Etomidate Lipuro

/ Lapidot

The dosage is adjusted according to the individual response and the clinical effect.
The following dosage guidelines should be followed:
As a rule, the effective hypnotic dose is between 0.15 and 0.3 mg of etomidate per kg body weight, corresponding to 0.075 to 0.15 ml of etomidate per kg body weight.
Children up to the age of 15 and elderly patients are given a single dose of 0.15 to 0.2 mg of etomidate, corresponding to 0.075 to 0.1 ml of etomidate per kg body weight. Also, in patients belonging to these age groups, the exact dosage has to be adjusted according to the clinical effect. In children up to the age of 15 the dosage may be increased by up to 30 % of the adult dose because it is sometimes necessary in order to obtain the same depth and duration of sleep.
Since etomidate has no analgesic action, appropriate analgesics should be used in procedures involving painful stimuli.
Do not exceed a total dose of 30 ml (3 ampoules). Etomidate should only be given by slow intravenous injection.
In patients with liver cirrhosis and patients having been premedicated with neuroleptics opioids or sedatives the dose has to be reduced.
In the special case of narcosis to terminate a status epilepticus or serial epileptic seizures a sufficient dose of etomidate (0.3 mg/kg body weight, corresponding to 0.15 ml/kg body weight of etomidate) should be injected quickly, i. e. within 10 sec. This dose may be repeated several times, if required.
Method of administration
Etomidate must be injected strictly intravenously and, as a rule, slowly (a single dose in approx. 30 sec), and fractionated, if required.
Intra-arterial injection must be avoided as there is a danger of etomidate to cause necroses if injected intra-arterially. Paravenous injection will cause strong pain.
Prior to administration of etomidate appropriate premedication should be given in order to avoid the occurrence of myocloni. The use of benzodiazepines is recommended, e. g. diazepam which may be injected intramuscularly about 1 hour or intravenously 10 min. prior to administration of etomidate.
In patients with manifest epilepsy or with an increased tendency to convulsions, Etomidate should be injected quickly, i. e. within a few seconds, in order to avoid too slow diffusion of etomidate into the brain. The good bioavailability of etomidate and its rapid distribution within the brain prevent activation of convulsions.

Induction of general anesthesia.
Notice: For short-term narcosis, Etomidate-®Lipuro must be combined with an analgesic drug.

* Hypersensitivity to etomidate, soya, peanut or to any of the excipients.
* Neonates and infants up to the age of 6 months should be excluded from treatment with etomidate except for imperative indications during in-patient treatment.

Induction with etomidate 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.
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. These movements have been ascribed to subcortical disinhibition. 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.
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 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.
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 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.
Etomidate may be used only by a doctor skilled in endotracheal intubation.
When etomidate is used, resuscitation equipment should be readily available to manage respiratory depression and the possibility of apnoea.

Very common: Cortisol decreased, dyskinesia,
Common: Myoclonus, hypotension, apnoea, hyperventilation, stridor, vomiting, nausea, rash.
See prescribing information for full details.

The hypnotic effect of etomidate may be enhanced by:
• neuroleptic drugs
• opioids
• sedatives
• alcohol.
Induction with etomidate may be accompanied by a slight and transient reduction in peripheral resistance which may enhance the effect of other drugs reducing blood pressure.
Alfentanil: Co-administration of etomidate with alfentanil has been reported to decrease the terminal half-life of etomidate to approximately 29 minutes. Caution should be used when both drugs are administered together as the concentrations of etomidate may drop below the hypnotic threshold.
Fentanyl: The total plasma clearance and volume of distribution of etomidate is decreased by a factor of 2 to 3 without a change in half-life when administered with fentanyl intravenously. When etomidate is co-administered with fentanyl intravenously, the dose may need to be reduced.
Ketamine: Co-administration of etomidate and ketamine appears to have no significant effect on the plasma concentrations or pharmacokinetic parameters of ketamine or its principal metabolite, norketamine.
Adrenergic neurone blockers, alpha blockers: Combination with general anaesthetics leads to an enhancement of the hypotensive effect of these substances.
Calcium channel blockers (Verapamil, Diltiazem): Combination with general anaesthetics results in an enhancement of the hypotensive effect and also AV delay.
Monoamine oxidase inhibitors (MAOI): Because of hazardous interactions between general anaesthetics and MAOIs, MAOIs should normally be stopped 2 weeks before surgery.

Pregnancy: Safety of the use during pregnancy has not been established.
Etomidate should be used during pregnancy only if the potential benefit justifies the risks to the foetus.
During obstetric anaesthesia, etomidate may cross the placenta. The Apgar scores of the newborns whose mothers have received etomidate are comparable with those of infants born after the use of other hypnotic agents.
A transient fall in cortisol levels lasting about 6 hours was observed in the neonate after the mother was given etomidate. The decreased values remained within the normal range.
Lactation: Etomidate is excreted into breastmilk. Caution should be exercised when etomidate is administered to a nursing mother.
If etomidate must be given during the lactation period, nursing is to be interrupted and not to be resumed before 24 hours after administration; breastmilk secreted during this period must be discarded.

An overdose of etomidate, administered as a bolus, deepens sleep and may cause respiratory depression and even respiratory arrest, in which case adequate respiratory support is mandatory.
Hypotension has also been observed in such cases.
Overdosage may depress cortical secretion. This may be associated with disorientation and delayed awakening.
Treatment
Treatment depends on the nature and severity of the symptoms, including, if necessary, respiratory support.
In addition to supportive measures (e.g. of respiration) administration of 50-100 mg hydrocortisone (not ACTH) may be required.
All equipment and medication usually required in general anaesthetic procedures should be available.

Store below 25°C.
Keep ampoules in the outer carton in order to protect from light.
After first opening: To be used immediately.