From the Guidelines
Singulair Pediatric 4mg (montelukast) is approved for children aged 2 to 5 years old, and it is not recommended for children under 2 years old. The medication is specifically formulated for young children and comes as chewable tablets or oral granules that can be mixed with a small amount of soft food 1. According to the FDA approval, the 4mg dose is suitable for children between 2 to 5 years old, while children 6 to 14 years old should take a 5mg dose, and adolescents 15 years and older should take the adult dose of 10mg 2.
Key Considerations
- The medication works by blocking leukotrienes, substances in the body that cause airway constriction, mucus production, and inflammation in the lungs 3.
- Parents should follow their healthcare provider's instructions exactly and be aware that Singulair is not for treating acute asthma attacks.
- The decision to initiate long-term daily therapy should be based on consideration of issues regarding diagnosis and prognosis, including the child's symptoms, medical history, and response to treatment 3.
- It is essential to monitor the child's response to therapy closely and adjust the treatment plan as needed to ensure the best possible outcomes 3.
Age Limitations
- Children under 2 years should not take the 4mg formulation of Singulair Pediatric 1.
- The medication is approved for children 2 to 5 years old, and the dose should be adjusted according to the child's age and response to treatment 2.
Administration and Dosage
- Singulair is typically prescribed once daily in the evening for asthma management or to relieve symptoms of seasonal allergies 2.
- The 4mg dose is specifically formulated for young children and comes as chewable tablets or oral granules that can be mixed with a small amount of soft food 1.
From the FDA Drug Label
The 4-mg oral granule formulation should be used for pediatric patients 12 to 23 months of age for the treatment of asthma, or for pediatric patients 6 to 23 months of age for the treatment of perennial allergic rhinitis 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 age limit for Singulair Pediatric 4Mg is 6 months to 23 months for perennial allergic rhinitis and 12 to 23 months for asthma, as 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 [4] [5].
From the Research
Singulair Pediatric 4Mg Age Limit
- The age limit for Singulair Pediatric 4Mg is 2 to 5 years, as indicated in the study 6.
- This study showed that montelukast, the active ingredient in Singulair, is effective and well-tolerated in children aged 2 to 5 years with persistent asthma.
- The dosage of 4mg was determined to be safe and effective for this age group through a pharmacokinetic approach, as described in the study 7.
- Other studies, such as 8 and 9, also support the use of leukotriene modifiers, including montelukast, in the management of asthma in children, but do not specifically address the age limit for the 4mg dosage.
- The study 10 does not provide information on the age limit for Singulair Pediatric 4Mg, as it focuses on the addition of anti-leukotriene agents to inhaled corticosteroids in children with persistent asthma, and does not include preschoolers in the analysis.