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Elocon Warnings, Precautions, Pregnancy, Nursing, Abuse - Mometasone Furoate (nasal spray)
Elocon Warnings, Precautions, Pregnancy, Nursing, Abuse - Mometasone Furoate (nasal spray)
WARNINGS
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; i.e., joint
and/or muscular pain, lassitude,
and depression. Careful attention
must be given when patients previously treated for prolonged periods
with systemic corticosteroids
are transferred to topical
corticosteroids, with careful monitoring for acute adrenal
insufficiency
in response to stress.
This is particularly important in those patients who have associated
asthma or other clinical
conditions where too rapid a decrease in systemic
corticosteroid
dosing may cause a severe
exacerbation of
their symptoms.
If recommended doses of intranasal
corticosteroids are exceeded or if individuals are particularly
sensitive or predisposed
by virtue of recent systemic steroid
therapy, symptoms of
hypercorticism
may occur, including very rare cases of menstrual irregularities,
acneiform lesions,
and cushingoid features. If such
changes occur, topical
corticosteroids should be discontinued slowly, consistent with accepted
procedures for discontinuing oral
steroid therapy.
Persons who are on drugs which 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 nonimmune children or adults on corticosteroids. In
such children or adults
who have not had these diseases, particular care should be taken
to avoid exposure. How the dose, route, and duration
of corticosteroid
administration
affects 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 globin (VZIG)
may be indicated. If exposed 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.
PRECAUTIONS
General
In clinical studies
with NASONEX Nasal Spray, 50 µg, the development of localized
infections of the nose
and pharynx with Candida
albicans has occurred only rarely. When such
an infection develops,
use of NASONEX Nasal Spray, 50 µg should be discontinued and
appropriate local
or systemic therapy
instituted, if needed.
Nasal corticosteroids should be used with caution, if at all, in
patients with active or quiescent
tuberculous infection
of the respiratory
tract, or in untreated fungal, bacterial, systemic
viral infections, or ocular
herpes simplex.
Rarely, immediate
hypersensitivity
reactions may occur after the intranasal administration of mometasone
furoate mono-hydrate. Extreme rare instances of wheezing
have been reported.
Rare instances of nasal
septum perforation
and increased intraocular pressure have also been reported following
the intranasal application
of aerosolized corticosteroids. As
with any long-term topical
treatment of the nasal
cavity, patients using NASONEX Nasal Spray, 50 µg 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
with NASONEX Nasal Spray, 50 µg at 200 µg/day, using
intraocular pressure
mea- surements and slit
lamp examination. No significant
change from baseline
was noted in the mean intraocular
pressure measurements for the 141 NASONEX-treated patients in the
12-week study, as compared with 141 placebo-treated patients. No
individual NASONEX-treated patient was noted to have developed a
significant elevation
in intraocular pressure or cataracts in this 12-week study. Likewise,
no significant
change from baseline
was noted in the mean intraocular
pressure measurements
for the 139 NASONEX- treated patients in the 12-month study and
again, no cataracts were
detected in these patients. Nonetheless, nasal
and inhaled corticosteroids have been associated with the development
of glaucoma and/or
cataracts. Therefore, close follow-up
is warranted in patients with a change in vision and with a history
of glaucoma and
or cataracts.
When nasal corticosteroids
are used at excessive doses, systemic
corticosteroid effects such
as hypercorticism
and adrenal suppression
may appear. If such changes occur, NASONEX Nasal Spray, 50 µg
should be discontinued slowly, consistent with accepted procedures
for discontinuing oral
steroid therapy.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In Sprague Dawley rats, mometasone furoate demonstrated no
statistically significant increase in the incidence
of tumors at an inhalation
dose of 67 µg/kg
(approximately 3 times the maximum
recommended daily intranasal dose in adults on a µg/m2
basis). In Swiss CD-i mice,
mometasone furoate demonstrated no
statistically significant
increase in the incidence
of tumors at an inhalation
dose of 160 µg/kg
(approximately 4 times the maximum
recommended daily intranasal
dose in adults on a µg/m2
basis).
