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REGULATORY INFORMATION

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Guidelines and Codes

Update to Section 12.10.6 Corticosteroids as aqueous solutions for nasal inhalation [NZRGM, Volume 1, 5th edition]

Added to web site: July 2006

Low dose beclomethasone, budesonide, fluticasone and mometasone aqueous nasal preparations may be sold as Pharmacy Medicines for use in the short-term prophylaxis and treatment of allergic rhinitis when the following conditions apply:

Type of preparation Non CFC aqueous formulations
Strength Beclomethasone NMT 50mcg/actuation
Budesonide NMT 50 mcg/actuation
Fluticasone NMT 50 mcg/actuation
Mometasone NMT 50 mcg/actuation
Pack size Not more than 200 doses
Indications Short term (3-6 months) prophylaxis or treatment of allergic rhinitis (hay fever) in adults and children aged 12 years and over
Dosage Beclomethasone & Budesonide
Maximum of 400mcg (200mcg/nostril) per day in divided doses
Fluticasone & Mometasone
Maximum daily dose of 200 mcg as a single dose
Use1 Do not exceed maximum stated dose
Dose should be reduced for maintenance treatment once full effect obtained
Do not use for more than 6 months without the advice of your doctor or pharmacist.
Warning Statements1 See your doctor or pharmacist before using this product if:
  • you are already taking another steroid product, e.g. tablets, asthma or nasal inhaler or eye/nose drops.

See your doctor or pharmacist before using this product if:

  • you have a nasal or sinus infection;
  • you have recently had an injury or surgery to your nose;
  • you have ulceration in your nose.

See your doctor or pharmacist if:

  • symptoms are not relieved within 7 days;
  • your nose bleeds;
  • you develop signs or symptoms of a nasal or sinus infection such as fever, pain or swelling, or discoloured nasal discharge;
  • you have eye pain or visual disturbances
Contraindications As per data sheet
Adverse Effects As per data sheet
Additional Warnings and Precautions As per data sheet


1This information may be presented as words of similar meaning, and may be present on either the label or the package insert. Where the information is included in the package insert, the label should include a statement such as:
Read the enclosed package insert before starting to use this product