Lioresal (Intrathecal)

Intrathecal baclofen is used to help relax certain muscles in your body. It relieves muscle spasms, cramping, and tightness caused by medical issues such as multiple sclerosis, cerebral palsy, or specific spine injuries. Intrathecal baclofen does not cure these conditions, but it may make other treatments, like physical therapy, more effective in improving your condition.

Intrathecal baclofen works on the central nervous system (CNS) to create its muscle relaxant effects. Its effects on the CNS may also lead to some side effects of the medicine.

This medicine is delivered by a drug pump directly into the spinal fluid in your back. A doctor will surgically place the pump and monitor the amount of medication delivered by it. The dose of intrathecal baclofen will vary for each patient and will depend on the type of muscle tightness you have.

Intrathecal baclofen is given only by or under the direct supervision of a doctor.

Your doctor should check how you are doing 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 need to be changed frequently to fit your individual needs.

Make sure to keep all appointments to refill the pump. If the pump is not refilled on time, you may experience a 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 increase 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, a 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 reduce this problem.

In deciding to use a medicine, it is important to consider the risks of taking the medicine alongside the benefits it may provide. This decision is made between you and your doctor. For this medicine, you should think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

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

Geriatric

Elderly patients may experience side effects such as hallucinations, confusion or mental depression, other mood or mental changes, and severe drowsiness. They may be more sensitive than younger adults to the effects of intrathecal baclofen.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while other medicines may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose, or other precautions might be necessary. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Alfentanil
• Alprazolam
• Amifampridine
• Benzhydrocodone
• Bromazepam
• Buprenorphine
• Bupropion
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Cetirizine
• Clobazam
• Clonazepam
• Codeine
• Daridorexant
• Dexmedetomidine
• Dihydrocodeine
• Donepezil
• Doxylamine
• Esketamine
• Fentanyl
• Flibanserin
• Gabapentin
• Gabapentin Enacarbil
• Hydrocodone
• Hydromorphone
• Ketamine
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofexidine
• Loxapine
• Magnesium Oxybate
• Meperidine
• Methadone
• Metoclopramide
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Olanzapine
• Oxycodone
• Oxymorphone
• Pentazocine
• Periciazine
• Phenobarbital
• Potassium Oxybate
• Pregabalin
• Primidone
• Remifentanil
• Remimazolam
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Topiramate
• Tramadol
• Trazodone
• Zolpidem
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

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

• 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 worsen this condition

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.

In the U.S.

• Gablofen
• Lioresal

Available Dosage Forms:

• Solution

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Chemical Class: Gamma Aminobutyric Acid (class)

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.