Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3634
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FLONASE (Spray)
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Patients should
use FLONASE Nasal Spray at regular intervals for optimal effect.<br/>Adults: The recommended starting dosage in adults is 2 sprays (50 mcg of fluticasone
propionate each) in each nostril once daily (total daily dose, 200 mcg).
The same dosage divided into 100 mcg given twice daily (e.g.,
8 a.m. and 8 p.m.) is also effective. After the first few
days, patients may be able to reduce their dosage to 100 mcg
(1 spray in each nostril) once daily for maintenance therapy. Some
patients (12 years of age and older) with seasonal allergic rhinitis
may find as-needed use of 200 mcg once daily effective for symptom
control (see CLINICAL TRIALS). Greater symptom control may be achieved
with scheduled regular use.<br/>Adolescents and Children (4
Years of Age and Older): Patients should be started with 100 mcg (1 spray
in each nostril once daily). Patients not adequately responding to
100 mcg may use 200 mcg (2 sprays in each nostril).
Once adequate control is achieved, the dosage should be decreased
to 100 mcg (1 spray in each nostril) daily. The maximum total daily dosage should not exceed 2 sprays
in each nostril (200 mcg/day) (see CLINICAL TRIALS: Individualization
of Dosage) FLONASE Nasal Spray is not recommended
for children under 4 years of age.<br/>Directions for Use: Illustrated patient's instructions for proper
use accompany each package of FLONASE Nasal Spray.
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Fluticasone propionate,
the active component of FLONASE Nasal Spray, is a synthetic corticosteroid
having the chemical name S-(fluoromethyl)6��,9-difluoro-11��-17-dihydroxy-16��-methyl-3-oxoandrosta-1,4-diene-17��-carbothioate,
17-propionate and the following chemical structure: Fluticasone propionate is a white powder
with a molecular weight of 500.6, and the empirical formula is CHFOS. It is practically
insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide,
and slightly soluble in methanol and 95% ethanol. FLONASE Nasal Spray, 50 mcg is an aqueous suspension of
microfine fluticasone propionate for topical administration to the
nasal mucosa by means of a metering, atomizing spray pump. FLONASE
Nasal Spray also contains microcrystalline cellulose and carboxymethylcellulose
sodium, dextrose, 0.02% w/w benzalkonium chloride, polysorbate
80, and 0.25% w/w phenylethyl alcohol, and has a pH between 5
and 7. It is necessary to prime the pump
before first use or after a period of non-use (1 week or more).
After initial priming (6 actuations), each actuation delivers 50 mcg
of fluticasone propionate in 100 mg of formulation through the
nasal adapter. Each 16-g bottle of FLONASE Nasal Spray provides 120
metered sprays. After 120 metered sprays, the amount of fluticasone
propionate delivered per actuation may not be consistent and the unit
should be discarded.
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Mechanism of Action: Fluticasone propionate
is a synthetic trifluorinated corticosteroid with anti-inflammatory
activity. In vitro dose response studies on a cloned human glucocorticoid
receptor system involving binding and gene expression afforded 50%
responses at 1.25 and 0.17 nM concentrations, respectively. Fluticasone
propionate was 3-fold to 5-fold more potent thandexamethasone in
these assays. Data from the McKenzie vasoconstrictor assay in man
also support its potent glucocorticoid activity. In preclinical studies, fluticasone propionate revealed progesterone-like
activity similar to the natural hormone. However, the clinical significance
of these findings in relation to the low plasma levels (see Pharmacokinetics)
is not known. The precise mechanism through
which fluticasone propionate affects allergic rhinitis symptoms is
not known. Corticosteroids have been shown to have a wide range of
effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils,
macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids,
leukotrienes, and cytokines) involved in inflammation. In 7 trials
in adults, FLONASE Nasal Spray has decreased nasal mucosal eosinophils
in 66% (35% for placebo) of patients and basophils in 39% (28% for
placebo) of patients. The direct relationship of these findings to
long-term symptom relief is not known. FLONASE
Nasal Spray, like other corticosteroids, is an agent that does not
have an immediate effect on allergic symptoms. A decrease in nasal
symptoms has been noted in some patients 12 hours after initial
treatment with FLONASE Nasal Spray. Maximum benefit may not be reached
for several days. Similarly, when corticosteroids are discontinued,
symptoms may not return for several days.<br/>Pharmacokinetics:<br/>Absorption: The activity
of FLONASE Nasal Spray is due to the parent drug, fluticasone propionate.
Indirect calculations indicate that fluticasone propionate delivered
by the intranasal route has an absolute bioavailability averaging
less than 2%. After intranasal treatment of patients with allergic
rhinitis for 3 weeks, fluticasone propionate plasma concentrations
were above the level of detection (50 pg/mL) only when recommended
doses were exceeded and then only in occasional samples at low plasma
levels. Due to the low bioavailability by the intranasal route, the
majority of the pharmacokinetic data was obtained via other routes
of administration. Studies using oral dosing of radiolabeled drug
have demonstrated that fluticasone propionate is highly extracted
from plasma and absorption is low. Oral bioavailability is negligible,
and the majority of the circulating radioactivity is due to an inactive
metabolite.<br/>Distribution: Following intravenous administration, the initial
disposition phase for fluticasone propionate was rapid and consistent
with its high lipid solubility and tissue binding. The volume of distribution
averaged 4.2 L/kg. The percentage
of fluticasone propionate bound to human plasma proteins averaged
91% with no obvious concentration relationship. Fluticasone propionate
is weakly and reversibly bound to erythrocytes and freely equilibrates
between erythrocytes and plasma. Fluticasone propionate is not significantly
bound to human transcortin.<br/>Metabolism: The total blood clearance of fluticasone propionate
is high (average, 1,093 mL/min), with renal clearance accounting
for less than 0.02% of the total. The only circulating metabolite
detected in man is the 17��-carboxylic acid derivative of fluticasone
propionate, which is formed through the cytochrome P450 3A4 pathway.
This inactive metabolite had less affinity (approximately 1/2,000)
than the parent drug for the glucocorticoid receptor of human lung
cytosol in vitro and negligible pharmacological activity in animal
studies. Other metabolites detected in vitro using cultured human
hepatoma cells have not been detected in man.<br/>Elimination: Following intravenous dosing, fluticasone propionate
showed polyexponential kinetics and had a terminal elimination half-life
of approximately 7.8 hours. Less than 5% of a radiolabeled oral
dose was excreted in the urine as metabolites, with the remainder
excreted in the feces as parent drug and metabolites.<br/>Special Populations: Fluticasone propionate nasal spray was not studied
in any special populations, and no gender-specific pharmacokinetic
data have been obtained.<br/>Drug Interactions: Fluticasone propionate is a substrate of cytochrome
P450 3A4. Coadministration of fluticasone propionate and the highly
potent cytochrome P450 3A4 inhibitor ritonavir is not recommended
based upon a multiple-dose, crossover drug interaction study in 18
healthy subjects. Fluticasone propionate aqueous nasal spray (200 mcg
once daily)was coadministered for 7 days with ritonavir (100 mg
twice daily). Plasma fluticasone propionate concentrations following
fluticasone propionate aqueous nasal spray alone were undetectable
(<10 pg/mL) in most subjects, and when concentrations were
detectable, peak levels (C) averaged 11.9 pg/mL (range,
10.8 to 14.1 pg/mL) and AUCaveraged 8.43 pg���hr/mL
(range, 4.2 to 18.8 pg���hr/mL). Fluticasone propionate
Cand AUCincreased to 318 pg/mL
(range, 110 to 648 pg/mL) and 3,102.6 pg���hr/mL (range,
1,207.1 to 5,662.0 pg���hr/mL), respectively, after coadministration
of ritonavir with fluticasone propionate aqueous nasal spray. This
significant increase in plasma fluticasone propionate exposure resulted
in a significant decrease (86%) in plasma cortisol area under the
plasma concentration versus time curve (AUC). Caution should be exercised when other potent cytochrome P450
3A4 inhibitors are coadministered with fluticasone propionate. In
a drug interaction study, coadministration of orally inhaled fluticasone
propionate (1,000 mcg) and ketoconazole (200 mg once daily)
resulted in increased fluticasone propionate exposure and reduced
plasma cortisol AUC, but had no effect on urinary excretion of cortisol. In another multiple-dose drug interaction study, coadministration
of orally inhaled fluticasone propionate (500 mcg twice daily)
and erythromycin (333 mg 3 times daily) did not affect fluticasone
propionate pharmacokinetics.<br/>Pharmacodynamics: In a trial to evaluate the potential systemic and
topical effects of FLONASE Nasal Spray on allergic rhinitis symptoms,
the benefits of comparable drug blood levels produced by FLONASE Nasal
Spray and oral fluticasone propionate were compared. The dosages used
were 200 mcg of FLONASE Nasal Spray, the nasal spray vehicle
(plus oral placebo), and 5 and 10 mg of oral fluticasone propionate
(plus nasal spray vehicle) per day for 14 days. Plasma levels
were undetectable in the majority of patients after intranasal dosing,
but present at low levels in the majority after oral dosing. FLONASE
Nasal Spray was significantly more effective in reducing symptoms
of allergic rhinitis than either the oral fluticasone propionateor
the nasal vehicle. This trial demonstrated that the therapeutic effect
of FLONASE Nasal Spray can be attributed to the topical effects of
fluticasone propionate. In another trial,
the potential systemic effects of FLONASE Nasal Spray on the hypothalamic-pituitary-adrenal
(HPA) axis were also studied in allergic patients. FLONASE Nasal Spray
given as 200 mcg once daily or 400 mcg twice daily was compared
with placebo or oral prednisone 7.5 or 15 mg given in the morning.
