Avocom Nasal Spray is indicated for use in adults and children 3 years of age and older to treat the
symptoms of seasonal allergic or perennial rhinitis.
Avocom Nasal Spray is indicated for the treatment of nasal polyps in adults 18 years of age and older.

After initial priming of the Avocom Nasal Spray pump, each actuation delivers approximately 100 mg of
mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50
micrograms mometasone furoate.

Posology
Seasonal Allergic or Perennial Rhinitis
Adults (including older patients) and children 12 years of age and older: The usual recommended dose is
two actuations (50 micrograms/actuation) in each nostril once daily (total dose 200 micrograms). Once
symptoms are controlled, dose reduction to one actuation in each nostril (total dose 100 micrograms) may
be effective for maintenance. If symptoms are inadequately controlled, the dose may be increased to a
maximum daily dose of four actuations in each nostril once daily (total dose 400 micrograms). Dose
reduction is recommended following control of symptoms.
Children between the ages of 3 and 11 years: The usual recommended dose is one actuation (50
micrograms/actuation) in
each nostril once daily (total dose 100 micrograms).
Avocom Nasal Spray demonstrated a clinically significant onset of action within 12 hours after the first
dose in some patients with seasonal allergic rhinitis; however, full benefit of treatment may not be
achieved in the first 48 hours.
Therefore, the patient should continue regular use to achieve full therapeutic benefit.
Treatment with Avocom Nasal Spray may need to be initiated some days before the expected start of the
pollen season in patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis.

Nasal Polyposis
The usual recommended starting dose for polyposis is two actuations (50 micrograms/actuation) in each
nostril once daily (total daily dose of 200 micrograms). If after 5 to 6 weeks symptoms are inadequately
controlled, the dose may be increasedto a daily dose of two sprays in each nostril twice daily (total daily
dose of 400 micrograms). The dose should be titrated to the lowest dose at which effective control of
symptoms is maintained. If no improvement in symptoms is seen after 5 to 6 weeks of twice daily
administration, the patient should be re-evaluated, and treatment strategy reconsidered.
Efficacy and Safety studies of Avocom Nasal Spray for the treatment of nasal polyposis were four months
in duration.
Paediatric population
Seasonal Allergic Rhinitis and Perennial Rhinitis
The safety and efficacy of Avocom Nasal Spray in children under 3 years of age have not been
established.
Nasal Polyposis
The safety and efficacy of Avocom Nasal Spray in children and adolescents under 18 years of age have
not been established.
Method of administration
Prior to administration of the first dose, shake container well and actuate the pump 10 times (until a
uniform spray is obtained). If the pump is not used for 14 days or longer, reprime the pump with 2
actuations until a uniform spray is observed, before next use.
Shake container well before each use. The bottle should be discarded after the labelled number of
actuations or within 2 months of first use.

 

 

Hypersensitivity to the active substance, mometasone furoate, or to any of the excipients listed in section 6.1. Avocom Nasal Spray should not be used in the presence of untreated localised infection involving the nasal mucosa, such as herpes simplex. 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.

Immunosuppression
Avocom 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, or systemic viral infections.

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.
Local Nasal Effects
Following 12 months of treatment with Avocom Nasal Spray in a study of patients with perennial rhinitis,
there was no evidence of atrophy of the nasal mucosa; also, mometasone furoate tended to reverse the
nasal mucosa closer to a normal histologic phenotype. Nevertheless, patients using Avocom Nasal Spray
over several months or longer should be examined periodically for possible changes in the nasal mucosa.
If localised fungal infection of the nose or pharynx develops, discontinuance of Avocom Nasal Spray
therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an
indication for discontinuing Avocom Nasal Spray.
Avocom is not recommended in case of nasal septum perforation (see section 4.8).
In clinical studies, epistaxis occurred at a higher incidence compared to placebo. Epistaxis was generally
self- limiting and mild in severity (see section 4.8).
Avocom Nasal Spray contains benzalkonium chloride. Benzalkonium chloride may cause irritation or
swelling inside the nose, especially if used for a long time.

