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This document outlines critical safety information and warnings associated with the use of metaxalone. It is important to read these details carefully and discuss any concerns with your healthcare provider.

• Serotonin Syndrome Risk: There have been instances of serotonin syndrome occurring in individuals taking metaxalone alone or in combination with certain other medications. This rare but potentially life-threatening condition results from an excess of serotonin in the brain, a chemical that influences mood. The risk increases when taking medications that also affect serotonin levels.

• Impact on Driving and Concentration: Metaxalone can induce drowsiness and impair concentration and focus. These effects may be more pronounced in individuals over the age of 65 or when taken with a full meal. The risk is heightened if combined with alcohol, illicit substances, or other medications that cause drowsiness.

• Use in Individuals with Liver or Kidney Issues: Those with liver or kidney problems should exercise caution when using metaxalone, as the drug is metabolized by these organs. Impaired liver or kidney function can lead to accumulation of the drug in the body, increasing the likelihood of severe side effects like serotonin syndrome. This is particularly concerning for individuals with a history of liver or kidney issues.

Contraindications: Metaxalone should not be used in the following conditions due to serious health risks:

• Severe kidney problems
• Severe liver problems
• History of anemia

If any of these conditions apply, it is crucial to consult your healthcare provider before using this medication.

When taking this medication, you may encounter some common side effects such as dizziness, drowsiness, headache, nervousness, irritability, nausea, vomiting, and an upset stomach. These effects are generally mild and temporary, but if they persist or worsen, it's advisable to consult your healthcare provider for guidance.

In some cases, more serious side effects may occur, which require prompt medical attention. These include yellowing of the skin or eyes, which could indicate liver issues, and mental or mood changes like confusion. There is also a risk, albeit rare, of developing serotonin syndrome, a serious condition characterized by symptoms such as agitation, fever, sweating, fast heartbeat, severe nausea or vomiting, shakiness, muscle tightness, and confusion. If you experience any of these symptoms, seek medical help immediately.

Another rare but severe side effect is a hypertensive crisis, marked by extremely high blood pressure. Symptoms to watch for include severe headache, chest pain, irregular heartbeat, neck stiffness, severe nausea or vomiting, and vision changes. Immediate medical intervention is crucial if these symptoms arise.

Allergic reactions to this medication are infrequent but serious. Watch for signs such as rash, trouble breathing, or swelling of the face, lips, tongue, or throat, and seek emergency medical assistance if they occur. Remember to contact your healthcare provider if you notice any unusual side effects not listed here.

When taking Metaxalone, it's essential to be aware of its potential interactions with various medications and supplements. Inform your doctor and pharmacist about all other medications, including prescriptions, over-the-counter drugs, vitamins, and dietary or herbal supplements, that you are currently using.

Certain drugs that may interact with Metaxalone include those used for weight loss (such as diethylpropion), attention deficit disorder (like atomoxetine and methylphenidate), and some Parkinson's disease medications (such as entacapone, levodopa, and tolcapone). It also interacts with opioid pain relievers like fentanyl, methadone, and tapentadol. Additionally, drugs for depression, including tricyclic antidepressants (like amitriptyline and doxepin), and supplements such as tryptophan and tyramine, can lead to interactions.

The risk of serotonin syndrome or toxicity can increase if Metaxalone is used with drugs that raise serotonin levels. These include certain antidepressants like SSRIs (such as fluoxetine and paroxetine) and SNRIs (such as duloxetine and venlafaxine), as well as triptans used for migraines (such as sumatriptan and zolmitriptan).

It's crucial to avoid mixing Metaxalone with MAO inhibitors (such as isocarboxazid and phenelzine) as this can lead to severe, potentially fatal interactions. These inhibitors should not be taken within two weeks before or after using Metaxalone.

Moreover, combining Metaxalone with certain herbal products, nasal decongestants, and stimulants can cause dangerously high blood pressure. Drugs causing drowsiness, such as opioids, alcohol, sleep medications, and other muscle relaxants, should be used with caution.

Always check medication labels for drowsiness-inducing ingredients and consult your pharmacist for safe use. Also, Metaxalone may affect certain lab tests, potentially leading to false results, so ensure your healthcare providers are informed about your Metaxalone use.