midazolam maleate: clinical use

Prescribing considerations

• Confirm diagnosed epilepsy, a clear emergency seizure plan and appropriately trained caregivers.
• Use in infants aged 3–6 months only in hospital with respiratory monitoring and resuscitation facilities.
• Exercise caution with chronic respiratory insufficiency, renal impairment, hepatic or cardiac dysfunction, older age and frailty because effects may be enhanced or prolonged.
• Avoid in patients with a history of alcohol or drug misuse where clinically practicable.
• Review all CNS depressants and CYP3A4 inhibitors or inducers before prescribing.

Contraindications and cautions

• Hypersensitivity to midazolam, other benzodiazepines or an excipient
• Myasthenia gravis
• Severe respiratory insufficiency
• Sleep apnoea syndrome
• Severe hepatic impairment

Monitoring

• Observe airway, respiratory rate, oxygenation, consciousness and seizure response after administration.
• Continue supervision until satisfactory recovery; monitor more closely when respiratory or cardiac disease, hepatic impairment, frailty or interacting medicines are present.
• If emergency services attend, communicate the exact product used and provide the empty syringe.

Clinical pharmacology

Midazolam is an imidazobenzodiazepine and positive allosteric modulator of GABA-A receptors. Oromucosal absorption is rapid; it is metabolised predominantly by CYP3A4 to an active hydroxylated metabolite, with relatively short clinical action because of rapid biotransformation.

Formulation and product differences

• Epistatus contains midazolam as the maleate salt in a clear oromucosal solution supplied in a single-use, needle-free pre-filled oral syringe.
• Other oromucosal midazolam products may use a different salt, concentration or syringe presentation; products should not be assumed interchangeable.
• The formulation contains ethanol and liquid maltitol. It is unsuitable for people with hereditary fructose intolerance and should not be co-administered with disulfiram.
• Store below 25°C in the original packaging, protected from light; do not refrigerate or freeze.

Oromucosal preparation

Route: Oromucosal

Strengths: 2.5 mg, 5 mg, 7.5 mg, 10 mg