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DRUGS & SUPPLEMENTS
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Radenarcon
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Radenarcon uses
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
- Animal toxicology and/or pharmacology
INDICATIONS AND USAGE
Radenarcon is indicated by intravenous injection for the induction of general anesthesia. When considering use of Radenarcon, 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 Radenarcon 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.
CONTRAINDICATIONS
Radenarcon is contraindicated in patients who have shown hypersensitivity to it.
WARNINGS
INTRAVENOUS Radenarcon 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 PRECAUTIONS/Pregnancy, Pediatric Use, ANIMAL PHARMACOLOGY AND/OR TOXICOLOGY ).
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.
PRECAUTIONS
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Long-term animal studies to evaluate the carcinogenic potential of Radenarcon have not been completed.
Mutagenesis
Studies to evaluate the mutagenic potential of Radenarcon 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 Radenarcon 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 Radenarcon 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 Radenarcon 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
Animal Data
No malformations or adverse fetal effects were noted in a study in which pregnant rats were intravenously administered 0.31, 1.25, or 5 mg/kg/day Radenarcon during organogenesis (Gestation Days 6–15).
Reduced pup survival was noted in all doses tested in a study in which pregnant rabbits were intravenously administered 1.5 or 4.5 mg/kg/day Radenarcon (1.6 or 4.9 times the human induction dose of 0.3 mg/kg based on body surface area) during organogenesis (Gestation Day 6–18). These doses also produced maternal toxicity (increased mortality).
Increased still born fetuses and decreased pup survival was noted at all doses tested in a study where pregnant rats were intravenously administered 0.31, 1.25, or 5 mg/kg/day Radenarcon (0.17, 0.68, or 2.7 times the human induction dose of 0.3 mg/kg based on body surface area) during gestation and throughout lactation (Gestation Day 16 through Lactation Day 21). These doses also produced maternal toxicity (decreased food consumption and increased mortality). In this study, offspring were not evaluated for sexual maturation, neurobehavioral function including learning and memory, or reproductive function.
In a published study in primates, administration of an anesthetic dose of ketamine for 24 hours on Gestation Day 122 increased neuronal apoptosis in the developing brain of the fetus. In other published studies, administration of either isoflurane or propofol for 5 hours on Gestation Day 120 resulted in increased neuronal and oligodendrocyte apoptosis in the developing brain of the offspring. With respect to brain development, this time period corresponds to the third trimester of gestation in the human. The clinical significance of these findings is not clear; however, studies in juvenile animals suggest neuroapoptosis correlates with long-term cognitive deficits (See WARNINGS/Pediatric Neurotoxicity, PRECAUTIONS/Pregnancy, ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY ).
Labor and Delivery
There are insufficient data to support use of intravenous Radenarcon 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 Radenarcon is administered to a nursing mother.
Pediatric Use
There are inadequate data for Radenarcon to make dosage recommendations for induction of anesthesia in patients below the age of ten years; therefore, such use is not recommended (see also DOSAGE AND ADMINISTRATION ).
Published juvenile animal studies demonstrate that the administration of anesthetic and sedation drugs, such as Radenarcon, 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 WARNINGS/Pediatric Neurotoxicity, PRECAUTIONS/Pregnancy, and ANIMAL PHARMACOLOGY AND/OR TOXICOLOGY )
Geriatric Use
Clinical data indicates that Radenarcon 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 Radenarcon than younger patients. Age-related differences in pharmacokinetic 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.
Plasma Cortisol Levels
Induction doses of Radenarcon have been associated with reduction in plasma cortisol and aldosterone concentrations. 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.
Information for Patients
Effect of anesthetic and sedation drugs on early brain development
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 WARNINGS/Pediatric Neurotoxicity ).
ADVERSE REACTIONS
The most frequent adverse reactions associated with use of intravenous Radenarcon are transient venous pain on injection and transient skeletal muscle movements, including myoclonus:
- Transient venous pain was observed immediately following intravenous injection of Radenarcon in about 20% of the patients, with considerable difference in the reported incidence. This pain is usually described as mild to moderate in severity but it is occasionally judged disturbing. The observation of venous pain is not associated with a more than usual incidence of thrombosis or thrombophlebitis at the injection site. Pain also appears to be less frequently noted when larger, more proximal arm veins are employed and it appears to be more frequently noted when smaller, more distal, hand or wrist veins are employed.
