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HYPNOMIDATE is a brand name for Etomidate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hypnomidate is an intravenous induction agent of anaesthesia.
Verbatim from this product's MHRA label. Tap a section to expand.
For intravenous administration. Hypnomidate should be injected slowly by the intravenous route. Equipment for artificial respiration must be available. It is recommended to wear gloves while opening the ampoule. In the case of any accidental dermal exposure, rinse the affected area with water.
Avoid use of soap, alcohol and other cleaning materials that may cause chemical or physical abrasions tothe skin. 3 mg/kg bodyweight given intravenously at induction of anaesthesia,gives sleep lasting from 4 to 5 minutes. Dosage should be adjusted to the individual patient response and to clinical effects.
In children under 15 years of age the dosage may need to be increased: a supplementary doseof 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. 2 mg/kg bodyweight should be given and the dose should be furtheradjusted according to the individual patient response and to clinical effects (see Section
The safety of Hypnomidate was evaluated in 812 subjects who participated in 4 open-label clinical trials of Hypnomidate used for the induction of general anaesthesia. These subjects took at least one dose of Hypnomidate and provided safety data.
6). Including the above-mentioned ADRs, the following table displays ADRs that have been reported with the use of Hypnomidate from either clinical trial or postmarketing experiences.
The displayed frequency categories use the following convention:
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); and not known (cannot be estimatedfrom the available clinical trial data). Adverse Drug Reactions Frequency Category System Organ Class Very Common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Not Known Immune System Disorders Hypersensitivity (such as anaphylactic shock, anaphylactic reaction, anaphylactoid reaction) Endocrine Disorders Cortisol decreased Adrenal insufficiency Nervous System Disorders Dyskinesia Myoclonus Hypertonia, Muscle contractions involuntary, Nystagmus Convulsion (including grand mal convulsion) Cardiac Disorders Bradycardia, Extrasystoles, Ventricular extrasystoles Cardiac arrest, Atrioventricular block complete Vascular Disorders Vein pain, Hypotension Phlebitis, Hypertension Shock, Thrombophlebitis (including superficial thrombophlebitis and deep vein thrombosis) Respiratory, Thoracic and Mediastinal Disorders Apnoea, Hyperventilation, Stridor Hypoventilation, Hiccups, Cough Respiratory depression, 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 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
). Since Hypnomidate has no analgesic action, appropriate analgesics should be used inprocedures involving painful stimuli. Hypnosis can be prolonged by additional injections of Hypnomidate. Do not exceed a total dose of 30 ml (3 ampoules) per procedure.
Hypnomidate may be diluted with sodium chloride infusion BP or dextrose infusionBP but it is not compatible with compound sodium lactate infusion BP (Hartmann’s solution). Combinations with pancuronium bromide may show a very slightopalescence; for this reason the two should not be mixed together.
1. 4 Special warnings and precautions for use Warnings: In patients with liver cirrhosis, or in those who have already received neuroleptic, opiate or sedative agents, the dose of etomidate should be reduced. Induction with Hypnomidate may be accompanied by a slight and transient drop in blood pressure due to a reduction of the peripheral vascular resistance.
In debilitatedpatients in whom hypotension may be harmful, the following measures should be taken: 1. Keep the patient supine during induction. 2. Ensure good intravenous access to manage circulatory blood volume. 3. g. ). 4. Avoid giving other induction agents if possible.
When Hypnomidate is used, resuscitation equipment should be readily available tomanage respiratory depression and the possibility of apnoea. 1 Pharmacodynamic Properties). Where concern exists for the patients undergoing severe stress, particularly those withadrenocortical dysfunction, supplementation with exogenous cortisol should be considered.
Etomidate should be used with caution in critically ill patients, including patients with sepsis. Prolonged suppression of endogenous cortisol and aldosterone may occur as a directconsequence of etomidate when given by continuous infusion or in repeated doses.
Use of Hypnomidate for maintenance of anaesthesia should therefore be avoided. Insuch situations stimulation of the adrenal gland with adrenocorticotropic hormone (ACTH) is not useful. However, when etomidate is used for induction, the post- operative rise in serum cortisol which has been observed after thiopentone inductionis delayed for approximately 3-6 hours.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Spontaneous movements may occur in one or more groups of muscles, particularly when no premedication has been administered. These movements have been ascribedto subcortical disinhibition. They can be largely prevented by the intravenous administration of small doses of fentanyl, with diazepam 1-2 min.
before induction with Hypnomidate. Myoclonus and pain on injection, including venous pain, is observed during the administration of Hypnomidate especially when it is injected into a small vein. g. fentanyl, 1 to 2 minutes before induction.
2 Posology and Method of Administration for recommended dose in the elderly). Convulsions may occur in unpremedicated patients. g. 10 ml over 30-60 seconds). This medicine contains 3626 mg propylene glycol in 10 ml. Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old.
While propylene glycol has not been shown to cause reproductive or developmental toxicity in animals or humans, it may reach the foetus and was found in milk. As a consequence, administration of propylene glycol to pregnant or lactating patients should be considered on a case by case basis.
Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction.