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TOMVI is a brand name for Etomidate, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TOMVI™ is indicated for use in health care settings by appropriately trained health care providers in the fields of emergency medicine or anesthesia for: The induction of general anesthesia The supplementation of subpotent anesthetic agents during anesthesia for short operative procedures such as dilation and…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Dosage and rate of administration should be individualized and titrated to the desired effect according to clinically relevant factors including pre-induction and concomitant medications, age, ASA status and level of debilitation of the patient.
In heavily premedicated patients, both the induction and maintenance doses should be reduced. Since TOMVI™ has no analgesic action, appropriate analgesics should be used in procedures involving painful stimuli. Convulsions may occur in unpremedicated patients.
4 mg/kg of bodyweight, and must be individualized in each case. 3 mg/kg, injected over a period of 30 to 60 seconds. Geriatric patients may require reduced doses. Do not exceed a total dose of 30 mL. TOMVI™ Product Monograph Page 6 of 29 Smaller increments of intravenous TOMVI™ may be administered to adult patients during short operative procedures to supplement subpotent anesthetic agents, such as nitrous oxide.
The dosage employed under these circumstances, although usually lower than the original induction dose, must be individualized. There are insufficient data to support the use of TOMVI™ for longer procedures, therefore, such use is not recommended.
The use of intravenous fentanyl and other neuroactive drugs employed during the conduct of anesthesia may alter the TOMVI™ dosage requirements. Consult the prescribing information for all other such drugs before using. In patients who have already received neuroleptic, opiate or sedative agents, the dose of TOMVI™ may need to be reduced and titrated to effect.
Geriatrics (≥65 years of age) TOMVI™ should be used with caution in geriatric patients, since the potential exists for decreases in cardiac output, which have been reported with doses greater than recommended. 2 mg/kg of bodyweight should be given and the dose should be further adjusted according to the individual patient response and to clinical effects.
Pediatrics (<18 years) Health Canada has not authorized an indication for pediatric use. 3 Administration TOMVI™ is for intravenous use. g. 10 mL over 30 to 60 seconds). TOMVI™ may be diluted with sodium chloride infusion or dextrose infusions, but is NOT compatible with sodium lactate infusion (Hartmann’s solution).
Combinations with pancuronium bromide may show a very slight opalescence; for this reason, the two should not be mixed together. Do not use product if solution shows haziness, particulate matter, discolouration, or leakage. 4 Reconstitution No dilution is necessary before use.
1 Adverse Reaction Overview The most frequent adverse events that occurred in patients who received etomidate for induction included muscle movements (myoclonus), pain on injection, nausea and vomiting. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. A double-blind randomized controlled trial in the United Kingdom enrolled 100 adult patients (65 male, 35 female) scheduled for outpatient cystoscopy.
5 mg/kg methohexitone for the procedure with the anesthetist blinded to the drug administered. Adverse events for this study are listed in Table 2. Anesthesia was maintained with 1% halothane in 66% nitrous oxide and oxygen. Table 2 - Adverse events in patients undergoing cystoscopy Etomidate n = 50 (%) Methohexitone n = 50 (%) General disorders and administration site conditions Injection site pain 2 (4) 3 (6) Nervous system disorders Myoclonus 11 (22) 0 Respiratory disorders Apnea 0 0 TOMVI™ Product Monograph Page 12 of 29 Cough 2 (4) 9 (18) Note: Causality of adverse events was not reported.
A double-blind randomized controlled trial conducted in Canada enrolled 48 patients undergoing minor gynaecological procedures. 3 mg/kg etomidate or 75 mcL/kg alfathesin as intravenous induction agents. Adverse events for this study are listed in Table 3.
Additional increments of etomidate or alfathesin were injected at 25% of induction dose if patients moved in response to surgical stimulus. Table 3 - Adverse events in patients undergoing minor gynaecological operations Etomidate n = 24 (%) Alfathesin n = 24 (%) Gastrointestinal disorders Nausea and/or vomiting 9 (38) 2 (8) General disorders and administration site conditions Injection site pain 10 (42) 0 Nervous system disorders Dyskinesia 12 (50) 6 (25) Respiratory disorders Apnea 5 (21) 9 (38) Note: Causality of adverse events was not reported.
Please see the Serious Warnings and Precautions Box at the beginning of Part I:
Health Professional Information. General For use in induction or supplementation of anesthesia for surgical/diagnostic procedures, TOMVI™ should only be administered by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedures.
Patients should be continuously monitored and facilities for maintenance of a patent airway, artificial ventilation, and oxygen enrichment and circulatory resuscitation must be immediately available. Because of the hazards of prolonged suppression of endogenous cortisol and aldosterone production, this formulation is not intended for administration by prolonged infusion (see Endocrine and Metabolism, ADVERSE REACTIONS, Abnormal Laboratory Findings).
Transient venous pain on injection may be observed during the administration of etomidate, especially when it is injected into a small vein. The observation of venous pain does not seem to be associated with a higher incidence of thrombosis or thrombophlebitis at the injection site.
g. For management of a suspected drug overdose, contact your regional poison control centre. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous 2 mg/mL etomidate solution Propylene glycol 35% v/v and Water for Injection TOMVI™ Product Monograph Page 8 of 29 fentanyl, 1 to 2 minutes before induction.
Driving and Operating Machinery TOMVI™ has a major influence on the ability to drive and use machines. Even though a patient may regain normal alertness 30 to 60 minutes after awakening, it is recommended that patients do not drive or use machines for at least 24 hours after administration of TOMVI™.
