Metaxalone
Generic: METAXALONE
Basic Information
Manufacturer
BluePoint Laboratories
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
c91c0fb0-0b61-4e45-8bea-d0bf57ca7068
Indications & Usage
1 INDICATIONS AND USAGE Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older.
Metaxalone tablet 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 adults and pediatric patients 13 years of age and older.
( 1 )
Metaxalone tablet 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 adults 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 tablets 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: CNS : cases of serotonin syndrome have been reported during concomitant use of metaxalone tablets (within the recommended dosage range) and other serotonergic drugs and with the use of metaxalone tablets as the only serotonergic drug at a dosage higher than the recommended dosage [see Warnings and Precautions (5.1) , Drug Interactions (7.1) and Overdosage (10) ] .
Hematologic : leukopenia; hemolytic anemia; Hepatobiliary : jaundice; Immune System : anaphylaxis, hypersensitivity reaction, rash with or without pruritus.
Most common adverse reactions (incidence >5%) are nausea and vomiting.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories, Inc.
at 1-888-375-3784 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: CNS : cases of serotonin syndrome have been reported during concomitant use of metaxalone tablets (within the recommended dosage range) and other serotonergic drugs and with the use of metaxalone tablets as the only serotonergic drug at a dosage higher than the recommended dosage [see Warnings and Precautions (5.1) , Drug Interactions (7.1) and Overdosage (10) ] .
Hematologic : leukopenia; hemolytic anemia; Hepatobiliary : jaundice; Immune System : anaphylaxis, hypersensitivity reaction, rash with or without pruritus.
Most common adverse reactions (incidence >5%) are nausea and vomiting.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories, Inc.
at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .