ALEPAM

What it is

ALEPAM is an oxazepam tablet available in 15 mg and 30 mg strengths. Oxazepam is an anti-anxiety agent which belongs to the benzodiazepine class of drugs.

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

For optimal results, dose, frequency of administration and duration of therapy should be individualised according to patient response. ALEPAM is not indicated for use in children under 16 years of age.

Key safety warnings

Patients receiving ALEPAM should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from ALEPAM 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 ALEPAM. Following the prolonged use of ALEPAM 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. Benzodiazepines should be prescribed for short periods only (e.g. 2 to 4 weeks), and continuous long-term use of ALEPAM is not recommended. The use of benzodiazepines may lead to dependence, and withdrawal symptoms similar in character to those noted with barbiturates and alcohol have occurred following abrupt discontinuation, ranging from insomnia, anxiety, dysphoria, palpitations, panic attacks, vertigo, myoclonus, akinesia, hypersensitivity to light, sound and touch, abnormal body sensations, depersonalisation, derealisation, delusional beliefs, hyperreflexia and loss of short-term memory, to a major syndrome which may include convulsions, tremor, abdominal and muscle cramps, confusional states, delirium, hallucinations, hyperthermia, psychosis, vomiting and sweating. Paradoxical reactions such as acute rage, stimulation or excitement may occur; should such reactions occur, ALEPAM should be discontinued.

Contraindications

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

PBS listing

ALEPAM 15 mg tablets are listed on the PBS with 4 items as unrestricted or authority required, at an ex-manufacturer price of A$2.50.

Regulatory history

ALEPAM received its first approval on 20 September 1991. ARTG 17572 (ALEPAM 15 mg tablet bottle) was first listed on 1991-09-20, while ARTG 385081 and ARTG 385082 (ALEPAM 15 mg and 30 mg tablet blister packs) were first listed on 2022-07-12.