NEW ZEALAND DATA SHEET
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1. NASONEX
®
AQUEOUS NASAL SPRAY
50 micrograms/actuation nasal spray solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Mometasone furoate (as the monohydrate) 50 micrograms/actuation.
Excipient(s) with known effect
This medicinal product contains 0.02 mg of benzalkonium chloride per actuation.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Nasal spray solution.
White to off-white opaque suspension.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
NASONEX Aqueous Nasal Spray is indicated for the treatment of symptoms associated with seasonal
allergic rhinitis and perennial allergic rhinitis and the prophylaxis of seasonal allergic rhinitis in adults,
adolescents and children between the ages of 3 and 11 years.
NASONEX Aqueous Nasal Spray is also indicated for use in adults and adolescents 12 years of age
and older as adjunctive treatment to antibiotics for acute episodes of sinusitis.
4.2 Dose and method of administration
Dose
DO NOT EXCEED THE RECOMMENDED DOSAGE.
Seasonal Allergic Rhinitis or Perennial Allergic Rhinitis
The effect of NASONEX Aqueous Nasal Spray is not immediate. Full therapeutic benefit takes a few
days to develop. Dosage should be administered as directed and not be taken by the patients at will for
symptomatic relief.
In patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic
treatment with NASONEX Aqueous Nasal Spray is recommended two to four weeks prior to the
anticipated start of the pollen season.
Clinically significant onset of action occurs as early as 12 hours after the first dose.
Adults (including geriatric patients) and children 12 years of age and over
The usual recommended dose for prophylaxis and treatment is two sprays (50 micrograms/spray) in
each nostril once daily (total daily dose of 200 micrograms). Once symptoms are controlled, reducing
the dose to one spray in each nostril (total daily dose of 100 micrograms) may be effective for
maintenance.
If symptoms are inadequately controlled, the dose may be increased to four sprays in each nostril (total
daily dose of 400 micrograms). Dose reduction is recommended following the control of symptoms.
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Paediatric Population
Children between the ages of 3 and 11 years
The usual recommended dose is one spray (50 micrograms/spray) in each nostril once daily (total daily
dose 100 micrograms).
Adjunctive Treatment of Acute Episodes of Sinusitis
Adults (including geriatric patients) and children 12 years of age and over: The usual recommended
dose is two sprays (50 micrograms/spray) in each nostril twice daily (total daily dose 400 micrograms).
If symptoms are inadequately controlled, the dose may be increased to four sprays (50 micrograms
/spray) in each nostril twice daily (total daily dose 800 micrograms).
Method of Administration
Shake container well before each use. Do not pierce the nasal applicator. After the initial priming of the
NASONEX Aqueous Nasal Spray pump (10 actuations, until a uniform spray is observed), each
actuation delivers approximately 100 mg of mometasone furoate suspension, containing mometasone
furoate monohydrate equivalent to 50 micrograms of mometasone furoate. If the spray pump has not
been used for 14 days or longer, it should be reprimed with 2 actuations, until a uniform spray is
observed, before the next use.
4.3 Contraindications
- Patients with known hypersensitivity to mometasone furoate or any of the excipients
- Severe nasal infection, especially candidiasis
- Persons with haemorrhagic diathesis or with a history of recurrent nasal bleeding
4.4 Special warnings and precautions for use
NASONEX Aqueous Nasal Spray should not be used in the presence of untreated localised infection
involving the nasal mucosa.
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced
recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.
Following 12 months of treatment with NASONEX Aqueous Nasal Spray, there was no evidence of
atrophy of the nasal mucosa. Mometasone furoate tended to reverse the nasal mucosa closer to a
normal histological phenotype. As with any long-term treatment, patients using NASONEX Aqueous
Nasal Spray over several months or longer should be examined periodically for possible changes in the
nasal mucosa, including the development of nasal ulcerations. If localised fungal infection of the nose
or pharynx develops, discontinuance of NASONEX Aqueous Nasal Spray therapy or appropriate
treatment may be required. Persistence of nasopharyngeal irritation may be an indication for
discontinuing NASONEX Aqueous Nasal Spray.
NASONEX Aqueous Nasal Spray should be used with caution, if at all, in patients with active or
quiescent tuberculous infections of the respiratory tract, or in untreated fungal, bacterial, systemic viral
infections or ocular herpes simplex.
Topical corticosteroids may be absorbed in amounts that can have systemic effects. Use of excessive
doses may suppress hypothalamic-pituitary-adrenal (HPA) axis function. Physicians should be alert for
evidence of systemic effects, especially in chronically treated patients.
