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*
Claritirf
Allegra*
more than Nasonex
more than Zyrtec
more than Claritin
more than Allegra
FLONASE 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
When you get it all, all it takes is FiOflciSG®
1-800-427-52951 www.flonase.com (fluticasone propionate)
* Available by prescription only,
t Available over-the-counter.
* “Allegra, Claritin, Zyrtec, Flonase, Nasonex, and Clarinex are among the leading prescription allergic rhinitis products.” Source: Scott-Levin's Source™
Nasal Spray, 50 meg
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 are not affiliated with and do not endorse GlaxoSmithKline or its products
Please see important information below.
FLONASE®
BRIEF SUMMARY
I Spray, 50 meg
For intranasal Use Only.
The tollmwng Is a bfief summary only; see Wl ^escribing intomaton tor complete product
information.
CONTRAINDICATIONS
aONASE Nasal Spray is contraireJicated in patieerts vw#i a hypefsensiflvtty to any of its
SHAKE GBITIY BEFORE USE
WARNINGS
The replacement of a systemic corticosteroid with a topical corticosteroid can he
accompanied by signs ot adrenal insutficiency, and in addition some patients may experience
symptoms ot wdlwawal, e.g, joint and/or muscular pain, lassitude, and depression. Patients
previously treated tor prolonged periods with systemic corticosteroids and transferred to
topical corticosteroids should he carefully monitored for acute adrenal insufficiency in
may cause a severe exacerbation of their symptoms.
The concomitant use of intranasaf corticosteroids with other inhaled corticosteroids
could increase the risk of signs or symptoms of hypercoiticism and/or suppression ot the
hypo&iic-piMary-adrenal fflA) axis.
Persons who are using drugs that suppress the immune system are more susceptible to
infections ttan healthy individuals. Chickenpox and measles, for example, can have a more
serious or even fatal course in susceptible children or adults using corticosteroids. In children
or adults who have not had these diseases or been property immunized, particular care
should be taken to avoid exposure How the dose, route, and duration of corticosteroid
administration affect the risk ol developing a disseminated infection is not known. The
contribution ol the underlying disease and/or prior corticosteroid treatment to the risk is also
not known. II exposed to chdrenpox, prophylaxis with varicella zoster immune globulin (VZIG)
may be indicated. II exposed lo measles, prophylaxis with pooled intramuscular
aKpscnuirio tormaboruSSonlS^'h'MS wi&viralagents may
be considered.
Avoid spraying in eyes.
PRECAUTIONS
General: Intranasal corticosteroids may cause a reduction in growth velocity when
administered to pediatric patents (see PRECAUTIONS: Pediatric Use).
Rarely, immediate hypersensitivity reactions or contact dermatitis may occur alter the
administration of R.0WSE Nasal Spiray. Rare instances ol wheezing, nasal septum
perforation, cataracts, glaucoma, and increased intraocular pressure have been reported
following the intranasal application ol corticosteroids, including fluticasone propionate
Use ot excessive doses ot corticosteroids may lead to signs or symptoms of
hypercortidsm and/or suppression ot HRA (unction.
Allhough systemic afects have been minimal with recommended doses ol HONASE
Nasal Spray, potential risk increases with larger doses. Therefore, larger than recommended
doses oTaffe Nasal Spray should be avoided.
When used at Ityier man recommended doses or in rare rtkviduals a! recommended
t as hypercorticism and adrenal suppression mas
of FtuNASE Nasal Spray should be discontinued
slowly consistent wifri accepted procedures for discontinuing oral corticosteroid therapy.
In clinical studies with fluticasone proptar' ' ’ " ' ' ” --
of localized it
rarefy, When such an infection develops, it may require treatment with appropriate local
them and discontinuation of treatment with FIONAS Nasal Spray. Patients using RONASE
Nasal Spray over several months or lortg» ^ould be examined periodicalty for evidence o'
CMda infection or other signs ol adverse effects on the nasal mucosa.
I corticosteroid should b .
doses, SBtemic corticosteroid effects such asjt
appear. I such changes occur, to dosage of
stent paprapted procedures fi ,. „ .
