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Baclofen (BAK loe fen)

Pediatric Medication

Brand Names: U.S.

EnovaRX-Baclofen; Gablofen; Lioresal

Brand Names: Canada

Apo-Baclofen; Ava-Baclofen; Dom-Baclofen; Lioresal; Lioresal D.S.; Lioresal Intrathecal; Mylan-Baclofen; Novo-Baclofen; PHL-Baclofen; PMS-Baclofen; ratio-Baclofen; Riva-Baclofen; VPI-Baclofen Intrathecal

Warning

Shot:

  • Unsafe side effects have happened when this drug was stopped all of a sudden. Some of these side effects have been high fever, mental changes, more spasms, and muscle stiffness. Rarely, these side effects have led to very bad muscle problems, organ problems, and death. Avoid stopping this drug all of a sudden without talking with the doctor. Be sure you get your child’s pump refilled on time and you know about the pump alarms and what to do if the pump alarm goes off. Tell the doctor if your child has ever had signs of withdrawal while getting baclofen tablets or shot. Call the doctor right away if your child has signs of withdrawal.
  • Read the package insert for more details.

What is this drug used for?

  • It is used to calm muscles.
  • It is used to treat spasms in patients with MS (multiple sclerosis) or spinal cord disease.
  • It may be given to your child for other reasons. Talk with the doctor.

What do I need to tell the doctor BEFORE my child takes this drug?

All products:

  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

Tablet:

  • If your child has any of these health problems: Cerebral palsy, Parkinson’s disease, or stroke.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of their drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

All products:

  • Tell dentists, surgeons, and other doctors that your child is using this drug.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • To lower the chance of feeling dizzy or passing out, have your child get up slowly over a few minutes when sitting or lying down. Have your child be extra careful climbing stairs.
  • Do not stop giving this drug to your child all of a sudden without calling the doctor. Your child may have a greater risk of side effects. If your child needs to stop this drug, you will want to slowly stop it as told by the doctor.
  • Chance of seizures may be higher. Talk with the doctor.
  • Alcohol may interact with this drug. Be sure your child does not drink beer, wine, or mixed drinks.
  • Talk with the doctor before giving your child other drugs and natural products that may slow your child’s actions.

If your child is pregnant or breast-feeding a baby:

  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks of using this drug.

Tablet:

  • Do not give to a child younger than 12 years of age.

Shot:

  • If your child is being treated for any infection, talk with the doctor.
  • Use with care in children. Talk with the doctor.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Feeling very tired or weak.
  • Very bad dizziness or passing out.
  • Change in thinking clearly and with logic.
  • Change in how you act.
  • Seizures.
  • Change in eyesight.
  • Chest pain.
  • Muscle pain or weakness.
  • Muscle stiffness.
  • A burning, numbness, or tingling feeling that is not normal.
  • Trouble breathing, slow breathing, or shallow breathing.
  • Not able to pass urine or change in how much urine is passed.
  • Blood in the urine.
  • Mood changes.
  • Hallucinations.
  • Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
  • Not able to control eye movements.
  • A heartbeat that does not feel normal.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Feeling sleepy.
  • Dizziness.
  • Feeling tired or weak.
  • Upset stomach.
  • Headache.
  • Hard stools (constipation).
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read and follow the dosing on the label closely.

Tablet:

  • Give this drug with or without food. Give with food if it causes an upset stomach.

Shot:

  • It is given as a shot into the spine.

What do I do if my child misses a dose?

Tablet:

  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.

Shot:

  • Call your child’s doctor to find out what to do.

How do I store and/or throw out this drug?

Tablet:

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.

Shot:

  • This drug will be given to your child in a hospital or doctor’s office. You will not store it at home.

All products:

  • Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

General drug facts

  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Copyright

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