ATROPEN Auto-Injector atropine 1 mg/.7mL Injection, 7 mL — NDC 11704-105-01 (Billing 11704-0105-01)
This is a package of 7 mL of ATROPEN Auto-Injector atropine 1 mg/.7mL Injection from Meridian Medical Technologies LLC, marketed since Jun 2003 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 11704-105-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 11704 labeler · 105 product · 01 package
- Package marketed since
- Jun 19, 2003
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 7 mL per package
- Barcode (UPC)
- 0311704101017
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 063332
- GCN: 99082
- GPI-14 (Medi-Span): 4910101010D530
- HICL (First Databank): 002004
- AHFS class code: 12:08.08.00
- RxCUI (RxNorm): 1190536
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Anticholinergic class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It depends on the form. The injection is used in emergencies like poisonings and slow heart rhythms, and around surgery to reduce secretions. The eye drops and ointment dilate the...
- Injections are given by a healthcare professional, usually into a vein. ATROPEN is injected into the outer thigh in an emergency, and you should seek medical care right away. Eye p...
- Dry mouth, blurred vision, light sensitivity, a faster heartbeat, flushing, dizziness, and constipation are common. These come from atropine's drying effects. Injection site pain c...
- Seek emergency help for trouble breathing, swelling or a spreading rash, chest pain, a racing or irregular heartbeat, hallucinations, or a high fever with no sweating. Eye pain wit...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Atropine — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per 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. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 11704-0105-01 You're viewing this Main listing | .7 mL in 1 SYRINGE, PLASTIC | 2003-06-19 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| ATROPEN Auto-Injector 1 mg/.7mLthis 11704-0105-01 | Meridian | 7 ml | — | — | FDA listed | — |
| Atropine Sulfate Injection USP, 1 mg/0.7 mL 1 mg/.7mL 71053-0591-01 | Rafa | 7 ml | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Atropine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII N762921K75
A colorless, odorless gas that makes up most of the air we breathe. In medicines, it's used as a packaging gas or propellant to protect products from oxidation and maintain freshness.
-
UNII 339NCG44TV
Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
-
UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Meridian Medical Technologies LLC labeler code 11704
- ATROPEN Auto-Injector atropine 2 mg/.7mL Injection NDC 11704-101-01
- ATROPEN Auto-Injector atropine .5 mg/.7mL Injection NDC 11704-104-01
- ATROPEN Auto-Injector atropine 2 mg/.7mL Injection NDC 11704-106-01
- ATROPEN Auto-Injector atropine .25 mg/.3mL Injection NDC 11704-107-01
- Diazepam 10 mg/2mL Injection NDC 11704-600-01
- DuoDote atropine and pralidoxime chloride Kit NDC 11704-620-01
- ATNAA atropine and pralidoxime chloride Auto-Injector Kit NDC 11704-777-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients. ATROPEN is a cholinergic muscarinic antagonist indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION ATROPEN is a single-dose autoinjector intended as an initial treatment of the muscarinic symptoms of insecticide or nerve agent poisonings; definitive medical care should be sought immediately. ( 2.1 ) Dosage is dependent on weight. ( 2.2 ) Dosage for Mild Symptoms: If the patient experiences two or more mild symptoms, administer one injection intramuscularly into the mid-lateral thigh.
If, at any time after the first dose, the patient develops any of the severe symptoms, administer two additional injections intramuscularly in rapid succession. ( 2.2 ) Dosage for Severe Symptoms: If the patient is either unconscious or has any of the severe symptoms, immediately administer three injections intramuscularly into the patient's mid-lateral thigh in rapid succession. ( 2.2 )
2.1Important Administration Information It is recommended that three ATROPEN autoinjectors be available for use in each patient at risk for organophosphorus or carbamate poisoning; one (1) for mild symptoms plus two (2) more for severe symptoms [see Dosage and Administration ( 2.2 )] . Different dose strengths of ATROPEN are available depending on the patient's weight. ATROPEN should be used by persons who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication, but may be administered by a caregiver or self-administration if a trained provider is not available.
