NIKP-Montelukast Special Precautions

The efficacy of oral Montelukast for the treatment of acute asthma attacks has not been established. Therefore, oral Montelukast Sodium should not be used to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available. While the dose of concomitant inhaled corticosteroid may be reduced gradually under medical supervision, Montelukast should not be abruptly substituted for inhaled or oral corticosteroids.
Neuropsychiatric events have been reported in patients taking Montelukast (see Adverse Reactions). Since other factors may have contributed to these events, it is not known if they are related to Montelukast. Physicians should discuss these adverse experiences with their patients and/or caregivers. Patients and/or caregivers should be instructed to notify their physician if these changes occur.
In rare cases patients receiving anti-asthma agents, including leukotriene receptor antagonists have experienced one or more of the following: eosinophilia, vasculitis, rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy sometimes diagnosed as Churg-Strauss syndrome, a systemic eosinophilic vasculitis. These cases have been sometimes associated with the reduction or withdrawal of oral corticosteroid therapy. Although a causal relationship with leukotriene receptor antagonism has not been established, caution and appropriate clinical monitoring are recommended in patients receiving Montelukast.
Use in Children: Safety and effectiveness in pediatric patients younger than 6 months of age have not been studied. Studies have shown that Montelukast does not affect the growth rate of pediatric patients.
Use in the Elderly: In clinical studies, there were no age-related differences in the efficacy or safety profiles of Montelukast.