FLONASE Nasal Spray at either dosage for 4 weeks did not affect the
adrenal response to 6-hour cosyntropin stimulation, while both dosages
of oral prednisone significantly reduced the response to cosyntropin.
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FLONASE Nasal Spray is contraindicated in patients
with a hypersensitivity to any of its ingredients.
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FLONASE Nasal
Spray, 50 mcg is supplied in an amber glass bottle fitted witha white metering atomizing pump, white nasal adapter, and green dust
cover in a box of 1 (NDC 0173-0453-01) with patient's instructions
for use. Each bottle contains a net fill weight of 16 g and will
provide 120 actuations. Each actuation delivers 50 mcg of fluticasone
propionate in 100 mg of formulation through the nasal adapter.
The correct amount of medication in each spray cannot be assured after
120 sprays even though the bottle is not completely empty.The bottle
should be discarded when the labeled number of actuations has been
used. Store between
4��and 30��C (39��and 86��F). GlaxoSmithKline Research Triangle
Park, NC 27709 ��2007, GlaxoSmithKline.
All rights reserved. August 2007FLN:1PI
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General: Intranasal corticosteroids may cause a reduction
in growth velocity when administered to pediatric patients (see PRECAUTIONS:
Pediatric Use). Rarely, immediate hypersensitivity
reactions or contact dermatitis may occur after the administration
of FLONASE Nasal Spray. Rare instances of wheezing, nasal septum perforation,
cataracts, glaucoma, and increased intraocular pressure have been
reported following the intranasal application of corticosteroids,
including fluticasone propionate. Use of
excessive doses of corticosteroids may lead to signs or symptoms of
hypercorticism and/or suppression of HPA function. Although systemic effects have been minimal with recommended
doses of FLONASE Nasal Spray, potential risk increases with larger
doses. Therefore, larger than recommended doses of FLONASE Nasal Spray
should be avoided. When used at higher than
recommended doses or in rare individuals at recommended doses, systemic
corticosteroid effects such as hypercorticism and adrenal suppression
may appear. If such changes occur, the dosage of FLONASE Nasal Spray
should be discontinued slowly consistent with accepted procedures
for discontinuing oral corticosteroid therapy. In clinical studies with fluticasone propionate administered
intranasally, the development of localized infections of the nose
and pharynx with Candida albicans has occurred only rarely. When such an infection develops, it may
require treatment with appropriate local therapy and discontinuation
of treatment with FLONASE Nasal Spray. Patients usingFLONASE Nasal
Spray over several months or longer should be examined periodically
for evidence of Candida infection
or other signs of adverse effects on the nasal mucosa. Intranasal corticosteroids should be used with caution,
if at all, in patients with active or quiescent tuberculous infections
of the respiratory tract; untreated local or systemic fungal or bacterial
infections; systemic viral or parasitic infections; or ocular herpes
simplex. Because of the inhibitory effect
of corticosteroids on wound healing, patients who have experienced
recent nasal septal ulcers, nasal surgery, or nasal trauma should
not use a nasal corticosteroid until healing has occurred.<br/>Information for Patients: Patients being treated with FLONASE Nasal Spray
should receive the following information and instructions. This information
is intended to aid them in the safe and effective use of this medication.
It is not a disclosure of all possible adverse or intended effects. 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 effect.
