Metaxalone

5 WARNINGS AND PRECAUTIONS Serotonin Syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of metaxalone tablets (within the recommended dosage range) and other serotonergic drugs and with the use of metaxalone tablets as the only serotonergic drug taken at a dosage higher than the recommended dosage. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dosage increases. Discontinue metaxalone tablets if serotonin syndrome is suspected or it occurs. ( 5.1 , 7.1 ) Central Nervous System (CNS) Depression : Metaxalone tablets may impair mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a motor vehicle, especially when used with other CNS depressants including alcohol. Follow patients closely for signs and symptoms of respiratory depression and sedation. If concomitant use is warranted, closely monitor for signs of respiratory depression and sedation, particularly during treatment initiation and dosage increases. ( 5.2 , 7.2 ) 5.1 Serotonin Syndrome Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of metaxalone tablets (within the recommended dosage range) and other serotonergic drugs [see Drug Interactions (7) ] and with the use of Metaxalone tablets as the only serotonergic drug taken at a dosage higher than the recommended dosage [see Overdosage (10) ]. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms generally occurs within several hours to a few days after initiation of a serotonergic drug, but may occur later than that. If concomitant use of metaxalone tablets and another serotoneric drug is warranted, reassess the patient, particularly during treatment initiation and dosage increases. Discontinue metaxalone tablets if serotonin syndrome is suspected or it occurs. 5.2 Central Nervous System Depression Because of its central nervous system (CNS) depressant effects, metaxalone tablets may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle, especially when used with other CNS depressants including alcohol. Geriatric patients may be especially susceptible to CNS depression associated with metaxalone tablets use. When used concomitantly, the sedative effects of metaxalone tablets and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive [see Drug Interactions (7) ]. Follow metaxalone tablets-treated patients closely for signs and symptoms of respiratory depression and sedation. If concomitant use of metaxalone tablets and another CNS depressant is warranted, closely monitor for signs of respiratory depression and sedation, particularly during treatment initiation and dosage increases.