Generic Name: baclofen (BAK-loe-fen)
Brand Name: Examples include Lioresal and Gablofen
Do not suddenly stop taking Gablofen. 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.
Gablofen is used for:
Treating severe muscle spasms due to a variety of causes, including brain or spinal cord injuries.
Gablofen 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 Gablofen if:
- you are allergic to any ingredient in Gablofen
Contact your doctor or health care provider right away if any of these apply to you.
Before using Gablofen:
Some medical conditions may interact with Gablofen. 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 Gablofen. 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 Gablofen 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 Gablofen:
Use Gablofen as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Gablofen 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 Gablofen 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 Gablofen, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Gablofen.
Important safety information:
- Gablofen may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Gablofen 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 Gablofen; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do not suddenly stop using Gablofen. Your doctor can tell you the best way to slowly reduce the dose.
- If you are using a pump to receive Gablofen, 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.
- Gablofen 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 Gablofen while you are pregnant. It is not known if Gablofen is found in breast milk. If you are or will be breast-feeding while you use Gablofen, check with your doctor. Discuss any possible risks to your baby.
If you suddenly stop taking Gablofen, 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 Gablofen:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; constipation; diarrhea; dizziness; drowsiness; fatigue; headache; increased salivation; muscle weakness; nausea; vomiting.
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 Gablofen:
Gablofen is usually handled and stored by a health care provider. If you are using Gablofen at home, store Gablofen as directed by your pharmacist or health care provider. Keep Gablofen out of the reach of children and away from pets.
- If you have any questions about Gablofen, please talk with your doctor, pharmacist, or other health care provider.
- Gablofen 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 Gablofen 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 Gablofen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Gablofen. 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 Gablofen.
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.
More about Gablofen (baclofen)
- Other brands: Lioresal