Montelukast Interactions

FDA Black Box Warning

WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium tablets. The typesof events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with montelukast sodium tablets use are currently not well understood [ see Warnings and Precautions ( 5.1 ) ]. Because of the risk of NP events, the benefits of montelukast sodium tablets may not outweigh the risks in somepatients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of montelukast sodium tablets for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies [ see Indications and Usage ( 1.3 )]. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risksbefore prescribing montelukast sodium tablets. Discuss the benefits and risks of montelukast sodium tablets with patients and caregivers when prescribing montelukast sodium tablets. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking montelukast sodium tablets. If changes in behavior are observed, or if new NP symptomsor suicidal thoughts and/or behavior occur, advise patients to discontinue montelukast sodium tablets and contact a healthcare provider immediately [ see Warnings and Precautions ( 5.1 ) ].