Source: FDA, National Drug Code (US) Revision Year: 2018
SKELAXIN (metaxalone) is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.
The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.
Deaths by deliberate or accidental overdose have occurred with metaxalone, particularly in combination with antidepressants, and have been reported with this class of drug in combination with alcohol.
Serotonin syndrome has been reported when SKELAXIN was used at doses higher than the recommended dose (see WARNINGS and ADVERSE REACTIONS).
When determining the LD50 in rats and mice, progressive sedation, hypnosis, and finally respiratory failure were noted as the dosage increased. In dogs, no LD50 could be determined as the higher doses produced an emetic action in 15 to 30 minutes.
Gastric lavage and supportive therapy. Consultation with a regional poison control center is recommended.
Store at Controlled Room Temperature, between 15°C and 30°C (59°F and 86°F).
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