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Baclofen

This fact sheet has been written for parents and carers about the use of baclofen for severe muscle spasm (spasticity) in children. This may be due to cerebral palsy or other conditions that affect the brain or spinal cord.

This information sometimes differs from that provided by the manufacturers, because their information is usually aimed at adult patients. Please read this information carefully and keep it somewhere safe so that you can read it again.

ALERT: 
Do not stop giving baclofen to your child suddenly as this may cause serious side-effects:

  • Anxiety (increased worry)
  • Behaviour changes
  • Seizures
  • High temperature
  • Muscle spasms become worse

Any dose changes must be decided by a doctor and the dose must be reduced slowly before stopping.

Baclofen is available as

  • Tablets: 10 mg and 25 mg
  • Injection: 10 mg/ 5 mL, 50 microgram/ mL (for children with implanted pump devices only)

It is also known by the following brand names

  • Tablets: APO-Baclofen®, Clofen®, GenRx Baclofen®, Lioresal®, Stelax®
  • Injection: Bacthecal®, Lioresal Intrathecal®, Sintetica Baclofen Intrathecal®

The brand of the product supplied to your child is:

Why is it important for my child to take this medicine?

Baclofen relaxes muscles. The benefits of this include:

  • Improved ability to move joints
  • Less pain due to muscle spasm or cramps

Baclofen is used in children with tight muscles. Baclofen acts on the brain and spinal cord and reduces the messages that are sent out by the nervous system to cause muscle contraction.  It acts on the whole body and does not target specific muscles.

When should I give baclofen?

Baclofen is started at a low dose, and slowly increased until a good response is seen. It is usually given three or four times per day, and is best tolerated if given with or just after food.

Some patients receive baclofen delivered directly into the spinal cord via special implanted pump. A lower dose is used and it may be the best option for some patients.

How much should I give?

Your doctor will work out the amount of baclofen (the dose) that is right for your child. Your doctor will ask you how well the medicine is working, and may suggest that you change the amount you give, or when you give it, to get the best effect. If you think the dose is not right, talk to your doctor.
It is important that you follow your doctor’s instructions about how much to give.

Dosage Plan (for tablet administration):

Patient name:
UR Number: Date of Plan:
Date of Birth: Prescriber Name:
Use Baclofen _______ mg tablets to make up the doses as listed below
Week 1
Date: __________
Week 2
Date: __________
Week 3
Date: __________
Week 4
Date: __________
Morning ____ tablets = ____ mg ____ tablets = ____ mg ____ tablets = ____ mg ____ tablets = ____ mg
Lunch ____ tablets = ____ mg ____ tablets = ____ mg ____ tablets = ____ mg ____ tablets = ____ mg
Dinner ____ tablets = ____ mg ____ tablets = ____ mg ____ tablets = ____ mg ____ tablets = ____ mg
Bedtime ____ tablets = ____ mg ____ tablets = ____ mg ____ tablets = ____ mg ____ tablets = ____ mg

How should I give it?

Tablets should be swallowed with a glass of water, juice, or similar liquid. Tablets can be cut in half or crushed and mixed with liquid to be given via mouth or feeding tube. Your pharmacist can provide you with details on how to administer crushed or partial tablets.

If your child is receiving baclofen via a pump, it is important to receive training on the pump and how to program it and monitor how it delivers the baclofen. You also need to know what to do to ensure the pump does not run out, stop accidentally or delivers too much baclofen.

When should the medicine start working and how will I know?

You should expect to see some positive effects from the medication after a few days of taking it regularly (three to four days). Your child’s muscles should begin to feel less stiff. It may take up to ten days for the maximum effect to occur.

What if my child vomits or misses doses?

  • If your child vomits less than 30 minutes after having a dose of baclofen by mouth, give them the same dose again.
  • If your child vomits more than 30 minutes after having a dose of baclofen by mouth, you do not need to give them another dose. Wait and give the next dose as normal.

If your child vomits again or misses several doses in a row, contact your doctor or hospital immediately. They will decide what to do based on your child’s condition.

What if I forget to give it?

Give the missed dose as soon as you remember during the day. Ensure there is at least four hours before the next oral dose is given.

You do not need to wake up a sleeping child to give a missed dose.

Never give a double dose of the medicine to catch up a missed dose.

What if I give too much?

It can be dangerous for your child to have too much baclofen. Signs that your child has had too much baclofen can include: excessive sleepiness, trouble breathing, and becoming unconscious.

If you think your child may have had too much baclofen, take your child to hospital straight away or contact the Queensland Poisons Information Service on 13 11 26. Tell the doctor or person on the phone that your child may have had too much baclofen.

