ATNAA

ATNAA
Combination of
Atropine	Anticholinergic Agent
Pralidoxime chloride	Antidote
Clinical data
Trade names	Atnaa, Duodote
AHFS/Drugs.com	Professional Drug Facts
License data	US DailyMed: Atropine_and_pralidoxime;
Routes of; administration	Intramuscular injection (IM)
ATC code	None;
Legal status
Legal status	US: ℞-only ;
Identifiers
UNII	7C0697DR9I; P7MU9UTP52;

An ATNAA (Antidote Treatment Nerve Agent Autoinjector) is any of a variety of autoinjectors in use with the US Armed Forces. An autoinjector is a medical device designed to deliver a single dose of a particular (typically life-saving) drug.

Most autoinjectors are spring-loaded syringes. By design, autoinjectors are easy to use and are intended for self-administration by patients. The site of injection depends on the drug loaded, but it typically is administered into the thigh or the buttocks. The injectors were initially designed to overcome the hesitation associated with self-administration of the needle-based drug delivery device. It is the newer delivery vehicle to be used in lieu of the Mark I NAAK.

Purpose

The ATNAA provides atropine and pralidoxime chloride in a single delivery system, although the two drugs are separate within the device.[1][2][3] The use of the device is only to be administered in the extreme case of organophosphate poisoning. The delivery system is designed for use by military personnel only, and is only issued to DOD personnel that are considered to be in immediate danger of a chemical attack or work in a position (such as ordnance disposal) where there is a high likelihood of nerve agent exposure.[4]

FDA approval

During initial trials and submission to the FDA for approval, the United States Department of Defense requested that the Food and Drug Administration (FDA) waive the requirement for the phrase 'Rx only' being included on the labeling for the ATNAA device; the rationale being that it would be confusing to troops. The waiver request was denied. The DoD opted to include the phrase at the end of the package insert instead, and this modification was found acceptable. [5]

Training

As a condition of approval, the FDA lists on the device label the precise instructions that are to be given to military personnel on dosage and administration.[1]^{: dosage and administration} While each branch of the DoD typically provides their own tailored training, an example of the MK I NAAK and ATNAA are referenced in the United States Air Force Self Aid Buddy Care Training (SABC). SABC encompasses basic life support and limb-saving techniques to help wounded or injured personnel survive in medical emergencies until medical help is available.[6]

References

Meridian Medical Technologies, Inc. "ATNAA Factsheet" (PDF). U.S. Food and Drug Administration.
"Atnaa Atropine And Pralidoxime Chloride Auto-Injector- atropine and pralidoxime chloride kit". DailyMed. 22 March 2017. Retrieved 27 May 2020.
"Duodote- atropine and pralidoxime chloride kit". DailyMed. 22 October 2018. Retrieved 27 May 2020.
FDA approval process "ATNAA Injection in an (Atropine/Pralidoxime) Autoinjector". Drug Approval Package. U.S. Food and Drug Administration.
"Clinical Pharmacology and Biopharmaceutical Review" (PDF). Center for Drug Evaluation and Research. U.S. Food and Drug Administration. p. 59. Archived from the original (PDF) on 2008-10-22. Retrieved 2009-05-13.
"Training Objectives AFI 36-2238, SABC Training" (PDF). Archived from the original (PDF) on 2010-02-15.

External links

"Atropine mixture with pralidoxime chloride". Drug Information Portal. U.S. National Library of Medicine.

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[ATNAA_Facts-1] Meridian Medical Technologies, Inc. "ATNAA Factsheet" (PDF). U.S. Food and Drug Administration.

[Atnaa_FDA_label-2] "Atnaa Atropine And Pralidoxime Chloride Auto-Injector- atropine and pralidoxime chloride kit". DailyMed. 22 March 2017. Retrieved 27 May 2020.

[Duodote_FDA_label-3] "Duodote- atropine and pralidoxime chloride kit". DailyMed. 22 October 2018. Retrieved 27 May 2020.

[4] FDA approval process "ATNAA Injection in an (Atropine/Pralidoxime) Autoinjector". Drug Approval Package. U.S. Food and Drug Administration.

[5] "Clinical Pharmacology and Biopharmaceutical Review" (PDF). Center for Drug Evaluation and Research. U.S. Food and Drug Administration. p. 59. Archived from the original (PDF) on 2008-10-22. Retrieved 2009-05-13.

[6] "Training Objectives AFI 36-2238, SABC Training" (PDF). Archived from the original (PDF) on 2010-02-15.