Flonase is approved to treat more triggers
than any of these allergy medicines.
Pollen
Pet Dander Dust Mites
Pollution
Smoke Strong Odors
Flonase*
Nasonex*
Zyrtec*
Claritin1
Allegra*
more than Nasonex
more than Zyrtec
more than Claritin
more than Allegra
F LONASE is approved to treat more triggers than these leading* allergy medicines.
If you re like most people with nasal allergies, you suffer from more than just seasonal allergies.. .you may
also suffer from indoor triggers or get nasal symptoms from smoke, strong odors, or pollution. But all it takes
Is FLONASE to treat all those triggers. Not even these leading pills and nasal spray are approved to do that
More reason than ever to talk to your doctor about FLONASE.
Results may vary. If side effects occur, they are generally mild, and may include headache, nosebleed, or sore
throat For best results, use daily. Maximum relief may take several days. Available by prescription only.
GlaxoSmithKline
" Available by prescription only,
t Available over-the-counter.
* “Allegra, Claritin, Zyrtec, Flonase, Nasonex, and Clarinex are
When you get it all, all it takes is
1-800-427-52951 www.flonase.com (fluticasone propionate)
Nasal Spray 50 meg
among the leading prescription allergic rhinitis products.” Source: Scott-Levin’s Source™ Prescription Audit (SPA) from Verispan; October 2001-September 2002.
The brands listed are trademarks of their respective owners and are not trademarks of The GlaxoSmithKline Group of Companies. The makers of these brands
Please see important information below.
are not affiliated with and do not endorse GlaxoSmithKline or its products
FLONASE®
(fluticasone propionate)
Nasa! Spray, 50 meg
For intranasat Use (My. SHAK£ G0fTLY BEFORE USE.
Thetojgwing is a brief summary only; see tub prescribing intormatnn (or conyitete product
CONTRAINDICATIONS
FIONASE Nasal Spray is sxmtraindicated in paHenb wffi a hypersensitivity to any of its
Die replacement of a systemic corticosteroid with a topical corticosteroid can be
ararpamwl by siots ot adrenal insufSaency, and in aOdition some patients may experience
symptom ot withdrawal, e.g., joint ante muscular pain, lassitude, ana depression. Patients
prewusly treated for prolonged periods with systemic corticosteroids and transferred to
topkial corticosteroids shoutflbe carefully monitored tor acute adrenal insufficiency in
response to stress. In Btose patents who have asthma or other clinical conditions requiring
long-term systemic corticosteroid treatment too rapid a decrease in systemic corticosteroids
may cause a severe exacerbation of their symptom.
The concomitant use of intranasal corticosteroids with other inhaled corticosteroids
raid increase the nsk of signs or symptoms ot hypercortictsm and/or suppression of the
nypoinajamic-pituitaiy-adrenal (HPA) axis.
■jSBjuyBisssasi
senousror even fatal course in susceptible children or adults using corticosteroide. In children
or adute who have not had these teases or been properly immunized, particular care
should be taken to avoid exposure. How the dose, route, and duration (/corticosteroid
administration affect the nsk of developing a disseminated inteebon is not known. The
contribution of the undertying disease ante prior corticosteroid treatment to the risk is also
not known. It exposed to chftenpox. prophylaxis with varicella zoster immune globulin (VZIG)
may be indicated. If exposed to measles, prophylaxis with pooled intramuscular
immunoglobulin IIG) ray be indicated. (See the respective package inserts tor complete VZIG
beroradOTd9 rtomH,lon*11 develops, treatment with antiviral agents may
Avoid spraying in eyes.
PRECAUTIONS
-rrrr -rr—. <■*!«„ a (eduction in 9™wlh velocity when
adnrnstered to pediatnc patients (see PRECAUTIONS: Pediatric Use)
, Rarety. mimejfete.riypgsensibvity reactions or contact dermafe may occur after the
adl!"!!S3tl0l(,, Nasal W instances ot wheezing, nasaJ septum
.. #ough systemic afects have been mininial with reranmended doses ot FLONASE
used at higher than recommended doses or in rare individuals at recommended
do*s, asteny corticosteroid gfecte such as hvp«rar8cism and adrenai suppression may
appear, i «uflWffi Mg*™SE Nasal SprayjWd bediscocrfinued
slowy consistent w® accepted procedures lor discontinuing oral cortcosteroid therapy.
itfPtfegsal
Candite infection or other signs of adverse effects on Die nasal mucosa.
