Special Warning : אזהרת שימוש

4.4    Special warnings and precautions for use
Special warnings

An injection of Etomidate-Lipuro should only be administered intravenously.
Induction with Etomidate-Lipuro may be accompanied by a slight and transient drop in blood pressure due to a reduction of the peripheral vascular resistance (especially after previous administration of droperidol). In debilitated patients in whom hypotension may be hazardous, the following measures should be taken: 1. Before induction, intravenous access should be obtained for the management of circulatory blood volume.
2. Other inducing agents should be avoided to the extent possible.
3. The induction should be carried out with the patient supine.
4. The drug should be injected slowly (e.g. 10 ml in 1 min.).

Etomidate inhibits the adrenocortical biosynthesis of steroids. Single induction doses of etomidate can lead to transient adrenal insufficiency and decreased serum cortisol and aldosterone levels, unresponsive to ACTH administration. When etomidate is used for induction, the postoperative rise of serum cortisol observed after thiopentone induction is delayed for approximately 3 – 6 hours (see section 5.1).

Where concern exists for patients undergoing severe stress, particularly those with adrenocortical dysfunction, supplementation with exogenous cortisol (e.g. 50 – 100 mg hydrocortisone) should be considered. In such situations stimulation of the adrenal gland with ACTH is not useful.

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 etomidate for maintenance of anaesthesia should therefore be avoided. In such situations stimulation of the adrenal gland with ACTH is not useful.

Etomidate should be used with caution in critically-ill patients, including patients with sepsis.

In patients with liver cirrhosis, or in those who have already received neuroleptic, opiate, or sedative agents, the dose of etomidate should be reduced.

Spontaneous movements may occur in one or more groups of muscles, particularly when no premedication has been administered (see also section 4.8). These movements have been ascribed to subcortical disinhibition (see section 5.1). They can be largely prevented by the intravenous administration of small doses of fentanyl, with droperidol or diazepam 1-2 min before induction with Etomidate- Lipuro (see also section 4.2).

Myoclonus and local pain on injection, which is usually mild, is observed during the administration of Etomidate-Lipuro especially when it is injected undiluted 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. To minimise the risk of local pain, larger veins should be used.
Etomidate-Lipuro 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).

In animal experiments, Etomidate-Lipuro has been shown to possess a porphyrogenic potential. Therefore it should not be administered to patients with hereditary disorder of haem biosynthesis, unless there is no safer alternative.

Precautions for use

Since Etomidate-Lipuro has no analgesic action, appropriate analgesics should be used during surgical procedures. If used for short-term narcosis, a strong analgesic, e. g. fentanyl, must be given prior to or simultaneously with Etomidate-Lipuro ).
Attention should be paid also to instructions given in sections 4.5 and 6.6.

Etomidate-Lipuro may be used only by a doctor skilled in endotracheal intubation.

When Etomidate-Lipuro is used, resuscitation equipment should be readily available to manage respiratory depression and the possibility of apnoea.

Etomidate-Lipuro contains less than 1 mmol (23 mg) sodium (as sodium oleate) per ampoule, i.e. it is essentially sodium-free.

Effects on Driving

4.7    Effects on ability to drive and use machines

Etomidate has a major influence on the ability to drive and use machines.
It is not recommended to use potentially dangerous machines or to drive a car during the first 24 hours after administration.
The return of normal alertness may vary according to the duration of the operation, the total dose of etomidate administered and concomitant medication used. Hence, a decision to allow for driving or operating machinery must be a judgment made by the post-anaesthesiology treatment team.