Pronunciation:

BAK-loe-fen

Brand Names:

• Fleqsuvy
• Lyvispah
• Ozobax
• Ozobax DS
• Lioresal
• Lioresal Double Strength

Dosage Forms:

• Tablet
• Solution
• Packet
• Suspension

Classifications:

Therapeutic—

Skeletal Muscle Relaxant, Centrally Acting

Chemical—

Gamma Aminobutyric Acid (class)

Uses of This Medicine:

Baclofen is used to help relax certain muscles in your body. It relieves the spasms, cramping, and tightness of muscles caused by medical problems, including multiple sclerosis or certain injuries to the spine. Baclofen does not cure these problems, but it may allow other treatment, such as physical therapy, to be more helpful in improving your condition.

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. Baclofen may also be used to relieve other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of baclofen oral liquid and granules in children younger than 12 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of baclofen tablets in the pediatric population. Safety and efficacy have not been established..

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of baclofen oral liquid and granules in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution for patients receiving this medicine.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of baclofen tablet in the elderly. 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 are usually more sensitive than younger adults to the effects of this medicine.

Breast-feeding—

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.

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 taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the 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

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:

• Autonomic dysreflexia, history of or
• Diabetes or
• Epilepsy or
• Mental illness or problems (eg, psychosis, schizophrenia) or
• Ovarian cysts or
• Posture or balance problems or
• Stroke, recent—Use with caution. May make these conditions worse.

• Kidney disease—The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, or do not take it longer than your doctor ordered.

This medicine comes with a patient information and instructions leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

To use the granules:

• Open the packet and empty all the granules directly into your mouth. The granules will dissolve in your mouth or can be swallowed. You may drink water after taking the medicine.
• You may mix the granules with 1 tablespoon (15 mL) of liquid (eg, apple juice or milk) or soft foods (eg, applesauce, pudding, or yogurt). Take this mixture within 2 hours of mixing.
• This medicine can also be given using a nasogastric or gastric feeding tube. Mix the granules with 1 tablespoon (15 mL) of liquid (eg, apple juice or milk). Give this mixture within 2 hours of mixing. After the medicine is given, flush the tube with an additional 1 tablespoon (15 mL) of water.
• Take all the contents of the packet to get a full dose. Do not take only part of this medicine. Do not save a portion for later use.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup.

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.

• For muscle relaxation:
  • For oral dosage form (granules):
    • Adults and children 12 years of age and older—At first, 5 milligrams (mg) 3 times a day for 3 days. Your doctor may increase your dose by 5 mg every 3 days as needed and tolerated. However, the dose is usually not more than 80 milligrams (mg) per day (20 mg four times a day).
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (solution):
    • Adults and children 12 years of age and older—At first, 5 milliliters (mL) 3 times a day for 3 days. Your doctor may increase your dose by 5 mL every 3 days as needed and tolerated. However, the dose is usually not more than 80 milligrams (mg) per day (20 mg four times a day).
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults and teenagers—At first, 5 milligrams (mg) 3 times a day. Your doctor may increase your dose by 5 mg every 3 days until the desired response is reached. However, the dose is not more than 80 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the oral liquid in the refrigerator. Do not freeze.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Do not suddenly stop using this medicine without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely. Unwanted side effects (eg, hallucinations, seizures, high fever, rhabdomyolysis) may occur if baclofen is stopped suddenly.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). 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, medicine for seizures or barbiturates, other muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using baclofen.

This medicine may cause dizziness, drowsiness, 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.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has shakiness or tremors, seizures, or increased muscle tone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 immediately if any of the following side effects occur:

Less common or rare

Bloody or dark urine

chest pain

clumsiness, unsteadiness, trembling, or other problems with muscle control

fainting

false sense of well-being

mental depression or other mood changes

pounding heartbeat

ringing or buzzing in the ears

seeing or hearing things that are not there

skin rash or itching

slurred speech or other speech problems

swelling of the ankles

unexplained muscle stiffness

unusual excitement

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision

dizziness

drowsiness

irregular, fast or slow, or shallow breathing

lightheadedness

loss of strength or energy

muscle pain or weakness

pale or blue lips, fingernails, or skin

seizures

sleepiness or unusual drowsiness

trouble breathing

unusual weak feeling

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

Confusion

constipation

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

headache

increased need to urinate

nausea

passing urine more often

sweating

trouble sleeping

unusual tiredness or weakness

Less common or rare

Diarrhea

loss of appetite

muscle or joint pain

numbness or tingling in the hands or feet

stomach pain or discomfort

stuffy nose

weight gain

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.