FDA label 7018ae1b-fb87-5669-e053-2a91aa0a2cc8

WARNINGS Metaxalone may enhance the effects of alcohol and other CNS depressants. PRECAUTIONS Metaxalone should be administered with great care to patients with pre-existing liver damage. Serial liver function studies should be performed in these patients. False-positive Benedict’s tests, due to an unknown reducing substance, have been noted. A glucose-specific test will differentiate findings. Taking metaxalone with food may enhance general CNS depression; elderly patients may be especially susceptible to this CNS effect. (See CLINICAL PHARMACOLOGY: Pharmacokinetics and PRECAUTIONS: Information for Patients section). Information for Patients Metaxalone 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. Drug Interactions The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously. Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of metaxalone has not been determined. Pregnancy Reproduction studies in rats have not revealed evidence of impaired fertility or harm to the fetus due to metaxalone. Post marketing experience has 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 judgement 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.

The most frequent reactions to metaxalone include: CNS: drowsiness, dizziness, headache, and nervousness or “irritability”; Digestive: nausea, vomiting, gastrointestinal upset. Other adverse reactions are: Immune System: hypersensitivity reaction, rash with or without pruritus; Hematologic: leukopenia; hemolytic anemia; Hepatobiliary: jaundice. Though rare, anaphylactoid reactions have been reported with metaxalone.