SINGULAIR

What it is

SINGULAIR contains montelukast sodium and is available in three tablet strengths: 10 mg film-coated tablets, 5 mg chewable tablets, and 4 mg chewable tablets. SINGULAIR is a selective and orally active leukotriene receptor antagonist that specifically inhibits the cysteinyl leukotriene CysLT₁ receptor.

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

Adults 15 years of age and older should take one 10 mg tablet daily. 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. SINGULAIR should be taken once daily, with the dose for asthma taken in the evening. The therapeutic effect of SINGULAIR 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. The symptoms may be serious and continue if the treatment is not withdrawn; therefore treatment with montelukast should be discontinued if neuropsychiatric symptoms occur during treatment.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 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. 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. 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; caution and appropriate clinical monitoring are recommended in patients receiving montelukast.

Contraindications

SINGULAIR is contraindicated in patients with hypersensitivity to any component of these products.

PBS listing

In November 2017, PBAC recommended an amendment to the current PBS listing to allow montelukast to be used as an add-on therapy for asthma in adult and paediatric patients.

Regulatory history

SINGULAIR 10 mg tablets were first listed on the ARTG on 11 May 1998, and the 5 mg chewable tablets were first listed on the same date. The 4 mg chewable tablet formulation was first listed on 23 May 2001.