MURELAX

What it is

MURELAX is an anti-anxiety agent which belongs to the benzodiazepine class of drugs. MURELAX contains oxazepam 15 mg or 30 mg per tablet. Benzodiazepines exert their effects by binding to specific receptors at several sites within the central nervous system, either by potentiating the effects of synaptic or pre-synaptic inhibition mediated by gamma-aminobutyric acid or by directly affecting the action potential generating mechanisms.

Approved indications

— Management of anxiety disorders or for the short-term relief of the symptoms of anxiety. — Anxiety associated with depression. — Alcoholics with acute tremulousness, confusional state or anxiety associated with alcohol withdrawal.

Dosing overview

Dose, frequency of administration and duration of therapy should be individualised according to patient response. MURELAX is not indicated for use in children under 16 years of age.

Key safety warnings

Patients receiving MURELAX should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from MURELAX therapy. Abilities may be impaired on the day following use. Patients should be advised that their tolerance for alcohol and other CNS depressants will be diminished and that these medications should either be eliminated or given in reduced dosage in the presence of MURELAX. Benzodiazepines should be prescribed for short periods only (e.g. 2 to 4 weeks). Continuous long-term use of MURELAX is not recommended. Following the prolonged use of MURELAX at therapeutic doses, withdrawal from the medication should be gradual. An individualised withdrawal timetable needs to be planned for each patient in whom dependence is known or suspected. Periods from four weeks to four months have been suggested. The use of benzodiazepines may lead to dependence, as defined by the presence of a withdrawal syndrome on discontinuation of the drug. Withdrawal symptoms similar in character to those noted with barbiturates and alcohol have occurred following abrupt discontinuation of benzodiazepines. Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines. Elderly or debilitated patients may be particularly susceptible to the sedative effects of benzodiazepines and associated giddiness, ataxia and confusion which may increase the possibility of a fall.

Contraindications

MURELAX is contraindicated in patients with known hypersensitivity to benzodiazepines. MURELAX is contraindicated in patients with chronic obstructive airways disease with incipient respiratory failure. MURELAX is contraindicated in patients with sleep apnoea.

Regulatory history

MURELAX was first approved on 20 September 1991. ARTG 12952 for MURELAX Oxazepam 30 mg tablet blister pack was first listed on 19 August 1991, and ARTG 75122 for MURELAX Oxazepam 15 mg tablet was first listed on 20 July 2000.