Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3177
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Amidate (Injection, Solution)
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Etomidate injection is intended for administration only by
the intravenous route (see CLINICAL PHARMACOLOGY). 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 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 etomidate 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. Premedication: Etomidate injection is compatible with commonly administered pre-anesthetic
medications, which may be employed as indicated. See also CLINICAL PHARMACOLOGY,
ADVERSE REACTIONS, and dosage recommendations for maintenance of anesthesia. Etomidate
hypnosis does not significantly alter the usual dosage requirements of neuromuscular
blocking agents employed for endotracheal intubation or other purposes shortly
after induction of anesthesia. Parenteral drug products
should be inspected visually for particulate matter and discoloration prior
to administration, whenever solution and container permit. To
prevent needle-stick injuries, needles should not be recapped, purposely bent,
or broken by hand.
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dailymed-instance:descripti... |
Amidate (etomidate injection) 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:
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Etomidate is a hypnotic drug without analgesic activity.
Intravenous injection of etomidate produces hypnosis characterized by a rapid
onset of action, usually within one minute. Duration of hypnosis is dose dependent
but relatively brief, usually three to five minutes when an average dose of
0.3 mg/kg is employed. Immediate recovery from anesthesia (as assessed by
awakening time, time needed to follow simple commands and time to perform
simple tests after anesthesia as well as they were performed before anesthesia),
based upon data derived from short operative procedures where intravenous
etomidate was used for both induction and maintenance of anesthesia, is about
as rapid as, or slightly faster than, immediate recovery after similar use
of thiopental. These same data revealed that the immediate recovery period
will usually be shortened in adult patients by the intravenous administration
of approximately 0.1 mg of intravenous fentanyl, one or two minutes before
induction of anesthesia, probably because less etomidate is generally required
under these circumstances (consult the package insert for fentanyl before
using). The most characteristic effect of intravenous
etomidate on the respiratory system is a slight elevation in arterial carbon
dioxide tension (PaCO). See also ADVERSE REACTIONS. Reduced
cortisol plasma levels have been reported with induction doses of 0.3 mg/kg
etomidate. These persist for approximately 6 to 8 hours and appear to be unresponsive
to ACTH administration. The intravenous administration
of up to 0.6 mg/kg of etomidate to patients with severe cardiovascular disease
has little or no effect on myocardial metabolism, cardiac output, peripheral
circulation or pulmonary circulation. The hemodynamic effects of etomidate
have in most cases been qualitatively similar to those of thiopental sodium,
except that the heart rate tended to increase by a moderate amount following
administration of thiopental under conditions where there was little or no
change in heart rate following administration of etomidate. However, clinical
data indicates that etomidate administration in geriatric patients, particularly
those with hypertension, may result in decreases in heart rate, cardiac index,
and mean arterial blood pressure. There are insufficient data concerning use
of etomidate in patients with recent severe trauma or hypovolemia to predict
cardiovascular response under such circumstances. Clinical
experience and special studies to date suggest that standard doses of intravenous
etomidate ordinarily neither elevate plasma histamine nor cause signs of histamine
release. Limited clinical experience, as well as animal
studies, suggests that inadvertent intra-arterial injection of etomidate,
unlike thiobarbiturates, will not usually be followed by necrosis of tissue
distal to the injection site. Intra-arterial injection of etomidate is, however,
not recommended. 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 provided for avoidance of hypercapnia.
Information concerning regional cerebral perfusion in patients with intracranial
space occupying lesions is too limited to permit definitive conclusions. Preliminary
data suggests that etomidate will usually lower intraocular pressure moderately. Etomidate
is rapidly metabolized in the liver. Minimal hypnotic plasma levels of unchanged
drug are equal to or higher than 0.23��g/mL; they decrease rapidly up
to 30 minutes following injection and thereafter more slowly with a half-life
value of about 75 minutes. Approximately 75% of the administered dose is excreted
in the urine during the first day after injection. The chief metabolite is
R-(+)-1-(1-phenylethyl)-1H-imidazole-5-carboxylic acid, resulting from hydrolysis
of etomidate, and accounts for about 80% of the urinary excretion. Limited
pharmacokinetic data in patients with cirrhosis and esophageal varices suggest
that the volume of distribution and elimination half-life of etomidate are
approximately double that seen in healthy subjects. (Reference:
H. Van Beem, et. al., Anaesthesia 38 (Supp 38:61-62, July 1983). In
clinical studies, elderly patients demonstrated decreased initial distribution
volumes and total clearance of etomidate. Protein binding of etomidate to
serum albumin was also significantly decreased in these individuals. Reduced
plasma cortisol and aldosterone levels have been reported following induction
doses of etomidate. These results persist for approximately 6-8 hours and
appear to be unresponsive to ACTH stimulation. This probably represents blockage
of 11 beta-hydroxylation within the adrenal cortex. (References:
1. R.J. Fragen, et. al., Anesthesiology 61:652-656, 1984. 2. R.L. Wagner&P.F. White, Anesthesiology 61:647-651, 1984. 3. F.H. DeJong, et. al., Clin.
