Metaxalone Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
Metaxalone is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
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.
What should I know before taking it?
Metaxalone tablets are contraindicated in patients with: Known hypersensitivity to any component of metaxalone tablets.Known tendency to drug induced, hemolytic, or other anemias.Severe renal or hepatic impairment.
What important warnings are listed?
5 WARNINGS AND PRECAUTIONS Serotonin Syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, 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 taken at a dosage higher than the recommended dosage. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dosage increases. Discontinue metaxalone tablets if serotonin syndrome is suspected or it occurs. ( 5.1 , 7.1 ) Central Nervous System (CNS) Depression : Metaxalone tablets may impair mental and/or physical abilities.
How is this medication usually taken?
The recommended dosage of metaxalone tablets in adults and pediatric patients 13 years of age and older is two 400 mg tablets (800 mg) or one 800 mg tablet orally three to four times a day [see Use in Specific Populations (8)]. Metaxalone tablets, 400 mg and 800 mg are not substitutable on a mg to mg basis with Metaxalone Tablets, 640 mg [see Clinical Pharmacology (12.3)]. When it is appropriate to switch: Switch only in patients who have been taking metaxalone tablets, 640 mg on an empty stomach. Stop metaxalone tablets, 640 mg three times a day and start metaxalone tablets, 800 mg or two 400 mg tablets three times a day on an empty stomach, OR stop metaxalone tablets 640 mg four times a.
What side effects are listed?
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.
What interactions are listed?
7 DRUG INTERACTIONS 7.1 Serotonergic Drugs If concomitant use of metaxalone tablets and another serotoneric drug is warranted, carefully observe the patient, particularly during treatment initiation and dosage modification. Discontinue metaxalone tablets if serotonin syndrome is suspected or if it occurs. Serotonin syndrome has resulted from concomitant use of metaxalone tablets (within the recommended dosage range) with other serotonergic drugs [see Warnings and Precautions (5.1) and Adverse Reactions (6) ] . Serotonergic drugs include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1cef46bb-e590-4a58-82e0-7cf1fc3836a5
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.