Cardiovascular Hypertension, hypotension, tachycardia, bradycardia and other arrhythmias have occasionally been observed during induction and maintenance of anesthesia. Induction with TOMVI™ may be accompanied with a slight and transient drop in blood pressure due to a reduction of the peripheral vascular resistance.
TOMVI™ is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
TOMVI™ is contraindicated when sedation or general anesthesia are contraindicated. 1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Pain on injection was seen in 10 patients, all of whom received etomidate. This was more frequent in patients receiving etomidate into a hand vein (57%) versus an arm vein (20%) but this difference was not statistically significant.
3 seconds). Involuntary movements occurred more frequently following etomidate than alfathesin. Respiratory disturbances comprising hiccough, coughing, and mild laryngospasm occurred with similar incidence in both groups. In the recovery room, nine patients (38%) vomited after etomidate compared to two (8%) after alfathesin.
After discharge from hospital, the two groups were comparable in terms of vomiting (etomidate: 16%, alfathesin: 6%) and drowsiness (etomidate: 58%, alfathesin: 39%). A double-blind randomized controlled trial in China enrolled 240 female patients undergoing surgical TOMVI™ Product Monograph Page 13 of 29 abortion.
02 mg/kg midazolam (PFM; N=40 each). 2 mg/kg etomidate (group dependent) was administered. Adverse events are listed in Table 4. 5) E=etomidate; EF=etomidate and fentanyl; EFM=etomidate, fentanyl, and midazolam; P=propofol; PF= propofol and fentanyl; PFM= propofol, fentanyl, and midazolam There was a significant difference in the incidence of injection-induced pain in the propofol groups and the etomidate groups.
5%, 60% and 80%), complained of injection-induced pain vs. 5%). There were no significant differences in pain levels amongst the three groups of propofol or etomidate. Myoclonus and postoperative nausea and vomiting were lower in the propofol groups than in the etomidate groups.
5%), recorded myoclonus vs. 5%). 5% and 0%), recorded nausea and vomiting vs. 5%). There were no significant differences in incidence of myoclonus and postoperative nausea and vomiting amongst the three propofol groups. 5%) and EF (60% and 50%).
Data from 4 open label clinical trials of etomidate provided safety information on 812 subjects TOMVI™ Product Monograph Page 14 of 29 undergoing induction of general […]
Geriatric patients, in particular those with hypertension, may be at increased risk for development of cardiac depression following TOMVI™ administration. In frail geratric patients’ the potential exists for decreases in cardiac output.
Etomidate administration has been studied in patients with low ejection fraction undergoing elective coronary artery bypass graft surgery. In one randomized active controlled trial of 81 patients with ischemic left ventricular dysfunction (Ejection Fraction <40%) undergoing coronary artery bypass graft surgery with American Society of Anesthesiologists (ASA) physical status class II and III, patients were given etomidate at induction and were compared to those receiving ketofol.
Both groups had a relative decrease at induction in hemodynamic parameters (HR, BP, MAP) compared to baseline values. Endocrine and Metabolism A single induction dose of etomidate has been associated with a reduction in plasma cortisol and aldosterone concentrations (see ADVERSE REACTIONS).
For patients undergoing severe stress, particularly those with adrenocortical dysfunction, supplementation with exogenous cortisol should be considered. TOMVI™ should be used with extreme caution in patients with underlying cortico-adrenal insufficiency and in patients with critical illness, including those with sepsis, as etomidate has been associated with in increased risk of mortality in some studies in such patients (see Serious Warnings and Precautions Box at the beginning of Part I: Health Professional Information).
Prolonged suppression of endogenous cortisol and aldosterone may occur as a direct consequence of TOMVI™ when given by continuous infusion or in repeated doses. Use of TOMVI™ for maintenance of anesthesia should therefore be avoided.
In such situations, stimulation of the adrenal gland with adrenocorticotropic hormone (ACTH) is not useful. TOMVI™ Product Monograph Page 9 of 29 Gastrointestinal Postoperative nausea and vomiting have been reported following induction with etomidate with a large range in reported incidence (10-75%).
Patients who received etomidate combined with a benzodiazepine or propofol appeared to have a lower incidence of nausea and vomiting in several small studies. Hepatic In patients with liver cirrhosis, the dose of TOMVI™ should be reduced and titrated to effect.
Neurologic Spontaneous movements may occur in one or more groups of muscles, particularly when no premedication has been administered. These movements have been ascribed to subcortical disinhibition and are often described as myoclonic movements.
They may be largely prevented by the intravenous administration of small doses of fentanyl, with diazepam 1-2 minutes before induction with TOMVI™. In a randomized active controlled trial etomidate was compared to propofol and thiopentone for induction and sedation prior to electroconvulsive therapy.
A total of 90 patients were randomized into three groups. 0001). Etomidate induction is associated with a transient 20-30% decrease in cerebral blood flow. This reduction in blood flow appears to be uniform in the absence of intracranial space occupying lesions.
As with other intravenous induction agents, reduction in cerebral oxygen utilization is roughly proportional to the reduction in cerebral blood flow. In patients with and without intracranial space occupying lesions, etomidate induction is usually followed by a moderate lowering of intracranial pressure, lasting several minutes.
All of these studies avoided hypercapnia. Information concerning regional cerebral perfusion in patients with intracranial space occupying lesions is too limited to permit definitive conclusions. Renal […]