Kastair EZ Tab 4 mg: Risks for Serious Neuropsychiatric Events: Serious neuropsychiatric events have been reported with the use of montelukast. The highly variable types of neuropsychiatric events reported with montelukast included, but are not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide).
Because of the risk of neuropsychiatric events, the benefits of montelukast may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies.
The benefits and risks of montelukast should be discussed with patients and/or caregivers.
The use of montelukast should be reserved for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies. In patients with asthma or exercise-induced bronchoconstriction, the benefits and risks should be considered before prescribing montelukast.
When taking montelukast, patients and/or caregivers must be alert for any changes in behavior or new neuropsychiatric symptoms. If changes in behavior are observed, or if new neuropsychiatric symptoms or suicidal thoughts and/or behavior occur, patients should be advised to discontinue montelukast and to contact a physician immediately.
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