A skeletal muscle relaxant - It may be used to treat symptoms of multiple sclerosis or spinal cord i... more
FDA Alerts
Intrathecal Baclofen Withdrawal
Abrupt discontinuation of intrathecal baclofen may result in seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity; in rare cases, progression to rhabdomyolysis, multisystem organ failure, and death may occur.
Give careful attention to programming and monitoring of infusion system, refill scheduling and procedures, and pump alarms to prevent abrupt discontinuance. (See Warnings under Cautions.)
Advise patients and caregivers of the importance of keeping scheduled refill visits and of the early signs and symptoms of baclofen withdrawal.
Give special attention to patients at apparent risk for withdrawal (e.g., spinal cord injury at T6 level or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).
Take this medicine by mouth. Swallow it with a drink of water. Follow the directions on the prescription label. Do not take more medicine than you are told to take.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Do not suddenly stop taking your medicine. If you do, you may develop a severe reaction. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects. Follow the advice of your doctor.
Baclofen can affect blood sugar levels. If you have diabetes, talk with your doctor or health care professional before you take the medicine.
You may get drowsy or dizzy when you first start taking the medicine or change doses. Do not drive, use machinery, or do anything that may be dangerous until you know how the medicine affects you. Stand or sit up slowly.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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