DIAZEPAM-WGR

What it is

DIAZEPAM-WGR is a benzodiazepine that exhibits anxiolytic, sedative, muscle relaxant and anticonvulsant effects. This is presumed to result from facilitating the action of gamma-aminobutyric acid (GABA), a naturally occurring inhibitory neurotransmitter, in the brain.

Approved indications

— Management of anxiety disorders or for the short term relief of symptoms of anxiety. — Acute alcohol withdrawal, where diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. — Relief of reflex muscle spasms due to local trauma (injury, inflammation) to muscles, bones and joints. — Spasticity due to upper motor neuron lesions such as cerebral palsy and paraplegia, as well as in athetosis and stiff man syndrome. — Controlling status epilepticus and the spasms of tetanus (by intravenous injection). — Pre-operative medication.

Dosing overview

The usual adult dose is 2 to 10 mg by intramuscular or intravenous injection repeated every three to four hours as required. In general, the maximum adult dose should not exceed 30 mg over an eight hour period. Intravenous injections should be given into a large vessel, such as an antecubital vein, and the solution should be administered slowly at a rate not exceeding 5 mg per minute. Benzodiazepines should not be given to children without careful assessment of the indication; intravenous administration should be made slowly over a 3 minute period at a dosage not exceeding 0.25 mg per kilogram.

Key safety warnings

Concomitant use of diazepam with alcohol and drugs including opioids that have a depressive effect on the central nervous system should be avoided, as these agents can enhance the clinical effects of diazepam and can possibly result in deep sedation, clinically significant respiratory and cardiovascular depression, coma, and death. Benzodiazepines should be prescribed for short periods only, for example 2 to 4 weeks, and continuous long term use of diazepam is not recommended. The use of benzodiazepines may lead to dependence, with the risk of dependence increasing with dose and duration of treatment, and being more pronounced in patients on long term therapy and high dosage, particularly in predisposed patients with a history of alcohol or drug abuse. Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines, with anterograde amnesia possibly occurring using therapeutic doses, the risk increasing at higher doses, and amnestic effects potentially being associated with inappropriate behaviour. Paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, delusion, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects may occur, and they are more likely to occur in children and the elderly.

Contraindications

DIAZEPAM-WGR is contraindicated in patients with a known hypersensitivity to benzodiazepines or any of the excipients. It is contraindicated in patients with severe respiratory failure, or chronic obstructive airways disease with incipient respiratory failure. It is contraindicated as sole therapy in psychosis including primary depressive disorders. DIAZEPAM-WGR is contraindicated in patients with Myasthenia gravis. The drug should not be administered intravenously to patients in shock, coma, patients with cardiac or respiratory insufficiency or those with acute alcoholic intoxication with depressed vital signs.

Regulatory history

DIAZEPAM-WGR was first approved on 16 February 2005. The brand is currently registered on the ARTG with four variants: diazepam 2 mg tablets (blister pack and bottle) and diazepam 5 mg tablets (blister pack and bottle), all first listed on 2 July 2020.