Have the medication with you if you telephone for advice, or take it to the hospital, so that the doctor can see what has been given.

Are there any possible side effects?

We use medicines to make our children better, but sometimes they have other effects that we don’t want (side effects). Side effects due to baclofen usually occur when the medicine is first started. Your doctor will suggest starting with a small dose and increasing slowly to try to minimise side effects.

Side effects you must do something about
Take your child to the hospital or call 000 for an ambulance if your child has:

  • A seizure (fit or convulsion)
  • Shallow or slow breathing or stops breathing
  • Difficulty being woken up (your child becomes very sleepy)
  • Urinary retention (passing less urine than normal or feeling that their bladder is full but can’t be emptied), especially if it happens suddenly
Other side effects you need to know about
The following side effects should go away after being on the medicine for a little while. If you are concerned or if they continue, see your doctor.

  • Sleepiness (feeling sleepy or sluggish). This can last for a few hours after a dose is taken.
  • Low muscle tone (muscles become very floppy). Your child may need a smaller dose. Seek help from your doctor.
  • Stomach upset (feeling sick or vomiting). Give baclofen with food. If your child feels sick for more than one day, contact your doctor.
  • Mood changes (confusion, nightmares, feeling more happy or more sad than normal, or changes in sleep pattern). If you are concerned about your child’s mood, contact your doctor.
  • Dry mouth (less saliva than normal). Sucking on a sugar-free sweet or using a mouth spray may help.
  • Change in bladder function (weeing less often than usual, or passing urine without meaning to). If you are concerned, contact your doctor.

There may be other side effects that are not listed above. Contact your doctor if you notice anything unusual and you are concerned about your child.

Can other medicines be given at the same time as baclofen?

  • You can give your child medicines that contain paracetamol or ibuprofen (to treat pain and fever), unless your doctor has told you not to.
  • Baclofen should not be taken with some other medicines that you get on prescription or over the counter. Tell your doctor and pharmacist about any other medicines your child is taking before starting baclofen.
  • Always check with your doctor or pharmacist before giving any other new medicines to your child. This includes herbal or complementary medicines or medicines available over the counter at the pharmacy.
  • If your child is receiving baclofen via a pump, it is important to tell all healthcare professionals that this is your child’s regular therapy.

Is there anything else I need to know about baclofen?

If baclofen does not seem to be controlling your child’s muscle spasms, or if the spasms become worse, contact your doctor for advice.

If your doctor decides that baclofen is not right for your child, you will need to reduce the dose bit by bit over a few weeks so that your child doesn’t get side-effects. Do not reduce the dose without talking to your doctor first.

Where should I keep this medicine?

  • Keep baclofen in a cupboard, away from heat and direct sunlight. It does not need to be kept in the fridge.
  • Make sure that children cannot see or reach the medicine.
  • Keep the medicine in the container it came in.

General advice about medicines

  • Try to give the medicine at about the same times each day. This will help you remember to give it every day.
  • Only give this medicine to your child. Never give it to anyone else, even if their condition appears to be the same, as this could do harm.
  • If you think someone else may have taken the medicine, contact your doctor or the Queensland Poisons Information Centre on 13 11 26 straight away.
  • Make sure that you always have enough medicine. Order a new prescription at least two weeks before you will run out.
  • Make sure that the medicine you have at home has not reached the ‘best before’ or ‘use by’ date on the packaging. Give old medicines to your pharmacist to dispose of appropriately.

Who to contact for more information

Your doctor, pharmacist or nurse will be able to give you more information about baclofen and about other medicines used to treat generalised muscle stiffness.

Contact us

Pharmacy Department
Level 2, Queensland Children’s Hospital
501 Stanley Street, South Brisbane 4101
t: 07 3068 1901

In an emergency, always contact 000 for immediate assistance.

Fact sheet developed by Rehabilitation Medical Team and Pharmacy Department, Queensland Children’s Hospital, Updated: November 2019.

The primary source for the information in this fact sheet is the Australian Medicines Handbook Children’s Dosing Companion and UK Medicines for Children.
For details on any other sources used to create this fact sheet, please contact us via CHQMedicationSafety@health.qld.gov.au.

We take great care to make sure that the information in this fact sheet is correct and up-to-date. However, medicines can be used in different ways for different patients. It is important that you ask the advice of your doctor or pharmacist if you are not sure about something.
This fact sheet is about the use of these medicines in Australia, and may not apply to other countries. Children’s Health Queensland Hospital and Health Service cannot be held responsible for the accuracy of information, omissions of information, or any actions that may be taken as a consequence of reading this fact sheet.

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