Some patients (12 years of age and older) with seasonal allergic rhinitis
may find as-needed use of 200 mcg once daily effective for symptom
control (see CLINICAL TRIALS). A decrease
in nasal symptoms may occur as soon as 12 hours after starting therapy
with FLONASE Nasal Spray. Results in several clinical trials indicate
statistically significant improvement within the first day or two
of treatment; however, the full benefit of FLONASE Nasal Spray may
not be achieved until treatment 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 maximum improvement, the patient should
read and follow carefully the patient's instructions accompanying
the product.<br/>Drug Interactions: Fluticasone propionate is a substrate of cytochrome
P450 3A4. A drug interaction study with fluticasone propionate aqueous
nasal spray in healthy subjects has shown that ritonavir (a highly
potent cytochrome P450 3A4 inhibitor) can significantly increase plasma
fluticasone propionate exposure, resulting in significantly reduced
serum cortisol concentrations (see CLINICAL PHARMACOLOGY: Drug Interactions).
During postmarketing use, there have been reports of clinically significant
drug interactions in patients receiving fluticasone propionate and
ritonavir, resulting in systemic corticosteroid effects including
Cushing syndrome and adrenal suppression. Therefore, coadministration
of fluticasone propionate and ritonavir is not recommended unless
the potential benefit to the patient outweighs the risk of systemic
corticosteroid side effects. In a placebo-controlled
crossover study in 8 healthy volunteers, coadministration of a single
dose of orally inhaled fluticasone propionate (1,000 mcg; 5 times
the maximum daily intranasal dose) with multiple doses of ketoconazole
(200 mg) to steady state resulted in increased plasma fluticasone
propionate exposure, a reduction in plasma cortisol AUC, and no effect
on urinary excretion of cortisol. Caution should be exercised when
FLONASE Nasal Spray is coadministered with ketoconazole and other
known potent cytochrome P450 3A4 inhibitors.<br/>Carcinogenesis, Mutagenesis,
Impairment of Fertility: Fluticasone propionate demonstrated no tumorigenic
potential in mice at oral doses up to 1,000 mcg/kg (approximately
20 times the maximum recommended daily intranasal dose in adults and
approximately 10 times the maximum recommended daily intranasal dose
in children on a mcg/mbasis) for 78 weeks or in
rats at inhalation doses up to 57 mcg/kg (approximately 2 times
the maximum recommended daily intranasal dose in adults and approximately
equivalent to the maximum recommended daily intranasal dose in children
on a mcg/mbasis) for 104 weeks. Fluticasone propionate did not induce gene mutation in prokaryotic
or eukaryotic cells in vitro. No significant clastogenic effect was seen in cultured human peripheral
lymphocytes in vitro or in the mouse micronucleus test. No evidence of impairment of fertility was observed
in reproductive studies conducted in male and female rats at subcutaneous
doses up to 50 mcg/kg (approximately 2 times the maximum recommended
daily intranasal dose in adults on a mcg/mbasis). Prostate
weight was significantly reduced at a subcutaneous dose of 50 mcg/kg.<br/>Pregnancy:<br/>Teratogenic Effects: Pregnancy Category C. Subcutaneous studies in the
mouse and rat at 45 and 100 mcg/kg, respectively (approximately
equivalent to and 4 times, respectively, the maximum recommended daily
intranasal dose in adults on a mcg/mbasis), revealed
fetal toxicity characteristic of potent corticosteroid compounds,
including embryonic growth retardation, omphalocele, cleft palate,
and retarded cranial ossification. In the
rabbit, fetal weight reduction and cleft palate were observed at a
subcutaneous dose of 4 mcg/kg (less than the maximum recommended
daily intranasal dose in adults on a mcg/mbasis). However,
no teratogenic effects were reported at oral doses up to 300 mcg/kg
(approximately 25 times the maximum recommended daily intranasal dose
in adults on a mcg/mbasis) of fluticasone propionate
to the rabbit. No fluticasone propionate was detected in the plasma
in this study, consistent with the established low bioavailability
following oral administration (see CLINICAL PHARMACOLOGY). Fluticasone propionate crossed the placenta following
oral administration of 100 mcg/kg to rats and 300 mcg/kg
to rabbits (approximately 4 and 25 times, respectively, the maximum
recommended daily intranasal dose in adults on a mcg/mbasis). There are no adequate and well-controlled
studies in pregnant women. Fluticasone propionate should be used during
pregnancy only if the potential benefit justifies the potential risk
to the fetus. Experience with oral corticosteroids
since their introduction in pharmacologic, as opposed to physiologic,
doses suggests that rodents are more prone to teratogenic 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 and many
will not need corticosteroid treatment during pregnancy.<br/>Nursing Mothers: It is not known whether fluticasone propionate is
excreted in human breast milk. However, other corticosteroids have
been detected in human milk. Subcutaneous administration to lactating
rats of 10 mcg/kg of tritiated fluticasone propionate (less than
the maximum recommended daily intranasal dose in adults on a mcg/mbasis) resulted in measurable radioactivity in the milk.
