Drug Facts
Composition & Profile
Identifiers & Packaging
Metaxalone Tablets, USP, for oral administration, are available as 800 mg Rose-colored, capsule-shaped tablets, debossed “E 448” on one side and scored on the other side Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by Sandoz Inc., Princeton, NJ 08540 Rev. May 2016 46188486 MF0448REV05/16; 091; 832-90
- Metaxalone Tablets, USP, for oral administration, are available as 800 mg Rose-colored, capsule-shaped tablets, debossed “E 448” on one side and scored on the other side Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by Sandoz Inc., Princeton, NJ 08540 Rev. May 2016 46188486 MF0448REV05/16
- 091
- 832-90
Overview
Metaxalone tablets, USP are available as an 800 mg tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy)methyl]-2-oxazolidinone. The empirical formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structural formula is: [Chemical Structure] 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: corn starch, alginic acid, acacia, sodium starch glycolate, magnesium stearate and FD&C red No. 40 aluminum lake.
Indications & Usage
Metaxalone tablets are 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
Metaxalone tablets 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.
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