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.

SKELAXIN is contraindicated in patients with known tendency to drug induced, hemolytic, or other anemias and in patients with significantly impaired renal or hepatic function.

Metaxalone should be administered with great care to patients with pre-existing liver damage. Serial liver function studies should be performed in these patients.

Taking metaxalone tablets with food may enhance general CNS depression; elderly patients may be especially susceptible to this CNS effect.

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 alcohol or other CNS depressants.

Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of serotonergic drugs with SKELAXIN used within the recommended dosage range and with SKELAXIN as a single agent taken at doses higher than the recommended dose. Serotonergic drugs include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, opioids (particularly fentanyl, meperidine, and methadone), drugs that affect the serotonergic neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and drugs that impair metabolism of serotonin (including monoamine oxidase (MAO) inhibitors, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

The sedative effects of SKELAXIN and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants (TCAs)) may be additive. Exercise caution with patients who take more than one of these CNS depressants simultaneously. Follow patients closely for signs and symptoms of respiratory depression and sedation.

False-positive Benedict’s tests, due to an unknown reducing substance, have been noted. A glucose specific test will differentiate findings.

Safe use of metaxalone has not been established with regard to possible adverse effects upon fetal development. Therefore, metaxalone tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless, in the judgement of the physician, the potential benefits outweigh the possible hazards.

It is not known whether this drug is secreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

GoToSource

• Use as monotherapy for musculoskeletal conditions. GoToSource

• Fibromyalgia. GoToSource

• Use in patients under the age of 12. GoToSource

• Rheumatoid arthritis. GoToSource

• Diabetic neuropathy. GoToSource

Sedation, dependency, blurred vision, increased fall and fracture risk, hemolytic anemia, leukopenia and jaundice. GoToSource

Designated as a potentially inappropriate medication for patients over 65 years of age due to sedation, fall and fracture risk. GoToSource 

Serotonin syndrome (potentially life-threatening drug reaction). GoToSource

Lawsuits filed for falls and cognitive impairment.