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Baclofen oral

Updated 2 Feb 2023 | Skeletal muscle relaxants


Oral formulations of baclofen.

Drugs List

  • baclofen 10mg tablets
  • baclofen 10mg/5ml oral solution sugar-free
  • baclofen 5mg/5ml oral solution sugar-free
  • LIORESAL 10mg tablets
  • LIORESAL 5mg/5ml liquid
  • LYFLEX 5mg/5ml oral solution sugar-free
  • Therapeutic Indications


    Muscular spasticity

    Unlicensed Uses

    Hiccough in terminal care


    Treatment with baclofen should not be initiated until the spastic state has become stabilised and it should be administered selectively. It is most likely to be of benefit to patients whose spasticity constitutes a handicap to activities or physiotherapy.

    Before commencing treatment the overall extent of clinical improvement that the patient may be expected to achieve must be realistically assessed. Careful titration of dosage is essential (particularly in the elderly) until the patient is stabilised. If the initial dosage is too high 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 affected limbs or where spasticity is necessary for support.

    Some patients benefit from the use of baclofen at night to counteract painful flexor spasm, similarly, a single dose given approximately one hour prior to performance of specific tasks such as washing, dressing, shaving or physiotherapy, will often improve mobility.

    Treatment should always be gradually discontinued over a period of 1 to 2 weeks, unless serious adverse effects occur.


    Initial dose: 15mg daily, in divided doses.

    The following gradually increasing dosage regimen is suggested, but should be adjusted to individual patient requirements:

    5mg three times a day for three days.

    10mg three times a day for three days.

    15mg three times a day for three days.

    20mg three times a day for three days.

    Satisfactory control of symptoms is usually obtained with doses up to 60mg daily but a careful adjustment is often necessary to meet the requirements of each individual patient. Dosage may be slowly increased where necessary to a maximum daily dose of not more than 100mg unless the patient is in hospital under careful medical supervision.

    Unlicensed use - Hiccup due to gastric distension in palliative care

    5mg twice a day.


    Children aged 1 month to 17 years
    Initial dose: 0.3mg/kg daily, in 4 divided doses.

    The dose should then be gradually raised at 1 week intervals until it becomes sufficient for the child's individual requirements. The usual daily maintenance therapy ranges between 0.75mg/kg and 2mg/kg body weight.

    Maximum daily dose in children 8 years and above should not exceed 60mg a day.
    Maximum daily dose in children younger than 8 years should not exceed 40mg a day.

    The tablets are not suitable for use in children with a body weight of less than 33kg.

    Patients with Renal Impairment

    In patients with impaired renal function or undergoing chronic haemodialysis a low dosage of 5mg daily is required.

    The Renal Drug Handbook suggests doses:
    Glomerular filtration rate 20 to 50mL/minute: 5mg three times a day and titrate according to patients individual response.
    Glomerular filtration rate 10 to 20mL/minute: 5mg twice a day and titrate according to patients individual response.
    Glomerular filtration rate less than 10mL/minute: 5mg once a day and titrate according to patients individual response.


    Peptic ulcer

    Precautions and Warnings

    Children under 1 year
    Patients over 65 years
    Restricted sodium intake
    Cerebrovascular accident
    Confusional states
    Diabetes mellitus
    Epileptic disorder
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Hereditary fructose intolerance
    History of drug misuse
    History of peptic ulcer
    Hypertonic bladder sphincter
    Lactose intolerance
    Parkinson's disease
    Psychiatric disorder
    Renal impairment
    Respiratory depression

