Active Ingredient: Baclofen
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.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 15 milligrams baclofen, divided daily, 3 doses in total, over the duration of 3 days. Afterwards, oral, 30 milligrams baclofen, divided daily, 3 doses in total, over the duration of 3 days. The maximum allowed total dose is 60 milligrams baclofen daily. Afterwards, oral, 45 milligrams baclofen, divided daily, 3 doses in total, over the duration of 3 days. The maximum allowed total dose is 60 milligrams baclofen daily. Afterwards, oral, 60 milligrams baclofen, divided daily, 3 doses in total. The maximum allowed total dose is 60 milligrams baclofen daily.
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.
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.
Baclofen should be taken during meals.
For:
Oral, 0.3 milligrams baclofen per kilogram of body weight, divided daily, 2 to 4 doses in total. Afterwards, oral, between 0.75 milligrams baclofen per kilogram of body weight and 2 milligrams baclofen per kilogram of body weight, divided daily, 2 to 4 doses in total.
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.
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 should be taken during meals.
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