Systemic Effects of Corticosteroids
Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged
periods. These effects are much less likely to occur than with oral corticosteroids and may vary in
individual patients and between different corticosteroid preparations. Potential systemic effects may
include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children
and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioral effects
including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in
children).
Following the use of intranasal corticosteroids, instances of increased intraocular pressure have been
reported (see section4.8).
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.
Patients who are transferred from long-term administration of systemically active corticosteroids to
Avocom 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 or symptoms of withdrawal (e.g., joint and/or
muscular pain, lassitude, and depression initially) despite relief from nasal symptoms, systemic
corticosteroid administration should be resumed, and other modes of therapy and appropriate measures
instituted. Such transfer may also unmask pre- existing allergic conditions, such as allergic conjunctivitis
and eczema, previously suppressed by systemic corticosteroid therapy.
Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If
there is evidence for higher than recommended doses being used, then additional systemic corticosteroid
cover should be considered during periods of stress or elective surgery.

Nasal Polyps

The safety and efficacy of Avocom Nasal Spray has not been studied for use in the treatment of unilateral
polyps, polyps associated with cystic fibrosis, or polyps that completely obstruct the nasal cavities.
Unilateral polyps that are unusual or irregular in appearance, especially if ulcerating or bleeding, should
be further evaluated.
Effect on Growth in Paediatric Population
It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is
regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of
nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained. In
addition, consideration should be given to referring the patient to a paediatric specialist.
Non-nasal Symptoms
Although Avocom Nasal Spray will control the nasal symptoms in most patients, the concomitant use of
appropriate additional therapy may provide additional relief of other symptoms, particularly ocular
symptoms.

 

 

 

See 4.4 Special warnings and special precautions for use with systemic corticosteroids) A clinical
interaction study was conducted with loratadine. No interactions were observed.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the
risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the
increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for
systemic corticosteroid side-effects.

Pregnancy
There are no or limited amount of data from the use of mometasone furoate in pregnant women. Studies
in animals have shown reproductive toxicity (see section 5.3). As with other nasal corticosteroid
preparations, AVOCOM Nasal Spray should not be used in pregnancy unless the potential benefit to the
mother justifies any potential risk to the mother, fetus or infant. Infants born of mothers who received
corticosteroids during pregnancy should be observed carefully for hypoadrenalism.
Lactation
It is unknown whether mometasone furoate is excreted in human milk. As with other nasal corticosteroid
preparations, a decision must be made whether to discontinue breast-feeding or to discontinue/abstain
from Avocom Nasal Spray therapy taking into account the benefit of breast feeding for the child and the
benefit of therapy for the woman.
Fertility
There are no clinical data concerning the effect of mometasone furoate on fertility. Animal studies have
shown reproductive toxicity, but no effects on fertility (see section 5.3).

 

None known.

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 when compared to the active control nasal
corticosteroids studied (up to 15%) as reported in clinical studies for allergic rhinitis. The incidence of all
other adverse events was comparable with that of placebo. In patients treated for nasal polyposis, the
overall incidence of adverse events was similar to that observed for patients with allergic rhinitis.
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for
prolonged periods.
Tabulated list of adverse reactions
Treatment related adverse reactions (≥1%) reported in clinical trials in patients with allergic rhinitis or
nasal polyposis and post-marketing regardless of indication are presented in Table 1. Adverse reactions
are listed according to MedDRA primary system organ class. Within each system organ class, adverse
reactions are ranked by frequency. Frequencies were defined as follows: Very common (≥1/10); common
(≥1/100 to <1/10); Table*

 

Paediatric population
In the paediatric population, the incidence of recorded adverse events in clinical studies, e.g., epistaxis
(6%), headache (3%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.

Reporting of suspected adverse reactions
To reports any side effect(s):
- Saudi Arabia: The National Pharmacovigilance Centre (NPC)
SFDA call center: 19999
E-mail: npc.drug@sfda.gov.sa
Website: https://ade.sfda.gov.sa

Other GCC States:
Please contact the relevant competent authority

 

Symptoms
Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of HPA
axis function.
Management
Because the systemic bioavailability of NASONEX Nasal Spray is <1%, overdose is unlikely to require
any therapy other than observation, followed by initiation of the appropriate prescribed dosage.