At cytotoxic doses,
mometasone furoate produced an increase in chromosome aberrations
in vitro in Chinese hamster
ovary-cell cultures in the nonactivation phase, but not in the presence
of rat liver
S9 fraction. Mometasone furoate was not mutagenic in the mouse-lymphoma
assay and the Salmonella
E. coli mammalian microsome
mutation assay,
a Chinese hamster lung
cell (CHL) chromosomal-aberrations
assay, an in vivo
mouse bone-marrow erythrocyte-micronucleus assay,
a rat bone-marrow clastogenicity
assay, and the mouse male
germ-cell clastogenicity assay. Mometasone furoate also did not
induce unscheduled DNA synthesis
in vivo in rat hepatocytes.
In reproductive
toxicity studies in
rats, mometasone furoate administered subcutaneously caused prolonged
gestation, prolonged
and difficult labor, reduced offspring survival, and reduced maternal
body weight
gain following treatment
at 15 µg/kg (approximately the maximum
recommended daily intranasal dose
in adults on a µg/m2 basis). Impairment of fertility
in rats was not produced by subcutaneous
doses up to 15 µg/kg.
Pregnancy
Teratogenic Effects: Pregnancy Category C: Mometasone
furoate caused cleft palate
in mice at subcutaneous
doses of 60 and 180 µg/kg, (approximately 2 and 4 times the
maximum recommended
daily intranasal dose in
adults on a µg/m2 basis, respectively). Offspring
survival was reduced
in the 180 µg/kg group. The nonteratogenic subcutaneous dose
level in mice was 20 µg/kg (approximately the maximum recommended
daily intranasal
dose in adults on a µg/m2
basis).
In rabbits, mometasone furoate was teratogenic
and caused flexed front paws at a topical
dermal dose of 150 µg/kg
(approximately 14 times the maximum
recommended daily intranasal
dose in adults on a µg/m2
basis).
In rats, mometasone furoate produced umbilical
hernia, cleft
palate, and delayed ossification
at a topical dermal
dose of 600 µg/kg
(approximately 30 times the maximum
recommended daily intranasal
dose in adults on a µg/m2
basis). At 1200 µg/kg
(approximately 60 times the maximum
recommended daily intranasal
dose in adults on a µg/m2
basis), microphthalmia, umbilical hernias, and delayed ossification
were observed in rat pups.
In these teratogenicity studies, there were also reductions in
maternal body weight
gain and effects on fetal
growth (lower fetal
body weights and/or delayed
ossification) in mice (60 and 180 µg/kg), rabbits (150 µg/kg),
and rats (600 µg/kg).
In an oral teratology
study in rabbits, at 700 µg/kg, (approximately 70 times the
maximum recommended
daily intranasal
dose in adults on a µg/m2
basis), increased incidences of resorptions and malformations, including
cleft palate and/or head
malformations (hydrocephaly or domed head) were observed. Pregnancy
failure was observed
in most rabbits at 2800 µg/kg (approximately 270 times the
maximum recommended
daily intranasal
dose in adults on a µg/m2 basis).
There are no adequate, and
well-controlled studies in pregnant
women. NASONEX Nasal Spray, 50 µg, like other corticosteroids,
should be used during pregnancy
only if the potential
benefits justify 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.
Nonteratogenic Effects: Hypoadrenalism may occur in infants
born to women receiving corticosteroids during pregnancy. Such infants
should be carefully monitored.
Nursing Mothers
It is not known if mometasone furoate is excreted in human
milk. Because other corticosteroids are excreted in human
milk, caution should be used when NASONEX Nasal Spray, 50 µg
is administered to nursing
women.
Pediatric Use
Safety and effectiveness
in children less than 12 years of age
have not been established.
Geriatric Use
A total of 203 patients above 64 years of age
(age range 64 to 85) have
been treated with NASONEX Nasal Spray, 50 µg for up to 3 months.
The adverse reactions reported in this population
were similar in type and incidence
to those reported by younger patients.
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