MONTELUKAST-WGR

What it is

MONTELUKAST-WGR 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

MONTELUKAST-WGR should be taken once daily. Dosing varies by age group and indication:

For asthma, the dose should be taken in the evening. The therapeutic effect on parameters of asthma control occurs within one day. No dosage adjustment is necessary for paediatric patients, for the elderly, for patients with renal insufficiency, or mild to moderate hepatic impairment, or for patients of either gender.

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 The symptoms may be serious and continue if the treatment is not withdrawn, and therefore treatment with MONTELUKAST-WGR should be discontinued if neuropsychiatric symptoms occur during treatment. Patients and caregivers should be alert for neuropsychiatric events and instruct them to notify their physician if these changes in behaviour occur. The efficacy of oral montelukast for the treatment of acute asthma attacks has not been established, and therefore oral tablets of MONTELUKAST-WGR should not be relied upon to treat acute asthma attacks. 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. These cases have been 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

MONTELUKAST-WGR is contraindicated in patients with hypersensitivity to any component of the product.

Regulatory history

MONTELUKAST-WGR was first registered on the Australian Register of Therapeutic Goods on 9 July 2024, with three variant strengths listed: the 4 mg chewable tablet (ARTG 444254), the 5 mg chewable tablet (ARTG 444255), and the 10 mg film-coated tablet (ARTG 444256).