Atropine and pralidoxime chloride

FDA label, Meridian Medical Technologies, LLC, intramuscular, effective 2022-07-18. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

Renal Impairment Pralidoxime chloride can cause decreased renal function [see Adverse Reactions ]. Individuals with severe renal impairment may require less frequent doses after the initial dose .

Dosing in liver impairment

Hepatic Impairment Individuals with severe hepatic impairment may require less frequent doses after the initial dose .

Preparation and administration

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Your numbers for atropine and pralidoxime chloride. Take vial strength, diluent, and limits from the label below.

Basis

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Important Administration Information Three ATNAA single-dose autoinjectors should be available for use by each service member at risk for organophosphorus nerve agent poisoning; one for mild symptoms plus two more for severe symptoms [see Dosage and Administration ] . Note that individuals may not have all symptoms included under the mild or severe symptom category.

For optimal reactivation of organophosphorus-inhibited cholinesterase, the ATNAA should be administered as soon as possible after appearance of symptoms of organophosphorus nerve agent poisoning. ATNAA should be self- or buddy–administered by service members after donning protective mask and hood at the first sign of a chemical attack, and only if some or all of the mild symptoms of organophosphorus nerve agent exposure are present.

Only administer ATNAA to service members experiencing symptoms of organophosphorus nerve agent poisoning in a situation where exposure is known or suspected. The ATNAA autoinjector is intended as an initial treatment of the symptoms of organophosphorus nerve agent poisoning as soon as symptoms appear; definitive medical care should be sought immediately.

Close supervision of all treated service members is indicated for at least 48 to 72 hours. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit [see Dosage Forms and Strengths ] .

Administration Instructions The following instructions should be given to service members for the administration of ATNAA single-dose injections. Self-Aid Administer one 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.

Giving yourself a second set of injections may cause an overdose of the ATNAA which could result in incapacitation. If symptoms of organophosphorus 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.

Buddy-Aid If you encounter a service member suffering from any of the severe symptoms of organophosphorus nerve agent poisoning, render the following aid: Mask the casualty, if necessary. Do not fasten the hood. If self-aid (one ATNAA injection) has been administered, administer in rapid succession two additional ATNAA injections into the casualty's lateral thigh muscle or buttocks.

Use the casualty's own ATNAAs when providing aid. Do not use your own autoinjectors on a casualty. If you do, you may not have any antidote available when needed for self-aid. If self-aid (one ATNAA injection) has not been administered, administer in rapid succession three ATNAA injections into the casualty's lateral thigh muscle or buttocks.

Drug interactions

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  • Atropine and pralidoxime chloride
Label text (2 paragraphs)

Succinylcholine and Mivacurium: Accelerated reversal of neuromuscular blocking effects may occur; monitor with concomitant administration. ( 7.1 )

7.1 Succinylcholine and Mivacurium Since pralidoxime chloride in ATNAA reactivates cholinesterases and succinylcholine and mivacurium are metabolized by cholinesterases, service members poisoned by susceptible organophosphorus nerve agents having anticholinesterase activity who have received ATNAA may exhibit accelerated reversal of the neuromuscular blocking effects of succinylcholine and mivacurium (relative to poisoned service member who has not received pralidoxime). Monitor for neuromuscular effects with concomitant administration.

Contraindications

None. None. ( 4 )

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for atropine and pralidoxime chloride. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary Atropine readily crosses the placental barrier and enters fetal circulation. There are no adequate data on the developmental risk associated with the use of atropine, pralidoxime chloride, or the combination in pregnant women. Adequate animal reproduction studies have not been conducted with atropine, pralidoxime chloride, or the combination. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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