LUKAFAST

What it is

LUKAFAST is available in three strengths: 10 mg film-coated tablets containing 10.4 mg montelukast sodium (equivalent to 10.0 mg montelukast), 5 mg chewable tablets containing 5.2 mg montelukast sodium (equivalent to 5.0 mg montelukast), and 4 mg chewable tablets containing 4.16 mg montelukast sodium (equivalent to 4.0 mg montelukast). LUKAFAST 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

LUKAFAST should be taken once daily. For asthma, the dose should be taken in the evening. For seasonal allergic rhinitis, the time of administration may be individualised to suit patient needs. Patients with both asthma and seasonal allergic rhinitis should take only one tablet daily in the evening. 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, chewed and not swallowed whole. Paediatric patients 2 to 5 years of age should take one 4 mg chewable tablet daily, chewed and not swallowed whole. 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 including 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 The symptoms may be serious and continue if the treatment is not withdrawn.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 the 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. Patients should be advised to have appropriate rescue medication available. In rare cases patients receiving anti-asthma agents including leukotriene receptor antagonists have experienced one or more of the following: 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

Hypersensitivity to any component of these products.

Regulatory history

LUKAFAST was first registered on the Australian Register of Therapeutic Goods on 7 January 2013 for the 4 mg and 5 mg chewable tablets, with the 10 mg film-coated tablet registered on 3 April 2013.