Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For intrathecal baclofen, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to intrathecal or oral baclofen. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—This medicine has not been studied in pregnant women. However, studies in animals have shown that baclofen causes birth defects and other problems during pregnancy. Before taking this medicine make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Oral baclofen passes into the breast milk. However, it is not known whether intrathecal baclofen passes into breast milk. This medicine has not been reported to cause problems in nursing babies.

Children—This medicine has been tested in children 4 years of age and older. Effective doses have not been shown to cause different side effects or problems in children than it does in adults. However, this medicine may not be safe for children younger than 4 years of age.

Older adults—Side effects such as hallucinations, confusion or mental depression, other mood or mental changes, and severe drowsiness may be especially likely to occur in elderly patients, who may be more sensitive than younger adults to the effects of intrathecal baclofen.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using intrathecal baclofen, it is especially important that your health care professional know if you are using any of the following:

• Alcohol or
• Central nervous system (CNS) depressants (medicines that may make you drowsy)—The chance of side effects may be increased

Other medical problems—The presence of other medical problems may affect the use of intrathecal baclofen. Make sure you tell your doctor if you have any other medical problems, especially:

• Breathing difficulties or
• Stroke or other brain disease—Baclofen may make these conditions worse

• Communication difficulties or
• Spinal cord injuries, at or above T-6 or
• Withdrawal symptoms, history of—These conditions may increase your risk for side effects of baclofen

• Epilepsy or
• Kidney disease or
• Mental or emotional problems or
• Spinal lesions—The chance of side effects may be increased

• Parkinson's disease—Baclofen may make this condition worse