"ATNAA"
(ANTIDOTE TREATMENT - NERVE AGENT, AUTO-INJECTOR)
ATROPINE INJECTION, 2.1 mg/0.7 mL PRALIDOXIME CHLORIDE INJECTION, 600 mg/2 mL

FOR USE IN NERVE AGENT POISONING ONLY STERILE SOLUTIONS FOR INTRAMUSCULAR USE ONLY

The Antidote Treatment - Nerve Agent, Auto-Injector (ATNAA) provides Atropine Injection and Pralidoxime Chloride Injection in separate chambers as sterile, pyrogen-free solutions for intramuscular injection.

The ATNAA is a specially designed unit for automatic self-or buddy-administration by military personnel. When activated, the ATNAA sequentially administers atropine and pralidoxime chloride through a single needle. The recommended procedure (see DOSAGE AND ADMINISTRATION) is to inject the spans of the auto-injector into the muscles of an outer thigh or into the buttocks.

When activated, each ATNAA dispenses:

2.1 mg atropine in 0.7 mL of a sterile, pyrogen-free solution containing 12.47 mg glycerin and not more than 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 - 5.0.

And

600 mg of pralidoxime chloride in 2 mL of a sterile, pyrogen-free solution containing 40 mg benzyl alcohol, 22.5 mg glycine, and Water for Injection. The pH is adjusted with hydrochloric acid. The pH range is 2.0-3.0.

After a ATNAA has been activated, the empty container should be disposed of properly (see DOSAGE AND ADMINISTRATION).It cannot be refilled, nor can the protruding needle be retracted.

Atropine, an anticholinergic agent (muscarinic antagonist), occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly soluble in water, soluble in glycerin and ether, and freely soluble in alcohol and chloroform with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and I- hyoscyamine, whose activity is due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1[[alpha]]H,5[[alpha]]H-Tropan-3[[alpha]]-ol ([[plusmn]])-tropate. Its empirical formula is C₁₇H₂₃NO₃ and its structural formula is:

Pralidoxime chloride, a cholinesterase reactivator, is an odorless, white to pale-yellow crystalline powder, freely soluble in water, with a molecular weight of 172.61. Chemically, pralidoxime chloride is designated as 2-formyl-1-methylpyridinium chloride oxime. Its empirical formula is C₇H₉CIN₂O and its structural formula is:

The specific activity of the drug resides in the 2-formyl-1-methylpyridinium ion and is independent of the particular salt employed. The chloride salt is preferred because of physiologic compatibility, excellent water solubility at all temperatures, and high potency per gram, due to its low molecular weight.

The ATNAA is indicated for the treatment of poisoning by susceptible organophosphorous nerve agents having anticholinesterase activity.

In the face of life-threatening poisoning by organophosphorous nerve agents, there are no absolute contraindications for the use of the ATNAA (see WARNINGS).

While ATNAA can be administered to all individuals with a life-threatening exposure to organophosphorous nerve agents, it should be administered with extreme caution to individuals with the following disorders when the symptoms of nerve agent poisoning are less severe: individuals who are hypersensitive to any component of the product, disorders of heart rhythm such as atrial flutter, severe narrow angle glaucoma, pyloric stenosis, or prostatic hypertrophy.

More than one dose of ATNAA, to a maximum of three doses, may be necessary, especially when exposure is massive or symptoms are severe (see DOSAGE AND ADMINISTRATION). Children are more susceptible than adults to the toxic effects of anticholinergic agents.

Severe difficulty in breathing requires artificial respiration in addition to the use of the ATNAA.

Pralidoxime is not effective in the treatment of poisoning due to phosphorus, inorganic phosphates, or organophosphates not having anticholinesterase activity.

Mild to moderate pain may be experienced at the site of injection.

Atropine and pralidoxime chloride are not subject to abuse and possess no known potential for dependence.

Supportive treatment should be administered as indicated. If respiration is depressed, artificial respiration with oxygen is necessary. Ice bags, alcohol sponges or a hypothermia blanket may be required to reduce fever, especially in children. Catheterization may be necessary if urinary retention occurs. Since atropine elimination takes place through the kidney, urinary output must be maintained and increased if possible; intravenous fluids may be indicated. Because of the affected person's photophobia, the room should be darkened.

In the event of toxic overdosage, a short acting barbiturate or diazepam may be given as needed to control marked exclient and convulsions. Large doses for sedation should be avoided because central depressant action may coincide with the depression occurring late in atropine poisoning. Central stimulants are not recommended. Physostigmine, given as an atropine antidote by slow intravenous injection of 1 to 4 mg (0.5 to 1.0 mg in children), rapidly abolishes delirium and coma caused by large doses of atropine. Since physostigmine has a short duration of action, the patient may again lapse into coma after one or two hours and repeated doses are likely to be required. Neostigmine, pilocarpine, and methacholine are of little real benefit, since they do not penetrate the blood-brain barrier.

