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AMIDATE
Overview
What is AMIDATE?
AMIDATE (Etomidate Injection, USP) is a sterile, nonpyrogenic solution. Each milliliter contains etomidate, 2 mg, propylene glycol 35% v/v. The pH is 6.0 (4.0 to 7.0).
It is intended for the induction of general anesthesia by intravenous injection.
The drug etomidate is chemically identified as (R)-(+)-ethyl-1-(1-phenylethyl)-1H-imidazole-5-carboxylate and has the following structural formula:
What does AMIDATE look like?
What are the available doses of AMIDATE?
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What should I talk to my health care provider before I take AMIDATE?
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How should I use AMIDATE?
AMIDATE is indicated by intravenous injection for the induction of general anesthesia. When considering use of AMIDATE, the usefulness of its hemodynamic properties (see ) should be weighed against the high frequency of transient skeletal muscle movements (see ).
Intravenous AMIDATE is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.
Do not administer unless solution is clear and container is undamaged. Discard unused portion (see).
AMIDATE is intended for administration only by the intravenous route (see ). The dose for induction of anesthesia in adult patients and in pediatric patients above the age of ten (10) years will vary between 0.2 mg/kg and 0.6 mg/kg of body weight, and it must be individualized in each case. The usual dose for induction in these patients is 0.3 mg/kg, injected over a period of 30 to 60 seconds. There are inadequate data to make dosage recommendations for induction of anesthesia in patients below the age of ten (10) years; therefore, such use is not recommended. Geriatric patients may require reduced doses of etomidate.
Smaller increments of intravenous AMIDATE 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 smaller than the original induction dose, must be individualized. There are insufficient data to support this use of etomidate for longer adult procedures or for any procedures in pediatric patients; therefore, such use is not recommended. The use of intravenous fentanyl and other neuroactive drugs employed during the conduct of anesthesia may alter the etomidate dosage requirements. Consult the prescribing information for all other such drugs before using.
What interacts with AMIDATE?
AMIDATE is contraindicated in patients who have shown hypersensitivity to it.
What are the warnings of AMIDATE?
4. Dobutamine injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes, in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
INTRAVENOUS AMIDATE SHOULD BE ADMINISTERED ONLY BY PERSONS TRAINED IN THE ADMINISTRATION OF GENERAL ANESTHETICS AND IN THE MANAGEMENT OF COMPLICATIONS ENCOUNTERED DURING THE CONDUCT OF GENERAL ANESTHESIA.
BECAUSE OF THE HAZARDS OF PROLONGED SUPPRESSION OF ENDOGENOUS CORTISOL AND ALDOSTERONE PRODUCTION, THIS FORMULATION IS NOT INTENDED FOR ADMINISTRATION BY PROLONGED INFUSION.
Pediatric Neurotoxicity
Published animal studies demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than 3 hours. The clinical significance of these findings is not clear. However, based on the available data, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life, but may extend out to approximately three years of age in humans (see).
Some published studies in children suggest that similar deficits may occur after repeated or prolonged exposures to anesthetic agents early in life and may result in adverse cognitive or behavioral effects. These studies have substantial limitations, and it is not clear if the observed effects are due to the anesthetic/sedation drug administration or other factors such as the surgery or underlying illness.
Anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, and no specific medications have been shown to be safer than any other. Decisions regarding the timing of any elective procedures requiring anesthesia should take into consideration the benefits of the procedure weighed against the potential risks.
What are the precautions of AMIDATE?
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Long-term animal studies to evaluate the carcinogenic potential of etomidate have not been completed.
Mutagenesis
Studies to evaluate the mutagenic potential of etomidate have not been completed.
Impairment of Fertility
In a fertility and early embryonic development study in which male and female rats were treated intravenously with 0.31, 1.25, and 5 mg/kg/day etomidate (0.17, 0.68, and 2.7 times the human induction dose of 0.3 mg/kg based on body surface area) prior to mating, no adverse effects on fertility were noted.
Pregnancy
Risk Summary
There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, fetal deaths and reduced pup survival were noted after intravenous administration of etomidate to pregnant rats at doses 0.17 times the human induction dose of 0.3 mg/kg. Reduced pup survival was noted after intravenous administration of etomidate to pregnant rabbits at 1.6 times the human induction dose. Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. There are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Labor and Delivery
There are insufficient data to support use of intravenous AMIDATE in obstetrics, including Caesarean section deliveries. Therefore, such use is not recommended.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AMIDATE is administered to a nursing mother.