Only administer ATROPEN to patients experiencing symptoms of organophosphorus or carbamate poisoning in a situation where exposure is known or suspected. ATROPEN is a single-dose autoinjector intended as an initial treatment of the muscarinic symptoms of insecticide or nerve agent poisonings (generally breathing difficulties due to increased secretions); definitive medical care should be sought immediately. ATROPEN should be administered as soon as symptoms of organophosphorus or carbamate poisoning appear.
In severe poisonings, it may also be desirable to concurrently administer an anticonvulsant (preferably a benzodiazepine) if seizure is suspected in the unconscious individual since the classic tonic-clonic jerking may not be apparent due to the effects of the poison. A cholinesterase reactivator such as pralidoxime may serve as an important adjunct to atropine therapy. Close supervision of all treated patients 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 Different dose strengths of ATROPEN are available depending on the patient's age and weight (see Table 1 ). Table 1: Recommended Dose Strength per ATROPEN Injection Age and Body Weight Strength of each ATROPEN Injection Adults and pediatric patients weighing over 41 kg (90 pounds) (generally over 10 years of age) ATROPEN 2 mg (green label) Pediatric patients weighing 18 kg to 41 kg (40 pounds to 90 pounds) (generally 4 to 10 years of age) ATROPEN 1 mg (red label) Pediatric patients weighing 7 kg to 18 kg (15 pounds to 40 pounds) (generally 6 months to 4 years of age) ATROPEN 0.5 mg (blue label) Pediatric patients weighing less than 7 kg (15 pounds) (generally less than 6 months of age) ATROPEN 0.25 mg (yellow label) Dosage for Mild Symptoms First Dose: If the patient experiences two or more mild symptoms of nerve agent or insecticide exposure listed in Table 2 , administer one (1) ATROPEN injection intramuscularly into the mid-lateral (outer) thigh.
Additional Doses: If, at any time after receiving the first ATROPEN injection, the patient has any of the severe symptoms listed in Table 2 , administer two (2) additional ATROPEN injections in rapid succession. If possible, a person other than the patient should administer the second and third ATROPEN injections. Wait 10 to 15 minutes for ATROPEN to take effect.
If after 10 to 15 minutes, the patient does not dev… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: Each single-dose ATROPEN autoinjector contains a clear sterile solution of atropine. Four strengths of ATROPEN are available 0.25 mg/0.3 mL (yellow label): 0.21 mg atropine (equivalent to 0.25 mg atropine sulfate) in 0.3 mL 0.5 mg/0.7 mL (blue label): 0.42 mg atropine (equivalent to 0.5 mg atropine sulfate) in 0.7 mL 1 mg/0.7 mL (red label): 0.84 mg atropine (equivalent to 1 mg atropine sulfate) in 0.7 mL 2 mg/0.7 mL (green label): 1.67 mg atropine (equivalent to 2 mg atropine sulfate) in 0.7 mL Injection: Each prefilled single-dose autoinjector contains atropine in a self-contained unit, and is available in four strengths 0.25 mg/0.3 mL, 0.5 mg/0.7 mL, 1 mg/0.7 mL, and 2 mg/0.7 mL.
( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Cardiovascular (CV) Risks: Tachycardia, palpitations, premature ventricular contractions, flutter, fibrillation, etc. Use caution in patients 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: May precipitate in patient with bladder outflow obstruction. ( 5.4 ) Pyloric Stenosis: May precipitate complete obstruction.
( 5.5 ) Exacerbation of Chronic Lung Disease: Atropine may cause inspissation of bronchial secretions and formation of dangerous viscid plugs in individuals with chronic lung disease; monitor respiratory status. ( 5.6 ) Hypersensitivity: Atropine may cause hypersensitivity reactions, including anaphylaxis. ( 5.7 )
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 [see Adverse Reactions ( 6 )] . In patients 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.
ATROPEN should be used with caution in patients with known cardiovascular disease or cardiac conduction problems.
5.2Heat Injury ATROPEN 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 Adverse Reactions ( 6 ), Overdosage ( 10 )] .
5.3Acute Glaucoma ATROPEN may cause acute glaucoma and should be administered with caution in patients at risk for acute glaucoma or who have severe narrow angle glaucoma. Monitor for signs and symptoms of intraocular pressure, as appropriate.
5.4Urinary Retention ATROPEN may cause urinary retention and should be administered with caution to patients with clinically significant bladder outflow obstruction.
