MONTELAIR

What it is

MONTELAIR is a selective and orally active leukotriene receptor antagonist that specifically inhibits the cysteinyl leukotriene CysLT₁ receptor. The medicine is available in three strengths: 10 mg film-coated tablets, 5 mg chewable tablets, and 4 mg chewable tablets.

Approved indications

— Prophylaxis and treatment of chronic asthma in adults and children 2 years of age and older. — Symptomatic treatment of seasonal allergic rhinitis.

Dosing overview

MONTELAIR should be taken once daily, with adults 15 years of age and older taking one 10 mg tablet daily. For asthma, the dose should be taken in the evening. Paediatric patients 6 to 14 years of age should take one 5 mg chewable tablet daily. Paediatric patients 2 to 5 years of age should take one 4 mg chewable tablet daily. MONTELAIR may be taken with or without food.

Key safety warnings

Serious neuropsychiatric events such as behavioural changes, depression and suicidality have been reported in all age groups taking montelukast. The symptoms may be serious and continue if the treatment is not withdrawn, so treatment with montelukast should be discontinued if neuropsychiatric symptoms occur during treatment. Prescribers should discuss the benefits and risks of montelukast use with patients and caregivers, and patients and caregivers should be advised to be alert for changes in behaviour or for new neuropsychiatric symptoms when taking MONTELAIR. The efficacy of oral montelukast for the treatment of acute asthma attacks has not been established, so oral tablets of montelukast should not be relied upon to treat acute asthma attacks, and patients should be advised to have appropriate rescue medication available. In rare cases patients receiving anti-asthma agents including leukotriene receptor antagonists have experienced eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy sometimes diagnosed as Churg-Strauss syndrome, sometimes associated with the reduction or withdrawal of oral corticosteroid therapy; although a causal relationship with leukotriene receptor antagonism has not been established, caution and appropriate clinical monitoring are recommended in patients receiving montelukast.

Contraindications

MONTELAIR is contraindicated in patients with hypersensitivity to any component of the product.

PBS listing

No information regarding PBS listing status is provided in the source documents.

Regulatory history

MONTELAIR was first registered on the Australian Register of Therapeutic Goods on 17 May 2012, with three variants listed: MONTELAIR 4 (4 mg chewable tablets, ARTG 184837), MONTELAIR 10 (10 mg film-coated tablets, ARTG 184828), and MONTELAIR 5 (5 mg chewable tablets, ARTG 184825), all under licence category RE.