ATNAA atropine and pralidoxime chloride Auto-Injector Kit — NDC 11704-0777-01 package photo

ATNAA atropine and pralidoxime chloride Auto-Injector Kit

by Meridian Medical Technologies, LLC · 1 KIT in 1 CARTON (11704-777-01) * .7 mL in 1 SYRINGE, GLASS * 2 mL in 1 SYRINGE, GLASS
NDC 11704-0777-01
🏷️ FDA NDC (as labeled) 11704-777-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 11704-777-01
Product NDC 11704-777
11-digit billing NDC 11704077701
RxCUI 727415
Application # NDA021175
SPL Set ID 596c7a8f-27cd-4de2-9491-476f43570b8b
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2002-01-17
Route INTRAMUSCULAR
Dosage form KIT
GCN Seq No 062654
GCN 98428
HICL code 033238
Ingredient (HICL) Pralidoxime Chloride/Atropine
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C8
Therapeutic class — intermediate (HIC2) Antidotes To Poisons
HIC3 code C8F
Therapeutic class — specific (HIC3) Cholinesterase Reactivat.-Muscarinic Antg.antidote
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name ANTIDOTE TX 2.1 MG/600 MG SYR
FDB brand name Antidote Treatment Nerve Agent
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 11704-777-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 11704-0777-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anticholinergic class.

Pharmacologic class Anticholinergic, Cholinergic Muscarinic Antagonist
Drug family (ATC) Belladonna alkaloids, tertiary amines, Anticholinergics, Antidotes
How it works Cholinergic Muscarinic Antagonists, Cholinergic Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerMeridian Medical Technologies, LLC
Application holderUS ARMY MEDICAL RESEARCH MATERIEL COMMAND
FDA applicationNDA021175 (NDA)
Labeler code11704
First marketedJan 2002
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ANTIDOTE TX 2.1 MG/600 MG SYR Ingredient Pralidoxime Chloride/Atropine
📗 Our plain-language guide HelloPharmacist
  • Both are emergency antidotes for poisoning by organophosphorus nerve agents — the kind used in chemical attacks. DuoDote is also approved for organophosphorus insecticide poisoning...
  • What exactly are DuoDote and ATNAA used for?
  • Both products are injected into the muscle of the outer thigh — DuoDote into the mid-lateral thigh, ATNAA into the lateral thigh or buttocks. The auto-injectors are designed to fir...
  • How do I use the auto-injector, and where do I inject it?
📖 Read our full Atropine / Pralidoxime guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
DuoDote 11704-0620-01 Meridian 1 kit FDA listed
ATNAA atropine and pralidoxime chloride Auto-Injectorthis 11704-0777-01 Meridian 1 kit FDA listed
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2002
On the market since
Jan 2002
📍
2026
Currently FDA-listed
24 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
11704-0777-01 You're viewing this 1 KIT in 1 CARTON (11704-777-01) * .7 mL in 1 SYRINGE, GLASS * 2 mL in 1 SYRINGE, GLASS 2002-01-17 Active

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 11704-777-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 11704-0777-01, written without dashes as 11704077701. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 11704-0777-01, the first segment (11704) is the labeler code FDA assigned to Meridian Medical Technologies, LLC; the middle segment (0777) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Meridian Medical Technologies, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Meridian Medical Technologies, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 57 words

1 INDICATIONS AND USAGE ATNAA is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity in adults. ATNAA, a combination of atropine, a cholinergic muscarinic antagonist, and pralidoxime chloride, a cholinesterase reactivator, is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity in adults. ( 1 )

⏱️ Dosage and Administration ~3 min read

2 DOSAGE AND ADMINISTRATION ATNAA is intended as an initial treatment as soon as symptoms appear; definitive medical care should be sought immediately. ( 2.1 ) Dosage for Mild Symptoms: If a service member experiences some or all of the mild symptoms, they should self-administer one injection intramuscularly into the lateral thigh muscle or buttocks. If, at any time after the first dose, the service member develops any of the severe symptoms or if the mild symptoms are not relieved, a buddy should administer two additional injections intramuscularly in rapid succession.

( 2.2 ) Dosage for Severe Symptoms: If a service member has any of the severe symptoms, immediately buddy-administer three injections intramuscularly into the service member's lateral thigh muscle or buttocks in rapid succession. ( 2.2 )

2.1Important Administration Information Three (3) ATNAA single-dose autoinjectors should be available for use by each service member at risk for organophosphorus nerve agent poisoning; one (1) for mild symptoms plus two (2) more for severe symptoms [see Dosage and Administration (2.2) ] . 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 (3) ] .

