Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Metaxalone is available as an 800 mg , light pink to pink, capsule shaped, scored uncoated tablet with debossing ‘AN’ on the left side of the scoring and ‘553’ on the right side of the scoring. Other side of the tablet is plain. They are available as follows: Bottles of 10: NDC 63187-490-10 Bottles of 30: NDC 63187-490-30 Bottles of 60: NDC 63187-490-60 Bottles of 90: NDC 63187-490-90 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Rx Only Manufactured By: Amneal Pharmaceuticals Co. (I) Pvt. Ltd. Ahmedabad, INDIA 382220 Distributed By: Amneal Pharmaceuticals Glasgow, KY 42141 Repackaged By: Proficient Rx LP Thousand Oaks, CA 91320 Rev. 05-2012; PRINCIPAL DISPLAY PANEL 63187-490-30
- HOW SUPPLIED Metaxalone is available as an 800 mg , light pink to pink, capsule shaped, scored uncoated tablet with debossing ‘AN’ on the left side of the scoring and ‘553’ on the right side of the scoring. Other side of the tablet is plain. They are available as follows: Bottles of 10: NDC 63187-490-10 Bottles of 30: NDC 63187-490-30 Bottles of 60: NDC 63187-490-60 Bottles of 90: NDC 63187-490-90 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Rx Only Manufactured By: Amneal Pharmaceuticals Co. (I) Pvt. Ltd. Ahmedabad, INDIA 382220 Distributed By: Amneal Pharmaceuticals Glasgow, KY 42141 Repackaged By: Proficient Rx LP Thousand Oaks, CA 91320 Rev. 05-2012
- PRINCIPAL DISPLAY PANEL 63187-490-30
Overview
Metaxalone is available as an 800 mg, light pink to pink, capsule shaped, scored uncoated 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: calcium carbonate, FD&C Red #40, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone, silicone dioxide, sodium starch glycolate and sodium stearyl fumarate. chemical structure
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, 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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