Precautions and Warnings

Acute alcohol intoxication
Predisposition to increased intracranial pressure
Shock
Upper respiratory tract surgery
Breastfeeding
Central nervous system disorder
Chronic alcoholism
Decompensated cardiac failure
Glaucoma
Hepatic cirrhosis
Hepatic impairment
History of angina
History of drug misuse
History of psychiatric disorder
Ischaemic heart disease
Ocular surgery
Penetrating ocular injury
Porphyria
Pregnancy
Severe psychiatric disorder
Unstable angina
Within 6 months of a myocardial infarction

Dose adjustment may be necessary in patients with hepatic impairment
Advise patient ability to drive or operate machinery may be impaired
Advise patient not to drive until they know how the medicine affects them
Advise patient not to drive/operate machinery within 24 hours of treatment
Advise patient this medicine is subject to driving restrictions
Not all available brands are licensed for all indications
Resuscitation facilities must be immediately available
Treatment to be administered by or under supervision of specialist
Ventilatory support facilities must be immediately available
May cause respiratory depression
Monitor vital signs, respiration & cardiac function
Potential for drug abuse
Hospital use only
Advise patient not to take alcohol during and for 24 hours after therapy

Emergence reactions may occur, including flashbacks, hallucinations, dysphoria, anxiety, insomnia or disorientation. The risk of emergence reactions during recovery from anaesthesia can be reduced by co-administration of benzodiazepine.

Increased salivation can occur, atropine or another anticholinergic can be used as a prophylaxis.

Muscle relaxants and supplemental analgesia are indicated when esketamine is used in a procedure that causes visceral pain.

Esketamine is not suitable for long term use, haemorrhagic cystitis and hepatotoxicity has been reported in long term racemic ketamine use.

Caution is advised if intracranial pressure is elevated or in patients with damage or diseases of the central nervous system, as elevation of cerebrospinal pressure has been reported with ketamine anaesthesia.

Caution is advised if used during ocular examination or surgery where intraocular pressure should not increase.

Avoid in situations which require relaxed uterus myometrium such as threatening uterus rupture.

Muscle relaxants and controlled ventilation may be necessary in procedures on the pharynx larynx and bronchi.

Patient should be accompanied home after use of anaesthesia as an outpatient.

Esketamine should not be used as the sole anaesthetic agent in patients with manifest ischaemic cardiac disorders.

Cardiac function should be monitored continuously in hypertensive or cardiac decompensation patients.

Presentation

Solution for injection containing esketamine hydrochloride.

Drugs List

esketamine 250mg/10ml solution for injection ampoule

esketamine 25mg/5ml solution for injection ampoule

esketamine 50mg/2ml solution for injection ampoule

Therapeutic Indications

Uses

Analgesia for painful procedures
Analgesia in artificial respiration
Analgesia in emergency medicine
Induction and maintenance of anaesthesia

Dosage

The individual response to esketamine varies. The doses recommended are not fixed and should be titrated for patient's requirements.

Adults

Induction and maintenance of general anaesthesia
Intermittent dosing
Induction: 0.5 to 1mg/kg given by slow intravenous injection or 2 to 4mg/kg given by intramuscular injection.
Maintenance: Half the initial dose to be given as needed, every 10 to 15 minutes.

Continuous dosing
0.5 to 3mg/kg/hour given by continuous intravenous infusion.

Analgesia in emergency medicine
0.125 to 0.25mg/kg by slow intravenous injection or 0.25 to 0.5mg/kg by intramuscular injection.

Analgesic supplementation of regional and local anaesthesia
0.125 to 0.25mg/kg/hour by intravenous infusion.

Analgesia in artificial respiration (intubated intensive care patients)
Initial dosing
0.25mg/kg by bolus injection.

Continuous dosing
0.2 to 0.5 (up to 1.5) mg/kg/hour given by continuous intravenous infusion with benzodiazepine.

Maximum 4 to 6 weeks use for permanent infusion.

Children

Specific doses are not provided by the manufacturer. Dosage in children has not been adequately studied but is not expected to differ substantially from adult doses.

Additional Dosage Information

Dose reduction is required in patients with multiple injuries and in patients with poor general health e.g. shock, approximately half the normal dose should be used as a guideline.

Administration

Slow intravenous injection, intramuscular injection or intravenous infusion only.

Intravenous injection should be administered slowly to reduce risk of respiratory depression.

Fast 4 to 6 hours before administration if possible.

Contraindications

Eclampsia
Hyperthyroidism
Pre-eclampsia
Raised intracranial pressure
Severe hypertension
Umbilical cord prolapse
Uncontrolled hypertension
Uterine rupture