LUKAIR

What it is

LUKAIR is montelukast sodium, available as film-coated tablets containing 10 mg of montelukast (equivalent to 10.4 mg montelukast sodium), and as chewable tablets containing 5 mg or 4 mg of montelukast. LUKAIR is a selective and orally active leukotriene receptor antagonist that specifically inhibits the cysteinyl leukotriene CysLT₁ receptor. It binds with high affinity and selectivity to the CysLT1 receptor and potently inhibits physiologic actions of LTC4, LTD4, and LTE4 at the CysLT1 receptor without any agonist activity.

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

LUKAIR should be taken once daily. Dosing varies by age and indication:

For asthma, the dose should be taken in the evening. LUKAIR may be taken with or without food. The therapeutic effect of LUKAIR on parameters of asthma control occurs within one day.

Key safety warnings

Serious neuropsychiatric events such as behavioural changes, depression and suicidality have been reported in all age groups taking montelukast. Although events are generally mild and may be coincidental, symptoms may be serious and continue if the treatment is not withdrawn; therefore treatment with montelukast should be discontinued if neuropsychiatric symptoms occur during treatment.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 with montelukast use include agitation, aggressive behaviour or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behaviour (including suicidality), and tremor. 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, a systemic eosinophilic vasculitis, sometimes associated with the reduction or withdrawal of oral corticosteroid therapy. 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.

Contraindications

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

Regulatory history

LUKAIR was first listed on the Australian Register of Therapeutic Goods on 25 January 2013 in three formulations: the 10 mg film-coated tablet (ARTG 197285), the 5 mg chewable tablet (ARTG 197284), and the 4 mg chewable tablet (ARTG 197283).