For optimal reactivation of organophosphorous-inhibited cholinesterase, the ATNAA should be administered as soon as possible after appearance of symptoms of nerve agent poisoning (see below).

The ATNAA should be self- or buddy-administered by military personnel after donning protective mask and hood at the first sign of a chemical attack, and only if some or all of the following mild symptoms of nerve agent exposure are present:

• -Unexplained runny nose
• -Unexplained sudden headache
• -Sudden drooling
• -Difficulty in seeing (dimness of vision and miosis)
• -Tightness of chest or difficulty in breathing
• -Wheezing and coughing
• -Localized sweating and muscular twitching in the area of contaminated skin
• -Stomach cramps
• -Nausea, with or without vomiting
• -Tachycardia followed by bradycardia

The following are the instructions that should be given to military personnel.

• Administer one (1) ATNAA into your lateral thigh muscle or buttocks as follows:
  • Remove gray safety cap from back end.
  • Place front end on outer thigh and push hard until injector functions.
    Hold firmly in place for ten seconds.
  • Using a hard surface, bend needle into hook. Push ejected needle through a pocket flap (or other thick and conspicuous part of outer clothing).
• Wait 10 to 15 minutes for the antidote to take effect. If you are able to ambulate, know who you are, and where you are, you will NOT need a second injection. Warning: Giving yourself a second set of injections may cause an overdose of the ATNAA which could result in incapacitation.
• If symptoms of nerve agent poisoning are not relieved after administering one injection, seek someone else to check your symptoms. A buddy must administer the second and third injections, if needed.

• Casualties with severe symptoms may experience most or all of the mild symptoms described above, plus most or all of the following:
  • -Strange or confused behavior
  • -Increased wheezing and increased difficulty in breathing
  • -Severely pinpointed pupils
  • -Red eyes with tearing
  • -Vomiting
  • -Severe muscular twitching and general weakness
  • -Involuntary urination and defecation
  • -Convulsions
  • -Unconsciousness
  • -Respiratory failure
  • -Bradycardia
• If you encounter a service member suffering from severe signs of nerve agent poisoning, render the following aid:
  • Mask the casualty, if necessary. Do not fasten the hood.
  • If self-aid (one ATNAA) has been administered, administer, in rapid succession, two (2) additional ATNAAs into the casualty's lateral thigh muscle or buttocks.

    Note: Use the casualty's own ATNAAs when providing aid. Do not use your own injectors on a casualty. If you do, you may not have any antidote available when needed for self-aid.

  • If self-aid (one ATNAA) has not been administered, administer, in rapid succession, three (3) ATNAAs into the casualty's lateral thigh muscle or buttocks.

IMPORTANT: PHYSICIANS AND/OR MEDICAL PERSONNEL ASSISTING EVACUATED VICTIMS OF NERVE AGENTS, SHOULD AVOID EXPOSING THEMSELVES TO CONTAMINATION BY THE VICTIM'S CLOTHING.

The Antidote Treatment - Nerve Agent, Auto-Injector (ATNAA) provides Atropine Injection (atropine, 2.1 mg/0.7 mL) and Pralidoxime Chloride Injection (pralidoxime chloride, 600 mg/2 mL) in sterile solutions for intramuscular injection. The ATNAA is a self-contained unit designed for automatic self- or buddy-administration by military personnel. ATNAAs are supplied through the Directorate of Medical Materiel, Defense Supply Center, Philadelphia.

Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F)

[see USP Controlled Room Temperature]
Keep from Freezing. Protect from Light.

Manufactured by:

MERIDIAN MEDICAL TECHNOLOGIES, INC. GOVERNMENT SYSTEMS
COLUMBIA, MD 21046

Rx only.
0000979
3/02

• Landauer, W: Cholinomimetic teratogens. V. The effect of oximes and related cholinesterase reactivators. Teratology 15: 33 (Feb) 1977.
• Moller, K.O., Jensen-Holm, J. and Lausen, H.H.: Ugeskr Laeg. 123: 501,1961.
• Namba, T, Nolte, C.T., Jackrel, J. and Grob, D: Poisoning due to organophosphate insecticides. Acute and chronic manifestations. Amer. J. Med. 50: 475 (Apr), 1971.
• Arena, J.M.: Poisoning, Toxicology Symptoms, Treatments, ed. 4, Springfield, IL, Charles C.Thomas, 1979, p. 133.
• Brachfeld, J., and Zavon, M.R.: Organic phosphate (Phosdrin®) intoxication. Report of a case and the results of treatment with 2-PAM, Arch. Environ. Health 11: 859, 1965.
• Hayes, W.J., Jr.: Toxicology of Pesticides. Baltimore, The Williams &Wilkins Company, 1975, p. 416.