Is montelukast (Singulair) safe and effective for a 2-year-old with severe refractory allergic rhinitis?

From the Guidelines

Montelukast is a safe and effective treatment option for a 2-year-old with severe refractory allergic rhinitis, but it should be used with caution and under close monitoring. For children aged 2-5 years, the recommended dose is 4 mg once daily, typically given in the evening 1. While montelukast is FDA-approved for allergic rhinitis in children as young as 2 years old, it should generally be tried only after other treatments like nasal corticosteroids and antihistamines have failed. The medication works by blocking leukotriene receptors, which helps reduce inflammation and allergic symptoms. However, parents should be aware of potential side effects, and the child's pediatrician or allergist should monitor them regularly while on this medication 1.

Key Considerations

• Montelukast is less effective than intranasal corticosteroids, but can be considered for patients who are unresponsive or non-compliant with intranasal corticosteroids 1
• The combination of montelukast and a second-generation antihistamine may show added benefit for allergic rhinitis and provide better protection against seasonal decrease in lung function 1
• Montelukast may be considered for patients with coexisting asthma, as it can benefit both upper and lower airway diseases 1

Monitoring and Precautions

• Parents should be aware of potential neuropsychiatric side effects, including behavior changes, depression, and rarely suicidal thoughts 1
• Common side effects may include headache, ear infection, and upper respiratory infections 1
• The child's pediatrician or allergist should monitor them regularly while on this medication, and discontinue it immediately if any concerning behavioral changes occur 1

From the FDA Drug Label

The efficacy of SINGULAIR for the treatment of seasonal allergic rhinitis in pediatric patients 2 to 14 years of age and for the treatment of perennial allergic rhinitis in pediatric patients 6 months to 14 years of age is supported by extrapolation from the demonstrated efficacy in patients 15 years of age and older with allergic rhinitis as well as the assumption that the disease course, pathophysiology and the drug’s effect are substantially similar among these populations. The safety of SINGULAIR 4-mg and 5-mg chewable tablets in pediatric patients aged 2 to 14 years with allergic rhinitis is supported by data from studies conducted in pediatric patients aged 2 to 14 years with asthma. A safety study in pediatric patients 2 to 14 years of age with seasonal allergic rhinitis demonstrated a similar safety profile

The safety and effectiveness of montelukast in pediatric patients 2 years of age and older with allergic rhinitis have been established. However, the label does not specifically address severe refractory allergic rhinitis in this age group.

• Key points:
  • Montelukast is approved for use in pediatric patients 2 to 14 years of age with allergic rhinitis.
  • The safety profile of montelukast in pediatric patients 2 to 14 years of age with allergic rhinitis is similar to that in adults.
  • There is no specific information on the use of montelukast in pediatric patients with severe refractory allergic rhinitis. Based on the available information, montelukast may be considered for use in a 2-year-old patient with allergic rhinitis, but the decision to use it for severe refractory allergic rhinitis should be made with caution and under the guidance of a healthcare professional 2.

From the Research

Safety and Efficacy of Montelukast in Children

• Montelukast has been found to be relatively safe and effective in reducing symptoms associated with allergic rhinitis in children 3.
• The safety and efficacy of montelukast in pediatric patients, including those as young as 2 years old, have been established, with alternative dosage forms such as liquids or oral disintegrating tablets available for ease of administration 3.
• Montelukast is well tolerated and has a favorable safety profile, with adverse events occurring at similar frequencies in patients taking either montelukast or placebo 4.

Treatment of Allergic Rhinitis in Children

• A tripartite treatment strategy that includes environmental control, immunotherapy, and pharmacologic treatment is recommended for the management of allergic rhinitis in children 5.
• Oral or topical antihistamines and intranasal corticosteroids are the mainstay of pharmacologic therapy for allergic rhinitis, depending on its severity 5.
• Montelukast has been shown to be effective in treating allergic rhinitis, either as monotherapy or in combination with antihistamines, and is a viable option for children with severe refractory allergic rhinitis 6, 4.

Considerations for Severe Refractory Allergic Rhinitis

• For children with severe refractory allergic rhinitis, combination therapy with montelukast and an oral antihistamine may be more effective than either treatment alone 6.
• The use of montelukast in combination with other treatments, such as intranasal corticosteroids, may also be considered for severe cases of allergic rhinitis 6, 4.
• It is essential to consider the individual child's needs and medical history when selecting a treatment plan for severe refractory allergic rhinitis 3, 5.