Post on 03-Jun-2018
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Injectable Drugs
Etomidate-Lipuro 2 mg/ml
An IV hypnotic with outstanding local and systemic tolerance Lipuro-Technology by B.Braun
B.Braun Melsungen AG | Hospital Care | 34209 Melsungen | Germany
Tel. +49 5661 71-0 | www.bbraun.com X. 00.00.00/0 Nr. 000 0000A
Literature1Altmayer P., Grundmann U., Ziehmer M., Larsen R.; Comparative Study on Bioavailability and Side Effects of a New Galenic Formulation of Etomidate; Ansthesiol.
Intensivmed. Nofallmed. Schmerzther. 1993, 28: 415-4192A. Doenicke, A. Kugler, N. Vollmann, H. Suttmann, K. Taeger: Etomidat with a new solubilizer Clinical and experimental investigations on venous tolerance and
bioavailability. Anaesthesist 39, 475480 (1990)3Doenicke A., Nebauer A.E., Hoernecke R., Mayer M., Roizen M.F.; Osmolalities of Propylene Glycol-Containing Drug Formulations for Parenteral Use. Should Propylene
Glycol Be Used as a Solvent? Anesth Analg 1992, 75: 431-54St. Pierre M., Dunkel, M., Rutherford A., Hering W.; Does etomidate increase postoperative nausea? A double-blind controlled comparison of etomidate in lipid emulsi
on with propofol for balanced anaesthesia. Eur J Anaesthesiol 2000, 17(10) : 634-41.5Thiemicke J., Doenicke A., Mckter H., Hoernicke R., Soukup J.; Influence of S(+) ketamine on endocrine and cardiovascular reaction during total intravenous anaesthesia
with etomidate and propofol; Ansthesiologie & Intensivmedizin 2002, 43: 584-592.
ProductTotal
Volume
Container
Type
Sales
Unit
Etomidate-Lipuro2 mg/ml
20 mg/10 ml
GlassAmpoule
10 x 10 ml
Etomidate-Lipuro
Composition1 ml emulsion for injection contains 2 mg of etomidate
Excipients: Soya-bean oil, medium-chain triglycerides,glycerol, egg lecithin, sodium oleate, water for injections.
IndicationsInduction of general anaesthesia
Contraindications- Hypersensitivity to etomidate, soya, peanut or to any
other ingredient of the medicinal product- Neonates and infants up to the age of 6 months
should be excluded from treatment withEtomidate-Lipuro 2 mg/ml except for imperativeindications during in-patient treatment
Special warnings and precautionsEtomidate-Lipuro 2 mg/ml has no analgesic effect. If used forshort-term narcosis, a strong analgesic, e. g. fentanyl, must begiven prior to or simultaneously with Etomidate-Lipuro 2 mg/ml;attention must be paid also to drug interactions.Etomidate-Lipuro 2 mg/ml may be used only by a doctorskilled in endotracheal intubation with equipment for artificialrespiration available.Even when Etomidate-Lipuro 2 mg/ml is used as directed, patientshaving received this medicinal product will not be able to drive orto use machines for at least 24 hours after administration.
Undesirable effectsLike most general anaesthetics, etomidate may affect respiratory andvascular functions. The effects of etomidate on cardiac functions are
rare and usually mild. Like some other general anaesthetics, etomidatemay cause involuntary muscle movements. Besides this, etomidatefrequently affects adrenocortical functions.Immunesystem disorders
Very rare: Allergic reactions; of varying severity including systemic ana-phylactic reactions up to shock. After administration of etomidate, re-lease of histamine has been noted. Etomidate-Lipuro 2 mg/ml containssoya-bean oil, which may very rarely cause severe allergic reactions.Endocrinedisorders
Very common: Etomidate inhibits the adrenocortical biosynthesis ofsteroids. After a single dose of etomidate the adrenocortical responseto stressors is markedly reduced for approx. 3 6 hours.Nervous system disorders
Very common: After a single dose of etomidate, especially in unpreme-dicated patients, myoclonus is observable. It can be prevented by pre-medication with opioids or benzodiazepines.Uncommon: Shivering
Very rare: ConvulsionsCardiac disordersRare: Cardiac arrhythmiaVasculardisordersCommon: A drop in blood pressure may occur due to a reduction ofthe peripheral vascular resistance.Respiratory, thoracic andmediastinal disordersCommon: Respiratory depression and apnoea may occur especiallyafter administration of higher doses of etomidate in combination with
central depressant drugs. In patients of 55 years of age or older,respiratory depression and apnoea may occur especially after dosesexceeding the recommended maximum dose of 0.2 mg of etomidate
per kg body weight.Rare: Coughing, laryngospasmGastrointestinal disordersCommon: After administration of etomidate, nausea and vomitingmay occur, which are, however, more likely to be caused by opioidsgiven simultaneously or as premedication.Rare: HiccupsGeneral disorders andadministration siteconditionsCommon: Local pain during injection, which is usually mild and occursmainly when the drug is injected undiluted into small veins withoutprevious administration of an analgesic (e.g. fentanyl). To minimise therisk of local pain, larger veins should be used.
For prescription only!
Version 06/2011ManufacturerB.Braun Melsungen AG34209 Melsungen, Germany
See local Prescribing Information for full details, as PrescribingInformation may vary from country to country.
Indication: Induction of general anaesthesia
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Etomidate-Lipuro State of the Art
During its more than 40 years of clinical use, etomidate has beenthe induction anesthetic of choice. It is especially favourable in
high-riskpatients with cardiovascular instability, and emergencysituations where the medical history of the patient is unknown.
Previously known side effects like injection pain or vein irritation
have been eliminated by the latest generation etomidate.Now Etomidate-Lipuro is an even better choice for you and your
patients.
Etomidate-Lipuro 2 mg/ml No pain on injection
Well-established in clinical use Etomidate-Lipuro is a non-barbiturate hypnotic licensed
for IV induction of general anesthesia, and as a short-acting anesthetic in combination with an analgesic. Etomidate-Lipuro offers a broad therapeutic spectrum, causes
minimal cardiovascular complications. Therefore, it is favorable
for patients with hemodynamic instability or cardiac ischemia
or for emergency patients with unknown medical history and risks. Etomidate-Lipuro leads to a decrease in serum cortisol levels
within 3-6 hours. This effect is without clinical relevance as
the cortisol level stays within the normal range.5
Lipuro inside
The innovative Etomidate-Lipuro is based on the original B. Braun
Lipuro-Technology, which uses an MCT/LCT lipid emulsion as thedrug carrier system for the sedative agent etomidate. Nausea
Compared to propofol in a long-chain triglyceride (LCT) emulsion,Etomidate-(R)Lipuro does not increase the incidence of nausea
during the early postoperative phase.
Excellent venous tolerance
Etomidate-Lipuro contains no irritating solvents. Instead, it isformulated in the oil phase of a lipid emulsion. Formulations
containing medium- and long-chain triglycerides (MCT/LCT) are
well established in clinical practice and have been used in pa-
renteral nutrition for years.Etomidate-Lipuro has an osmolarity of only 390 mOsmol/l
compared to the 4900 mOsmol/l3of the etomidate formulated in
propylene glycol. Thanks to its low osmolarity, Etomidate-Lipuro
does not cause injection pain, vein irritation or sequelae such
as thrombophlebitis.
User benefits:
No pain on injection
No thrombophlebitis
Minimal cardiovascular effects
Ready-to-use: No pre-dissolvingor dilution necessary
Patients(%)
25
20
15
10
5
R ep ul si ng m ove me nt s S po nt an eo us c omp la int s
Injection pain n= 232
0% 10% 0% 23.4%
Etomidate-Lipuro does not cause injection pain.1
Patients(%)
16
14
12
10
18
20
8
6
4
2
0
Phlebitis Thrombosis
1 day postoperative 7 days postoperative
Phlebitis Thrombosis Thrombo-
phlebitis
Venous reactions n= 100
0% 0% 0% 0% 0%6.4%19.1% 4.3% 10.6% 8.6%
Etomidate-Lipuro reduces the risk of phlebitis, thrombosis and
thrombophlebitis.2
Etomidate-Lipuro
Etomidate propylene glycol
Patients(%
)
30
25
20
15
10
male female
Postoperative nausea n= 164
14.6% 14.2% 0% 23.4%
Etomidate Lipuro dos not increase the incidence of nausea.4
Etomidate-Lipuro Propofol LCT
Etomidate-Lipuro
Etomidate propylene glycol