MONTELUKAST LUPIN

What it is

Montelukast Lupin is available as 4 mg chewable tablets, 5 mg chewable tablets, and 10 mg film-coated tablets, each containing montelukast sodium. Montelukast is an orally active compound that binds with high affinity and selectivity to the cysteinyl leukotriene type-1 receptor and potently inhibits the physiologic actions of cysteinyl leukotrienes.

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 Lupin tablets 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 of montelukast on asthma control parameters occurs within one day. Montelukast Lupin tablets can be taken with or without food. 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

Neuropsychiatric events such as behavioural changes, depression and suicidality have been reported in all age groups taking montelukast, and the symptoms may be serious and continue if the treatment is not withdrawn. Therefore, treatment with montelukast should be discontinued if neuropsychiatric symptoms occur during treatment. Post-marketing reports include agitation, aggressive behaviour or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behaviour including suicidality, and tremor. If changes in behaviour are observed, or if new neuropsychiatric symptoms or suicidal thoughts and/or behaviour occur, patients should be advised to discontinue montelukast and contact a healthcare provider immediately. The efficacy of oral montelukast for the treatment of acute asthma attacks has not been established. Therefore, 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. These cases have sometimes been associated with the reduction or withdrawal of oral corticosteroid therapy, and caution and appropriate clinical monitoring are recommended in patients receiving montelukast.

Contraindications

Montelukast Lupin is contraindicated in patients with hypersensitivity to any component of this product.

PBS listing

No information regarding PBS listing has been provided in the source documents.

Regulatory history

Montelukast Lupin 4 mg, 5 mg, and 10 mg variants were first listed on the ARTG on 25 November 2019. The product information was revised on 30 May 2025 to add a boxed warning for serious neuropsychiatric events and to include prescriber instructions for monitoring of neuropsychiatric events post medication commencement.