Metaxalone 800 mg/1
Metaxalone · TABLET · American Health Packaging
Metaxalone is a muscle relaxant tablet taken by mouth that is used to relieve muscle pain and stiffness caused by muscle injuries or sprains. The standard strength is 800 mg per tablet.
Key Facts
- Brand Name
- Metaxalone
- Generic Name
- Metaxalone
- NDC Code (Product)
60687-663- Manufacturer
- American Health Packaging
- Strength
- 800 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207466
- Drug Class
- Muscle Relaxant [EPC]
- Marketing Start
- 01/06/2023
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Aidapak Services, LLC
Labeling: Label Mixup; METAXALONE Tablet, 800 mg may be potentially mislabeled as ESTERIFIED ESTROGENS, Tablet, 0.625 mg, NDC 61570007301, Pedigree: W003736, EXP: 6/26/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage & Administration
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.
Warnings
WARNINGS Serotonin Syndrome Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of serotonergic drugs with Metaxalone used within the recommended dosage range (see PRECAUTIONS: Drug Interactions ) and with Metaxalone as a single agent taken at doses higher than the recommended dose (see OVERDOSAGE ). Serotonergic drugs include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, opioids (particularly fentanyl, meperidine, and methadone), drugs that affect the serotonergic neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and drugs that impair metabolism of serotonin (including monoamine oxidase (MAO) inhibitors, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) (see PRECAUTIONS: Drug Interactions ). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hype…
Contraindications
CONTRAINDICATIONS Known hypersensitivity to any components of this product. Known tendency to drug induced, hemolytic, or other anemias. Significantly impaired renal or hepatic function.
Drug Interactions
Drug Interactions CNS Depressants : The sedative effects of Metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants (TCAs)) may be additive. Exercise caution with patients who take more than one of these CNS depressants simultaneously. Follow patients closely for signs and symptoms of respiratory depression and sedation (see WARNINGS ). Serotonergic Drugs : Serotonin syndrome has resulted from concomitant use of serotonergic drugs with Metaxalone used within the recommended dosage range (see WARNINGS ). If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Metaxalone if serotonin syndrome is suspected. Examples of serotonergic drugs include: selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, opioids (particularly fentanyl, meperidine, and methadone), drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorder…
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 : anaphylaxis, hypersensitivity reaction, rash with or without pruritus; Hematologic : leukopenia; hemolytic anemia; Hepatobiliary : jaundice; CNS : cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of serotonergic drugs with metaxalone used within the recommended dosage range and with metaxalone as a single agent taken at doses higher than the recommended dose (see WARNINGS , PRECAUTIONS: Drug Interactions , and OVERDOSAGE ).
Frequently Asked Questions
What is Metaxalone used for?
Metaxalone is a muscle relaxant tablet taken by mouth that is used to relieve muscle pain and stiffness caused by muscle injuries or sprains. The standard strength is 800 mg per tablet.
Is Metaxalone a controlled substance?
Metaxalone is not classified as a controlled substance by the DEA.
What is the generic name for Metaxalone?
The generic name for Metaxalone is Metaxalone. There are no other listed brand versions of Metaxalone.
What is the NDC code for Metaxalone 800 mg/1?
The NDC (National Drug Code) for Metaxalone 800 mg/1 is 60687-663, listed by American Health Packaging.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)