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Metaxalone
Each pale rose, scored tablet contains: metaxalone, 400 mg. Skelaxin (metaxalone) has the following chemical
name: 5-[(3,4-dimethylphenoxy)methyl]-2-oxazolidinone.
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.
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 two tablets (800 mg) three to four times a day. HOW SUPPLIED Skelaxin is available as a 400 mg pale rose tablet, inscribed with 8862 on the scored side and "C" on the other. Store at Controlled Room Temperature, between 15°C and 30°C (59°F and 86°F).
The most frequent reactions to metaxalone include nausea, vomiting, gastrointestinal upset, drowsiness, dizziness, headache, and nervousness or "irritability." Other adverse reactions are: hypersensitivity reactions, characterized by a light rash with or without pruritus; leukopenia; hemolytic anemia; jaundice.
No information provided.
No information provided.
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's 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 possible 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.
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