ATIVAN

What it is

ATIVAN is lorazepam, available in tablet strengths of 1 mg and 2.5 mg. The tablets contain lorazepam as the active ingredient. The tablets contain lactose monohydrate as an excipient with known effect.

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

Dose, frequency of administration and duration of therapy should be individualised according to patient response for optimal results. The average daily dosage for treatment of anxiety is 2–3 mg administered in divided doses, however, this may range between 1 and 10 mg. For insomnia due to anxiety or transient situational stress, a single daily dose of 1–2 mg may be given, usually at bedtime. For pre-surgical medication, a dosage of 2–4 mg of ATIVAN is recommended the night before surgery and/or 1–2 hours prior to the surgical procedure. 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.

Key safety warnings

For patients with anxiety and/or insomnia the duration of treatment should not exceed 4 weeks, including tapering off process. Continuous long-term use of ATIVAN is not recommended. Following prolonged use of ATIVAN 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 concomitant use of lorazepam with alcohol or CNS depressants should be avoided. 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. Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines. Patients receiving ATIVAN should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from ATIVAN therapy. Abilities may be impaired on the day following use. Benzodiazepines cross the placenta and may cause hypotonia, reduced respiratory function and hypothermia in the newborn infant. Continuous treatment during pregnancy and administration of high doses in connection with delivery should be avoided.

Contraindications

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

Regulatory history

ARTG registration for ATIVAN lorazepam 1 mg and 2.5 mg tablet blister packs occurred on 4 July 1991. The medicine was first approved on 6 April 1993.