Metaxalone
Generic: METAXALONE
Basic Information
Manufacturer
Proficient Rx LP
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
c796d4a1-fad4-4a0c-a459-8ae3b5b52fb6
Indications & Usage
INDICATIONS AND 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.
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.
Warnings
WARNINGS Metaxalone tablets may enhance the effects of alcohol and other CNS depressants.
Adverse Reactions
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.
To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
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.
To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.