BACLOFEN (Intrathecal-Systemic)
Some commonly used brand names are:
In the U.S.?
In Canada?
Category
Description
Intrathecal baclofen (In-trah-THE-kal BAK-loe-fen) is used to help relax certainmuscles in your body. It relieves the spasms, cramping, and tightness of musclescaused by medical problems such as multiple sclerosis, cerebral palsy, orcertain injuries to the spine. Intrathecal baclofen does not curethese 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 produceits muscle relaxant effects. Its actions on the CNS may also cause some ofthe medicine's side effects.
This medicine is delivered by a drug pump directly into the spinal fluidof your back. A doctor will surgically place the pump and monitor the doseof the medication that is delivered by the pump. The dose of intrathecal baclofenwill be different for different patients and will depend on the type of muscletightness that you have.
Intrathecal baclofen is given only by or under the direct supervision ofa 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 orallergic reaction to intrathecal or oral baclofen. Also tell your health careprofessional 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 defectsand other problems during pregnancy. Before taking this medicine make sureyour 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. Thismedicine has not been reported to cause problems in nursing babies.
Children?This medicine has been tested in children 4 yearsof age and older. Effective doses have not been shown to cause different sideeffects or problems in children than it does in adults. However, this medicinemay not be safe for children younger than 4 years of age.
Older adults?Side effects such as hallucinations, confusion ormental depression, other mood or mental changes, and severe drowsiness maybe especially likely to occur in elderly patients, who may be more sensitivethan younger adults to the effects of intrathecal baclofen.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are usingintrathecal baclofen, it is especially important that your health care professionalknow if you are using any of the following:
- Alcohol or
- Central nervous system (CNS) depressants (medicines that may makeyou drowsy)?The chance of side effects may be increased
Other medical problems?The presence of other medicalproblems may affect the use of intrathecal baclofen. Make sure you tell yourdoctor if you have any other medical problems, especially:
- Breathing difficulties or
- Stroke or other brain disease?Baclofen may make these conditionsworse
- Communication difficulties or
- Spinal cord injuries, at or above T-6 or
- Withdrawal symptoms, history of?These conditions may increaseyour 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 doctorshould check your progress at regular visits, especially during the firstfew weeks of treatment with this medicine. During this time, the amount ofmedicine you are using may have to be changed often to meet your individualneeds.
Make sure to keep all appointments to refill the pump. If the pump isnot refilled on time, you may experience return of your muscle tightness andearly withdrawal symptoms which might include:
- itching of the skin
- decreased blood pressure
- blurred vision
- confusion
- dizziness, faintness, or lightheadedness when getting up from a lyingor 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 depressantsare 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 doctorbefore 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 youdrive, use machines, or do anything else that could be dangerous if you arenot 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 salivasubstitute. However, if dry mouth continues for more than 2 weeks, check withyour medical doctor or dentist. Continuing dryness of the mouth may increasethe chance of dental disease, including tooth decay, gum disease, and fungusinfections.
Dizziness, lightheadedness, or fainting may occur when you get up suddenlyfrom 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 mayneed medical attention.
Check with your doctor as soon as possible if any of the following sideeffects occur:
Less common or rare
Blurred vision or double vision; fainting; mental depression; muscleweakness; ringing or buzzing in ears; seeing, hearing, or feeling things that are not there; shortness of breath or troubled breathing
Other side effects may occurthat usually do not need medical attention. These side effects may go awayduring treatment as your body adjusts to the medicine. However, check withyour doctor if any of the following side effects continue or are bothersome:
Less common
Clumsiness, unsteadiness, trembling, or other problems with musclecontrol; diarrhea; difficultysleeping; dizziness or lightheadedness, especiallywhen getting up from a lying or sitting position; dry mouth; frequent urge to urinate; irritation of the skin at the site where the pump is located; itching of the skin; sexual problems; slurred speech or other speech problems; swelling of ankles, feet, or lower legs; trembling or shaking
Some side effects may occur after you havestopped 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 feelingthings that are not there
Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.
Revised: 02/20/2003
