Isivas Special Precautions



Full Prescribing Info
Special Precautions
The efficacy of oral Isivas for the treatment of acute asthma attacks has not been established. Therefore, oral Montelukast 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, Isivas should not be abruptly substituted for inhaled or oral corticosteroids.
Neuropsychiatric events have been reported in patients taking Isivas (see SIDE EFFECTS). Since other factors may have contributed to these events, it is not known if they are related to Isivas. Physician 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 Isivas.
Isivas should not be used as monotherapy for the treatment and management of exercise-induced bronchospasm. Patients who have exacerbations of asthma after exercise should continues to use their usual regimen of inhaled-agonist as prophylaxis and have available for rescue a short-acting inhaled-agonist.
Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal antiinflamatory agent while taking Montelukast. Although Isivas is effective in improving airway function in asthmatic with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor response to aspirin and other NSAIDs in aspirin-sensitive asthmatic patients.
Use in Children: Isivas 10 mg tablets should not be prescribed to patients <15 years of age.
Use in Elderly: In clinical studies, there were no age-related differences in the efficacy or safety profiles of Isivas.
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