APO-LORAZEPAM

What it is

APO-Lorazepam is a lorazepam immediate release tablet. The medicine is available in two strengths: 1 mg and 2.5 mg tablets. The 1 mg tablets are white, round, flat, bevelled and scored tablets, whilst the 2.5 mg tablets are also white, round, flat, bevelled and scored.

Approved indications

— Management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. — Pre-surgical medication taken the night before surgery and/or 1–2 hours prior to the surgical procedure.

Dosing overview APO-Lorazepam is administered orally.

For elderly or debilitated patients, an initial dosage of 1 or 2 mg per day in divided doses is recommended, to be adjusted as needed and tolerated. For patients with anxiety and/or insomnia, the duration of treatment should not exceed 4 weeks, including tapering off process.

Key safety warnings

Patients receiving lorazepam should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from lorazepam therapy, as abilities may be impaired on the day following use. Following prolonged use of lorazepam 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 being suggested. The use of benzodiazepines may lead to dependence as defined by the presence of a withdrawal syndrome on discontinuation of the drug, with withdrawal symptoms similar in character to those noted with barbiturates and alcohol having occurred following abrupt discontinuation. 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. Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines. The concomitant use of lorazepam with alcohol or CNS depressants should be avoided, as such concomitant use has the potential to increase the clinical effects of lorazepam which may include severe sedation, clinically relevant respiratory and/or cardiovascular depression.

Contraindications

— Patients with a known hypersensitivity to benzodiazepines. — Patients with chronic obstructive airways disease with incipient respiratory failure. — Patients with sleep apnoea. — Lorazepam should not be used as monotherapy in patients with depression, or symptoms of anxiety associated with depression, due to a risk of suicide.

Regulatory history

APO-Lorazepam 1 mg and 2.5 mg tablet blister packs were first registered on the Australian Register of Therapeutic Goods on 22 July 2019.