CLOFEN

What it is

CLOFEN is a tablet containing baclofen as the active ingredient, available in strengths of 10 mg and 25 mg. Baclofen is an effective antispastic agent with a spinal site of action, and its mechanism of action and pharmacological properties differ from those of other antispastic agents. Baclofen depresses monosynaptic and polysynaptic reflex transmission, probably through various actions including stimulation of GABA-β receptors.

Approved indications

CLOFEN is indicated for suppression of voluntary muscle spasm in multiple sclerosis and spinal lesions of traumatic, infectious, degenerative, neoplastic and unknown origin that cause skeletal hypertonus and spastic and dyssynergic bladder dysfunction. — 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. Baclofen is not recommended in Parkinson's disease or spasticity arising from strokes, cerebral palsy or rheumatoid disorders.

Dosing overview

Treatment should be started with a dose of 5 mg three times daily, subsequently increased at three-day intervals by 5 mg three times daily until the optimum response has been attained. The optimum dosage generally ranges from 30 to 75 mg daily, although occasionally in hospitalised patients, daily doses up to 100 mg may be necessary. The optimum daily dosage should be individually adapted to each patient's requirements so that clonus, flexor and extensor spasms, and spasticity are reduced while retaining enough muscle tone to permit active movements and avoiding adverse effects.

Key safety warnings

Suicide and suicide-related events have been reported in patients treated with baclofen, particularly in those with additional risk factors such as alcohol use disorder, depression and a history of previous suicide attempts, and these patients should be kept under close supervision. Caution is needed in patients with epilepsy or other convulsive conditions, as baclofen may cause deterioration of seizure control and may precipitate convulsions, although it can be used under appropriate supervision if adequate anticonvulsive therapy is continued, as lowering of the convulsion threshold may occur and seizures have been reported after cessation or overdosage. Cases of encephalopathy have been reported, with symptoms including somnolence, depressed level of consciousness, confusion, myoclonus and coma which are usually reversible after discontinuation, and baclofen should be discontinued if any signs or symptoms of encephalopathy are observed. Upon abrupt withdrawal of baclofen, anxiety, confusional states, delirium, hallucinations, psychotic or paranoid states, convulsions, dyskinesia, tachycardia, hyperthermia and temporary aggravation of spasticity may occur, and treatment should always be gradually withdrawn by successive dosage reduction over approximately 1 to 2 weeks except in overdose emergencies or where serious adverse effects have occurred.

Contraindications

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

Regulatory history

CLOFEN 10 mg and CLOFEN 25 mg tablets were first listed on the Australian Register of Therapeutic Goods on 17 September 1992.