Baclofen

Generic name: baclofen (BAK-loe-fen)

Drug class: Skeletal muscle relaxants

Brand name: FIRST Baclofen, Ozobax, Lioresal, Lioresal Intrathecal, Gablofen

Commonly used brand name(s)

In the U.S.

Ozobax

In Canada

Lioresal
Lioresal Double Strength

Available Dosage Forms:

Tablet
Solution
Powder for Suspension

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Chemical Class: Gamma Aminobutyric Acid (class)

Uses for baclofen

Baclofen 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 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.

Baclofen is available only with your doctor's prescription.

HOW SUPPLIED

Baclofen Tablets, USP are supplied as:

10 mg: White colored, circular, flat, uncoated tablets with 'N029' debossed on one side and scoreline on the other side.

Boxes of 10 x 10 UD 100 NDC 63739-479-10

20 mg: White colored, circular, flat, uncoated tablets with 'N030' debossed on one side and scoreline on the other side.

Boxes of 10 x 10 UD 100 NDC 63739-480-10

PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Split tablet to be stored at controlled room temperature (20° to 25°C) for not more than 2 weeks.

Before using baclofen

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 baclofen, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to baclofen 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

Appropriate studies have not been performed on the relationship of age to the effects of baclofen oral liquid 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..

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of baclofen oral liquid 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 baclofen oral liquid.

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 baclofen tablet.

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.

Interactions with 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 baclofen, 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 baclofen 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
Butorphanol
Calcium Oxybate
Cannabidiol
Cetirizine
Clobazam
Codeine
Dihydrocodeine
Donepezil
Doxylamine
Esketamine
Fentanyl
Flibanserin
Gabapentin
Gabapentin Enacarbil
Hydrocodone
Hydromorphone
Ketamine
Lemborexant
Levocetirizine
Levorphanol
Lofexidine
Loxapine
Magnesium Oxybate
Meperidine
Methadone
Metoclopramide
Midazolam
Morphine
Morphine Sulfate Liposome
Nalbuphine
Oxycodone
Oxymorphone
Pentazocine
Periciazine
Potassium Oxybate
Pregabalin
Remifentanil
Remimazolam
Scopolamine
Sodium Oxybate
Sufentanil
Tapentadol
Tramadol
Trazodone
Zolpidem

Interactions with food/tobacco/alcohol

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.

Proper use of baclofen

Take baclofen 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.

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

Dosing

The dose of baclofen 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 baclofen. 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 (solution):
  - Adults and children 12 years of age and older—At first, 5 milliliters (mL) three 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) three 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 baclofen, 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.

OVERDOSE

Signs and Symptoms

Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression and seizures.

Treatment

In the alert patient, empty the stomach promptly by induced emesis followed by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Maintain adequate respiratory exchange, do not use respiratory stimulants.

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 baclofen

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 baclofen 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.

Baclofen 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.

Baclofen may cause dizziness, drowsiness, vision problems, or clumsiness or unsteadiness in some people. Make sure you know how you react to baclofen 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.

Baclofen 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 baclofen 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.

Baclofen 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 immediately if any of the following side effects occur:

Less common or rare

Bloody or dark urine
chest pain
fainting
mental depression or other mood changes
ringing or buzzing in the ears
seeing or hearing things that are not there
skin rash or itching

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

Symptoms of overdose

Blurred vision
convulsions
difficult or troubled breathing
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
sleepiness or unusual drowsiness
unusual weak feeling
unusually slow 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

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

Abdominal or stomach pain or discomfort
clumsiness, unsteadiness, trembling, or other problems with muscle control
diarrhea
false sense of well-being
loss of appetite
muscle or joint pain
numbness or tingling in the hands or feet
pounding heartbeat
slurred speech or other speech problems
stuffy nose
swelling of the ankles
unexplained muscle stiffness
unusual excitement
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.

Baclofen

Baclofen

Commonly used brand name(s)