2.2Dosage Information Dosage for Mild Symptoms First Dose : If you experience some or all of the mild symptoms of nerve agent exposure listed in Table 1, self-administer one (1) ATNAA injection intramuscularly into the lateral thigh muscle or buttocks. Wait 10 to 15 minutes for ATNAA to take effect. If, after 10 to 15 minutes, the symptoms of organophosphorus nerve agent poisoning are not relieved, seek someone else to check your symptoms.

Another service member must administer the second and third injections. Additional Doses : If you encounter a service member suffering from severe symptoms of organophosphorus nerve agent poisoning listed in Table 1 and one ATNAA has been self-administered, administer two (2) additional ATNAA injections intramuscularly in rapid succession into the casualty's lateral thigh muscle or buttocks. Dosage for Severe Symptoms Casualties with severe symptoms may experience most or all of the mild symptoms of organophosphorus nerve agent poisoning, plus most or all of the severe symptoms listed in Table 1.

If a service member is encountered suffering from severe signs of organophosphorus nerve agent poisoning and ATNAA self-aid has not been administered, immediately administer in rapid succession three (3) ATNAA injections into the casualty's lateral thigh muscle or buttocks. Table 1. Common Symptoms of Organophosphorus Nerve Agent Exposure Mild Symptoms Severe Symptoms 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…

💊 Dosage Forms and Strengths 89 words

3 DOSAGE FORMS AND STRENGTHS Injection: Each single-dose ATNAA autoinjector contains the following in two separate chambers: front chamber (visible): a clear, colorless to yellow, sterile solution of atropine (2.1 mg/0.7 mL) back chamber (not visible): a clear, colorless to yellow, sterile solution of pralidoxime chloride (600 mg/2 mL) equivalent to pralidoxime (476.6 mg/2 mL) When activated, ATNAA sequentially administers both drugs intramuscularly through a single needle in one injection. Injection: Each single-dose ATNAA autoinjector contains atropine (2.1 mg/0.7 mL) plus pralidoxime chloride (600 mg/2 mL).

( 3 )

Contraindications 7 words

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~2 min read

5 WARNINGS AND PRECAUTIONS Cardiovascular (CV) Risks: Tachycardia, palpitations, premature ventricular contractions, flutter, fibrillation, etc. Use caution in individuals with known CV disease or conduction problems. ( 5.1 ) Heat Injury: May inhibit sweating and lead to hyperthermia; avoid excessive exercising and heat exposure.

( 5.2 ) Acute Glaucoma: May precipitate in susceptible individuals. ( 5.3 ) Urinary Retention : Administer with caution in individuals with bladder outflow obstruction. ( 5.4 ) Pyloric Stenosis: May convert into complete obstruction.

( 5.5 ) Exacerbation of Chronic Lung Disease: Atropine may cause inspiration of bronchial secretions and formation of dangerous viscid plugs in individuals with chronic lung disease; monitor respiratory status. ( 5.6 )

5.1Cardiovascular Risks Cardiovascular adverse reactions reported in the literature for atropine include, but are not limited to, sinus tachycardia, palpitations, premature ventricular contractions, atrial flutter, atrial fibrillation, ventricular flutter, ventricular fibrillation, cardiac syncope, asystole, and myocardial infarction. In individuals with a recent myocardial infarction and/or severe coronary artery disease, there is a possibility that atropine-induced tachycardia may cause ischemia, extend or initiate myocardial infarcts, and stimulate ventricular ectopy and fibrillation.

ATNAA should be used with caution in individuals with known cardiovascular disease or cardiac conduction problems.

5.2Heat Injury Atropine may inhibit sweating which, in a warm environment or with excessive exercise, can lead to hyperthermia and heat injury. To the extent feasible, avoid excessive exercise and heat exposure [see Overdosage (10.2) ].

5.3Acute Glaucoma Atropine should be administered with caution in individuals at risk for acute glaucoma.

5.4Urinary Retention Atropine should be administered with caution in individuals with clinically significant bladder outflow obstruction because of the risk of urinary retention.

5.5Pyloric Stenosis Atropine should be administered with caution in individuals with partial pyloric stenosis because of the risk of complete pyloric obstruction.

5.6Exacerbation of Chronic Lung Disease Atropine may cause inspiration of bronchial secretions and formation of dangerous viscid plugs in individuals with chronic lung disease. Respiratory status should be monitored in individuals with chronic lung disease following administration of ATNAA.

