- Symptomatic treatment of seasonal or year-round allergic rhinitis for adults, adolescents and young children from 3 years old.
In patients with a history of moderate to severe seasonal allergic rhinitis, prophylactic Zentason treatment should be started 2 to 4 weeks before the onset of the allergic season.
- Treatment of nasal polyps and related symptoms such as congestion and deodorization in patients 18 years of age and older.
- Support treatment of sinusitis.
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.
Paediatric population
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).
Zentason 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 Zentason 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 increased to 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 mometasone furoate 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 mometasone furoate nasal spray in children under 3 years of age have not been established.
Nasal Polyposis
The safety and efficacy of mometasone furoate nasal spray in children and adolescents under 18 years of age have not been established.
Method of administration
Prior to administration of to the first dose, shake container well.
After initial priming of the Zentason pump (usually 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 mometasone furoate. If the pump is not used for 14 days or longer, reprime the pump with 2 actuations, 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.
