Metaxalone
Generic: METAXALONE
Basic Information
Manufacturer
INA Pharmaceutics Inc
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
fc6de1a6-26aa-47ac-a5d2-bf127a6ca563
Indications & Usage
1 INDICATIONS AND USAGE Metaxalone Tablets, 640 mg, are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older.
Metaxalone Tablets, 640 mg, is a muscle relaxant, indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adult and pediatric patients 13 years of age and older.
( 1 )
Metaxalone Tablets, 640 mg, is a muscle relaxant, indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adult and pediatric patients 13 years of age and older.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions associated with the use of metaxalone were identified in clinical studies or postmarketing reports.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most frequent reactions to metaxalone were: CNS : drowsiness, dizziness, headache, and nervousness or “irritability” Digestive : nausea, vomiting, gastrointestinal upset.
Other adverse reactions were: Allergic : anaphylaxis have been reported with metaxalone.
CNS : cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of metaxalone (within the recommended dosage range) and other serotonergic drugs and with the use of metaxalone as the only serotonergic drug taken at a dosage higher than the recommended dosage [see Warnings and Precautions (5.1) , Drug Interactions (7.2) , and Overdosage (10) ].
Hematologic : leucopenia; hemolytic anemia.
Hepatobiliary : jaundice.
Immune System : hypersensitivity reaction, rash with or without pruritus.
The most common adverse reactions to Metaxalone Tablets, 640 mg include drowsiness, dizziness, headache, and nervousness or “irritability”, nausea, vomiting, gastrointestinal upset.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact INA Pharmaceutics, Inc.
at 1-866-835-0469 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most frequent reactions to metaxalone were: CNS : drowsiness, dizziness, headache, and nervousness or “irritability” Digestive : nausea, vomiting, gastrointestinal upset.
Other adverse reactions were: Allergic : anaphylaxis have been reported with metaxalone.
CNS : cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of metaxalone (within the recommended dosage range) and other serotonergic drugs and with the use of metaxalone as the only serotonergic drug taken at a dosage higher than the recommended dosage [see Warnings and Precautions (5.1) , Drug Interactions (7.2) , and Overdosage (10) ].
Hematologic : leucopenia; hemolytic anemia.
Hepatobiliary : jaundice.
Immune System : hypersensitivity reaction, rash with or without pruritus.
The most common adverse reactions to Metaxalone Tablets, 640 mg include drowsiness, dizziness, headache, and nervousness or “irritability”, nausea, vomiting, gastrointestinal upset.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact INA Pharmaceutics, Inc.
at 1-866-835-0469 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.