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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