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warnings and cautions
5 WARNINGS AND PRECAUTIONS Central Nervous System (CNS) Depression: Metaxalone Tablets 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 alcohol and other CNS depressants. (5.1) Hepatic and Renal Impairment: Metaxalone Tablets should be administered with caution to patients with mild to moderate hepatic and renal impairment. (5.2) 5.1 Central Nervous System (CNS) Depression Metaxalone Tablets may enhance the effects of alcohol and other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants) and 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. Therefore, Metaxalone Tablets should be used with caution in patients who take one or more of these CNS depressants. [See Drug Interactions (7.1) ] Elderly patients may be especially susceptible to CNS effects. 5.2 Hepatic and Renal Impairment Patients Metaxalone Tablets are metabolized by the liver and excreted in the urine. Use caution when administering Metaxalone Tablets in patients with mild to moderate hepatic or renal impairment. Consider monitoring of liver and renal function in these patients. Metaxalone Tablets are contraindicated in patients with severe hepatic or renal impairment [See Contraindications (4) and Use in Specific Populations (8.6, 8.7)].
6 ADVERSE REACTIONS The most frequent reactions to Metaxalone Tablets 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: leucopenia; hemolytic anemia; Hepatobiliary: jaundice. Anaphylactoid reactions have been reported with metaxalone. The most common adverse reactions to Metaxalone Tablets include drowsiness, dizziness, headache, and nervousness or “irritability”, nausea, vomiting, gastrointestinal upset. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact CorePharma, LLC at 1-800-850-2719 and www.corepharma.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .