BACLOFEN

Posology:

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 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 15mg 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 of more than 100mg 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 performance of specific tasks such as washing, dressing, shaving, physiotherapy, will often improve mobility.

Special Populations:

Elderly (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.

There is no evidence that the eventual average maximum dose differs from that in younger patients. e. approx. 5mg daily. Baclofen should be administered to end stage renal failure patients only if the expected benefit outweighs the potential risk.

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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 very cautious dosage schedule be adopted and that patients be kept under appropriate surveillance. 3mg/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. 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 dose of 60mg/day may be given. Method of administration Baclofen should be taken during meals with a little liquid.

g. sedation, somnolence and nausea), if the dosage is raised too rapidly, if large doses are employed, or in elderly patients. They are often transitory and can be attenuated or eliminated by reducing the dosage; they are seldom severe enough to necessitate withdrawal of the medication.

Should nausea persist following a reduction in dosage, it is recommended that baclofen be ingested with food or a milk beverage. g. stroke) as well as in elderly patients, adverse reactions may assume a more serious form. Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic patients.

Certain patients have shown increased spasticity as a paradoxical reaction to the medication. e. by reducing the doses given during the day and possibly increasing the evening dose). Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).

4) Investigations Not known: Blood glucose increased * 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 authorisations 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. 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.

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 AST, alkaline phosphatase and 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.

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 states, delirium, hallucinations, psychotic disorder, mania or paranoia, convulsions (status epilepticus), dyskinesia, tachycardia, hyperthermia, rhabdomyolysis and temporary aggravation of spasticity 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 population:

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. 2). Excipients: • Sorbitol- This medicine contains 1400 mg sorbitol in each 5 ml dose and therefore patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.

Sorbitol may cause gastrointestinal discomfort and mild laxative effect. • Baclofen oral liquid also contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). • Propylene glycol- This medicine contains 150 mg propylene glycol in each 5 ml of solution which is equivalent to 30 mg per ml of solution.

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