Singulair Special Precautions

The efficacy of oral SINGULAIR for the treatment of acute asthma attacks has not been established. Therefore, oral SINGULAIR 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, SINGULAIR should not be abruptly substituted for inhaled or oral corticosteroids. Neuropsychiatric events have been reported in patients taking SINGULAIR (see SIDE EFFECTS). Since other factors may have contributed to these events, it is not known if they are related to SINGULAIR. 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, vasculitic 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 SINGULAIR.
Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking SINGULAIR.
Although SINGULAIR is effective in improving airway function in asthmatics with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor response to aspirin and other documented aspirin sensitivity.
Use in Children: SINGULAIR has been studied in pediatric patients 6 months to 14 years of age (see Dosage & Administration). Safety and effectiveness in pediatric patients younger than 6 months of age have not been studied. Use in children 2 - 14 years of age for seasonal allergic rhinitis may be considered based on demonstrated safety in this age group, although efficacy has not been demonstrated in clinical trials. Efficacy can be extrapolated from clinical data in adults. Studies have shown that SINGULAIR 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 SINGULAIR.