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Baclofen

Pronunciation

Generic Name: baclofen (BAK-loe-fen)
Brand Name: Examples include Lioresal and Gablofen

Do not suddenly stop taking baclofen. Sudden withdrawal may cause serious and possibly life-threatening side effects, including high fever; confusion; changes in mental status; and muscle stiffness and spasms that, in rare cases, have progressed to serious muscle problems, multiple organ failure, and death. If you experience any of the symptoms listed above, seek immediate medical attention. It is important to ensure that this drug is not stopped suddenly by learning how to properly use the pump, refilling the pump on time, and being aware of the pump alarms and what to do if the pump alarm goes off. This is especially important for certain patients who are at greater risk (eg, spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from either oral or intrathecal baclofen). Keep your scheduled refill visits and talk with your health care provider about early withdrawal symptoms.


Baclofen is used for:

Treating severe muscle spasms due to a variety of causes, including brain or spinal cord injuries.

Baclofen is a muscle relaxant and antispastic agent. It reduces the frequency and severity of muscle spasms that occur as a result of neurological disorders, such as multiple sclerosis.

Do NOT use baclofen if:

  • you are allergic to any ingredient in baclofen

Contact your doctor or health care provider right away if any of these apply to you.

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Before using baclofen:

Some medical conditions may interact with baclofen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have kidney problems or are very confused
  • if you have a history of a certain nervous system problem (autonomic dysreflexia) or mood or mental problems (eg, schizophrenia)

Some MEDICINES MAY INTERACT with baclofen. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Epidural morphine because shortness of breath and a significant decrease in blood pressure may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if baclofen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use baclofen:

Use baclofen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Baclofen is administered into the spinal canal as an injection or through an implantable infusion pump at your doctor's office, hospital, or clinic. Discuss any questions or concerns with your doctor.
  • Do not use baclofen if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of baclofen, contact your doctor right away.

Ask your health care provider any questions you may have about how to use baclofen.

Important safety information:

  • Baclofen may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use baclofen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using baclofen; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do not suddenly stop using baclofen. Your doctor can tell you the best way to slowly reduce the dose.
  • If you are using a pump to receive baclofen, always keep your scheduled refill visits. If you miss an appointment, contact your doctor right away to reschedule before you run out of medicine.
  • Pumps should only be refilled by trained and qualified personnel in order to prevent potentially life-threatening overdose. Discuss any questions or concerns with your doctor.
  • Baclofen should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using baclofen while you are pregnant. It is not known if baclofen is found in breast milk. If you are or will be breast-feeding while you use baclofen, check with your doctor. Discuss any possible risks to your baby.

If you suddenly stop taking baclofen, you may experience WITHDRAWAL symptoms, including high fever; confusion; changes in mental status; and severe increase in muscle stiffness and spasms that, in rare cases, has progressed to muscle destruction (causing dark colored urine and muscle weakness, aching, and tenderness), multiple organ failure, and death. If you experience any of the above symptoms, seek immediate medical attention.

Possible side effects of baclofen:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; diarrhea; dizziness; drowsiness; fatigue; headache; increased salivation; muscle weakness; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts or movements; burning, numbness, or tingling; chest pain; confusion; decreased urination or inability to urinate; eye or vision problems (eg, double vision, lazy eye); fainting; fast, slow, or irregular heartbeat; fever or chills; hallucinations; loss of muscle tone; mental or mood problems (eg, agitation, anxiety, depression); new or worsening muscle stiffness or spasms; pain; one-sided weakness; seizures; severe or persistent dizziness or headache; shortness of breath; slow or shallow breathing; speech problems (eg, slurred speech); swelling of the hands, ankles, or feet; tremor; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; dizziness; drowsiness; lightheadedness; loss of consciousness; loss of muscle tone; seizures; slow or shallow breathing.

Proper storage of baclofen:

Baclofen is usually handled and stored by a health care provider. If you are using baclofen at home, store baclofen as directed by your pharmacist or health care provider. Keep baclofen out of the reach of children and away from pets.

General information:

  • If you have any questions about baclofen, please talk with your doctor, pharmacist, or other health care provider.
  • Baclofen is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take baclofen or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about baclofen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to baclofen. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using baclofen.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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