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SKELAXIN (METAXALONE): PRESCRIBING INFORMATION

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 C12H15NO3, which corresponds to a molecular weight of 221.25.

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 andor water.

Each Skelaxin tablet contains 800 mg metaxalone and the following inactive ingredients: ammonium calcium alginate, alginic acid, B-Rose Liquid, corn starch and magnesium stearate.


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.


CLINICAL PHARMACOLOGY

Skelaxin clinical pharmacology


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.


CONTRAINDICATIONS

Known hypersensitivity to any components of this product.

Known tendency to drug induced, hemolytic, or other anemias.

Significantly impaired renal or hepatic function.


WARNINGS

Skelaxin tablets may enhance the effects of alcohol and other CNS depressants.


PRECAUTIONS

Skelaxin precautions


ADVERSE REACTIONS

Skelaxin adverse reactions


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 LD50 in rats and mice, progressive sedation, hypnosis and finally respiratory failure were noted as the dosage increased. In dogs, no LD50 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.


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 100 and in bottles of 500.

Store at Controlled Room Temperature, between 15°C and 30°C (59°F and 86°F).

Manufactured by: Mallinckrodt Inc.
Distributed by: King Pharmaceuticals, Inc.

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