Since there are no data from controlled trials on the use of intranasal
fluticasone propionate by nursing mothers, caution should be exercised
when FLONASE Nasal Spray is administered to a nursing woman.<br/>Pediatric Use: Six hundred fifty (650) patients aged 4 to 11 years
and 440 patients aged 12 to 17 years were studied in US clinical trials
with fluticasone propionate nasal spray. The safety and effectiveness
of FLONASE Nasal Spray in children below 4 years of age have not been
established. Controlled clinical studies
have shown that intranasal corticosteroids 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
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 in growth velocity
associated with intranasal corticosteroids, including the impact on
final adult height, are unknown. The potential for���catch-up���growth following discontinuation of treatment with intranasal corticosteroids
has not been adequately studied. The growth of pediatric patients
receiving intranasal corticosteroids, including FLONASE Nasal Spray,
should be monitored routinely (e.g., via stadiometry). The potential
growth effects of prolonged treatment should be weighed against the
clinical benefits obtained and the risks/benefits of treatment alternatives.
To minimize the systemic effects of intranasal corticosteroids, including
FLONASE Nasal Spray, each patient should be titrated to the lowest
dose that effectively controls his/her symptoms. A 1-year placebo-controlled clinical growth study was conducted
in 150 pediatric patients (ages 3 to 9 years) to assess the effect
of FLONASE Nasal Spray (single daily dose of 200 mcg, the maximum
approved dose) on growth velocity. From the primary population of
56 patients receiving FLONASE Nasal Spray and 52 receiving placebo,
the point estimate for growth velocity with FLONASE Nasal Spray was
0.14 cm/year lower than that noted with placebo (95% confidence
interval ranging from 0.54 cm/year lower than placebo to 0.27 cm/year
higher than placebo). Thus, no statistically significant effect on
growth was noted compared to placebo. No evidence of clinically relevant
changes in HPA axis function or bone mineral density was observed
as assessed by 12-hour urinary cortisol excretion and dual-energy
x-ray absorptiometry, respectively. The
potential for FLONASE Nasal Spray to cause growth suppression in susceptible
patients or when given at higher doses cannot be ruled out.<br/>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 treated with FLONASE Nasal Spray in US and non-US clinical
trials. While the number of patients is too small to permit separate
analysis of efficacy and safety, the adverse reactions reported in
this population were similar to those reported by younger patients.
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Chronic overdosage
may result in signs/symptoms of hypercorticism (see PRECAUTIONS).
Intranasal administration of 2 mg (10 times the recommended dose)
of fluticasone propionate twice daily for 7 days to healthy human
volunteers was well tolerated. Single oral doses up to 16 mg
have been studied in human volunteers with no acute toxic effectsreported. Repeat oral doses up to80 mg daily for 10 days
in volunteers and repeat oral doses up to 10 mg daily for 14 days
in patients were well tolerated. Adverse reactions were of mild or
moderate severity, and incidences were similar in active and placebo
treatment groups. Acute overdosage with this dosage form is unlikely
since 1 bottle of FLONASE Nasal Spray contains approximately 8 mg
of fluticasone propionate. The oral and
subcutaneous median lethal doses in mice and rats were>1,000 mg/kg
(>20,000 and>41,000 times, respectively, the maximum recommended
daily intranasal dose in adults and>10,000 and>20,000 times, respectively,
the maximum recommended daily intranasal dose in children on a mg/mbasis).
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fluticasone propionate
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FLONASE (Spray)
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In controlled
US studies, more than 3,300 patients with seasonal allergic, perennial
allergic, or perennial nonallergic rhinitis received treatment with
intranasal fluticasone propionate. In general, adverse reactions in
clinical studies have been primarily associated with irritation of
the nasal mucous membranes, and the adverse reactions were reported
with approximately the same frequency by patients treated with the
vehicle itself. The complaints did not usually interfere with treatment.
