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).
This medicine is for injection into the space around the spinal cord. It can be given by a health care professional in a clinic or hospital setting. Patients can also have a pump implanted into their back for a continuous infusion.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 4 years old for selected conditions, precautions do apply.
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?
It is important to keep your appointments to have this medicine administered or to refill your pump. If you cannot make your appointment, contact your health care provider to make other arrangements.
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?
Visit your doctor for regular check ups. Tell your doctor if your symptoms do not get better or if you get worse.
Do not suddenly stop taking your medicine. If you do, you may develop a severe reaction. Contact your health care provider immediately if you notice any problems with your catheter (especially if it becomes disconnected), low volume in the pump, or low battery level. 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.
This medicine 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. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.
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:
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?
This drug is given in a hospital or clinic and will not be stored at home.
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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