Intranasal corticosteroids should be used with caution, if at all, in patients wttb active or
gu»sc^tLi^lousinfec^dOiefespifa^tract;untreated(o<yofsysterscfijngalof
^5»3srass5saara*ta
tnfcnjwUon fortati«itc ^ente being hjated with aONASE Nasal Spray should receive
•» Worn mformahon andinstructons. This information is intended to adtem in the sate
and effective use of this metecabon. It b not a disclosure of aU possible adverse or intended
Mente shouWuse MMSEM Spray at regular interyats tor optima) effect Some
^^once^e^^tDr^mpt3mcontrot(see^niS|lTHafe^ctontfM^M^fM
days. The patient should not mease the prescribed 4
| dosage txit should contact the physician
cSLnistrataof a single doseot orally inha^tKneTOilteltMrncjSte
maximum daily intranasd dose) wrth multiple doses of ketoconatole ($00 fngfto steady
state resulted in increased mean flubcasone prowonate concentrations, a reduction in
Plasm cortisol AUC. and no effect on urinary excretion of cortisol. This interaction may be
(fae to an inhibition ol cytochrome P450 3A4 by ketoconazole, which is also die route of
metetotem of fluticasone propionate. No drug interaction studies have been conducted with
SSSSSKWS'&’Bf
Ebs
(approximately 20 hmes de maximum recommended daily mtranasal dose in adultsand
approximaWy 10 hmes the maximum recommended daily mtranasal dose In children on a
mcgtm basis) for 78 weeks or in rate at inhalation doses up to 57 mcg/kg (approximately 2
lines the maximum recommended daily mtranasal dose in adults and approximately
equivalent to the maximum recommended daily intranasal dose in children on a mq/iff
basis) tor 104 weeks.
fluticasone propionate did not induce gene mutation in prokaryotic or eukaryotic cells in
vitro. No signiflcant dastogenc effect was seen in cultured human peripheral lymphocytes in
row in the mouse micranucieos tel
No evHlence of impairment of fertility ms observed in reproducth« studies conducted in
male and female ratsi at states doses up to 50 mcpg (approximately 2 times die
jssgsmsaaBsutta
ssasmt&asBt^ffajjg^sa
revealed fetal toxicity characteristic of potent corticosteroid
growth retardation omphalocele, deft palate, and retarded
, In the rabbit, fetal weight reduction and deft palate*
In the rabbit, fetal weight reduction and'deft palate were observed at a subcutaneous
dose of 4 mcata (less tote tnaxmum recommended daily =ntranasai dose in adults on a
beMB
propionate staid t^SediLnrJg pr^t^ if he poAalS |S tepS
risk to the fetus.
Experience with oral corticosteroids since their intoduction in pharmacologic, as
addition, because there is.a natural increase in
a lower exogenous
corticosteroid production during preonancy, most women will require a lower ext
sMRwaiESsitssiw
breast milk. However, other corticosteroids have been detected in human milk Subcutaneous
administration to lactathg rate of 10 mcgtoof total fluticasone propionate (less to the
maximum recomrondaf daily teanaal dose in adults on a mcghtf basis) resulted in
measurable radmactryite in the milk Since there are no data from controlled trials on
[Metric Uw live hundred MO) patients aged 4 to 11 years and 440 patents aped 12 to
17 years were stu
and effectiveness
Controlled clinical studies have shown tel intranasal corticosteroids may cause a
reduction m growth velocity in oeSatric patents. This effect has t- ' "
more sensitive indicator
commonly used tests of
velocity associated with
are unknown.Thee
etong
routnely (en„ via toiomety) The potenJorowlh effects Winged treatmentH
be wenhea
j&wassssws
ateraSes. To minimize the systemic effects of intranasal corticosteroids, induS
aONASENasal Spmeacb patiwt should be titrated to the lowest dose that effect
tattjcUK A limited number of patients f
age and okta (n=11) have been treated with
2:, -s.s-i.'-- ■ ~ —• FLONASE Masai Spay in OS and non-l^cHnical
tote. Wtele die number of patients is too small to permit separate antdysis of etfacy and
safety, die adverse reactions reported n this population were similar to those ported by
younger patente,
ADVERSE REACTIONS
Mi corflrotled USsfaidies ynofe than.3,300 patterns with seasonal aJeme, perennial allergic,
1 nonatlergic rhmits received treatment with intranasal fticasor* propionate.