Less than 2% of patients in clinical trials discontinued because of
adverse events; this rate was similar for vehicle placebo and active
comparators. Systemic corticosteroid side
effects were not reported during controlled clinical studies up to
6 months' duration with FLONASE Nasal Spray. If recommended
doses are exceeded, however, or if individuals are particularly sensitive
or taking FLONASE Nasal Spray in conjunction with administration of
other corticosteroids, symptoms of hypercorticism, e.g., Cushing syndrome,
could occur. The following incidence of
common adverse reactions (>3%, where incidence in fluticasone propionate-treated
subjects exceeded placebo) is based upon 7 controlled clinical trials
in which 536 patients (57 girls and 108 boys aged 4 to 11 years,
137 female and 234 male adolescents and adults) were treated with
FLONASE Nasal Spray 200 mcg once daily over 2 to 4 weeks
and 2 controlled clinical trials in which 246 patients (119 female
and 127 male adolescents and adults) were treated with FLONASE Nasal
Spray 200 mcg once daily over 6 months. Also included in
the table are adverse events from 2 studies in which 167 children
(45 girls and 122 boys aged 4 to 11 years) were treated with
FLONASE Nasal Spray 100 mcg once daily for 2 to 4 weeks. Other adverse events that occurred in���3%
but���1% of patients and that were more common with fluticasone
propionate (with uncertain relationship to treatment) included: blood
in nasal mucus, runny nose, abdominal pain, diarrhea, fever, flu-like
symptoms, aches and pains, dizziness, bronchitis.<br/>Observed During Clinical Practice: In addition to adverse events reported from clinical
trials, the following events have been identified during postapproval
use of intranasal fluticasone propionate in clinical practice. Because
they are reported voluntarily from a population of unknown size, estimates
of frequency cannot be made. These events have been chosen for inclusion
due to either their seriousness, frequency of reporting, or causal
connection to fluticasone propionate or a combination of these factors.<br/>General: Hypersensitivity reactions, including angioedema,
skin rash, edema of the face and tongue, pruritus, urticaria, bronchospasm,
wheezing, dyspnea, and anaphylaxis/anaphylactoid reactions, which
in rare instances were severe.<br/>Ear, Nose, and Throat: Alteration or loss of sense of taste and/or smell
and, rarely, nasal septal perforation, nasal ulcer, sore throat, throat
irritation and dryness, cough, hoarseness, and voice changes.<br/>Eye: Dryness and irritation, conjunctivitis, blurred
vision, glaucoma, increased intraocular pressure, and cataracts. Cases of growth suppression have been reported for
intranasal corticosteroids, including FLONASE (see PRECAUTIONS: Pediatric
Use).
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The replacement
of a systemic corticosteroid with a topical corticosteroid can be
accompanied by signs of adrenal insufficiency, and in addition some
patients may experience symptoms of withdrawal, e.g., joint and/or
muscular pain, lassitude, and depression. Patients previously treated
for prolonged periods with systemic corticosteroids and transferred
to topical corticosteroids should be carefully monitored for acute
adrenal insufficiency in response to stress. In those patients 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 symptoms. The concomitant use of intranasal corticosteroids with other
inhaled corticosteroids could increase the risk of signs or symptoms
of hypercorticism and/or suppression of the HPA axis. A drug interaction study in healthy subjects has shown that ritonavir
(a highly potent cytochrome P450 3A4 inhibitor) can significantly
increase plasma fluticasone propionate exposure, resulting in significantly
reduced serum cortisol concentrations (see CLINICAL PHARMACOLOGY:
Drug Interactions and PRECAUTIONS: Drug Interactions). During postmarketing
use, there have been reports of clinically significant drug interactions
in patients receiving fluticasone propionate and ritonavir, resulting
in systemic corticosteroid effects including Cushing syndrome and
adrenal suppression. Therefore, coadministration of fluticasone propionate
and ritonavir is not recommended unless the potential benefit to the
patient outweighs the risk of systemic corticosteroid side effects. Persons who are using drugs that suppress the immune
system are more susceptible to infections than 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 properly
immunized, particular care should be taken to avoid exposure. How
the dose, route, and duration of corticosteroid administration affect
the risk of developing a disseminated infection is not known. The
contribution of the underlying disease and/or prior corticosteroid
treatment to the risk is also not known. If exposed to chickenpox,
prophylaxis with varicella zoster immune globulin (VZIG) may be indicated.
Ifexposed to measles, prophylaxis with pooled intramuscular immunoglobulin
(IG) may be indicated. (See the respective package inserts for complete
VZIG and IG prescribing information.) If chickenpox develops, treatment
with antiviral agents may be considered. Avoid
spraying in eyes.
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FLONASE Nasal
Spray is indicated for the management of the nasal symptoms of seasonal
and perennial allergic and nonallergic rhinitis in adults and pediatric
patients 4 years of age and older. Safety
and effectiveness of FLONASE Nasal Spray in children below 4 years
of age have not been adequately established.
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FLONASE
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