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|Lioresal Intrathecal Intrathecal-Systemic

BACLOFEN (Intrathecal-Systemic)

Some commonly used brand names are:

In the U.S.—

• Lioresal Intrathecal

In Canada—

• Lioresal Intrathecal

Category

• Antispastic

Description

Intrathecal baclofen (In-trah-THE-kal BAK-loe-fen) is used to help relax certain muscles in your body. It relieves the spasms, cramping, and tightness of muscles caused by medical problems such as multiple sclerosis, cerebral palsy, or certain injuries to the spine. Intrathecal baclofen does not cure these problems, but it may allow other treatment, such as physical therapy, to be more helpful in improving your condition.

Intrathecal baclofen acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of the medicine"s side effects.

This medicine is delivered by a drug pump directly into the spinal fluid of your back. A doctor will surgically place the pump and monitor the dose of the medication that is delivered by the pump. The dose of intrathecal baclofen will be different for different patients and will depend on the type of muscle tightness that you have.

Intrathecal baclofen is given only by or under the direct supervision of a doctor. It is available in the following dosage form:

• Intrathecal
• Injection (U.S. and Canada)

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

Precautions While Using This Medicine

Your doctor should check your progress at regular visits, especially during the first few weeks of treatment with this medicine. During this time, the amount of medicine you are using may have to be changed often to meet your individual needs.

Make sure to keep all appointments to refill the pump. If the pump is not refilled on time, you may experience return of your muscle tightness and early withdrawal symptoms which might include:

• itching of the skin
• decreased blood pressure
  • blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • sweating
  • unusual tiredness or weakness
• burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
• seizures

Intrathecal baclofen will add to the effects of alcohol and other CNS depressants (medicines that may make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; and anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using intrathecal baclofen .

Intrathecal baclofen may cause dizziness, drowsiness, false sense of well-being, lightheadedness, vision problems, or clumsiness or unsteadiness in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, and able to see well .

Intrathecal baclofen may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Some side effects may occur after you have stopped using this medicine. Check with your doctor immediately if any of the following effects occur:

Convulsions (seizures); facial flushing, headache, increased sweating, or slow heartbeat; increased muscle spasms; seeing, hearing, or feeling things that are not there

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 02/20/2003

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