te jpraLadverse reactions m drat Ouches have been primarily associated wS rotation
w nasdimucous membranes^*! the adverse reactions were reported with amdmatety
teame frawby patents treated with the vetvicte itself the 00S1® ITnotusuSy
rtafere withjemM cess to 7% of patients in dHcal thateS&iued because
ol adverse eventsttis rate was.sirrdar lor vehciepiacteo andactive comparators.
Systemic corUindsttMi wm not reported dunng con* fcal studies up
te 6 months iteration with RONASE Nasal Spray, If recommended doses are excem
hoiyevB, or if ndrnitateare parfatarly sensitwe or taking RONASE Nasal Spray 1
cowncbon with administration ot other corticosteroids, smptoms of hypercortidsm, e.q
—■—4 sym(fc 01 hyperatafn' **•
The following rodeje ot common adverse rectos (>3%. where incidence, i
Ms m vdach 536 patients (57 girts and 108 boys aged 4 to 11 'years, 137 female and
^mateadotescer*»id^iMwere1reatedw«iff0NASEI*KdSpray2O0mcgonce
daily over 2 to 4 weeks and 2jcontro«ed clinical trials in which 246 pafaits 119 fen* and
12/ male adolescents aid adufts) were heated with RONASE Nasal Spray 200 meg once
Wy ffi6 R'wrths. Also induded in the table are adverse events from 2 studies in which
16/chiWren (45 guts aid 122 boys aged 4 to 11 years) were treated with RONASE Nasal
Spray 100 meg once daily for 2 to 4 weeks.
or Perennial Attwgic Rhinitis
Adverse Experience
Vehicle Placebo
(n=758)
FLONASE
100 meg Once
Daffy
(n=167)
%
FLONASE
200 meg Once
Dauv
(n=782)
%
Headache
Pharyngitis
Epistaxis
Nasal burning/
nasal irritation
Nausea/vomiting
Asthma symptoms
Cough
14.6
7.2
5.4
2.6
2.0
2.9
2.8
16.1
7.8
6.9
3.2
2.6
3.3
3.8
Other tevase events that occurred in s3% but *1% of patients and that were more
Mmmon with tlubcasone propionate (with uncertain relationship to treatment) included:
tod in nasal mucus rig nose, abdominal pain, tfarrhea, fever, flu-like symptoms, aches
ved Drag Clmwa! Practice: in adtffai to atverse events
mas, the Mowing events have be® idee ' '
piopionate in cWcai piie, Beeaise toy
unknown site, estimates ot frequency cannot_
fleam/: %pereensithjy reactions, including angioedema, ston rash, edema of the
Jar, tee art Dnat Alteration or los of sense of taste and/or small and, rarely, nasal
^^^^nasal ulcer, sore tat, throat nutation and dryness, cough, hoarseness,
QwrDrynessmdimtation, corymra»tlis,i)torre<tviaetn,9laucoma,wcreasedw>iaoculaff
pressure, 2nd cataracts.
OHWMff
Saigle oral dosesjjp to 16 mg nave been studied Arrian volunteers with no acute toxic
up to 80 mg daily for 10 days in votunteere and repeat
“ -«-■- ^ ^ Ue(j ,yvwse
and
fluticasone proponate twice daihy tor 7 days
Sngle oral doses up to 16 mg nave been s_
effects reported. Raieat oral tees up to 80 mg da
up to 10 mg daily for 14 days in
ere ot mid or moderate severity, and
oral doses ,r
reactions were
WjP*! the maxkniiT®arirnwded"ifei,|yirtraS
to* m.aifults.and >10,000 and >20000 Jmes, respectively, the maximum recommended
daily intranasal dose in children on a mgtrn basis).
GlaxoSmithKline
GlaxoSmithKline
Research Triangle Park, NC 27709
02002, GlaxoSmithKline. All rights reserved. May 2002
RL-1101
02003 The GlaxoSmithKline Group of Companies
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