    Sodium content of formulation may be significant
    Advise ability to drive/operate machinery may be affected by side effects
    Not all formulations are suitable for all age groups/body weights
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Some formulations contain lactose
    Some formulations contain wheat starch
    Some preps contain methyl & propylparaben; may cause allergic reactions
    Advise patient to take with or after food
    Monitor blood glucose closely in patients with diabetes mellitus
    Monitor for mental changes, suicidal depression and antisocial behaviour
    Monitor patients with a history of alcoholism and drug abuse
    Monitor patients with a history of depression and/or suicide attempts
    Monitor patients with renal impairment for toxic effects
    Review treatment after 6 weeks
    Advise patient to report any new or worsening depression/suicidal ideation
    Potential for withdrawal symptoms
    Avoid abrupt withdrawal
    Gradually withdraw over 2 weeks
    Careful dose titration may minimise incidence of side effects
    Maintain treatment at the lowest effective dose
    Start treatment at lowest recommended dose
    Advise patient to avoid alcohol during treatment
    Advise patient/carers to report signs of suicide ideation or behaviour

    Baclofen should only be administered to end stage renal failure patients (CKD stage 5, Glomerular filtration rate less than 15 mL/minute) only if expected benefit outweighs potential risk. These patients should be closely monitored for prompt diagnosis of early signs and/or symptoms of toxicity.

    Signs of overdose have been observed in patients with renal impairment taking oral baclofen at doses of more than 5mg a day. If severe baclofen toxicity occurs, unscheduled haemodialysis in addition to discontinuation of treatment, may be considered as a treatment.

    Monitor for symptoms of baclofen misuse, abuse or dependence e.g. dose escalation, drug-seeking behaviour, development of tolerance.

    Baclofen should be used with caution when spasticity is needed to sustain upright posture and balance.

    Pregnancy and Lactation


    Use baclofen with caution during pregnancy.

    The manufacturer advises caution if baclofen is used during pregnancy. The manufacturer suggests, especially in the first 3 months of pregnancy, baclofen should only be administered if essential and the benefits of the treatment for the mother outweigh the possible risks to the child. At the time of writing there is limited published information regarding the use of baclofen during pregnancy. Potential risks are unknown, however baclofen is known to cross the placenta. Postnatal convulsions have been reported as part of drug withdrawal reactions following intrauterine exposure of neonates to baclofen.


    Use baclofen with caution during breastfeeding.

    The manufacturer advises caution if baclofen is used when breastfeeding. Whilst available data indicates baclofen is present in human breast milk, the quantity is not considered to be sufficient to cause adverse effects in the breastfed infant.

    Monitor newborn infants for signs of sedation when using baclofen in breastfeeding.

    Side Effects

    Abdominal pain
    Blood glucose disturbances
    Cardiovascular depression
    Dry mouth
    Erectile dysfunction
    Gastro-intestinal symptoms
    Hepatic impairment
    Increased spasticity (paradoxical)
    Increased sweating
    Liver function disturbances
    Muscle hypotonia
    Muscle pain
    Respiratory depression
    Sleep apnoea
    Taste disturbances
    Urinary retention
    Visual disturbances
    Withdrawal syndrome - see product information


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2021

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Summary of Product Characteristics: Baclofen Tablets 10mg. Generics UK Ltd. Revised June 2020.

    Summary of Product Characteristics: Lioresal Tablets 10mg. Novartis Pharmaceuticals UK Ltd. Revised February 2021.

    Summary of Product Characteristics: Baclofen Tablets 10mg. Strides Pharma UK Ltd. Revised December 2019.

    Summary of Product Characteristics: Lioresal Liquid. Novartis Pharmaceuticals UK Ltd. Revised February 2021.

    Summary of Product Characteristics: Lyflex 5mg/5ml Oral Solution. Chemidex Pharma Ltd. Revised September 2019.

    Summary of Product Characteristics: Baclofen 10mg/5ml oral solution. Thame Laboratories. Revised July 2020.

    The Renal Drug Handbook. Fifth Edition (2019) ed. Ashley, C. and Dunleavy, A. Radcliffe Publishing Ltd, London.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Last revised: 03 June 2019
    Last accessed: 23 March 2021.

    NICE Evidence Services Available at: Last accessed: 23 March 2021

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