Etomidate Lipuro

/ Lapidot

The dosage is adjusted acc. 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-
®Lipuro 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-
®Lipuro per kg body weight. Also in patients belonging to these age groups,
the exact dosage has to be adjusted acc. 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-®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 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-
®Lipuro to cause necroses if injected intra-arterially. 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. 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-®Lipuro.
In patients with manifest epilepsy or with an increased tendency to convulsions,
Etomidate-®Lipuro 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.
Notice: Etomidate-®Lipuro does not contain antimicrobial preservatives. Immediately after opening of the ampoule, the emulsion has to be drawn up in a
syringe under aseptic conditions and injected, because fat emulsions promote
microbial growth. Unused portions must be discarded.
Ampoules should be shaken prior to use to ensure homo genous distribution.

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

Etomidate-®Lipuro must not be administered to patients with known hypersensitivity to etomidate or fat emulsions.
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 hembiosynthesis, unless the indication for administration of etomidate has been definitely established after careful consideration of its potential risks and expected benefits.
Newborns and infants up to the age of 6 months should be excluded from treatment with Etomidate-®Lipuro except for imperative indications during inpatient treatment. Pregnancy.

Etomidate should not be administered to patients with evidence, or suggestion
of, reduced adrenocortical function.
Reduced serum cortisol levels, unresponsive to ACTH injections, have been
reported in some patients during induction of anaesthesia but particularly
during maintenance of anaesthesia with etomidate; for this reason etomidate
should not be used for maintenance. 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.
In cases of adrenocortical gland dysfunction and during very long surgical
procedures, a prophylactic cortisol supplement may be required (for example
50 to 100 mg hydrocortisone). After prolonged continuous administration of
etomidate there is a risk of transient adrenocortical failure. Convulsions may
occur in unpremedicated patients. In patients with liver cirrhosis, or in those
who have already received neuroleptic, opiate or sedative agents, the dose
of etomidate should be reduced.
When Etomidate is used, resuscitation equipment should be readily available
to manage apnoea.
Etomidate should only be given by slow intravenous injection.
Etomidate-®Lipuro may be used only by a doctor skilled in endotracheal
intubation with equipment for mechanical ventilation available.
Etomidate-®Lipuro has no analgesic effect. If used for short-term narcosis,
a strong analgesic, e. g. fentanyl, must be given prior to or simultaneously
with Etomidate ®Lipuro.

Etomidate inhibits the adrenocortical biosynthesis of steroids. After a single
dose of etomidate the adrenocor tical response to stressors is markedly reduced for approx. 4−6 hours.
After a single dose of etomidate, in unpremedicated patients, unvoluntary
muscle movements (myocloni) are frequently observable. They correspond to
the disinhibition of diencephalic excitations, similar to hypnogenic myocloni
during physiological sleep. They can be prevented by premedication with
opioids or benzodiaze pines 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 shiver ing.
Rarely, after administration of etomidate, release of histamine has been
noted. Serious effects have been reported so far in 3 cases only. Yet, etomidate
is the fi rst-choice drug for patients with a history of allergy.
There are isolated reports about the occurrence of laryn gospasm after
etomidate.
A slight and transient drop in blood pressure may occur due to a reduction
of the peripheral vascular resistance. In vulnerable patients, special care
should be exercised to minimise this effect.
Respiratory depression may occur. Pain can occur after injection into the
small veins of the dorsum of the hand. Use of larger veins or an intravenous
application of a small dose of fentanyl 1 to 2 minutes before induction
reduces pain on injection.
Notice: Especially after administration of higher doses of etomi date and if combined with central depressant drugs, transient apnoea may occasionally occur.

The hypnotic effect of etomidate is enhanced by neuro leptics, opioids, sedatives, and alcohol.
Etomidate-®Lipuro must not be mixed with other injec tion solutions without
having previously been tested for compatibility. Furthermore, Etomidate-
®Lipuro must not be admini stered simultaneously with other injection solutions
through the same line, unless compatibility has been established.
Drugs to be given concurrently, e. g. an anal gesic, must therefore be administered consecutively through the same line or through separate venous
cannulae.
Etomidate-®Lipuro may be injected into the tubing of an infusion of isotonic
sodium chloride having temporarily been stopped.

Pregnancy: Safety of the use of Etomidate-®Lipuro during pregnancy has not been established. Therefore, Etomidate-®Lipuro should be administered to pregnant women only exceptionally if there is no alternative.
Lactation: Etomidate is secreted into breastmilk. If Etomidate -®Lipuro 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.

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 available.