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What is Baclofen ?
Baclofen is used to treat pain and certain types of spasticity (muscle stiffness and tightness) from multiple sclerosis, spinal cord injuries, or other spinal cord diseases. Baclofen is in a class of medications called skeletal muscle relaxants. Baclofen acts on the spinal cord nerves and decreases the number and severity of muscle spasms caused by multiple sclerosis or spinal cord conditions. It also relieves pain and improves muscle movement.
How should Baclofen be used?
Baclofen comes as a tablet and a solution (liquid) to take by mouth. It usually is taken 3 times a day at evenly spaced intervals. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take baclofen exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Use an oral syringe (measuring device) to accurately measure and take your dose of baclofen solution. Ask your pharmacist for an oral syringe if one is not included with your medication.
Continue to take baclofen even if you feel well. Do not stop taking baclofen without talking to your doctor, especially if you have taken large doses for a long time. Abruptly stopping this medication can cause seizures, fever, confusion, muscle stiffness, or hallucinations. Your doctor probably will want to decrease your dose gradually.
Baclofen Dosage
Baclofen is given orally in either tablet or liquid form. These two formulations are bioequivalent. The liquid may be particularly suitable for children or those adults who are unable to take tablets. Dosage titration can be more precisely managed with the liquid. The lowest dose compatible with an optimal response is recommended.
Posology
Before starting treatment with baclofen it is prudent to realistically assess the overall extent of the clinical improvement that the patient may be expected to achieve. Careful titration of dosage is essential (particularly in the elderly) until the patient is stabilised. If too high a dose is initiated or if the dosage is increased too rapidly side effects may occur. This is particularly relevant if the patient is ambulant in order to minimise muscle weakness in the unaffected limbs or where spasticity is necessary for support.
Once the maximum recommended dose has been reached, if the therapeutic effect is not apparent within 6 weeks a decision whether to continue with baclofen should be taken.
Discontinuation of the treatment should always be gradual by successively reducing the dosage over a period of approximately 1 to 2 weeks, except in overdose-related emergencies, or where serious adverse effects have occurred (see section 4.4).
Adults:
Treatment should be started with a dosage of 15 mg daily, preferably in divided doses. The following gradually increasing dosage regime is suggested, but should be adjusted to suit individual patient requirements.
| 5 mg | Three times a day for three days |
| 10 mg | Three times a day for three days |
| 15 mg | Three times a day for three days |
| 20 mg | Three times a day for three days |
Satisfactory control of symptoms is usually obtained with doses up to 60 mg daily, but a careful adjustment is often necessary to meet the requirements of each individual patient. The dose may be increased slowly if required, but a maximum daily dose of more than 100 mg is not advised unless the patient is in hospital under careful medical supervision. Small frequent dosage may prove better in some cases than larger spaced doses. Also some patients benefit from the use of baclofen only at night to counteract painful flexor spasm. Similarly a single dose given approximately 1 hour prior to the performance of specific tasks such as washing, dressing, shaving, physiotherapy, will often improve mobility.
Elderly:
Elderly patients may be more susceptible to side-effects, particularly in the early stages of introducing baclofen. Small doses should therefore be used at the start of the treatment, the dose being titrated gradually against the response, under careful supervision. There is no evidence that the eventual average maximum dose differs from that in younger patients.
Patients with renal impairment:
In patients with impaired renal function or undergoing chronic haemodialysis, a particularly low dosage of baclofen should be selected i.e. approximately 5 mg daily.
Baclofen should be administered to end stage renal failure patients only if the expected benefit outweighs the potential risk. These patients should be closely monitored for prompt diagnosis of early signs and/or symptoms of toxicity (e.g. somnolence, lethargy) (see sections 4.4 and 4.9).
Patients with hepatic impairment:
No studies have been performed in patients with hepatic impairment receiving baclofen therapy. The liver does not play a significant role in the metabolism of baclofen after oral administration of baclofen (see section 5.2). However, baclofen has the potential of elevating liver enzymes. Baclofen should be prescribed with caution in patients with hepatic impairment.
Patients with spastic states of cerebral origin:
Unwanted effects are more likely to occur in these patients. It is therefore recommended that a cautious dosage schedule be adopted and that patients be kept under appropriate surveillance.
Paediatric population
Treatment should usually be started with a very low dose (corresponding to approximately 0.3 mg/kg a day), in 2-4 divided doses (preferably in 4 divided doses). The dosage should be raised cautiously, at about 1 week intervals, until it becomes sufficient for the child’s individual requirements. The usual daily dosage for maintenance therapy ranges between 0.75 and 2 mg/kg body weight. The total daily dose should not exceed a maximum of 40 mg/day in children below 8 years of age. In children over 8 years of age, a maximum daily dose of 60 mg/day may be given.
Baclofen tablets are not suitable for use in children below 33 kg body weight.
Method of administration
Baclofen should be taken during meals with a little liquid.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Peptic ulceration.
Other uses for this medicine
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking baclofen,
- tell your doctor and pharmacist if you are allergic to baclofen, any other medications, or any of the ingredients in baclofen tablets and oral solution. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants, medications for anxiety, medications for mental illness, medications for seizures, sedatives, sleeping pills, or tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had epilepsy, a stroke, a rheumatic disease, cerebral palsy, Parkinson’s disease, a psychiatric condition such as schizophrenia or a confusional state, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking baclofen, call your doctor immediately.
- you should know that baclofen may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- ask your doctor about the safe use of alcoholic beverages while you are taking baclofen. Alcohol can make the side effects from baclofen worse.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Baclofen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- dizziness
- weakness
- confusion
- headache
- nausea
- constipation
- difficulty falling asleep or staying asleep
- tiredness
- frequent urination
Some side effects can be serious. If you experience either of the following symptoms, call your doctor immediately:
- seeing things or hearing voices that do not exist
- seizures
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). Store the oral solution in the refrigerator.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.
Symptoms of overdose may include:
- vomiting
- weak muscle tone
- drowsiness
- vision problems
- coma
- difficulty breathing
- seizures
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Brand names
- Kemstro®
- Lioresal®
- Ozobax®
If you forget to take it
If you forget a dose, take it as soon as you remember. If it’s less than 2 hours until your next dose, it’s better to leave out the missed dose and take your next one at the usual time.
Never take 2 doses at the same time. Never take an extra dose to make up for a forgotten one.
If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.
Stopping baclofen
If you stop taking baclofen suddenly, you may get withdrawal side effects such as:
- feeling anxious or confused
- seeing things that are not there (hallucinations)
- seizures or fits
- changes in mood or behaviour
- a fast heartbeat
- muscle spasms getting worse
You doctor will reduce your dose gradually before stopping it completely. This will help prevent these side effects.
Upon receiving a valid prescription of the product you have bought. The Doctor will review it according to the form of health condition you have completed. Once the doctors approve your prescription, our US licensed pharmacies will fill a prescription for a medication that is FDA approved. To assure confidentiality and privacy our US licensed Pharmacy will fill and ship your prescription in a discreet package.
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