Clinical Information
Gen. Code and Des.
51112 metaxalone ORAL TABLET 800 MG
GCN and Des.
91765 metaxalone ORAL TABLET 800 MG
Strength
800MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
12200400 CENTRALLY ACTING SKELETAL MUSCLE RELAXNT
Active Ingredients
1673 metaxalone 1665481
SKELAXIN- metaxalone tablet
King Pharmaceuticals, Inc.
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 C12 H15 NO3 , 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 or water.
CLINICAL PHARMACOLOGY
Mechanism of Action
The mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system depression. Metaxalone has no direct action on the contractile mechanism of striated muscle, the motor end plate, or the nerve fiber.
Pharmacokinetics
The pharmacokinetics of metaxalone have been evaluated in healthy adult volunteers after single dose administration of SKELAXIN under fasted and fed conditions at doses ranging from 400 mg to 800 mg.
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 may enhance the effects of alcohol and other CNS depressants.
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.
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 (NDC 60793-136-01) and in bottles of 500 (NDC 60793-136-05).
Store at Controlled Room Temperature, between 15�C and 30�C (59�F and 86�F).
Rx Only
Prescribing Information as of April 2008.
Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Manufactured by: Corepharma LLC, Middlesex, NJ 08846
