ETOMIDATE

Posology In all patients, the dosage should be adjusted according to the individual response and the clinical effect. 15 ml of Etomidate 2 mg/ml per kg body weight. Therefore, in an adult patient one ampoule usually suffices for a sleep duration of 4-5 min.

Hypnosis can be prolonged by additional injections of Etomidate 2 mg/ml. Do not exceed the total amount of 3 ampoules (30 ml). Paediatric population In children under 15 years the dosage may need to be increased: a supplementary dose of up to 30% of the normal dose for adults is sometimes necessary to obtain the same depth and duration of sleep as obtained in adults.

4). Other special patient groups In patients with liver cirrhosis or those who have already received neuroleptic, opiate or sedative medication, the dose of etomidate should be reduced. Method of administration Intravenous use Etomidate 2 mg/ml must be injected strictly intravenously and slowly, usually over approximately 30 seconds, in fractions if required.

Intra-arterial injection must be avoided. Paravenous injection causes severe local pain. 1). g. 1). The product must only be used by physicians trained in endotracheal intubation. 4).

Like most general anaesthetics, etomidate may affect respiratory and vascular functions. Like some other general anaesthetics, etomidate may cause involuntary muscle movements. Besides this, etomidate frequently affects adrenocortical functions.

Undesirable effects are listed according to their frequencies as follows:

Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (frequency cannot be estimated from the available data) Adverse Drug Reactions Frequency Category System Organ Class Very Commo n (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Not Known (cannot be estimated from the available data) Immune System Disorders Hypersensitivity1 (such as anaphylactic shock, anaphylactic reaction, anaphylactoid reaction) Endocrine Disorders Cortisol decreased Adrenal insufficiency Nervous System Disorders Dyskinesia Myoclonus Hypertonia, Muscle contractions involuntary, Nystagmus, Shivering Convulsion (including grand mal convulsion) Cardiac Disorders Bradycardia, Extrasystoles, Ventricular extrasystoles Cardiac arrest, Atrioventricular block complete Vascular Disorders Hypotension Hypertension Shock Respiratory, Thoracic and Mediastinal Disorders Apnoea2, Hyperventilati on, Stridor Hypoventilation, Hiccups, Cough Laryngospasm Respiratory depression2, Bronchospasm (including fatal outcome) Gastrointestinal Disorders Vomiting, Nausea Salivary hypersecretion Skin and Subcutaneous Tissue Disorders Rash Erythema Stevens-Johnson syndrome, Urticaria Musculoskeletal and Connective Tissue Disorders Muscle rigidity Trismus General Disorders and Administration Site Conditions Injection site pain Injury, Poisoning and Procedural Complications Anaesthetic complication, Delayed recovery from anaesthesia, Inadequate analgesia, Procedural nausea 1) After administration of etomidate, release of histamine has been noted.

Special warnings An injection of Etomidate 2 mg/ml should only be administered intravenously. Induction with Etomidate 2 mg/ml 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. g. ). 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.

1). 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. 8). 1). 2). Myoclonus and local pain on injection, which is usually mild, is observed during the administration of Etomidate 2 mg/ml especially when it is injected undiluted into a small vein.

g. fentanyl, 1 to 2 minutes before induction. To minimise the risk of local pain, larger veins should be used. 2). In animal experiments, Etomidate 2 mg/ml 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.

8). Neonates and infants up to the age of 6 months should be excluded from treatment with Etomidate 2 mg/ml except for imperative indications during in-patient treatment.