🤒 Adverse Reactions ~2 min read

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Cardiovascular Risks [see Warnings and Precautions (5.1) ] Heat Injury [see Warnings and Precautions (5.2) ] Acute Glaucoma [see Warnings and Precautions (5.3) ] Urinary Retention [see Warnings and Precautions (5.4) ] Pyloric Stenosis [see Warnings and Precautions (5.5) ] Exacerbation of Chronic Lung Disease [see Warnings and Precautions (5.6) ] The following adverse reactions associated with the use of atropine and pralidoxime chloride were identified in the literature.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Common adverse reactions of atropine include dryness of mouth, blurred vision, dry eyes, photophobia, confusion, headache, and dizziness among others. ( 6.1 ) The common adverse reactions of pralidoxime chloride include changes in vision, dizziness, headache, drowsiness, nausea, tachycardia, increased blood pressure, muscular weakness, dry mouth, emesis, rash, dry skin, hyperventilation, decreased renal function, excitement, manic behavior, and transient elevation of liver enzymes and creatine phosphokinase.

( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Meridian Medical Technologies ® , LLC at 1-833-739-0945 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Atropine Because ATNAA contains pralidoxime chloride, which may potentiate the effect of atropine, signs of atropinization may occur earlier than might be expected when atropine is used alone. Common adverse reactions of atropine can be attributed to its antimuscarinic action. These include dryness of the mouth, blurred vision, dry eyes, photophobia, confusion, headache, dizziness, tachycardia, palpitations, flushing, urinary hesitancy or retention, constipation, abdominal pain, abdominal distention, nausea and vomiting, loss of libido, and impotence.

Anhidrosis may produce heat intolerance and impairment of temperature regulation in a hot environment. Dysphagia, paralytic ileus, acute angle closure glaucoma, maculopapular rash, petechial rash, and scarletiniform rash have also been reported. Adverse cardiac reactions, including arrhythmias and myocardial infarction, have been reported with atropine [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2) ] .

Larger doses of atropine may produce central nervous system effects such as restlessness, tremor, fatigue, locomotor difficulties, delirium, and hallucinations [see Overdosage (10.1) ] . Hypersensitivity reactions will occasionally occur; these are usually seen as skin rashes, and may progress to exfoliation. Anaphylactic reaction and laryngospasm are rare.

6.2Pralidoxime Chloride Pralidoxime chloride can cause blurred vision, diplopia and impaired accommodation, dizziness, headache, drowsiness, nausea, tachycardia, increased systolic and diastolic blood pressure [see Clinical Pharmacology 12.2) ], muscular weakness, dry mouth, emesis, rash, dry skin, hyperventilation, decreased renal function, and decreased sweating when given parenterally to normal adult volunteers who have not been exposed to anticholinesterase poisons. In several cases of organophosphorus poisoning, excitement and manic behavior have occurred immediately following recovery of consciousness, in either the presence or absence of pralidoxime chloride administration.

However, similar behavior has not been reported in subjects given pralidoxime chloride in the absence of organophosphorus poisoning. Elevations in AST and/or ALT enzyme levels were observed in 1 of 6 normal adult volunteers given 1200 mg of pralidoxime chloride intramuscularly, and in 4 of 6 adult volunteers given 1800 mg intramuscularly. Levels returned to normal in about two weeks.

Transient elevations in creatine kinase were observed in all normal volunteers given the drug.

6.3 Injection Site Musc…

🔄 Drug Interactions 85 words

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

7.1Succinylcholine 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.

👥 Use in Specific Populations ~1 min read

8 USE IN SPECIFIC POPULATIONS Geriatric individuals may be more susceptible to the effects of atropine. ( 8.5 )

8.1Pregnancy 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.

8.2Lactation Risk Summary Atropine has been reported to be excreted in human milk. It is not known whether pralidoxime chloride is excreted in human milk. There are no data on the effects of atropine or pralidoxime chloride on the breastfed infant or the effects of the drugs on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ATNAA and any potential adverse effects on the breastfed infant from ATNAA or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness of ATNAA in pediatric patients have not been established.

8.5Geriatric Use Geriatric individuals may be more susceptible to the effects of atropine [see Clinical Pharmacology (12.3) ].

8.6Renal Impairment Pralidoxime chloride can cause decreased renal function [see Adverse Reactions (6.2) ]. Individuals with severe renal impairment may require less frequent doses after the initial dose .

8.7Hepatic Impairment Individuals with severe hepatic impairment may require less frequent doses after the initial dose .

🤰 Pregnancy 76 words

8.1Pregnancy 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.

🧒 Pediatric Use 15 words

8.4Pediatric Use Safety and effectiveness of ATNAA in pediatric patients have not been established.

🧓 Geriatric Use 19 words

8.5Geriatric Use Geriatric individuals may be more susceptible to the effects of atropine [see Clinical Pharmacology (12.3) ].

🆘 Overdosage ~1 min read

10 OVERDOSAGE

10.1Symptoms Atropine Manifestations of atropine overdose are dose-related and include flushing, dry skin and mucous membranes, tachycardia, widely dilated pupils that are poorly responsive to light, blurred vision, and fever (which can sometimes be dangerously elevated). Locomotor difficulties, disorientation, hallucinations, delirium, confusion, agitation, coma, and central depression can occur and may last 48 hours or longer. In instances of severe atropine intoxication, respiratory depression, coma, circulatory collapse, and death may occur.

Pralidoxime Chloride It may be difficult to differentiate adverse events caused by pralidoxime chloride from those caused by organophosphorus nerve agent poisoning. Symptoms of pralidoxime chloride overdose may include dizziness, blurred vision, diplopia, headache, impaired accommodation, nausea, and tachycardia. Transient hypertension caused by pralidoxime chloride may last several hours.

10.2Treatment For atropine overdose, supportive treatment should be administered. If respiration is depressed, artificial respiration with oxygen is necessary. Ice bags, a hypothermia blanket, or other methods of cooling may be required to reduce atropine-induced fever, especially in pediatric patients [see Use in Specific Populations (8.4) ].

Catheterization may be necessary if urinary retention occurs. Since atropine elimination largely takes place through the kidney, urinary output must be maintained and increased if possible; intravenous fluids may be indicated. Because of atropine-induced photophobia, the room should be darkened.

A benzodiazepine may be needed to control marked excitement and convulsions. However, large doses for sedation should be avoided because the central nervous system depressant effect may coincide with the depressant effect occurring late in severe atropine poisoning. Barbiturates are potentiated by the anticholinesterases; therefore, barbiturates should be used cautiously in the treatment of convulsions.

Central nervous system stimulants are not recommended.

🧬 Clinical Pharmacology ~2 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Atropine Atropine competitively blocks the effects of acetylcholine, including excess acetylcholine due to organophosphorus nerve agent poisoning, at muscarinic cholinergic receptors on smooth muscle, cardiac muscle, secretory gland cells, and in peripheral autonomic ganglia and the central nervous system. Pralidoxime Chloride Pralidoxime chloride reactivates acetylcholinesterase which has been inactivated by phosphorylation due to susceptible organophosphorus nerve agents having anticholinesterase activity .

However, pralidoxime chloride does not reactivate acetylcholinesterase inactivated by all organophosphorus nerve agents (e.g. soman). Pralidoxime chloride cannot reactivate phosphorylated acetylcholinesterases that have undergone a further chemical reaction known as "aging." Reactivated acetylcholinesterase hydrolyzes excess acetylcholine resulting from organophosphorus nerve agent poisoning to help restore impaired cholinergic neural function. Reactivation is clinically important because only a small proportion of active acetylcholinesterase is needed to maintain vital functions.

12.2Pharmacodynamics Atropine Atropine reduces secretions in the mouth and respiratory passages, relieves airway constriction, and may reduce centrally-mediated respiratory paralysis. In severe organophosphorus nerve agent poisoning, a fully atropinized patient may develop or continue to have respiratory failure and may require artificial respiration and suctioning of airway secretions. Atropine may cause thickening of secretions.

Atropine-induced parasympathetic inhibition may be preceded by a transient phase of stimulation, especially on the heart where small doses first slow the rate before characteristic tachycardia develops due to paralysis of vagal control. Atropine increases heart rate and reduces atrioventricular conduction time. Adequate atropine doses can prevent or abolish bradycardia or asystole produced by organophosphorus nerve agents.

Atropine may decrease the degree of partial heart block which can occur after organophosphorus poisoning. In some patients with complete heart block, atropine may accelerate the idioventricular rate; in others, the rate is stabilized. In some patients with conduction defects, atropine may cause paradoxical atrioventricular (A-V) block and nodal rhythm.

Atropine will not act on the neuromuscular junction and has no effect on muscle paralysis or weakness, fasciculations or tremors; pralidoxime is intended to treat these symptoms. Systemic doses of atropine slightly raise systolic and lower diastolic pressures and can produce significant postural hypotension. Such doses also slightly increase cardiac output and decrease central venous pressure.

Atropine can dilate cutaneous blood vessels, particularly the "blush" area (atropine flush), and may inhibit sweating, thereby causing hyperthermia, particularly in a warm environment or with exercise [see Warnings and Precautions(5.2) ]. Pralidoxime Chloride Pralidoxime chloride has its most critical effect in relieving respiratory muscle paralysis. Because pralidoxime chloride is less effective in relieving depression of the respiratory center, atropine is always required concomitantly to block the effect of accumulated acetylcholine at this site.

Pralidoxime chloride has a minor role in relieving muscarinic signs and symptoms, such as salivation or bronchospasm. ATNAA temporarily increases blood pressure, a known effect of pralidoxime chloride. In a study of 24 healthy young adults administered a single dose of atropine and pralidoxime chloride auto-injector intramuscularly (approximately 9 mg/kg pralidoxime chloride), diastolic blood pressure increased from baseline by 11 ± 14 mm Hg (mean ± SD), and systolic blood pressure increased by 16 ± 19 mm Hg, at 15 minutes post-dose.

Blood pressures remained elevated at these approximate levels through one hour post-dose, began to decrease at two hours post-dose, and…

🧬 Mechanism of Action 132 words

12.1Mechanism of Action Atropine Atropine competitively blocks the effects of acetylcholine, including excess acetylcholine due to organophosphorus nerve agent poisoning, at muscarinic cholinergic receptors on smooth muscle, cardiac muscle, secretory gland cells, and in peripheral autonomic ganglia and the central nervous system. Pralidoxime Chloride Pralidoxime chloride reactivates acetylcholinesterase which has been inactivated by phosphorylation due to susceptible organophosphorus nerve agents having anticholinesterase activity .

However, pralidoxime chloride does not reactivate acetylcholinesterase inactivated by all organophosphorus nerve agents (e.g. soman). Pralidoxime chloride cannot reactivate phosphorylated acetylcholinesterases that have undergone a further chemical reaction known as "aging." Reactivated acetylcholinesterase hydrolyzes excess acetylcholine resulting from organophosphorus nerve agent poisoning to help restore impaired cholinergic neural function. Reactivation is clinically important because only a small proportion of active acetylcholinesterase is needed to maintain vital functions.

📦 How Supplied / Storage and Handling 104 words

16 HOW SUPPLIED/STORAGE AND HANDLING Each single-dose ATNAA autoinjector contains atropine (2.1 mg/0.7 mL; colorless to yellow solution, visible in front chamber) and pralidoxime chloride (600 mg/2mL, equivalent to pralidoxime 476.6 mg/2 mL; colorless to yellow solution, not visible in rear chamber). ATNAA, NDC-11704-777-01, is supplied through the Directorate of Medical Materiel, Defense Supply Center, Philadelphia. Each ATNAA is supplied in a pouch that provides protection from light.

Store between 20ºC to 25ºC (68 ºF to 77ºF); excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF) [See USP Controlled Room Temperature]. Not made with natural rubber latex. Keep from freezing.

Protect from light.

📦 Storage and Handling 36 words

Store between 20ºC to 25ºC (68 ºF to 77ºF); excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF) [See USP Controlled Room Temperature]. Not made with natural rubber latex. Keep from freezing. Protect from light.

📋 Description ~1 min read

11 DESCRIPTION Each prefilled ATNAA is a single-dose autoinjector that provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist, and pralidoxime chloride, a cholinesterase reactivator, in a self-contained unit, specifically designed for automatic self- or buddy-administration by military personnel. When activated, each ATNAA injection delivers the following: 2.1 mg of atropine in 0.7 mL of sterile, pyrogen-free solution containing 12.47 mg glycerin, not more than 2.8 mg phenol, 3.05 mg sodium citrate dihydrate, 3.5 mg citric acid monohydrate, and Water for Injection.

The pH range is 4.0 – 5.0. 600 mg of pralidoxime chloride equivalent to 476.6 mg of pralidoxime in 2 mL of 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 ATNAA has been activated, the empty autoinjector should be disposed of properly [see Dosage and Administration (2.2) ] . It cannot be refilled, nor can the protruding needle be retracted.

Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, with activity due almost entirely to the levo isomer of the drug.

Chemically, atropine is designated as 1αH,5αH-Tropan-3α-ol (±)-tropate. Its empirical formula is C 17 H 23 NO 3 and its structural formula is as follows: Pralidoxime chloride 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 C 7 H 9 CIN 2 O and its structural formula is indicated above. Chemical Structure

💬 Information for Patients 84 words

17 PATIENT COUNSELING INFORMATION Use by Military Personnel ATNAA is intended for use by Military Personnel. See the illustrated Instruction Sheet for Military Personnel . Seek Definitive Medical Care If feasible and appropriate, advise service member that ATNAA is an initial emergency treatment, that they need additional care at a healthcare facility.

Avoid Overheating If feasible and appropriate, advise the service member to avoid a hot environment and excessive physical activity since ATNAA can inhibit sweating which can lead to overheating and heat injury.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.