LORAZE

What it is

LORAZE is a lorazepam solution for injection for acute use only. It contains 4 mg lorazepam per 1 mL ampoule. It is a clear, colourless solution supplied in clear glass ampoules. The product contains benzyl alcohol and propylene glycol.

Approved indications

— Pre-operative medication — Premedication for prolonged investigations — Treatment of acute anxiety states and acute agitation — Control of status epilepticus in adults, adolescents and children

Dosing overview

LORAZE can be given intravenously or intramuscularly, with the intravenous route preferred. For intravenous administration, LORAZE should always be diluted with normal saline or sterile water for injection as a 1:1 dilution. For intramuscular administration, a 1:1 dilution of LORAZE with normal saline or sterile water for injection is recommended. For elderly and debilitated patients, reduce the initial dose by approximately 50% and adjust the dosage as needed and tolerated.

Key safety warnings

Chronic use or excessive dosage risks toxicity. Prolonged repeat injections or infusions are not appropriate because of the possibility of propylene glycol toxicity. Severe anaphylactic and anaphylactoid reactions have been reported with benzodiazepines, including cases of angioedema involving the tongue, glottis or larynx. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Caution is recommended in patients with respiratory depression, as benzodiazepines can cause increased arterial carbon dioxide tension and decreased arterial oxygen tension in patients with chronic obstructive pulmonary disease. Transient amnesia or memory impairment has been reported in association with the use of LORAZE. Concomitant use of benzodiazepines and opioids may result in sedation, respiratory depression, coma, and death. The concomitant use of LORAZE with alcohol or CNS depressants should be avoided, as such concomitant use has the potential to increase clinical effects including severe sedation and clinically relevant respiratory and cardiovascular depression. Intravenous administration of benzyl alcohol has been associated with serious adverse events and death in neonates. Benzyl alcohol containing products should not be used in pre-term or full-term neonates and in young children under 3 years.

Contraindications

LORAZE is contraindicated in pulmonary insufficiency, sleep apnoea syndrome, myasthenia gravis, and severe hepatic insufficiency. LORAZE is also contraindicated in patients with hypersensitivity to benzodiazepines, including lorazepam, or to any of the excipients.

Regulatory history

LORAZE lorazepam 4 mg/1 mL solution for injection ampoule was first listed on the ARTG on 31 March 2022.