Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of SKELAXIN (within the recommended dosage range) and other serotonergic drugs [see Drug Interactions (7)] and with the use of SKELAXIN 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 SKELAXIN and another serotoneric drug is warranted, reassess the patient, particularly during treatment initiation and dosage increases. Discontinue SKELAXIN if serotonin syndrome is suspected or it occurs.
Because of its central nervous system (CNS) depressant effects, SKELAXIN 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 SKELAXIN use. When used concomitantly, the sedative effects of SKELAXIN and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive [see Drug Interactions (7)].
Follow SKELAXIN-treated patients closely for signs and symptoms of respiratory depression and sedation. If concomitant use of SKELAXIN and another CNS depressant is warranted, closely monitor for signs of respiratory depression and sedation, particularly during treatment initiation and dosage increases.
Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of SKELAXIN (within the recommended dosage range) and other serotonergic drugs [see Drug Interactions (7)] and with the use of SKELAXIN 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 SKELAXIN and another serotoneric drug is warranted, reassess the patient, particularly during treatment initiation and dosage increases. Discontinue SKELAXIN if serotonin syndrome is suspected or it occurs.
Because of its central nervous system (CNS) depressant effects, SKELAXIN 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 SKELAXIN use. When used concomitantly, the sedative effects of SKELAXIN and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive [see Drug Interactions (7)].
Follow SKELAXIN-treated patients closely for signs and symptoms of respiratory depression and sedation. If concomitant use of SKELAXIN and another CNS depressant is warranted, closely monitor for signs of respiratory depression and sedation, particularly during treatment initiation and dosage increases.
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