Ozobax (Oral)

Baclofen is used to help relax certain muscles in your body. It reduces spasms, cramping, and tightness of muscles caused by medical issues, including multiple sclerosis or some spinal injuries. Baclofen does not cure these issues, but it may help other treatments, like physical therapy, work better for improving your condition.

Baclofen works on the central nervous system (CNS) to provide its muscle relaxant effects. Its effects on the CNS may also lead to some side effects. Baclofen can also be used to treat other conditions as decided by your doctor.

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

It is very important for your doctor to check your progress at regular visits. This will help your doctor see if the medicine is working properly and decide if you should keep taking it.

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

This medicine will increase 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 these while 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.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it can provide. For this medicine, keep the following in mind:

Allergies

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

Pediatric

There have not been appropriate studies on how baclofen oral liquid and granules affect children younger than 12 years old. Safety and effectiveness have not been established.

There have not been appropriate studies on how baclofen tablets affect children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown age-specific problems that would limit the usefulness of baclofen oral liquid and granules in older adults. However, elderly patients are more likely to have age-related kidney, liver, or heart issues, which may require caution when using this medicine.

Current studies have not shown age-specific problems that would limit the usefulness of baclofen tablets in older adults. Side effects like hallucinations, confusion, mental depression, other mood or mental changes, and severe drowsiness may be more likely in elderly patients, who are usually more sensitive than younger adults to the effects of this medicine.

Breast Feeding

There are no adequate studies on the risk to infants when this medication is used 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 others can be used together even if there might be an interaction. In such cases, your doctor may want to adjust the dose or take other precautions. When you are 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 are 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 cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of 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

Some medicines should not be taken around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect how this medicine works. Make sure to inform your doctor if you have any other medical issues, especially:

• Autonomic dysreflexia, history of or
• Diabetes or
• Epilepsy or
• Mental illness or problems (e.g., psychosis, schizophrenia) or
• Ovarian cysts or
• Posture or balance problems or
• Stroke, recent—Use with caution. This may worsen these conditions.

• Kidney disease—Effects may be stronger due to slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Not everyone will experience these side effects, but if they do happen, you may need medical help.

Check with your doctor right away if you notice any of these less common or rare side effects:

• 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 you experience any of these overdose symptoms:

• 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 happen that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also have suggestions to prevent or lessen some of these side effects. Check with your health care professional if any of these side effects continue, are bothersome, or if you have any questions about them:

More common side effects:

• 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 side effects:

• 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 health care 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.

• Fleqsuvy
• Lyvispah
• Ozobax
• Ozobax DS

In Canada

• Lioresal
• Lioresal Double Strength

Available Dosage Forms:

• Tablet
• Solution
• Packet
• Suspension

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Chemical Class: Gamma Aminobutyric Acid (class)

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.