LORAZEPAM-WGR

What it is

Lorazepam-WGR is an immediate release tablet containing lorazepam as the active ingredient. The medicine is available in two strengths: 1 mg and 2.5 mg tablets. Lorazepam is a white or almost white crystalline powder.

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

Lorazepam-WGR is administered orally, and dose, frequency of administration and duration of therapy should be individualised according to patient response. For elderly or debilitated patients, an initial dosage of 1 or 2 mg/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. Lorazepam-WGR is not recommended for children.

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, and abilities may be impaired on the day following use. Following the 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 suggested. 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. For patients with anxiety and/or insomnia the duration of treatment should not exceed 4 weeks (including tapering off process), and continuous long-term use of lorazepam is not recommended. Although hypotension has occurred only rarely, lorazepam should be administered with caution to patients in whom a drop of blood pressure might lead to cardiac or cerebral complications, particularly in elderly patients. The concomitant use of lorazepam with alcohol or/and 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 cardio-vascular depression. Benzodiazepines should be used with caution and the prescription size should be limited, in patients with signs and symptoms of a depressive disorder or suicidal tendencies.

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

Lorazepam-WGR 1 mg and 2.5 mg tablets were first listed on the ARTG on 6 May 2024.