SEREPAX

What it is

SEREPAX is an anti-anxiety agent which belongs to the benzodiazepine class of drugs. SEREPAX oxazepam is available as tablets containing 15 mg or 30 mg of oxazepam. The exact mechanism of action of benzodiazepines has not yet been elucidated; however, benzodiazepines appear to work through several mechanisms, presumably exerting 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. — Acute tremulousness, confusional state or anxiety associated with alcohol withdrawal in alcoholics.

Dosing overview

For optimal results, dose, frequency of administration and duration of therapy should be individualised according to patient response. Dosing varies by indication:

SEREPAX should not be administered to alcoholics with acute inebriation. SEREPAX is not indicated for use in children under 16 years of age.

Key safety warnings

Patients receiving SEREPAX should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from SEREPAX therapy, as 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 SEREPAX. Following the prolonged use of SEREPAX at therapeutic doses, withdrawal from the medication should be gradual, with an individualised withdrawal timetable planned for each patient in whom dependence is known or suspected, with periods from four weeks to four months suggested. In general, benzodiazepines should be prescribed for short periods only (2 to 4 weeks), and continuous long-term use of SEREPAX is not recommended. Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines. Paradoxical reactions such as acute rage, stimulation or excitement may occur; should such reactions occur, SEREPAX should be discontinued. The use of benzodiazepines may lead to dependence, as defined by the presence of a withdrawal syndrome on discontinuation of the drug.

Contraindications

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

PBS listing

No source document contains information regarding PBS listing, restriction type, or ex-manufacturer price for SEREPAX.

Regulatory history

SEREPAX oxazepam 30 mg tablet blister pack was first listed on the ARTG on 4 July 1991. SEREPAX oxazepam 15 mg tablet blister pack was first listed on the ARTG on 23 November 2010.