Pediatric Use
There are inadequate data for AMIDATE to make dosage recommendations for induction of anesthesia in patients below the age of ten (10) years; therefore, such use is not recommended (see also).
Published juvenile animal studies demonstrate that the administration of anesthetic and sedation drugs, such as AMIDATE, that either block NMDA receptors or potentiate the activity of GABA during the period of rapid brain growth or synaptogenesis, results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. Based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life, but may extend out to approximately 3 years of age in humans.
In primates, exposure to 3 hours of ketamine that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer of isoflurane increased neuronal cell loss. Data from isoflurane-treated rodents and ketamine-treated primates suggest that the neuronal and oligodendrocyte cell losses are associated with prolonged cognitive deficits in learning and memory. The clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in pregnant women, neonates, and young children who require procedures with the potential risks suggested by the nonclinical data (See and).
Geriatric Use
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Clinical data indicates that AMIDATE may induce cardiac depression in elderly patients, particularly those with hypertension
Elderly patients may require lower doses of AMIDATE than younger patients. Age-related differences in pharmacokinetic parameters have been observed in clinical studies (see and ).
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.
Information for Patients
Studies conducted in young animals and children suggest repeated or prolonged use of general anesthetic or sedation drugs in children younger than 3 years may have negative effects on their developing brains. Discuss with parents and caregivers the benefits, risks, and timing and duration of surgery or procedures requiring anesthetic and sedation drugs. (See ).
What are the side effects of AMIDATE?
The most frequent adverse reactions associated with use of intravenous AMIDATE are transient venous pain on injection and transient skeletal muscle movements, including myoclonus:
Skeletal muscle movements appear to be more frequent in patients who also manifest venous pain on injection.
Other Adverse Observations Respiratory System
Hyperventilation, hypoventilation, apnea of short duration (5 to 90 seconds with spontaneous recovery); laryngospasm, hiccup and snoring suggestive of partial upper airway obstruction have been observed in some patients. These conditions were managed by conventional countermeasures.
Circulatory System
Hypertension, hypotension, tachycardia, bradycardia and other arrhythmias have occasionally been observed during induction and maintenance of anesthesia. One case of severe hypotension and tachycardia, judged to be anaphylactoid in character, has been reported.
Geriatric patients, particularly those with hypertension, may be at increased risk for the development of cardiac depression following etomidate administration (see ).
Gastrointestinal System
Postoperative nausea and/or vomiting following induction of anesthesia with etomidate is probably no more frequent than the general incidence. When etomidate was used for both induction and maintenance of anesthesia in short procedures such as dilation and curettage, or when insufficient analgesia was provided, the incidence of postoperative nausea and/or vomiting was higher than that noted in control patients who received thiopental.
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What should I look out for while using AMIDATE?
AMIDATE is contraindicated in patients who have shown hypersensitivity to it.
INTRAVENOUS AMIDATE SHOULD BE ADMINISTERED ONLY BY PERSONS TRAINED IN THE ADMINISTRATION OF GENERAL ANESTHETICS AND IN THE MANAGEMENT OF COMPLICATIONS ENCOUNTERED DURING THE CONDUCT OF GENERAL ANESTHESIA.
BECAUSE OF THE HAZARDS OF PROLONGED SUPPRESSION OF ENDOGENOUS CORTISOL AND ALDOSTERONE PRODUCTION, THIS FORMULATION IS NOT INTENDED FOR ADMINISTRATION BY PROLONGED INFUSION.
What might happen if I take too much AMIDATE?
Overdosage may occur from too rapid or repeated injections. Too rapid injection may be followed by a fall in blood pressure. No adverse cardiovascular or respiratory effects attributable to AMIDATE overdose have been reported.
In the event of suspected or apparent overdosage, the drug should be discontinued, a patent airway established (intubate, if necessary) or maintained and oxygen administered with assisted ventilation, if necessary.
How should I store and handle AMIDATE?
Storage and StabilitySIMPONI ARIA must be refrigerated at 2º C to 8º C (36º F to 46º F) and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.Storage and StabilitySIMPONI ARIA must be refrigerated at 2º C to 8º C (36º F to 46º F) and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.AMIDATE (Etomidate Injection, USP) is supplied in single-dose containers as follows:
