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Nasoril Nasal Spray
Mometasone Furoate Monohydrate
COMPOSITION
Each spray delivers:
Mometasone Furoate Monohydrate USP ……. 50 mcg
Mometasone Furoate Monohydrate equivalent to:
Mometasone Furoate USP…….… 0.05% w/v
Benzalkonium Chloride NF ………0.01% w/v (as preservative)
Phenyl Ethyl Alcohol USP ………. 0.25% v/v (as preservative)
INDICATIONS
NASORIL is indicated for the treatment of seasonal and
perennial allergic rhinitis symptoms in adults and paediatric
patients, 2 years of age and older. NASORIL is indicated
for the prophylaxis of seasonal allergic rhinitis symptoms in
adult and adolescent patients, 12 years and older. NASORIL
is also indicated in the treatment of nasal polyps in those aged
18 and above.
DOSAGE AND ADMINISTRATION
Seasonal or Perennial Allergic Rhinitis
Adults and adolescents (12 years of age and older): The
usual recommended dose is two sprays in each nostril once daily
(total dose of 200 mcg). Once symptoms are controlled, dose
reduction to one spray in each nostril (total dose of 100 mcg) may
be effective for maintenance. If symptoms are inadequately
controlled, the dose may be increased to a maximum dose of four
sprays in each nostril once daily (total dose of 400 mcg). Dose
reduction is recommended following control of symptoms.
Children (between the ages of 6–11 years): The usual
recommended dose is one spray in each nostril once daily (total
dose of 100 mcg). NASORIL demonstrated a clinically
significant onset of action within 12 hours after the first dose
in some patients with seasonal allergic rhinitis; however, the
full benefit of the treatment may not be achieved in the first 48
hours. Therefore, the patient should continue regular use to
achieve full therapeutic benefit.
Nasal Polyposis
The usual recommended starting dose for polyposis is two sprays in
each nostril once daily (total daily dose of 200 mcg). If after
5–6 weeks, symptoms are inadequately controlled, the dose may be
increased to a dose of two sprays in each nostril twice daily
(total daily dose of 400 mcg). The dose should be reduced
following control of symptoms. If no improvement in symptoms is
seen after 5–6 weeks of twice-daily administration, alternative
therapies should be considered.
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients of this preparation
contraindicates its use.
PACKAGING INFORMATION
NASORIL NASAL SPRAY
Sales pack contains 100 metered doses
NASORIL Nasal Spray 50 mcg
is a metered-dose, manual pump spray unit containing
an aqueous suspension of mometasone furoate
monohydrate equivalent to .......................0.05% w/w
mometasone furoate calculated on the anhydrous basis.
After initial priming (10 actuations), each actuation of the
pump delivers a metered spray
containing 100 mg or 100 microliter of suspension
containing mometasone furoate monohydrate equivalent to 50 mcg
of mometasone furoate
calculated on the anhydrous basis. Each bottle of NASORIL
NASAL SPRAY 50 MCG PROVIDES 120 SPRAYS.
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Quality
