Etomidate-Lipuro

Etomidate.

10 ml emulsion contains: Etomidate 20 mg.
Excipients/Inactive Ingredients: Soya oil, medium-chain triglycerides, glycerol, egg lecithin, sodium oleate, water for injections.

Pharmaco-therapeutic group: General anaesthetic.

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

The dosage is adjusted acc. to the individual response and the clinical effect.
Unless directed otherwise, the following dosage guidelines should be followed: As a rule, the safe hypnotic dose is between 0.15 and 0.3 mg of etomidate per kg B.W., corresponding to 0.075 to 0.15 ml of Etomidate-Lipuro per kg B.W.
Children up to 15 years old and elderly patients receive a single dose of 0.15 to 0.2 mg of etomidate, corresponding to 0.075 to 0.1 ml of Etomidate-Lipuro per kg B.W. Also in patients belonging to these age groups, the exact dosage is to be adjusted acc. to the clinical effect.
In patients with liver cirrhosis and patients having previously received neuroleptics the dose must be reduced.
In the special case of narcosis for interruption of a status epilepticus or serial epileptic seizures a sufficiently high dose of etomidate (0.3 mg/kg B.W., corresponding to 0.15 ml of Etomidate-Lipuro) should be injected quickly, i.e. within 10 sec. This dose may be repeated several times, if required.
Method and route of administration: Etomidate-Lipuro must exclusively be injected i.v. and, as a rule, slowly (injection time for a single dose: approx. 30 sec), divided in several portions, if required.
Intra-arterial injection must be avoided as there is a danger of Etomidate-Lipuro to cause necroses if injected i.a. Paravenous injection will cause strong pain.
Prior to administration of Etomidate-Lipuro appropriate premedication should be given in order to avoid the occurrence of myocloni. It is recommended to give a benzodiazepine, e.g. a diazepam injection which may be injected i.m. about 1 hour or i.v. 10 min. prior to administration of Etomidate-Lipuro.
In patients with manifest epilepsy or with an increased tendency to convulsions, injection of Etomidate-Lipuro must be performed quickly, i.e. within a few seconds, in order to avoid too slow diffusion of etomidate into the brain. Thus due to the good bioavailability of etomidate and its rapid distribution within the brain activation of convulsions is prevented.
Notice: Etomidate-Lipuro does not contain antimicrobial preservatives. Immediately after opening of the ampoule, the emulsion is to be drawn up under aseptic conditions and injected, because fat emulsions promote the growth of microorganisms. Unused portions must be discarded.
Ampoules should be shaken prior to use to ensure homogenous distribution.

In cases of overdosage, especially if etomidate is combined with inhalation narcotics, the sleeping period may be extended and short periods of apnoea may occur.
When using Etomidate-Lipuro, all equipment and medicaments usually required in general anaesthetic procedures should be made available.

Etomidate-Lipuro must not be administered to patients with known hypersensitivity to etomidate or fat emulsions.
New-borns and infants up to 6 months old should be excluded from treatment with Etomidate-Lipuro with the only exception that those patients are hospitalised and there is no alternative.

Effects on the ability to drive or to use machines: Even when Etomidate-Lipuro is used as directed, patients having received this drug will not be able to drive or to use machines for at least 24 hours after administration.

Etomidate-Lipuro has been shown to be porphyrogenic in animal experiments and should therefore not be administered to patients with impaired biosynthesis of heme, unless the indication for administration of etomidate has been definitely established.
Etomidate-Lipuro may be used only by a doctor trained in endotracheal intubation and if equipment for artificial respiration is available.
Etomidate-Lipuro does not have analgesic efficacy. If used for short-term narcosis, a strong analgesic, e.g. fentanyl, must be given prior to or simultaneously with Etomidate-Lipuro; attention must be paid also to further information given under Interactions.
Use in Pregnancy and Lactation: Safety of the use of Etomidate-Lipuro during pregnancy has not been established. Therefore, Etomidate-Lipuro should be administered to pregnant women only exceptionally and if there is no alternative.
Etomidate is secreted into breast milk. If Etomidate-Lipuro must be given during the lactation period, nursing must be interrupted and not resumed before 24 hours after administration; breast milk secreted during this period must be discarded.

Etomidate inhibits the adrenocortical biosynthesis of steroids. After a single dose of etomidate the response of the adrenal cortex to stressors is markedly reduced for approx. 4-6 hours.
After prolonged continuous administration of etomidate there is a risk of transient adrenocortical insufficiency.
After a single dose of etomidate, in patients not having received appropriate premedication, myocloni are frequently observable. Such myocloni, like hypnogenic myocloni, correspond to the disinhibition of diencephalic excitations. This can be prevented by administration of opioids or benzodiazepines prior to the administration of etomidate.
Occasionally, after administration of etomidate, nausea and vomiting are observable, which are, however, caused predominantly by opioids given simultaneously or as premedication, further coughing, singultus, and shivering.
Rarely, after etomidate, liberation of histamine has been noted. Very rarely, severe effects have been reported (3 documented cases). Yet, etomidate is the first-choice drug for patients with a history of allergy.
There are sporadic reports about the occurrence of laryngospasm after etomidate.
Notice: Especially after administration of higher doses of etomidate and if combined with C.N.S. depressant drugs, apnoea of short duration may occasionally occur.

The hypnotic effect of etomidate is enhanced by neuroleptics, opioids, sedatives, and alcohol.
Etomidate-Lipuro must not be mixed with other injection solutions without having previously been tested for compatibility.
Furthermore, Etomidate-Lipuro must not be administered simultaneously with other injection solutions through the same line, unless compatibility has been established. Drugs to be given concurrently, e.g. an analgesic, must therefore be administered consecutively through the same line or simultaneously through separate lines.
Etomidate-Lipuro may be injected into the piping of an infusion of isotonic sodium chloride having been transiently interrupted.

Protect from light. Do not store above 25°C.

Anaesthetics - Local & General

N01AX07 - etomidate ; Belongs to the class of other general anesthetics.

P₁S₁S₃