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Federal law prohibits dispensing without prescription.
Each pale rose, scored tablet contains: metaxalone, 400 mg.
Skelaxin® (metaxalone) has the following chemical structure and name:
5-[(3,4-dimethylphenoxy)methyl]-2 oxazolidinone
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The mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.
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.
Metaxalone is contraindicated in individuals who have shown hypersensitivity to the drug. Metaxalone should not be administered to patients with a known tendency to drug-induced, hemolytic, or other anemias. It is contraindicated in patients with significantly impaired renal or hepatic function.
Elevation in cephalin flocculation tests without concurrent changes in other liver function parameters have been noted. Hence, it is recommended that metaxalone be administered with great care to patients with pre-existing liver damage and that serial liver function studies be performed as required.
False-positive Benedict' tests, due to an unknown reducing substance, have been noted. A glucose-specific test will differentiate findings.
Pregnancy: Reproduction studies have been performed in rats and have revealed no evidence of impaired fertility or harm to the fetus due to metaxalone. Reactions reports from marketing experience have not revealed evidence of fetal injury, but such experience cannot exclude the possibility of infrequent or subtle damage to the human fetus. 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 judgment of the physician the potential benefits outweigh the possbile hazards.
Nursing Mothers: 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.
Pediatric Use: Safety and effectiveness in children 12 years of age and below have not been established.
The most frequent reactions to metaxalone include nausea, vomiting, gastrointestinal upset, drowsiness, dizziness, headache, and nervousness or "irritability." Other adverse reactions are: hypersensitivity reaction, characterized by a light rash with or without pruritus; leukopenia; hemolytic anemia; jaundice.
The recommended dose for adults and children over 12 years of age is two tablets (800 mg) three to four times a day.
Gastric lavage and supportive therapy as indicated. (When determining the LD 50 in rats and mice, progressive sedation, hypnosis and finally respiratory failure were noted as the dosage increased. In dogs, no LD 50 could be determined as the higher doses produced an emetic action in 15 to 30 minutes). No documented case of major toxicity has been reported.
Skelaxin® (metaxalone) is available as a 400 mg. pale rose tablet, inscribed with 8662 on the scored side and "C" on the other. Available in bottles of 100 (NDC 0086-0062-10) and in bottles of 500 (NDC 0086-0062-50).
Store at Controlled Room Temperature, between 15°C and 30°C (59°F and 86°F).
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Manufactured for Carnrick Laboratories
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