)l studies with fluticasone propionate administered intranasally, the development
infections of the nose and pharynx with Candida alimns lias occurred only
such an infection de^s^d my reguire treatment, with appropriate Jpd
sortengers
„ ofadversee
Intranasal cortcosteroirg should be used with caution, it at all. in patients with active or
quiescent tuberculous infections ol the respirator tract; untreated local or systemic fungal or
bacterial infections; systemic viral or parasitic infections; or ocular herpes simplex.
Because ot the inhibitory effect ot corticosteroids on wound healing, patients who have
experienced recent nasal septal ulcers, nasal surgery, or nasal trauma snould not use a nasal
corticosteroid until healing lias occurred.
Information for Patients Patients being treated with FLONASE Nasi Spravshould receive
the following information and instructions. This information is intended to aid them in the safe
indeffecbve use ot this medication. It is not a disclosure ol all possible adverse or intended
Patients should be warned to avoid exposure to chickenpox or measles and, if exposed,
to consult their physician without delay.
Patients should use FLONASE Nasal Spray at regular intervals for optimal etfect Some
patents (12 years of age and older) with seasonal allergic rhinitis may find as-needed use ot
200 meg once daily effective tor symptom control (see Clinical Trials section ot hill prescribing
information).
A decrease in nasal symptoms may occur as soon as 12 hours after starting therapy with
FLONASE Nasal Spray. &s In several clinical trials indicate statistically spirant
improvement wiWn the first day or two ol treatment: however, the Ml benefit ot FLONASE
Nasal Spray my not fie achieved until treatnienf has been administered for several
days. The patient should not increase the prescribed dosage but should contact the physician
if symptoms do not improve or if the condition worsens.
For the proper use of FLONASE Nasal Spray and to attain maximwn improvement, the
patient should read and follow carefully thepafienfs instructions accompanying Die product.
Drug interactions: In a placebo-controlled, crossover study in 8 healthy volunteers,
coaiifinisfiafion ol a single dose of orally inhaled fluticasone propionate (1.000 meg; 5 times
the maximum daily mtranasal dose) with multiple doses of ketoconazole ($00 mpi steady
state resulted in increased mean fluticasone propionate concentrations a reduction in
plasma cortisol AUC, aid no effect on urinary excretion ot cortisol. Tins interaction my be
due to an inhibition ot cytochrome P450 3A4 by ketoconazole, which is also the route ot
metabolism of fluticasone propionate. No drug interaction studies have been conducted with
FLONASE Nasal Spray: however, rare should be exercised when fluticasone propionate is
coadministered with long-term ketocorazole and other known cytochrome P450 3A4
deronsfrated'no tumongenc potSTSce"1at^'^ses^uMo'l.oSonS
(approximately 20 times file maximum recommended daily intranasal dose in adults and
approximately 10 times the maximum recommended daily intranasal dose io children on a
mcginr basis! tor 78 weeks or in rats at inhalation doses up to 57 meg/kg (approxktiatelY^
times the maximum recommended daily intranasal dose in adults and approximately
equivalent to the maximum recommended daily iiflranasai dose in children on a mcgfiir
basis) for 104 weeks.
Fluticasone propionate did not induce gene mutation in prokaryotic or eukaryotic ceils in
vitro. No significant dastogenic effect was seen in cultured human peripheral lymphocytes in
vito or in the mouse microitueleus test
No evidence ol impairment of fertility was observed
male and female rats at subcutaneous doses up to 50 ....
maximum recommended daily intranasal dose in adults on
risk to the fetus
Experience
s studies in the mouse
, , rt! to and 4 times the
Mpjjippippwpi—Wi adults on a n
revealed fetal toxicity charactenshc of potent corticosteroid o
growth retardation, omphalocele, cleft palate, and retarded c .
In die rabbit fetal weight reduction and deft palate were observed at a subcutaneous
dose ot 4 mcQ/kg (less than the maximum recommended daily intranasal dose in adults on a
mcg/nf basis}. However, no teratogenic effects were reported at oral doses up to 300 mcg/kg
(approximately 25 times the maximum recommended dally intranasal dose in adults on a
mcg/m-' basis) of fluticasone propionate to Die rabbit. No fluticasone propionate was detected
in me plasma in mis study, consistent with me established tow bioavailability following oral
administration (see CUNI«L PHARMACOLOGY section of full prescribing intonation).
