NASONEX AQUEOUS NASAL SPRAY 0.05%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MOMETASONE FUROATE MONOHYDRATE EQV MOMETASONE FUROATE

Available from:

ORGANON SINGAPORE PTE. LTD.

ATC code:

R01AD09

Dosage:

50 mcg/dose

Pharmaceutical form:

SPRAY

Composition:

MOMETASONE FUROATE MONOHYDRATE EQV MOMETASONE FUROATE 50 mcg/dose

Administration route:

NASAL

Prescription type:

Prescription Only

Manufactured by:

Organon Heist bv

Authorization status:

ACTIVE

Authorization date:

1999-02-19

Patient Information leaflet

Patient Information Leaflet
NASONEX® AQUEOUS NASAL SPRAY 0.05%
Mometasone Furoate 50 mcg/dose
Please read this leaflet carefully before you start using this
medicine.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.
What NASONEX is and what it is used for
2.
Before you use NASONEX
3.
How to use NASONEX
4.
Possible side effects
5.
How to store NASONEX
6.
Further information
1.
WHAT NASONEX IS AND WHAT IT IS USED FOR
What is NASONEX?
NASONEX Nasal Spray contains mometasone furoate, one of a group of
medicines
called corticosteroids. Mometasone furoate should not be confused with
“anabolic”
steroids misused by some athletes and taken as tablets or injections.
When tiny
amounts of mometasone furoate are sprayed into the nose, it can help
to relieve
inflammation, sneezing, itching and a blocked up or runny nose.
What is NASONEX used for?
NASONEX is used in adults and children aged 2 and older to treat the
symptoms of
seasonal or perennial rhinitis.
To help prevent moderate to severe symptoms of seasonal allergic
rhinitis, NASONEX
may be used 2 to 4 weeks before the beginning of the pollen season.
In adults aged 18 and over, NASONEX is also used to treat nasal
polyps.
NASONEX may also be used in adults and children 12 years of age and
older for the
treatment of symptoms of acute rhinosinusitis (inflammation and
blockage of the sinuses
behind the nose) without signs or symptoms of bacterial infection.
What is seasonal and perennial rhinitis?
Seasonal allergic rhinitis, which occurs at certain times of the year,
is an allergic reaction
caused by breathing in pollen from trees, grasses, weeds and also
moulds and fungal
spores. Perennial rhinitis occur

Summary of Product characteristics

S-CCDS-MK0887-NS-082017
NASONEX® Aqueous Nasal Spray
Brand of mometasone furoate monohydrate
FOR INTRANASAL ADMINISTRATION
DESCRIPTION:
NASONEX
Aqueous
Nasal
Spray
is
metered-dose,
manual
pump
spray
unit
containing a suspension of mometasone furoate. Each metered-dose pump
actuation of NASONEX
Aqueous Nasal Spray delivers approximately 100 mg of mometasone
furoate suspension, containing
mometasone furoate monohydrate equivalent to 50 micrograms mometasone
furoate.
Inactive
ingredients:
Cellulose,
glycerol,
citric
acid
monohydrate,
sodium
citrate
dihydrate,
polysorbate 80, benzalkonium chloride and purified water.
Preservatives: benzalkonium chloride
0.2 mg/g.
ACTIONS: Mometasone furoate is a topical glucocorticosteroid with
local anti-inflammatory properties
at doses that are not systemically active.
PRECLINICAL
PHARMACOLOGY
AND
TOXICOLOGY:
Preclinical
studies
demonstrate
that
mometasone furoate is devoid of androgenic, antiandrogenic, estrogenic
or antiestrogenic activity
but, like other glucocorticoids, it possesses some antiuterotrophic
activity and delays vaginal opening
in animal models at high oral doses of 56 mg/kg/day and 280 mg/kg/day.
In cell culture, mometasone furoate was shown to be at least ten times
more potent than other
steroids,
including
beclomethasone
dipropionate
(BDP),
betamethasone,
hydrocortisone
and
dexamethasone, at inhibiting the synthesis/release of IL-1, IL-6 and
TNFα . Mometasone furoate
(IC
50
= 0.12 Nm) was also at least six times more potent than BDP and
betamethasone at inhibiting
IL-5 production.
Also, in mixed leukocytes from atopic patients, mometasone was a more
potent
leukotriene production inhibitor than BDP.
In a preclinical model, the compound has been shown to reduce the
accumulation of eosinophils
markedly at the site of an allergic reaction. For example, in allergic
mice with IgE-mediated allergy,
inhaled mometasone furoate at doses as low as 10 micrograms/kg
inhibited eosinophil infiltration into
bronchoalveolar lavage fluid and the lung bronchi and bronchioles.
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