Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL
Baclofen is indicated for the relief of spasticity of voluntary muscle resulting from such disorders as multiple sclerosis, other spinal lesions e.g. tumours of the spinal cord, syringomyelia, motor neurone disease, transverse myelitis, traumatic partial section of the cord.
Baclofen is also indicated in adults and children for the relief of spasticity of voluntary muscle arising from e.g. cerebrovascular accidents, cerebral palsy, meningitis, traumatic head injury.
Patient selection is important when initiating baclofen therapy; it is likely to be of most benefit in patients whose spasticity constitutes a handicap to activities and/or physiotherapy. Treatment should not be commenced until the spastic state has become stabilized.
Baclofen is indicated in patients 0 to <18 years for the symptomatic treatment of spasticity of cerebral origin, especially where due to infantile cerebral palsy, as well as following cerebrovascular accidents or in the presence of neoplastic or degenerative brain disease.
Baclofen is also indicated for the symptomatic treatment of muscle spasms occurring in spinal cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin such as multiple sclerosis, spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord.
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.
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).
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 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.
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).
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.
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.
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.
Baclofen should be taken during meals with a little liquid.
Prominent features are signs of central nervous depression: somnolence, depressed level of consciousness, respiratory depression, coma. Also liable to occur are: confusion, hallucinations, agitation, accommodation disorder, impaired pupillary reflex, generalised muscular hypotonia, myoclonia, hyporeflexia or areflexia, convulsions, abnormal electroencephalogram (burst suppression pattern and triphasic waves), peripheral vasodilation, hypotension or hypertension, bradycardia, tachycardia or cardiac arrhythmia, hypothermia, nausea, vomiting, diarrhoea, salivary hypersecretion, increased hepatic enzymes, SGOT and AP values, rhabdomyolysis. Patients with renal impairment can develop signs of overdose even on low doses of oral baclofen (see sections 4.2 and 4.4).
A deterioration in the condition may occur if various substances or drugs acting on the central nervous system (e.g. alcohol, diazepam, tricyclic antidepressants) have been taken at the same time.
No specific antidote is known.
Supportive measures and symptomatic treatment should be given for complications such as hypotension, hypertension, convulsions, and respiratory or cardiovascular depression.
Elimination of the drug from the gastro-intestinal tract (induction of vomiting, gastric lavage; comatose patients should be intubated prior to gastric lavage), administration of activated charcoal; if necessary, saline aperient; in respiratory depression, administration of artificial respiration. Since the drug is excreted chiefly via the kidneys, generous quantities of fluid should be given, possibly together with a diuretic. Haemodialysis (sometimes unscheduled) may be useful in severe poisoning associated with renal failure (see section 4.4). In the event of convulsions diazepam should be administered cautiously I.V.
3 years.
Store in a dry place below 25°C in order to protect from light.
Baclofen Tablets are available either in polypropylene containers with polyethylene caps (with optional polyethylene ullage filler, or in PVDC aluminium foil blisters. The pack sizes available in both pack types are 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180 and for the polypropylene containers pack sizes of 50, 250 and 500 are also available.
Not all pack sizes may be marketed.
No special requirements for disposal.
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