Fluticasone propionate crossed the placenta following oral administration ol 100 mcg/kg
to rats or 300 nMg to rabbits (approximately 4 and 25 times, respectively, the maximum
recommended daSy intranasal dose in adults on a mcg/m! basis).
There are no adequate and well-controlled studies in pregnant women. Fluticasone
d be used during pregnancy only it the potential benefit justifies the potential
. with oral corticosteroids since Iheir introduction in pharmacologic, as
opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects
from corticosteroids than humans. In addition, because mere is a natural increase in
production during pregnancy, most women will require a lower exogenous
dose and many will not need corticosteroid treatment during p
k— »-‘.-J~J*— --|jon3)g |s fjp _ _
in human milk. Subcutaneous
than me
suited in
_ , __trials on
Je^ofitogtotexie propionate py nursing mothers, caution should be exercised
MMUKFive
17 years were studi
and effectiveness o
GnMted
corticosteroid dose _ BL JR_JHHHI
Nursing Mothers: it is not known whether fluticasone propionate is excreted inhuman
breast milk, However, other corticosteroids have been detected in bum
atenristalkin to rating rats of 10
maximum recommended daily i'
measurable radioactivity in the
f 10 mcg/kg of Mated fluticasone propionate (less
intranasal tee in adults on a mcg/m-' basis) ret
i milk. Since there are no data from controlled1
_r._yisadmnistefedfcanuisng_
Pediatric Use: Five hundred (500) patterns aged 4 to IT years.and 440 patients aged
17 years were studied in US tea! trials with fluticasone propionate nasal spray. The t
FLONASE Nasal Spray in children befow 4 years of age have not
- -.. (finical studies have shown that intranasal covtcosteroids may cause a
reduction in growth velocity in pediatric patients. This effect has been observed in the
absence of laboratory evidence of HPA axis suppression, suggesting mat growth velocity is a
more sensitive indicator ot systemic corticosteroid exposure in pediatric patients than some
comrriocily used tests of HPA axis function. The long-term effecfeofthis reduction in groveth
velocity associated with intranasal corticosteroids, including me impact on final adult bright,
are unknown. The potential lor ■catch-up" growth following discontinuation of treatment?*
Intranas^ corticwfioids has not been adequately sturted. The growth of pediatric patienls
receiving intranasal corticosteriods, including FLONASE Nasal fyray, should be monitored
routinely (el via stadrometry). The poteiaf growth effects of prolonged treatment should
be wewtef against the chncal benefits omened and the risks/benefits of treatment
alternatives. To minimi2e the systemic effects ot irrtranasai corticosteroids, including
FLONASE Nasal Spray, each patient should be titrated to the lowest dose mat effectively
controls his/her symptoms.
Geriatric Use: A limited number of patients 65 years of age and older |n=129) or 75 years of
age and older (n=11) have been Seated with FLUNASE & Spray in US and non-lSdinical
trials. While the number of patents is toe small in permit separate analysis of efficacy and
safety, the adverse reactions reported in this population were sWar to those reported by
younger patients.
ADVERSE REACTIONS
In controlled US studies pwe than 3,300 patients with seasons aSerac, perennial atomic,
or perennial noraiiergic diris received treatment wito intranasal fluticasone prapipnate.
5 jj^SamXreaCtalS81 stu*es •** •*« Primarily associated with imtation
the same frequency by patents treated with the vehicle itself. The complaints sdnot usually
interfere with treatment Less than 2% of patients in Med toals oXfinued because
d adverse events tfts rate was simlar tor vehide placebo andactive comparators.
Systemic corticosterwd side effects were not reported dicing controlled dinicat studies up
to 6 months' duration with FLONASE Nasal Spray. If recommended doses are exceeded
however, or If inMuals are particularly sensible or taking FLONASE Nasal Spray in
conjunction wi#i administration of other corticosterDids, symptoms of hypercorticism, e.g.,
Cushing syndrome, couid occur.