Endocrinology and Metabolism 59:(6):1143-1147, 1984, and three additional
drafts of Metabolic Studies, all submitted to NDA 18-228 on April 1, 1985).
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Etomidate is contraindicated in patients who have shown hypersensitivity
to it.
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Amidate (etomidate injection) is supplied
in single-dose containers as follows: Store at controlled room temperature 15��to 30��C
(59��to 86��F).[See USP.] May, 2004. ��Hospira
2004 Printed in USA HOSPIRA,
INC., LAKE FOREST, IL 60045 USA
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Do not administer unless solution is clear and container
is undamaged. Discard unused portion (see DOSAGE AND ADMINISTRATION).<br/>1. Carcinogenesis, Mutagenesis, Impairment of Fertility:: No carcinogenesis or mutagenesis studies have been carried
out on etomidate. The results of reproduction studies showed no impairment
of fertility in male and female rats when etomidate was given prior to pregnancy
at 0.31, 1.25 and 5 mg/kg (approximately 1X, 4X and 16X human dosage).<br/>2. Pregnancy Category C.: Etomidate has been shown to have an embryocidal effect in
rats when given in doses 1 and 4 times the human dose. There are no adequate
and well-controlled studies in pregnant women. Etomidate should be used during
pregnancy only if the potential benefit justifies the potential risks to the
fetus. Etomidate has not been shown to be teratogenic in animals. Reproduction
studies with etomidate have been shown to: a. Decrease
pup survival at 0.3 and 5 mg/kg in rats (approximately 1X and 16X human dosage)
and at 1.5 and 4.5 mg/kg in rabbits (approximately 5X and 15X human dosage).
No clear dose-related pattern was observed. b. Increase
slightly the number of stillborn fetuses in rats at 0.3 and 1.25 mg/kg (approximately
1X and 4X human dosage). c. Cause maternal toxicity
with deaths of 6/20 rats at 5 mg/kg (approximately 16X human dosage) and 6/20
rabbits at 4.5 mg/kg (approximately 15X human dosage).<br/>3. Labor and Delivery:: There are insufficient data to support use of intravenous
etomidate in obstetrics, including Caesarean section deliveries. Therefore,
such use is not recommended.<br/>4. 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 etomidate is administered to a nursing mother.<br/>5. Pediatric Use:: 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 (see also DOSAGE AND ADMINISTRATION).<br/>6. Geriatric Use:: Clinical data indicates that etomidate may induce cardiac
depression in elderly patients, particularly those with hypertension (see
CLINICAL PHARMACOLOGY and OTHER ADVERSE OBSERVATIONS, Circulatory System). Elderly patients may require lower doses of etomidate than younger patients.
Age-related differences in phamacokinetic parameters have been observed in
clinical studies (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). 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. 7. Plasma
Cortisol Levels: Induction doses of etomidate have been associated
with reduction in plasma cortisol and aldosterone concentrations (see CLINICAL
PHARMACOLOGY). These have not been associated with changes in vital signs
or evidence of increased mortality; however, where concern exists for patients
undergoing severe stress, exogenous replacement should be considered.
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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 etomidate 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. The LDof etomidate administered
intravenously to rats is 20.4 mg/kg.
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Etomidate
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Amidate (Injection, Solution)
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The most frequent adverse reactions associated with use of
intravenous etomidate 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. (Reference:
M. Sold and A. Rothhammer, Anaesthetist 34:208-210, 1985. Submitted to NDA
18-228 on 16 May 1985). Geriatric patients, particularly
those with hypertension, may be at increased risk for the development of cardiac
depression following etomidate administration (see CLINICAL PHARMACOLOGY). 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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INTRAVENOUS ETOMIDATE 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.
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Etomidate is indicated by intravenous injection for the induction
of general anesthesia. When considering use of etomidate, the usefulness of
its hemodynamic properties (see CLINICAL PHARMACOLOGY) should be weighed against
the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS). Intravenous
etomidate 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.
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Amidate
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