LIORESAL

What it is

Lioresal contains baclofen, a gamma-aminobutyric acid derivative. Lioresal tablets contain 10 mg or 25 mg baclofen.

Approved indications

Lioresal is indicated for suppression of voluntary muscle spasm in: — Multiple sclerosis — Spinal lesions of traumatic, infectious, degenerative, neoplastic and unknown origin, causing skeletal hypertonus — Spinal lesions of traumatic, infectious, degenerative, neoplastic and unknown origin, causing spastic and dyssynergic bladder dysfunction Lioresal is not recommended in Parkinson's disease or spasticity arising from strokes, cerebral palsy or rheumatoid disorders.

Dosing overview

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. In adults Lioresal should be given in at least three divided doses daily. 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 until the optimum response has been attained. 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.

Key safety warnings

Patients suffering from psychiatric disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously with Lioresal and kept under careful 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. Caution is needed in patients with epilepsy or other convulsive conditions, cortical or subcortical brain damage or significant EEG abnormalities, since ingestion of baclofen may cause deterioration of seizure control and EEG changes and may precipitate convulsions. Anxiety and confusional states, delirium, hallucinations, psychotic disorders, mania, or paranoia, convulsion, dyskinesia, tachycardia, hyperthermia and temporary aggravation of spasticity and hypertonia have been reported upon the abrupt withdrawal of Lioresal, especially after long-term medication. Except in overdose-related emergencies or where serious adverse effects have occurred, treatment should, therefore, always be gradually withdrawn by successive dosage reduction over a period of approximately 1 to 2 weeks. Since baclofen is largely eliminated by the kidneys, a dosage reduction is advised to avoid drug accumulation. Lioresal should be used with caution in patients with renal impairment and should be administered to end stage renal failure patients only if the expected benefit outweighs the potential risk.

Contraindications

Lioresal is contraindicated in patients with known hypersensitivity to baclofen or to any of the components of the formulation.

Regulatory history

Lioresal 10 mg tablet bottles and 25 mg tablet bottles were first listed on the ARTG on 2 August 1991. Lioresal intrathecal formulations were first listed on 19 March 1996. Lioresal 25 mg tablet blister packs were added to the register on 18 March 1999, and Lioresal 10 mg tablet blister packs were first listed on 21 January 2025.