What is the use of Montelukast (Singulair) in infants?

From the Guidelines

Montelukast (Singulair) should be considered for infants with recurrent wheezing or mild persistent asthma, particularly those with a positive asthma predictive index, at a dose of 4 mg once daily as oral granules. The decision to start long-term daily therapy with montelukast in infants should be based on the presence of specific criteria, such as 4 or more episodes of wheezing in the past year that lasted more than 1 day and affected sleep, and a positive asthma predictive index 1. It is essential to monitor response to therapy closely, as treatment of young children is often in the form of a therapeutic trial, and alternative therapies or diagnoses should be considered if a clear and beneficial response is not obvious within 4 to 6 weeks 1.

Key considerations for the use of montelukast in infants include:

• The medication should be used under the guidance of a pediatrician, who will determine the treatment duration based on symptom control
• Parents should be aware of potential neuropsychiatric side effects, although these are less common in infants
• Regular follow-up with a pediatrician is essential to monitor effectiveness and any potential side effects
• Alternative treatments like inhaled corticosteroids are often preferred as first-line therapy for persistent asthma symptoms in infants

The use of montelukast in infants is supported by the FDA approval of the medication for children as young as 1 year old, in the form of oral granules 1. However, it is crucial to weigh the potential benefits of montelukast against the potential risks and consider alternative treatment options, such as inhaled corticosteroids, which are often preferred as first-line therapy for persistent asthma symptoms in infants 1.

From the FDA Drug Label

SINGULAIR is prescribed for the treatment of asthma, the prevention of exercise-induced asthma, and allergic rhinitis: Asthma. SINGULAIR should be used for the long-term management of asthma in adults and children ages 12 months and older. The safety of SINGULAIR 4-mg oral granules in pediatric patients 12 to 23 months of age with asthma has been demonstrated in an analysis of 172 pediatric patients, 124 of whom were treated with SINGULAIR, in a 6-week, double-blind, placebo-controlled study The safety and effectiveness in pediatric patients below the age of 12 months with asthma and 6 months with perennial allergic rhinitis have not been established.

The use of Montelukast (Singulair) in infants 12 months and older is for the long-term management of asthma. However, the safety and effectiveness in pediatric patients below the age of 12 months with asthma have not been established 2.

From the Research

Use of Montelukast in Infants

• Montelukast is used in the treatment of asthma in children, including infants 3, 4, 5, 6, 7
• The majority of studies confirm the usefulness of montelukast as monotherapy and add-on therapy to inhaled corticosteroids (ICS) in mild to moderate childhood asthma across all age groups, including infants 3
• Montelukast has a place in the treatment of young children with viral-triggered wheezing diseases, exercise-induced asthma, and in children whose parents are steroid-phobic and find ICS unacceptable 3
• In children under school age, no comparative studies were available, but long-term montelukast treatment was found to be effective in placebo-controlled studies in asthmatic children aged >2 years 5

Efficacy and Safety

• Montelukast added to low-dose ICS is an effective and safe option for the treatment of asthma in children, including infants 4
• Montelukast has a favorable safety profile and is well-tolerated in patients of all ages, including infants 7
• The results of studies indicate that montelukast can produce clinically relevant improvements in asthma-related parameters, including symptoms, lung function parameters, quality of life, and the number of asthma exacerbations 4, 7

Comparison with Other Treatments

• ICS are generally superior to montelukast for asthma management, but montelukast can be considered as an alternative treatment for mild persistent asthma 3, 5
• Montelukast was compared with theophylline added to low-dose ICS therapy in asthmatic children, and the results showed that montelukast was more effective than theophylline in improving peak expiratory flow (PEF) 4
• A study comparing montelukast with azithromycin as inhaled corticosteroid-sparing agents in moderate-to-severe childhood asthma found that neither montelukast nor azithromycin was likely to be an effective inhaled corticosteroid-sparing alternative in children with moderate-to-severe persistent asthma 6