- Transient skeletal muscle movements were noted following use of intravenous Radenarcon in about 32% of the patients, with considerable difference in the reported incidence (22.7% to 63%). Most of these observations were judged mild to moderate in severity but some were judged disturbing. The incidence of disturbing movements was less when 0.1 mg of fentanyl was given immediately before induction. These movements have been classified as myoclonic in the majority of cases (74%), but averting movements (7%), tonic movements (10%), and eye movements (9%) have also been reported. No exact classification is available, but these movements may also be placed into three groups by location:
- Most movements are bilateral. The arms, legs, shoulders, neck, chest wall, trunk and all four extremities have been described in some cases, with one or more of these muscle groups predominating in each individual case. Results of electroencephalographic studies suggest that these muscle movements are a manifestation of disinhibition of cortical activity; cortical electroencephalograms, taken during periods when these muscle movements were observed, have failed to reveal seizure activity.
- Other movements are described as either unilateral or having a predominance of activity of one side over the other. These movements sometimes resemble a localized response to some stimuli, such as venous pain on injection, in the lightly anesthetized patient (averting movements). Any muscle group or groups may be involved, but a predominance of movement of the arm in which the intravenous infusion is started is frequently noted.
- Still other movements probably represent a mixture of the first two types.
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 ; 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 Radenarcon administration (see CLINICAL PHARMACOLOGY ).
Gastrointestinal System
Postoperative nausea and/or vomiting following induction of anesthesia with Radenarcon is probably no more frequent than the general incidence. When Radenarcon 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.
OVERDOSAGE
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 Radenarcon 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.
DOSAGE AND ADMINISTRATION
Do not administer unless solution is clear and container is undamaged. Discard unused portion.
Radenarcon 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 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 Radenarcon.
Smaller increments of intravenous Radenarcon 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 Radenarcon 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 Radenarcon dosage requirements. Consult the prescribing information for all other such drugs before using.
Premedication
Radenarcon 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.
Radenarcon anesthesia 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.
HOW SUPPLIED
Radenarcon (Etomidate Injection, USP) is supplied in single-dose containers as follows:
| Unit of Sale | Concentration | Each |
|---|---|---|
| NDC 0409-6695-01 Carton containing 10 Vials | 20 mg/10 mL (2 mg/mL) | NDC 0409-6695-11 10 mL Fliptop Vial |
| NDC 0409-6695-02 Carton containing 10 Vials | 40 mg/20 mL (2 mg/mL) | NDC 0409-6695-12 20 mL Fliptop Vial |
| NDC 0409-8061-01 Carton containing 5 Ampuls | 40 mg/20 mL (2 mg/mL) | NDC 0409-8061-11 20 mL Ampul |
| NDC 0409-8062-01 Carton containing 5 Ampuls | 20 mg/10 mL (2 mg/mL) | NDC 0409-8062-11 10 mL Ampul |
| NDC 0409-8060-29 Bundle containing 10 Abboject Syringes | 40 mg/20 mL (2 mg/mL) | NDC 0409-8060-39 20 mL Abboject Syringe with male luer lock adapter |
Store at 20 to 25°C (68 to 77°F).
ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY
Published studies in animals demonstrate that the use of anesthetic agents 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 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 an anesthetic regimen that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer increased neuronal cell loss. Data in rodents and in primates suggest that the neuronal and oligodendrocyte cell losses are associated with subtle but 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 neonates and young children who require procedures against the potential risks suggested by the nonclinical data (See WARNINGS/Pediatric Neurotoxicity, PRECAUTIONS/Pregnancy, Pediatric Use ).
Hospira, Inc., Lake Forest, IL 60045 USA
LAB-0922-3.0
May 2017
Logo
10 mL Single-dose Fliptop Vial
Radenarcon
Radenarcon Injection, USP
20 mg/10 mL (2 mg/mL)
INTRAVENOUS USE ONLY
Hospira, Inc., Lake Forest, IL 60045 USA
Radenarcon pharmaceutical active ingredients containing related brand and generic drugs:
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References
- Dailymed."AMIDATE (ETOMIDATE) INJECTION, SOLUTION AMIDATE (ETOMIDATE) INJECTION, SOLUTION [HOSPIRA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
- Dailymed."ETOMIDATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
- "Etomidate". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
Frequently asked Questions
Can i drive or operate heavy machine after consuming Radenarcon?Depending on the reaction of the Radenarcon after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Radenarcon not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Radenarcon addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Review
sdrugs.com conducted a study on Radenarcon, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Radenarcon consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.Visitor reports
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The information was verified by Dr. Rachana Salvi, MD Pharmacology