. 50 meg. primarily in patients treated
for longer than 4 weeks.
In postmarketing surveillance of this product cases of nasal burning and
irritation, anaphylaxis and angioedema and rare cases of nasal septai per
foration have been reported Disturbances of taste and smell have been
reported very rarely
OVEROOSAGE There are no data available on the effects of acute or chronic over
dosage with NASONEX Nasal Spray 50 meg Because of low systemic bioavailabil
ity and an absence of acute drug-related systemic findings in clinical studies over
dose is unlikeiy to require any therapy other than observation Intranasal adminis
tration of 1600 mco |4 times the recommended dose of NASONEX Nasal Spray.
50 meg) daily for 29 days to hea'thy human volunteers was well tolerated with no
increased incidence of adverse events Single intranasal doses up to 4000 meg
have been studied in human volunteers with no adverse effects reported. Single
oral ooses up to 8000 meg have been studied m human volunteers with no adverse
effects repoled Chronic overdosage with any corticosteroid may result in signs or
symptoms ot hypercolicism (see PRECAUTIONS. Acute overdosage with this
dosage form is unlikely since one bottle oi NASONEX Nasal Spray 50 meg con
tains approximately 8500 meg of mometasore furoate
Cl
Schenng Corporation
Kenilworth. NJ 07033 USA
Copyright © 1997 2003.2005. Schermg Corporation All rights reserved.
Rev. 9/05
26405289T-JBS
fm iftr yrfw* n
* 1 o?.' /
Photo: AldrV'Sd-’v r -
Paul Revere
fan Retta Zumwalt
of Bentonville, Ark.
(Continued from page 7)
to their roots. Many live close to where
they grew up, and return there on breaks
between shows—Fabian to Connersville,
Pa., Medley to California (he has homes
in Newport Beach and Palm Springs) and
Vee to St. Joseph, Minn. Several members
of The Comets have bought homes in
Branson, so certain that the crowds will
keep coming.
‘‘Our music is good, clean American
music,” says Comets sax player Joe DAmbrosio,
72. "And that’s what were about.” Zfr
A/anna Nash is a frequent contributor to
American Profile.
Call (877) 588-1957 for more
information.
Rate This Story
How did you like this story? Log
on to www.americanprofile.com/rate.
SPECIAL CD OFFER
Do You 7,
Love the FIFTIES
Music of
The Fabulous
from Tim- et
Life with 50 terrific hits from
the original artists. Enjoy the music
of Elvis, The Platters, Pat Boone, The
McGuire Sisters and Bobby Darin, and
hits like Que Sera, Sera, Chances Are,
Mr. Sandman, Goodnight Irene, Sixteen
Tons and -45 more Golden Memories.
To receive 3 CDs for $29.99, visit
www.americanprofile.eom/store
or please have your credit card ready and
call (800) 715-6248 or send check for
$34.95 to ’sos Music - Dept. AP, P.O.
Box 340, Harrison, AR 72602.
CA. TN. IL, AR. NY residents add state sales tax. NSF
checks automatically debited for amount of check plus
applicable fees. Expires 11/3/06. Please allow 2-1 weeks for
delivery. Offer good while supplies last!
American Profile •
Page 8