BUDAMAX AQUEOUS NASAL SPRAY

What it is

BUDAMAX contains 64 µg budesonide per actuation as a nasal spray suspension. The formulation is a white to off-white, viscous thixotropic suspension.

Approved indications

— Prophylaxis and treatment of seasonal and perennial allergic rhinitis. — Treatment of nasal polyps.

Dosing overview

For seasonal and perennial allergic rhinitis in adults and children 6 years and older, the initial total daily dose is 256 micrograms, given as either a single daily application of 128 micrograms into each nostril in the morning, or divided into two applications of 64 micrograms into each nostril, morning and evening. When a satisfactory therapeutic response has been achieved, the maintenance dose should be titrated to the minimum effective dose, which may be a total daily dose of 128 micrograms given as 64 micrograms into each nostril in the morning, or as low as 32 micrograms in each nostril in the morning in some patients. For treatment of nasal polyps in adults aged 18 years and older, the total daily dose is 256 µg given as a divided daily application of 64 µg into each nostril, morning and evening.

Key safety warnings

Continuous long-term use in children is not recommended due to the possibility of growth suppression. Controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growth velocity in children. Height measurements should be performed to identify patients with increased sensitivity, and each patient should be titrated to their lowest effective dose to minimise systemic effects. In continuous long-term treatment, care should be exercised to avoid the development of nasal mucosal atrophy, and the nasal mucosa should be inspected at least twice per year. Patients who have experienced recent nasal septal ulcers, nasal surgery or a nose injury that has not healed should not use a nasal corticosteroid until healing has occurred. Visual disturbance may be reported with corticosteroid use, and patients presenting with symptoms such as blurred vision or other visual disturbances should be considered for referral to an ophthalmologist for evaluation of possible causes including cataract, glaucoma or rare diseases such as central serous chorioretinopathy. If BUDAMAX is prescribed for patients already using corticosteroids, care should be taken to ensure that the daily dosage of BUDAMAX is included when determining total daily corticosteroid dose.

Contraindications

BUDAMAX is contraindicated in patients with hypersensitivity to any component of the product or to other corticosteroids. It is also contraindicated in severe nasal infections, especially candidiasis. BUDAMAX should not be used in persons with haemorrhagic diatheses or with a history of recurrent nasal bleeding.

Regulatory history

BUDAMAX AQUEOUS NASAL SPRAY budesonide 64 microgram/actuation was first listed on the ARTG on 24 August 2000. A 32 microgram/actuation variant was also first listed on the same date.