LEXOTAN

What it is

Lexotan is bromazepam, available as 3 mg and 6 mg tablets. Bromazepam is a benzodiazepine with anxiolytic action. At low doses, Lexotan selectively reduces tension and anxiety, whilst at high doses sedative and muscle-relaxant properties appear.

Approved indications

— Symptomatic relief of tension, anxiety and agitation.

Dosing overview

The average dose for ambulatory patients is 3 mg two or three times daily. For severe hospitalised cases, the dose is 6–12 mg two or three times daily. The maximum recommended dose is 60 mg daily. These amounts are general recommendations and dosage should be individually determined; treatment of outpatients should begin with low doses, gradually increasing to the optimum level. When treatment is ceased withdrawal should be gradual, and the duration of treatment should be as short as possible. The overall treatment should not be more than 2–4 weeks, followed by a tapering off process of up to 6–8 weeks.

Key safety warnings

Patients should be advised that their tolerance for alcohol and other CNS depressants will be diminished and concomitant use of Lexotan and alcohol should be avoided, as such concomitant use has the potential to increase clinical effects possibly including severe sedation, clinically relevant respiratory and/or cardiovascular depression that could result in coma or death. The use of benzodiazepines may lead to dependence; the risk of dependence increases with dose and duration of treatment and is greater in patients with a history of alcohol or drug abuse. After as little as one week of therapy, withdrawal symptoms can appear following the cessation of recommended doses. Transient amnesia or memory impairment has been reported in association with benzodiazepines, and anterograde amnesia may occur at therapeutic dosages with the risk increasing at higher dosages. There have been reports of falls and fractures in benzodiazepine users; the risk is increased in those taking concomitant sedatives and in the elderly, who may be particularly susceptible to the sedative effects including giddiness, ataxia and confusion.

Contraindications

Lexotan is contraindicated in patients with known hypersensitivity to benzodiazepines or any of the excipients, severe respiratory insufficiency including chronic obstructive airways disease with incipient respiratory failure, severe hepatic impairment as it may precipitate hepatic encephalopathy, sleep apnoea syndrome, and myasthenia gravis.

PBS listing

Lexotan 3 mg tablets are listed on the PBS with one item requiring authority approval; the ex-manufacturer price is A$9.33. Lexotan 6 mg tablets are listed on the PBS with one item requiring authority approval; the ex-manufacturer price is A$12.00.

Regulatory history

Lexotan was first approved on 9 May 1995.