Posology : מינונים

4.2   Posology and method of administration
Dosage

Treatment should always be initiated with small, gradually increasing doses of Lioresal.
The lowest dose compatible with an optimal response is recommended. The optimum daily dosage should be individualized in such a way that clonus, flexor and extensor spasms and spasticity are reduced, but adverse effects are avoided 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.
If no benefit is apparent within 6 to 8 weeks of achieving the maximum dosage, a decision should be taken whether to continue 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 (see Section 4.4).

Adults:
Treatment should be started with a dosage of 15 mg daily, preferably in 2 to 4 divided doses. Dose should be titrated upwards cautiously, by 15 mg/day increments at 3-day intervals until the requisite daily dosage has been attained. In certain patients reacting LIO API JAN22 V1                                                                 Page 1 of 10 sensitively to drugs, it may be advisable to begin with a lower daily dosage (5 or 10 mg) and to raise this dosage more gradually (see Section 4.4 Warnings and Precautions). The optimum dosage generally ranges from 30 to 80 mg daily. Daily doses of 100 to 120 mg may be given to carefully supervised patients in hospital.

Special populations

Elderly patients (aged 65 years or above):
Since unwanted effects are more likely to occur in elderly patients, it is recommended that a cautious dosage schedule be adopted in such cases and that the patient be kept under appropriate surveillance.

Paediatric population (0 to < 18 years):
Treatment should usually be started with a very low dose (corresponding to approximately 0.3 mg/kg a day), preferably in 2 to 4 divided doses. Therefore, Lioresal tablets are not suitable for use in children below 33 kg body weight.
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.

Patients with impaired renal function:
In patients with impaired renal function Lioresal should be given with caution and in lower doses. In patients undergoing chronic hemodialysis, baclofen concentrations in plasma are elevated and therefore a particularly low dosage of Lioresal should be selected, i.e.
approx. 5 mg daily.
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) (see section 4.4 and section 4.9).

Patients with hepatic impairment:

No studies have been performed in patients with hepatic impairment receiving Lioresal therapy. The liver does not play a significant role in the metabolism of baclofen after oral administration of Lioresal (see section 5.2). However, Lioresal has the potential of elevating liver enzymes. Lioresal should be prescribed with caution in patients with hepatic impairment.

Patients with spastic states of cerebral origin:
Since unwanted effects are more likely to occur in patients with spastic states of cerebral origin, it is recommended that a cautious dosage schedule be adopted in such cases and that the patient be kept under appropriate surveillance.

Method of administration
Lioresal should be taken during meals with a little liquid.