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BACLOFEN is a brand name for Baclofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Dosage Baclofen is given orally in either tablet or solution form. These two formulations are bioequivalent. The solution may be particularly suitable for children or those adults who are unable to take tablets. Dosage titration can be more precisely managed with the solution.
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 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. 4).
Adults:
Treatment should be started with a dosage of 15 mg daily, preferably in divided doses. The following gradually increasing dosage regimen is suggested, but should be adjusted to suit 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 of up to 60mg 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 should not exceed 100 mg. 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 performance of specific tasks such as washing, dressing, shaving physiotherapy, will often improve mobility.
Special populations Elderly patients (aged 65 years or above):
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 treatment, the dose being titrated gradually against the response, under careful supervision.
Table 1 Tabulated summary of adverse drug reactions Immune system disorders Not known: Nervous system disorders Very common: Common: .
Rare:
Not known: Eye disorders Common: Cardiac disorders Common: Not known: Vascular disorders Common: Gastrointestinal disorders Very common: Common: Rare: Hepatobiliary disorders Rare: Hypersensitivity Sedation, somnolence Respiratory depression, confusional state, dizziness, hallucination, depression, fatigue, insomnia, euphoric mood, muscular weakness, ataxia, tremor, nightmare, myalgia, headache, nystagmus, dry mouth.
4), swelling face and peripheral oedema Blood glucose increased *Drug withdrawal syndrome including postnatal convulsions in neonates has also been reported after intra-uterine exposure to oral Baclofen * Cases of central sleep apnoea syndrome have been observed with baclofen at high doses (≥ 100 mg) in patients who are alcohol dependent.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Psychiatric and nervous system disorders Psychotic disorders, schizophrenia, depressive or manic disorders, confusional states or Parkinson's disease may be exacerbated by treatment with Baclofen. Patients suffering from these conditions should therefore be treated cautiously and kept under close surveillance.
Suicide and suicide-related events have been reported in patients treated with baclofen. In most cases, the patients had additional risk factors associated with an increased risk of suicide including alcohol use disorder, depression and/or a history of previous suicide attempts.
Close supervision of patients with additional risk factors for suicide should accompany drug therapy. Patients (and caregivers of patients) should be alerted about the need to monitor for clinical worsening, suicidal behaviour or thoughts or unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Cases of misuse, abuse and dependence have been reported with baclofen. g. dose escalation, drug-seeking behaviour, development of tolerance. Epilepsy Baclofen may also exacerbate epileptic manifestations but can be employed provided appropriate supervision and adequate anticonvulsive therapy are maintained.
Encephalopathy Cases of encephalopathy have been reported in patients receiving baclofen at therapeutic doses, which were reversible after treatment discontinuation. Symptoms included somnolence, depressed level of consciousness, confusion, myoclonus and coma.
9). If signs of encephalopathy are observed, baclofen should be discontinued. 5). Baclofen should be used with caution in patients suffering from cerebrovascular accidents or from respiratory or hepatic impairment. 2). 2 Posology and method of administration).
g. confusion, disorientation, somnolence and depressed level of consciousness) have been observed in patients with renal impairment taking oral baclofen at doses of more than 5mg per day and at doses of 5mg per day in patients with end stage renal failure being treated with chronic haemodialysis.
• Hypersensitivity to baclofen or to any of the excipients • Peptic ulceration
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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There is no evidence that the eventual average maximum dose differs from that in younger patients. 3mg/kg a day), in 2-4 divided doses, preferably in 4 divided doses. The dosage should be cautiously raised at about 1 week intervals, until it becomes sufficient for the child’s individual requirements.
75 and 2mg/kg body weight. The total daily dose should not exceed a maximum of 40mg/day in children below 8 years of age. In children over 8 years of age, a maximum daily dosage of 60mg/day may be given. Baclofen tablets are not suitable for use in children below 33kg body weight.
e. approx. 5mg daily. Baclofen should be administered to end stage renal failure patients only if the expected benefit outweighs the potential risk. g. 9). Patients with hepatic impairment No studies have been performed in patients with hepatic impairment receiving Baclofen therapy.
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. Method of administration Baclofen should be taken during meals with a little liquid.
Patients with impaired renal function should be closely monitored for prompt diagnosis of early symptoms of toxicity. Particular caution is required when combining Baclofen to drugs or medicinal products that can significantly affect renal function.
Renal function should be closely monitored and Baclofen daily dosage adjusted accordingly to prevent baclofen toxicity. 9). Besides discontinuing treatment, unscheduled haemodialysis might be considered as a treatment alternative in patients with severe baclofen toxicity.
Haemodialysis effectively removes baclofen from the body, alleviates clinical symptoms of overdose and shortens the recovery time in these patients. Urinary disorders Under treatment with Baclofen neurogenic disturbances affecting emptying of the bladder may show an improvement.
In patients with pre-existing sphincter hypertonia, acute retention of urine may occur; the drug should be used with caution in such cases. Laboratory tests In rare instances elevated aspartate aminotransferase, blood alkaline phosphatase and blood glucose levels in serum have been recorded.
Appropriate laboratory tests should be performed in patients with liver diseases or diabetes mellitus in order to ensure that no drug induced changes in these underlying diseases have occurred. Excipients • Sorbitol liquid (E 420) - Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.
• This medicine contains less than 1 mmol sodium (23 mg) per ml that is to say essentially ‘sodiumfree’ • This product contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed). • This product also contains 3mg of propylene glycol per 5ml of dose.
Coadministration with any substrate of alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates.
Abrupt withdrawal:
Treatment should always, (unless serious adverse effects occur), be gradually discontinued by successively reducing the dosage over a period of about 1-2 weeks. Anxiety and confusional state, delirium, hallucination, psychotic disorder, mania or paranoia, convulsion (status epilepticus), dyskinesia, tachycardia, hyperthermia, rhabdomyolysis and temporary aggravation of spasticity and hypertonia have been reported with abrupt withdrawal of Baclofen, especially after long term medication.
6). Treatment should always, (unless serious adverse effects occur), therefore be gradually discontinued by successively reducing the dosage over a period of about 1- 2 weeks. Paediatric patients There is very limited clinical data on the use of Baclofen in children under the age of one year.
Use in this patient population should be based on the physician’s consideration of individual benefit and risk of therapy. Posture and balance Baclofen should be used with caution when spasticity is needed to sustain upright posture and […]