Baclofen oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of baclofen.
Drugs List
Therapeutic Indications
Uses
Muscular spasticity
Unlicensed Uses
Hiccough in terminal care
Dosage
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.
Adults
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
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.
Contraindications
Peptic ulcer
Precautions and Warnings
Children under 1 year
Patients over 65 years
Restricted sodium intake
Breastfeeding
Cerebrovascular accident
Confusional states
Depression
Diabetes mellitus
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of drug misuse
History of peptic ulcer
Hypertonic bladder sphincter
Lactose intolerance
Mania
Parkinson's disease
Pregnancy
Psychiatric disorder
Renal impairment
Respiratory depression
Schizophrenia
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
Pregnancy
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.
Lactation
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
Agitation
Anxiety
Ataxia
Blood glucose disturbances
Bradycardia
Cardiovascular depression
Confusion
Constipation
Convulsions
Depression
Diarrhoea
Dizziness
Drowsiness
Dry mouth
Dysarthria
Dysuria
Enuresis
Erectile dysfunction
Euphoria
Exhaustion
Fatigue
Gastro-intestinal symptoms
Hallucinations
Headache
Hepatic impairment
Hyperhidrosis
Hypotension
Hypothermia
Impotence
Increased spasticity (paradoxical)
Increased sweating
Insomnia
Lassitude
Light-headedness
Liver function disturbances
Muscle hypotonia
Muscle pain
Myalgia
Nausea
Nightmares
Nystagmus
Paraesthesia
Rash
Respiratory depression
Retching
Rhabdomyolysis
Sedation
Sleep apnoea
Somnolence
Taste disturbances
Tremor
Urinary retention
Urticaria
Visual disturbances
Vomiting
Weakness
Withdrawal syndrome - see product information
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
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: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Last accessed: 23 March 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 March 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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