There is no evidence of HPA-axis suppression following prolonged treatment with NASONEX Aqueous
Nasal Spray. However, patients who are transferred from long-term administration of systemically active
corticosteroids to NASONEX Aqueous Nasal Spray require careful attention. Systemic corticosteroid
withdrawal in such patients may result in adrenal insufficiency for a number of months until recovery of
HPA axis function. If these patients exhibit signs and symptoms of adrenal insufficiency, systemic
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corticosteroid administration should be resumed and other modes of therapy and appropriate measures
instituted.
During transfer from systemic corticosteroids to NASONEX Aqueous Nasal Spray, some patients may
experience symptoms of withdrawal from systemically active corticosteroids (e.g. joint and/or muscular
pain, lassitude and depression initially) despite relief from nasal symptoms and will require
encouragement to continue NASONEX Aqueous Nasal Spray therapy. Such transfer may also unmask
pre-existing allergic conditions such as allergic conjunctivitis and eczema, previously suppressed by
systemic corticosteroid therapy.
Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk
of exposure to certain infections (e.g. chickenpox, measles) and of the importance of obtaining medical
advice if such exposure occurs.
Following the use of intranasal aerosolised corticosteroids, instances of nasal septum perforation or
increased intraocular pressure have been reported very rarely.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and
intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual
disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of
possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as
central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical
corticosteroids
Paediatric Population
Controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growth
velocity in children. 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 children 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 children receiving intranasal corticosteroids should be monitored routinely (e.g. via
stadiometry). The potential growth effects of prolonged treatment should be weighed against the clinical
benefits and the availability of safe and effective non-corticosteroid alternatives. To minimise the
systemic effects of intranasal corticosteroids, each patient should be titrated to his/her lowest effective
dose.
However, in a placebo-controlled clinical trial in which paediatric patients were administrated NASONEX
100 micrograms daily for one year, no reduction in growth velocity was observed.
4.5 Interaction with other medicines and other forms of interaction
NASONEX Aqueous Nasal Spray has been administered concomitantly with loratadine with no
apparent effect on plasma concentrations of loratadine or its major metabolite. Mometasone furoate
plasma concentrations were not detectable. The combination therapy was well tolerated.
Mometasone furoate is metabolised by CYP3A4.
Coadministration with strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin,
ritonavir, cobicistat-containing products) may lead to increased plasma concentrations of corticosteroids
and potentially increase the risk for systemic corticosteroid side-effects. Consider the benefit of
coadministration versus the potential risk of systemic corticosteroid effects, in which case patients
should be monitored for systemic corticosteroid side-effects.
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4.6 Fertility, pregnancy and lactation
Pregnancy (Category B3)
There are no adequate or well controlled studies in pregnant women. Low levels of systemic
mometasone have been measured following nasal administration of NASONEX Aqueous Nasal Spray.
As with other nasal corticosteroid preparations, NASONEX Aqueous Nasal Spray should be used in
pregnant women or nursing mothers only if the potential benefit justifies the potential risk to the mother,
foetus, or infant. Infants born of mothers who received corticosteroids during pregnancy should be
observed carefully for hypoadrenalism.
Breast-feeding
See section 4.6 Pregnancy.
Fertility
In studies of reproductive function, subcutaneous mometasone furoate was well tolerated at doses up
to 7.5 mg/kg. At 15 mg/kg, mometasone furoate caused prolonged gestation and prolonged and
difficult labor occurred with a reduction in offspring survival and body weight or body weight gain. There
was no effect on fertility.
4.7 Effects on ability to drive and use machines
No studies on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Seasonal Allergic Rhinitis or Perennial Allergic Rhinitis
Treatment-related local adverse events reported in clinical studies include headache (8%), epistaxis i.e.
frank bleeding, blood-tinged mucus, and blood flecks (8%), pharyngitis (4%), nasal burning (2%), nasal
irritation (2%) and nasal ulceration (1%), which are typically observed with the use of a corticosteroid
nasal spray. Epistaxis was generally self-limiting and mild in severity, and occurred at a higher incidence
compared to placebo (5%), but at a comparable or lower incidence compared to other active control
nasal corticoids used in clinical studies (up to 15%). The incidence of all other effects was comparable
with that of placebo.
In the paediatric population, the most common adverse effects were epistaxis (6%), headache (3%),
nasal irritation (2%) and sneezing (2%).
