AMIDATE(TM) ETOMIDATE 2 mg/mL
AMIDATE(TM) ETOMIDATE · INJECTION, SOLUTION · HF Acquisition Co LLC, DBA HealthFirst
AMIDATE(TM) ETOMIDATE is a prescription injection, solution containing amidate(tm) etomidate at 2 mg/mL, taken intravenous. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.
Key Facts
- Brand Name
- AMIDATE(TM) ETOMIDATE
- Generic Name
- AMIDATE(TM) ETOMIDATE
- NDC Code (Product)
51662-1459- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Strength
- 2 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- NDA018227
- Drug Class
- General Anesthesia [PE]; General Anesthetic [EPC]
- Marketing Start
- 03/31/2020
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS & USAGE AMIDATE is indicated by intravenous injection for the induction of general anesthesia. When considering use of AMIDATE, 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 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.
Dosage & Administration
DOSAGE & ADMINISTRATION Do not administer unless solution is clear and container is undamaged. Discard unused portion (see DOSAGE AND ADMINISTRATION). AMIDATE 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 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…
Warnings
WARNINGS 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 PRECAUTIONS /Pregnancy, Pediatric Use, ANIMAL PHARMACOLOGY AND/OR TOXICOLOGY ). Some published studies in children suggest that similar deficits may occur after repeated or prol…
Contraindications
CONTRAINDICATIONS AMIDATE is contraindicated in patients who have shown hypersensitivity to it.
Adverse Reactions
ADVERSE REACTIONS The most frequent adverse reactions associated with use of intravenous AMIDATE are transient venous pain on injection and transient skeletal muscle movements, including myoclonus: Transient venous pain was observed immediately following intravenous injection of etomidate in about 20% of the patients, with considerable difference in the reported incidence (1.2% to 42%). 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 etomidate 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 giv…
Frequently Asked Questions
What is AMIDATE(TM) ETOMIDATE used for?
AMIDATE(TM) ETOMIDATE contains AMIDATE(TM) ETOMIDATE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is AMIDATE(TM) ETOMIDATE a controlled substance?
AMIDATE(TM) ETOMIDATE is not classified as a controlled substance by the DEA.
What is the generic name for AMIDATE(TM) ETOMIDATE?
The generic name for AMIDATE(TM) ETOMIDATE is AMIDATE(TM) ETOMIDATE. There are no other listed brand versions of AMIDATE(TM) ETOMIDATE.
What is the NDC code for AMIDATE(TM) ETOMIDATE 2 mg/mL?
The NDC (National Drug Code) for AMIDATE(TM) ETOMIDATE 2 mg/mL is 51662-1459, listed by HF Acquisition Co LLC, DBA HealthFirst.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)