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LIORESAL (BACLOFEN) TABLETS DOSAGE AND ADMINISTRATION

Treatment with Lioresal should always be started in hospital, using small doses which are then gradually increased in a stepwise manner. The lowest dose compatible with an optimal response is recommended. The optimum daily dosage should be individualised so that clonus, flexor and extensor spasms, and spasticity are reduced, at the same time retaining enough muscle tone to permit active movements and avoiding adverse effects as far as possible.

In order to prevent excessive weakness and falling, Lioresal should be used with caution when spasticity is needed to sustain upright posture and balance in locomotion or whenever spasticity is used to maintain function. It may be important to maintain some degree of muscle tone and allow occasional spasms to help support circulatory function.

Abrupt discontinuation of treatment should be avoided.

In adults Lioresal should be given in at least three divided doses daily.


Dosage Regimen

As a rule, treatment should be started with a dose of 5 mg three times daily, subsequently increased at 3-day intervals by 5 mg three times daily (i.e. the dosage regimen is 5 mg three times a day for 3 days, then 10 mg three times a day for 3 days, etc.) until the optimum response has been attained. In certain patients reacting sensitively to drugs, it may be advisable to begin with a lower daily dose (5 mg or 10 mg), increased by smaller steps at longer intervals. The optimum dosage generally ranges from 30 mg to 75 mg daily, although occasionally in hospitalised patients daily doses up to 100 mg may be necessary.

If no benefit is apparent within 6 to 8 weeks of achieving the maximum dosage, a decision should be taken whether or not to continue treatment with Lioresal.

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.

Special Populations

Renal impairment:

In patients with impaired renal function or undergoing chronic haemodialysis, low doses (ie. approx. 5 mg daily) should be used. Signs and symptoms of overdosage have been reported with doses at and above 5 mg daily in this setting. Lioresal 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).

Hepatic impairment:

No studies have been performed in patients with hepatic impairment under Lioresal therapy. Lioresal should be prescribed with caution in patients with hepatic impairment.

Elderly patients (aged 65 years or above):

Since unwanted effects are more likely to occur in elderly patients (due to increased risk of renal function impairment and CNS toxicity), a very cautious dosage schedule should be adopted and the patient kept under appropriate surveillance.

Toxicity due to baclofen may be mistaken for uraemic encephalopathy.

Paediatric patients:

Lioresal should be given with extreme caution to children under 16 years of age, as only limited data are available. Lioresal tablets are not suitable for use in children below 33 kg body weight.

Method of administration

Lioresal should be taken during meals with a little liquid.

Monitoring Advice

Since in rare instances elevated AST, alkaline phosphatase or glucose levels in the serum have been recorded, appropriate laboratory test s should be performed periodically in patients with liver diseases or diabetes mellitus, in order to ensure that no drug-induced changes in these underlying diseases have occurred.

Careful monitoring of respiratory and cardiovascular function is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.



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