Rarely, immediate hypersensitivity reactions (e.g. bronchospasm, dyspnoea) may occur after intranasal
administration of mometasone furoate monohydrate. Very rarely, anaphylaxis and angioedema have
been reported.
Disturbances of taste and smell have been reported very rarely.
Growth suppression has been reported in association with administration of intranasal corticosteroids
(see Section 4.4 Special warnings and precautions for use, Paediatric population).
Adjunctive Treatment of Acute Episodes of Sinusitis
In adults and adolescent patients receiving NASONEX Aqueous Nasal Spray treatment-related adverse
events which occurred at an incidence comparable to placebo, included headache (2%), pharyngitis
(1%), nasal burning (1%) and nasal irritation (1%). Epistaxis was mild in severity (5%).
Vision blurred has been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows
continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to
report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.
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4.9 Overdose
Because the systemic bioavailability of NASONEX Aqueous Nasal Spray is low and has been estimated
as <1%, overdose is unlikely to require any therapy other than observation. Treatment can be reinitiated
at the usual recommended dose.
Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of HPA
axis function.
For advice on the management of overdose please contact the National Poisons Centre on 0800
POISON (0800 764766).
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Decongestants and Other Nasal Preparations for Topical Use-
Corticosteroids
ATC code: R01AD90
Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses
that are not systemically active.
5.2 Pharmacokinetic properties
Systemic bioavailability of mometasone furoate was investigated in 24 healthy volunteers following
intranasal administration of 400 micrograms of the suspension. Mometasone was detectable in plasma
(at sporadic time points) in only 4 of the 24 subjects, despite the use of a sensitive assay with a limit of
quantitation of 50 picograms/mL. Thus, there were no relevant pharmacokinetic data for this dosage
form.
Systemic absorption of mometasone furoate suspension administered as aqueous nasal spray,
200 micrograms single dose, was measured using a sensitive assay with a lower quantitation limit of
0.25 picograms/mL. Mean C max was 5.77 picograms/mL (CV% 32) and mean AUC (0-12hr)
29.6 picograms.hr/mL (CV% 37). When compared with dose adjusted PK data for IV mometasone
administration from earlier studies with a quantitation limit of 50 picograms/mL and longer sampling
duration, the estimated relative systemic (or ‘absolute’) bioavailability is <1%. The bioavailability of
mometasone following intranasal administration is low.
Systemic effects were not detected in adults, adolescents, or children following the administration of
mometasone furoate aqueous nasal spray.
Mometasone furoate suspension is very poorly absorbed from the gastrointestinal tract, and the small
amount that may be swallowed and absorbed undergoes extensive first-pass metabolism prior to
excretion in urine and bile.
In studies utilising nasal antigen challenge, NASONEX Aqueous Nasal Spray has shown anti-
inflammatory activity in both the early- and late-phase allergic responses. This has been demonstrated
by decreases (vs. placebo) in histamine and eosinophil activity and reductions (vs. baseline) in
eosinophils, neutrophils, and epithelial cell adhesion proteins.
5.3 Preclinical safety data
No toxicologic effects unique to mometasone furoate exposure were demonstrated during the course
of preclinical testing. All observed effects are typical of this class of compounds and are related to
exaggerated pharmacologic effects of glucocorticoids.
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6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
NASONEX Aqueous Nasal Spray contains dispersible cellulose BP 65 cps, glycerol, citric acid, sodium
citric dihydrate, polysorbate 80, and purified water with benzalkonium chloride 0.2 mg/g as preservative.
NASONEX Aqueous Nasal Spray does not contain fluorocarbon propellants.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store below 25°C. Do not freeze.
6.5 Nature and contents of container
Boxes of 1 metered atomising pump unit containing mometasone furoate (as the monohydrate)
50 micrograms/actuation.
Pack sizes of 40, 65, and 140 metered doses.
NASONEX Aqueous Nasal Spray is currently not available in New Zealand.
6.6 Special precautions for disposal
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.
7. MEDICINE SCHEDULE
Prescription Medicine.
8. SPONSOR
Organon New Zealand Limited
P O Box 99 851
Newmarket
Auckland 1149
Tel: 0800 111 700
9. DATE OF FIRST APPROVAL
02 April 1998
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10. DATE OF REVISION OF THE TEXT
1 December 2020
S-CCDS-MK0887-NS-082017
SUMMARY TABLE OF CHANGES
Date Changed Summary of the Changes
01-Dec-2020 Section 8: Amend sponsor details due to transfer of sponsorship
