LIORESAL 10 TABLET 10 mg

NOVARTIS (SINGAPORE) PTE LTD

NOVARTIS (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

TABLET

**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 to 120 mg 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 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. The recommended daily dosages for maintenance therapy are as follows: Children aged 6 years – 8 years: 30 – 40mg Over 8 years: up to 60mg **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.