Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.

AZEP (Sigma)
0.1% nasal spray
Approved indication: allergic rhinitis
Australian Medicines Handbook Section 9.4.3

When seasonal or perennial rhinitis is severe enough to require drug treatment, a topical antihistamine is an alternative to topical nasal corticosteroids. Azelastine is an H1-receptor antagonist which has been approved for use in patients over five years old.

Patients spray a dose of azelastine into each nostril twice a day. Within 15minutes this starts to relieve nasal symptoms induced by histamine or allergens. The effect of a dose can last for up to 12 hours. Part of each dose is absorbed. This is then extensively metabolised with most of the metabolites being excreted in the faeces. The major metabolite, desmethylazelastine, is also an H1-receptor antagonist. It has a half-life of 56 hours so there is a potential for accumulation with twice-daily doses.

In studies of seasonal allergic rhinitis, azelastine was as effective as oral terfenadine at reducing symptoms such as rhinorrhoea, nasal irritation and sneezing. Similar results were observed in patients with perennial allergic rhinitis.

Most of the adverse effects occur in the nose. They include stinging, itching, sneezing and epistaxis. Some patients will develop an altered taste sensation and possibly nausea.

While azelastine may have a more rapid effect, it is not more effective than nasal corticosteroids. In a placebo-controlled trial budesonide had a significantly greater effect on the symptoms of perennial allergic rhinitis.1 A short study (two weeks) found that beclomethasone produced a greater improvement in the overall symptoms of seasonal allergic rhinitis.2