STELAX

What it is

STELAX contains baclofen, a gamma-aminobutyric acid derivative, as a racaemic mixture of the R(-) and S(+) isomers. STELAX is available as tablets containing 10 mg or 25 mg baclofen.

Approved indications

STELAX 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 STELAX is not recommended in Parkinson's disease or spasticity arising from strokes, cerebral palsy or rheumatoid disorders.

Dosing overview

Treatment with STELAX should always be started in hospital using small doses which are then gradually increased in a stepwise manner. 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. The lowest dose compatible with an optimal response is recommended. In patients with impaired renal function or undergoing chronic haemodialysis, low doses of approximately 5 mg daily should be used. Since unwanted effects are more likely to occur in elderly patients, a very cautious dosage schedule should be adopted and the patient kept under appropriate surveillance.

Key safety warnings

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. Cases of misuse, abuse and dependence have been reported with baclofen. Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of baclofen misuse, abuse or dependence such as dose escalation, drug-seeking behaviour, development of tolerance. 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. In patients with epilepsy and muscle spasticity, STELAX can be employed under appropriate supervision, provided adequate anticonvulsive therapy is continued. Cases of encephalopathy have been reported in patients treated with STELAX. Symptoms included somnolence, depressed level of consciousness, confusion, myoclonus and coma which are usually reversible after treatment discontinuation. If any signs or symptoms of encephalopathy are observed, baclofen should be discontinued. Anxiety and confusional states, delirium, hallucinations, psychotic disorders, mania, paranoia, convulsion, dyskinesia, tachycardia, hyperthermia and temporary aggravation of spasticity have been reported upon the abrupt withdrawal of STELAX, 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.

Contraindications

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

Regulatory history

STELAX was first listed on the Australian Register of Therapeutic Goods on 9 January 2003, with three registered variants: 10 mg tablets in bottle, 25 mg tablets in blister pack, and 25 mg tablets in bottle.