Montelukast (Singulair) PBS listed for exercise-induced asthma in children aged 6–14 years

Published in NPS RADAR

Date published: About this date

Clinical content may change after this date. This information is not intended as a substitute for medical advice from a qualified health professional. Health professionals should rely on their own expertise and enquiries when providing medical advice or treatment.

The Pharmaceutical Benefits Scheme (PBS) listing for montelukast 5 mg tablets was extended on 1 December 2009 to include preventing exercise-induced asthma in children aged 6–14 years. This Streamlined Authority listing is intended for children whose asthma is otherwise well controlled with an inhaled corticosteroid (ICS), but who require a short-acting beta2 agonist 3 or more times per week for residual exercise-related symptoms. For these children, adding montelukast to continuing ICS treatment is an alternative to adding a long-acting beta2 agonist (LABA; i.e. eformoterol or salmeterol).

Montelukast is not intended to be used in combination with a LABA under this listing. This means it cannot be prescribed for children already using a fixed-dose combination inhaler containing budesonide with eformoterol (Symbicort) or fluticasone with salmeterol (Seretide). The listing therefore does not cover using montelukast in addition to budesonide with eformoterol in a maintenance and reliever regimen (SMART).

Assess the nature and severity of exercise-induced symptoms

Note that exercise-induced symptoms often indicate that the patient’s asthma is not well controlled. Rule out poor adherence and poor inhaler technique before stepping up drug therapy.

Ensure that children correctly distinguish exercise-induced asthma from being short of breath during exercise. Symptoms of exercise-induced asthma get worse for 5–10 minutes after the exercise stops, then recover over the next 30 minutes or so.1

Non-drug strategies may be useful and physical fitness can raise the threshold of exercise intensity that provokes exercise-induced asthma.1

Dosing issues

There are different PBS listings of montelukast for younger and older children (Table 1). Montelukast is also available as a 10 mg film-coated tablet, indicated for adolescents over 15 years and adults, but is not PBS listed for this age group. Children with asthma should take montelukast once daily in the evenings.2

Table 1.
PBS listings of montelukast

Age of child
Frequent intermittent or mild persistent asthma* (when not requiring an ICS)
Exercise-induced asthma persisting after optimal dose of ICS
2–5 years
4 mg chewable tablet
Not listed
6–14 years
5 mg chewable tablet
5 mg chewable tablet
* First-line preventer, as the single preventer agent, as an alternative to sodium cromoglycate or nedocromil sodium. Not for use in combination with a LABA
† As an alternative to a LABA


  1. National Asthma Council Australia. Asthma Management Handbook. 2006. (accessed 11 November 2009).
  2. Merck Sharp & Dohme (Australia) Pty. Limited. Singulair product information. 16 June 2009.