LIORESAL 10 TABLET 10 MG [SIN05330P]

Product Info

LIORESAL 10 TABLET 10 MG

[SIN05330P]

INDICATIONS

Adult and Paediatric population (6–<18 years)

Lioresal is indicated 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.

Lioresal 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.

DOSAGE REGIMEN AND ADMINISTRATION

Dosage regimen

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 adapted to each individual in such a way that clonus, flexor and extensor spasms and spasticity are reduced, but adverse effects are avoided as far as possible.

If no benefit is apparent within 6 to 8 weeks of achieving the maximum dosage, a decision should be made whether to continue using Lioresal.

Discontinuation of 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 WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Adults

Treatment should be started with a dosage of 15 mg daily, preferably in 3 divided doses. The 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 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 WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The optimum dosage generally ranges from 30 to 75 mg daily. Daily doses of 100 mg to 120 mg tablets may be given to carefully monitored patients in hospital.

Special populations

Pediatric patients (6–<18 years)

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

The dosage should be cautiously increased, at about 3-day 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 recommended daily dosages for maintenance therapy are as follows:

Children aged 6 years – 8 years: 30 – 40mg

Over 8 years: up to 60mg

Maximum daily dose:

The maximum daily dose should not exceed 2 mg/kg/day.

The maximum daily dose should not exceed 40 mg/day in children below 8 years old and 60 mg/day in children 8 years and older.

Renal impairment

In patients with impaired renal function, Lioresal should be given with caution and at lower doses. These patients should be closely monitored for prompt diagnosis of early signs and/or symptoms of toxicity (e.g. somnolence, lethargy) (see section WARNINGS AND PRECAUTIONS and section OVERDOSAGE – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Lioresal should be administered to end-stage renal failure patients only if the expected benefit outweighs the potential risk.

Hepatic impairment

No studies have been performed in patients with hepatic impairment on Lioresal therapy. The liver does not play a significant role in the metabolism of baclofen after oral administration of Lioresal (see section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). However, Lioresal has the potential of elevating liver enzymes. Lioresal should be prescribed with caution in patients with hepatic impairment (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Geriatric patients (aged 65 years or above)

Since adverse 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.

Patients with spastic states of cerebral origin

Since adverse 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.

CONTRAINDICATIONS

Known hypersensitivity to baclofen or to any of the excipients.