AMIDATE How Supplied/Storage and Handling (etomidate injection, USP) | Pfizer Medical Information - US

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HOW SUPPLIED

AMIDATE™ (Etomidate Injection, USP) is supplied in single-dose containers as follows:

Unit of Sale	Concentration
NDC 0409-6695-01 Tray of 10 Single-dose Fliptop Vials	20 mg/10 mL (2 mg/mL)
NDC 0409-6695-02 Tray of 10 Single-dose Fliptop Vials	40 mg/20 mL (2 mg/mL)

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

AMIDATE Quick Finder

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Resources

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INDICATIONS AND 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 ...

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DOSAGE AND ADMINISTRATION

Do not administer unless solution is clear and container is undamaged. Discard unused portion (see DOSAGE AND ADMINISTRATION).

AMIDATE is intended...

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CONTRAINDICATIONS

AMIDATE is contraindicated in patients who have shown hypersensitivity to it.

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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.

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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:

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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 AMIDATE overdose have...

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DESCRIPTION

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...

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CLINICAL PHARMACOLOGY

Etomidate is a general anesthetic without analgesic activity. Intravenous injection of etomidate produces anesthesia characterized by a rapid onset of action, usually within one minute. Duration of...

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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...

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HOW SUPPLIED

AMIDATE™ (Etomidate Injection, USP) is supplied in single-dose containers as follows:

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For intravenous use

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Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.