APX-MONTELUKAST

What it is

APX-MONTELUKAST is available in three tablet presentations: a 10-mg tablet containing 10.4 mg montelukast sodium (equivalent to 10.0 mg montelukast free acid), a 5-mg chewable tablet containing 5.2 mg montelukast sodium (equivalent to 5.0 mg montelukast free acid), and a 4-mg chewable tablet containing 4.16 mg montelukast sodium (equivalent to 4.0 mg montelukast free acid). Montelukast sodium is a selective and orally active leukotriene receptor antagonist that 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

APX-MONTELUKAST 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. APX-MONTELUKAST may be taken with or without food. The therapeutic effect of montelukast 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

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. Neuropsychiatric events have been reported in adult, adolescent, and paediatric patients taking montelukast. 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. Patients and prescribers should be alert for neuropsychiatric events. Patients should be instructed to notify their prescriber if these changes occur. The reduction in systemic corticosteroid dose in patients receiving anti-asthma agents including leukotriene receptor antagonists has been followed in rare cases by the occurrence of eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy sometimes diagnosed as Churg-Strauss syndrome, a systemic eosinophilic vasculitis. Although a causal relationship with leukotriene receptor antagonism has not been established, caution and appropriate clinical monitoring are recommended when systemic corticosteroid reduction is considered in patients receiving montelukast.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Regulatory history

APX-MONTELUKAST was first listed on the Australian Register of Therapeutic Goods on 1 August 2012 in three presentations: the 4-mg chewable tablet (ARTG 189217), the 5-mg chewable tablet (ARTG 189216), and the 10-mg tablet (ARTG 189225).