The following incidence of common adverse reactions (>3%, where incidence in
fluticasone propionate-treated subjects exceeded placebn) is based upon 7 controlled clinical
trials in which 536 patients 157 guts and! 08 bows aged 4 to 11years, 137 female and
234 male adolescents and adults] were heated A FLONASE Nasa Spray 200 meg once
daily over 2 to 4 weeks and 2 controlled clinical trials in which 246 patients (f 19 ferrale and
127 male adolescents and adults) were treated with FLONASE Nasal Spray 200 meg once
daiy over 6 months. Also included in the table are adverse events tan 2 studies in which
167 children (45 gids and 122 boys aged 4 to 11 yens] were treated with FLONASE Nasal
Spray 100 meg once daily for 2 to 4 weeks.
Overall Adverse Experiences With >3% incidence on Fluticasone Propionate in
ContnM CMcalTrials With FLONASE Nasal Spray in Patients *4 Hears WiSeasenal
or Perennial Allergic RtMtis
Adverse Experience
(n=758)
%
FLONASE
100 meg Once
(n=d67)
%
FLONASE
200 meg Once
Daw
(n=782)
%
Headache
Pharyngitis
Epistaxis
Nasal burning/
nasal irritation
Nausea/vomiting
Asthma symptoms
14.6
7.2
5.4
2.6
2.0
2.9
2.8
6.6
6.0
6.0
2.4
4.8
7.2
3.6
16.1
7.8
6.9
3.2
2.6
3.3
3.8
Other adverse events that occurred in s3% but *1% ot patients and that were more
common with fluticasone propionate (with uncertain relationship to treatment included:
blood in nasal mucusruvvynose, abdominal pain, diarrhea, fever, flu-like symptoms, aches
and pains, dizziness, bronchitis.
Observed During Cluneal Practice: In addition to adverse events
trials, the following events have ten —
orooionate in clinical oractice. Because
unknown size, estimate ol frequency cannot be made. These events have been chosen lor
indusion due to either their seriousness frequency of reporting, or causal connection to
fluticasone propionate or a combination of these factors,
General Hypersensitivity reactions, including aiflpoedems, skin rash, edema of the
face and tongue, pruritus, urticaria, bronchospasm, wheezing, dyspnea, and
anaphytaxis/anaphytacfad reactions, which in rare instances were severe.
Or, Hose, arid fflnMt Alteration or loss ol sense of taste and/or smell and, rarely, nasal
septal perforation, nasal ulcer, sore throat throat irritation and dryness, cough, hoarseness,
and voice changes.
essure afid Scto,at0,,' con'u'<:|jvifc’^ &iucm tefeased
Cases ol growth suppression have been reported lot kfaasal corticosteroids, inducting
FtONASE (see PRECAUTONS: Pediatric Use).
OVERDOSAGE
*sws as 5 m&Jsaut
fluticasone propionate twice daily for 7 (toys to healthy human volunteers was weM tolerated.
Single oral doses up to 16 mg nave been studied in human volunteers with no acute toxic
effects reported. Repeat oral doses up to 80 mg daily tor 10 days in volunteers and repeat
oral doses up to 10 mg daily tor 14 days in patients were well tolerated. Adverse
reactions were ol mild or moderate severity, and incidences were similar in active and
placebo treatment groups. Acute overdosage with tins dosage form is unlikely since 1 bottle
of FIONAS Nasal Spray contains approximately 8 mgoffKone propionate.
The ora) and subcutaneous nwfen lethal doses in mice and rats were >1,000 mg/kg
(>20,000 and >41,000 times, respective!* the maximum recommended daily intrarias!
dose in adults and >10,000 and >20,000 times, respectively, the maximum recommended
daily intranasal dose in chfldren on a mg/nv basis
GlaxoSmithKline
GlaxoSmithKline
Research Triangle Park, NC 27709
02002, GlaxoSmithKline. AH rights reserved. May 2002 RL-1101
02003 The GlaxoSmithKline Group of Companies
All rights reserved.
Printed in USA 428NBS FL2846R0
April 2003