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Decongestants and Other Nasal Preparations for Topical Use-
Corticosteroids, ATC code: R01A D09
Mechanism of action

Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that
are not systemically active.
It is likely that much of the mechanism for the anti-allergic and anti-inflammatory effects of mometasone
furoate lies in its ability to inhibit the release of mediators of allergic reactions. Mometasone furoate
significantly inhibits the release of leukotrienes from leucocytes of allergic patients. In cell culture,
mometasone furoate demonstrated high potency in inhibition of synthesis and release of IL-1, IL-5, IL-6
and TNFα; it is also a potent inhibitor of leukotriene production. In addition, it is an extremely potent
inhibitor of the production of the Th2 cytokines, IL-4 and IL-5, from human CD4+ T-cells.

 

Pharmacodynamic effects
In studies utilising nasal antigen challenge, NASONEX 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.
In 28% of the patients with seasonal allergic rhinitis, NASONEX Nasal Spray demonstrated a clinically
significant onset of action within 12 hours after the first dose. The median (50%) onset time of relief was
35.9 hours.

Paediatric population
In a placebo-controlled clinical trial in which paediatric patients (n=49/group) were administered
NASONEX Nasal Spray 100 micrograms daily for one year, no reduction in growth velocity was observed.
There are limited data available on the safety and efficacy of NASONEX Nasal Spray in the paediatric
population aged 3 to 5 years, and an appropriate dosage range cannot be established. In a study
involving 48 children aged 3 to 5 years treated with intranasal mometasone furoate 50, 100 or 200 μg/day
for 14 days, there was no significant differences from placebo in the mean change in plasma cortisol level
in response to the tetracosactrin stimulation test.
The European Medicines Agency has waived the obligation to submit the results of studies with
NASONEX Nasal Spray and associated names in all subsets of the paediatric population in seasonal and
perennial allergic rhinitis (see section 4.2 for information on paediatric use).

Absorption
Mometasone furoate, administered as an aqueous nasal spray, has a systemic bioavailability of <1% in
plasma, using a sensitive assay with a lower quantitation limit of 0.25 pg/ml.
Distribution
Not applicable as mometasone is poorly absorbed via the nasal route.
Biotransformation
The small amount that may be swallowed and absorbed undergoes extensive first-pass hepatic
metabolism.
Elimination
Absorbed mometasone furoate is extensively metabolized and the metabolites are excreted in urine and
bile.

No toxicological effects unique to mometasone furoate exposure were demonstrated. All observed effects
are typical of this class of compounds and are related to exaggerated pharmacologic effects of
glucocorticoids.
Preclinical studies demonstrate that mometasone furoate is devoid of androgenic, antiandrogenic,
estrogenic or antiestrogenic activity but, like other glucocorticoids, it exhibits some antiuterotrophic activity
and delays vaginal opening in animal models at high oral doses of 56 mg/kg/day and 280 mg/kg/day.
Like other glucocorticoids, mometasone furoate showed a clastogenic potential in-vitro at high
concentrations. However, no mutagenic effects can be expected at therapeutically relevant doses.
In studies of reproductive function, subcutaneous mometasone furoate, at 15 micrograms/kg prolonged
gestation and prolonged and difficult labour occurred with a reduction in offspring survival and body
weight or body weight gain. There was no effect on fertility.
Like other glucocorticoids, mometasone furoate is a teratogen in rodents and rabbits. Effects noted were
umbilical hernia in rats, cleft palate in mice and gallbladder agenesis, umbilical hernia, and flexed front
paws in rabbits. There were also reductions in maternal body weight gains, effects on foetal growth (lower
foetal body weight and/or delayed ossification) in rats, rabbits and mice, and reduced offspring survival in
mice.
The carcinogenicity potential of inhaled mometasone furoate (aerosol with CFC propellant and surfactant)
at concentrations of 0.25 to 2.0 micrograms/l was investigated in 24-month studies in mice and rats.
Typical glucocorticoid-related effects, including several non-neoplastic lesions, were observed. No
statistically significant dose-response relationship was detected for any of the tumour types.

6.1 List of excipients
Glycerin
Citric acid anhydrous
Sodium Citrate Dihydrate
Tween 80
Benzalkonium chloride 50% solution
Dispersible cellulose
Purified Water

Not applicable

2 years

Do not store above 30°C.
Do not freeze.

PE bottle with spray pumps and nasal applicator with over cap Pack size of 120 metered sprays.

Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.