Skelaxin Information
Skelaxin (Metaxalone) Description
Skelaxin (Metaxalone) is available as an 800 mg oval, scored pink tablet.
Chemically, metaxalone is 5-[(3,5- dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is CHNO, 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: alginic acid, ammonium calcium alginate, B-Rose Liquid, corn starch and magnesium stearate.
Skelaxin (Metaxalone) Indications And Usage
Skelaxin (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.
Skelaxin (Metaxalone) Contraindications
Known hypersensitivity to any components of this product.
Known tendency to drug induced, hemolytic, or other anemias.
Significantly impaired renal or hepatic function.
Skelaxin (Metaxalone) Warnings
Skelaxin (Metaxalone) may enhance the effects of alcohol and other CNS depressants.
Skelaxin (Metaxalone) 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 Skelaxin (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).
Skelaxin (Metaxalone) 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.
Skelaxin (Metaxalone) Overdosage
Deaths by deliberate or accidental overdose have occurred with metaxalone, particularly in combination with antidepressants, and have been reported with this class of drug in combination with alcohol.
When determining the LD in rats and mice, progressive sedation, hypnosis and finally respiratory failure were noted as the dosage increased. In dogs, no LD could be determined as the higher doses produced an emetic action in 15 to 30 minutes.
Treatment - Gastric lavage and supportive therapy. Consultation with a regional poison control center is recommended.
Skelaxin (Metaxalone) Dosage And Administration
The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.
Skelaxin (Metaxalone) How Supplied
Skelaxin (Metaxalone) is available as an 800 mg oval, scored pink tablet inscribed with 8667 on the scored side and “S” on the other. Available in bottles of:
15 (NDC 21695-123-15)
30 (NDC 21695-123-30)
60 (NDC 21695-123-60)
90 (NDC 21695-123-90)
Store at Controlled Room Temperature, between 15°C and 30°C (59°F and 86°F).
Rx Only
Skelaxin (Metaxalone) Distributed By:
King Pharmaceuticals, Inc., Bristol, TN 37620
Skelaxin (Metaxalone) Manufactured By:
Mallinckrodt Inc., Hobart, NY 13788
Prescribing Information as of April 2007.
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
Skelaxin (Metaxalone) Principal Display Panel
