Warnings: In patients with liver cirrhosis, or in those who have already received neuroleptic, opiate or sedative agents, the dose of etomidate should be reduced.
Induction with Hypnomidate may be accompanied by a slight and transient drop in blood pressure due to a reduction of the peripheral vascular resistance. In debilitated patients in whom hypotension may be harmful, the following measures should be taken:
1. Keep the patient supine during induction.
2. Ensure good intravenous access to manage circulatory blood volume.
3. Give Hypnomidate by slow intravenous injection (e.g. 10 ml in 1 min.).
4. Avoid giving other induction agents if possible.
When Hypnomidate is used, resuscitation equipment should be readily available to manage respiratory depression and the possibility of apnoea.
Single induction doses of etomidate can lead to transient adrenal insufficiency and decreased serum cortisol levels (See section 5.1 Pharmacodynamic Properties).
Where concern exists for the patients undergoing severe stress, particularly those with adrenocortical dysfunction, supplementation with exogenous cortisol should be considered.
Etomidate should be used with caution in critically ill patients, including patients with sepsis.
Prolonged suppression of endogenous cortisol and aldosterone may occur as a direct consequence of etomidate when given by continuous infusion or in repeated doses. Use of Hypnomidate for maintenance of anaesthesia should therefore be avoided. In such situations stimulation of the adrenal gland with adrenocorticotropic hormone (ACTH) is not useful. However, when etomidate is used for induction, the post- operative rise in serum cortisol which has been observed after thiopentone induction is delayed for approximately 3-6 hours.
Spontaneous movements may occur in one or more groups of muscles, particularly when no premedication has been administered. These movements have been ascribed to subcortical disinhibition. They can be largely prevented by the intravenous administration of small doses of fentanyl, with diazepam 1-2 min. before induction with Hypnomidate.
Myoclonus and pain on injection, including venous pain, is observed during the administration of Hypnomidate especially when it is injected into a small vein. This can largely be avoided by intravenous application of a small dose of suitable opioids, e.g. fentanyl, 1 to 2 minutes before induction.
Hypnomidate should be used with caution in elderly patients, since the potential exists for decreases in cardiac output, which have been reported with doses greater than recommended (see Section 4.2 Posology and Method of Administration for recommended dose in the elderly).
Convulsions may occur in unpremedicated patients.
Precautions: Hypnomidate by injection should be given slowly (e.g. 10 ml over 30- 60 seconds).
This medicine contains 3626 mg propylene glycol in 10 ml.
Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old.
While propylene glycol has not been shown to cause reproductive or developmental toxicity in animals or humans, it may reach the foetus and was found in milk. As a consequence, administration of propylene glycol to pregnant or lactating patients should be considered on a case by case basis.
Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction.
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