Baclofen (Intrathecal Route)

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 .

This product is available in the following dosage forms:

• Solution


• Kit

Before Using

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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.

Geriatric

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.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Breathing difficulties or


• Stroke or other brain diseasea€”Baclofen may make these conditions worse

• Communication difficulties or


• Spinal cord injuries, at or above Ta€“6 or


• Withdrawal symptoms, history ofa€”These conditions may increase your risk for side effects of baclofen

• Epilepsy or


• Kidney disease or


• Mental or emotional problems or


• Spinal lesionsa€”The chance of side effects may be increased

• Parkinson`s diseasea€”Baclofen may make this condition worse

Proper Use

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions

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

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:

More common

• Convulsions (seizures)

Less common or rare

• Blurred vision or double vision


• Fainting


• Mental depression


• Muscle weakness


• Ringing or buzzing in ears


• Seeing, hearing, or feeling things that are not there


• Shortness of breath or troubled breathing

Symptoms of overdose

• Convulsions (seizures)


• Dizziness, drowsiness, or lightheadedness


• Increased watering of the mouth


• Mental confusion


• Muscle weakness


• Nausea and/or vomiting


• Shortness of breath or troubled breathing

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Constipation


• Difficult urination


• Dizziness


• Headache


• Nausea and/or vomiting


• Numbness or tingling in hands or feet


• Sleepiness

Less common

• Clumsiness, unsteadiness, trembling, or other problems with muscle control


• Diarrhea


• Difficulty sleeping


• Dizziness or lightheadedness, especially when 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

After you stop using this medicine, it may still produce some side effects that need attention . During this period of time, check with your doctor immediately if you notice the following side effects:

• 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 may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.