Metaxalone

Metaxalone is used along with rest and physical therapy in adults and children who are at least 13 years old to treat muscle conditions that cause pain or injury.

Metaxalone may also be used for reasons not mentioned in this medication guide.

Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use metaxalone in larger amounts, or for longer than prescribed.

Your dose may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes, and taking it exactly as directed.

You may take metaxalone with or without food, but take it the same way each time. Taking this medicine with food may cause increased drowsiness or dizziness.

This medicine can affect the results of certain medical tests. Tell laboratory staff or any doctor who treats you that you are using metaxalone.

Your treatment may also include rest, physical therapy, or other pain relief measures. Follow your doctor's instructions.

Store at room temperature away from moisture and heat.

You should not use metaxalone if you have anemia (low red blood cells), severe kidney disease, or severe liver disease.

You should not use metaxalone if you are allergic to it, or if you have:

• anemia or low red blood cells (caused by disease or by using certain medicine); or
• severe liver or kidney disease.

Tell your doctor if you have or have ever had:

• liver or kidney problems.

Tell your doctor if you also use stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with metaxalone could cause a serious condition called serotonin syndrome.

It is not known whether metaxalone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Metaxalone can slow or stop your breathing, especially if you have recently used an opioid medication or certain anxiety or mood disorder medications. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue-colored lips, or if you are hard to wake up.

Metaxalone may cause serious side effects. Stop using metaxalone and call your doctor at once if you have:

• feeling like you might pass out;
• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• pale or yellowed skin, dark-colored urine, fever, confusion or weakness; or
• jaundice (yellowing of the skin or eyes).

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common side effects of metaxalone may include:

• dizziness, drowsiness;
• nausea, vomiting, upset stomach;
• headache; or
• feeling nervous or irritable.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Muscle Spasm:

640 mg or 800 mg orally 3 to 4 times a dayComments:-Two 400 mg tablets or one 800 mg tablet are not substitutable on a mg-to-mg basis with 640 mg tablets. It is appropriate to switch:---Only in patients who have been taking 640 mg tablets on an empty stomach---Stop 640 mg tablets three times a day and start two 400 mg or one 800 mg three times a day on an empty stomach, OR stop 640 mg tablets four times a day and start two 400 mg or one 800 mg tablets four times a day on an empty stomach. -Do not switch in patients taking this drug with food.Use: Painful musculoskeletal conditions as an adjunct to rest, physical therapy, and other measures

Usual Pediatric Dose for Muscle Spasm:

Children 13 years and older:640 mg or 800 mg orally 3 to 4 times a dayComments:-Two 400 mg tablets or one 800 mg tablet are not substitutable on a mg-to-mg basis with 640 mg tablets. It is appropriate to switch:---Only in patients who have been taking 640 mg tablets on an empty stomach---Stop 640 mg tablets three times a day and start two 400 mg or one 800 mg three times a day on an empty stomach, OR stop 640 mg tablets four times a day and start two 400 mg or one 800 mg tablets four times a day on an empty stomach. -Do not switch in patients taking this drug with food.Use: Painful musculoskeletal conditions as an adjunct to rest, physical therapy, and other measures in patients 13 years of age and older

Take the medicine as soon as you can, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal.

Do not drink alcohol. Dangerous side effects could occur.

Avoid driving or doing anything dangerous until you know how metaxalone will affect you. Dizziness or drowsiness can lead to falls, accidents, or serious injuries.

Using metaxalone with other drugs that make you sleepy can make you feel even more tired. Talk to your doctor before taking opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may impact how metaxalone works, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.