Metaxalone

Metaxalone Tablets, 640 mg, are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older. Metaxalone Tablets, 640 mg, is a muscle relaxant, indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adult and pediatric patients 13 years of age and older.

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The use of Metaxalone Tablets, 640 mg is contraindicated in patients with: Known hypersensitivity to any components of this product. Known tendency for drug-induced, hemolytic, or other anemias. Severe renal or hepatic impairment.

• Known hypersensitivity to any components of this product. ( 4 )
• Known tendency to drug induced, hemolytic, or other anemias. ( 4 )
• Severe renal or hepatic impairment. ( 4 )

Serotonin Syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of metaxalone (within the recommended dosage range) and other serotonergic drugs and with the use of metaxalone as the only serotonergic drug taken at a dosage higher than the recommended dosage. If concomitant use with another serotonergic drug is warranted, carefully observe the patient, particularly during treatment initiation and dosage increases.

Discontinue Metaxalone Tablets, 640 mg if serotonin syndrome is suspected or it occurs. ( 5.1 , 7.1 ) Central Nervous System (CNS) Depression : Metaxalone Tablets, 640 mg may impair mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a motor vehicle, and may enhance the effects of other CNS depressants including alcohol. Follow patients closely for signs and symptoms of respiratory depression and sedation.

If concomitant use with another CNS depressant is warranted, closely monitor for signs of respiratory depression and sedation, particularly during treatment initiation and dosage increases. ( 5.2 , 7.2 ) Risk with Inappropriate Switching to Metaxalone Tablets, 640 mg Inappropriate switching on a mg-to-mg basis from SKELAXIN (metaxalone) tablets, 800 mg to Metaxalone Tablets, 640 mg to achieve the same total daily metaxalone dosage may result in a clinically significant increase in metaxalone exposure which may increase the risk of metaxalone-associated adverse reactions including CNS depression.