Medicine:ATNAA
| Combination of | |
|---|---|
| Atropine | Anticholinergic Agent |
| Pralidoxime chloride | Antidote |
| Clinical data | |
| Trade names | Atnaa, Duodote |
| AHFS/Drugs.com | Professional Drug Facts |
| License data | |
| Routes of administration | Intramuscular injection (IM) |
| ATC code |
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| Legal status | |
| Legal status |
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| Identifiers | |
| UNII | |
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
- ↑ 1.0 1.1 Meridian Medical Technologies, Inc.. "ATNAA Factsheet". U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa_prntlbl.pdf.
- ↑ "Atnaa Atropine And Pralidoxime Chloride Auto-Injector- atropine and pralidoxime chloride kit". 22 March 2017. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=596c7a8f-27cd-4de2-9491-476f43570b8b.
- ↑ "Duodote- atropine and pralidoxime chloride kit". 22 October 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=241f42a0-1a33-40e8-8221-201767d999e5.
- ↑ FDA approval process "ATNAA Injection in an (Atropine/Pralidoxime) Autoinjector". Drug Approval Package. U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa.cfm.
- ↑ "Clinical Pharmacology and Biopharmaceutical Review". Center for Drug Evaluation and Research. U.S. Food and Drug Administration. p. 59. Archived on 2008-10-22. Error: If you specify
|archivedate=, you must also specify|archiveurl=. https://www.fda.gov/cder/foi/nda/2002/21175_Atnaa_biopharmr.pdf. Retrieved 2009-05-13. - ↑ "Training Objectives AFI 36-2238, SABC Training". http://www.e-publishing.af.mil/shared/media/epubs/AFI36-2238.pdf.
Further reading
- "ATNAA Package Insert". Meridian Meds. http://www.meridianmeds.com/pdf/ATNAA_Pack_Insert.pdf.
- "Cholinomimetic teratogens. V. The effect of oximes and related cholinesterase reactivators". Teratology 15 (1): 33–42. February 1977. doi:10.1002/tera.1420150105. PMID 320703.
- "HH L. Treatment of acute phosphostigmine poisoning.". Ugeskrift for Laeger 123: 501–5. April 1961. PMID 13771863.
- "Poisoning due to organophosphate insecticides. Acute and chronic manifestations". The American Journal of Medicine 50 (4): 475–92. April 1971. doi:10.1016/0002-9343(71)90337-8. PMID 4324629.
- Poisoning. Toxicology, symptoms, treatments. (4th ed.). Springfield, IL: Charles C. Thomas.. 1974. p. 133.
- "Organic phosphate (phosdrin) intoxication. Report of a case and the results of treatment with 2-PAM". Archives of Environmental Health 11 (6): 859–62. December 1965. doi:10.1080/00039896.1965.10664314. PMID 5846083.
- Toxicology of Pesticides.. Baltimore: The Williams & Wilkins Company. 1975. p. 416.
External links
- "Atropine mixture with pralidoxime chloride". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/atropine%20mixture%20with%20pralidoxime%20chloride.
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