Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Metaxalone Tablets, USP are available as 800 mg pink, capsule shaped, scored tablets, debossed “LCI” on one side and “14” bisect “35” on the other side. 55700-494-21 55700-494-30 55700-494-60 55700-494-90 Store at 20ºC to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 Made in the USA CIB71144B Rev. 05/16; image description
- HOW SUPPLIED Metaxalone Tablets, USP are available as 800 mg pink, capsule shaped, scored tablets, debossed “LCI” on one side and “14” bisect “35” on the other side. 55700-494-21 55700-494-30 55700-494-60 55700-494-90 Store at 20ºC to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 Made in the USA CIB71144B Rev. 05/16
- image description
Overview
Metaxalone is available as an 800 mg pink, capsule shaped, scored tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy)methyl]-2-oxazolidinone. The empirical formula is C 12 H 15 NO 3 , which corresponds to a molecular weight of 221.25. The structural formula is: Metaxalone is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone and the following inactive ingredients: carboxymethylcellulose sodium, alginic acid, stearic acid, hydrogenated castor oil, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulfate, and FD&C Red #40 Aluminum Lake. metaxalone-struc
Indications & Usage
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.
Dosage & Administration
The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.
Warnings & Precautions
WARNINGS Metaxalone may enhance the effects of alcohol and other CNS depressants.
Contraindications
Known hypersensitivity to any components of this product. Known tendency to drug induced, hemolytic, or other anemias. Significantly impaired renal or hepatic function.
Adverse Reactions
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.
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.
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