montelukast (Singulair)

Following an abbreviated submission

Montelukast paediatric 4 mg granules (Singulair®) are accepted for use in NHS in Scotland for the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom 'as needed' short-acting beta-agonists provide inadequate clinical control of asthma. It is also accepted for the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.

This formulation is suitable for the treatment of children aged 6 months to 5 years, and the licence for montelukast has been extended to include children aged 6 months to 2 years, though the Summary of Product Characteristics adds that experience in those aged 6 to 12 months is limited. Its introduction is expected to have minimal resource implications in Scotland.