5.5Pyloric Stenosis ATROPEN may cause complete pyloric obstruction in patients with partial pyloric stenosis. These patients should be monitored for gastrointestinal symptoms following administration of ATROPEN.
5.6Exacerbation of Chronic Lung Disease Atropine may cause thickening 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 ATROPEN.
5.7Hypersensitivity Atropine can cause hypersensitivity reactions, including anaphylactic reactions [see Adverse Reactions ( 6 )] . Medical supervision is necessary in patients who have had previous anaphylactic reactions to atropine and require treatment for organophosphorus or nerve agent poisoning.
🤒 Adverse Reactions ▾
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 )] Hypersensitivity [see Warnings and Precautions ( 5.7 )] The following adverse reactions associated with the use of atropine 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. Mild to moderate pain may be experienced at the site of injection. Common adverse reactions of atropine include dryness of mouth, blurred vision, dry eyes, photophobia, confusion, headache, dizziness, tachycardia, palpitations, flushing, urinary hesitance or retention, constipation, abdominal pain, abdominal distention, nausea, vomiting, loss of libido, and impotency.
( 6 ) 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. Adverse Reactions at Recommended Doses 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 scarlatiniform rash have also been reported. Adverse cardiac reactions, including arrhythmias and myocardial infarction, have been reported with atropine [see Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.2 )].
Larger doses of atropine may produce central nervous system effects such as restlessness, tremor, fatigue, locomotor difficulties, delirium, hallucinations, depression and ultimately, medullary paralysis and death [see Overdosage ( 10 )] . Large doses can also lead to circulatory collapse. In such cases, blood pressure declines and death due to respiratory failure may ensue following paralysis and coma.
Hypersensitivity Hypersensitivity reactions will occasionally occur with atropine; these are usually seen as skin rashes and may progress to exfoliation. Anaphylactic reaction and laryngospasm have also occurred. Pediatric Patients Adverse events seen in pediatrics are similar to those that occur in adult patients although central nervous system complaints are often seen earlier and at lower doses.
Additional Adverse Reactions to Atropine by Organ System The following adverse reactions were reported in published literature for atropine in both adults and children: Cardiovascular : Sinus tachycardia, supraventricular tachycardia, junctional tachycardia, ventricular tachycardia, bradycardia, palpitations, ventricular arrhythmia, ventricular flutter, ventricular fibrillation, atrial arrhythmia, atrial fibrillation, atrial ectopic beats, ventricular premature contractions, bigeminal beats, trigeminal beats, nodal extrasystole, ventricular extrasystole, supraventricular extrasystole, asystole, cardiac syncope, prolongation of sinus node recovery time, cardiac dilation, left ventricular failure, myocardial infarction, intermittent nodal rhythm (no P wave), prolonged P wave, shortened PR segment, R on T phenomenon, shortened RT duration, widening and flattening of QRS complex, prolonged QT interval, flattening of T wave, repolarization abnormalities, altered ST-T waves, retrograde conduction, transie… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Pralidoxime: The signs of atropinization (flushing, mydriasis, tachycardia, dryness of the mouth and nose) may occur earlier than might be expected than when atropine is used alone. ( 7.1 ) Barbiturates: Atropine may potentiate the effect of barbiturates. ( 7.2 )
7.1Pralidoxime When atropine and pralidoxime are used together, the signs of atropinization (flushing, mydriasis, tachycardia, dryness of the mouth and nose) may occur earlier than might be expected when atropine is used alone because pralidoxime may potentiate the effect of atropine. Excitement and manic behavior immediately following recovery of consciousness have been reported in several cases. However, similar behavior has occurred in cases of organophosphate poisoning that were not treated with pralidoxime.
7.2Barbiturates Barbiturates are potentiated by the anticholinesterases; therefore, barbiturates should be used cautiously in the treatment of convulsions resulting from exposure to atropine.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Geriatric patients 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 in pregnant women. Adequate animal reproduction studies have not been conducted with atropine.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
8.2Lactation Risk Summary Atropine has been reported to be excreted in human milk. There are no data on the effects of atropine on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ATROPEN and any potential adverse effects on the breastfed infant from ATROPEN or from the underlying maternal condition.
8.4Pediatric Use A review of published literature supports the safety and effectiveness of atropine in the setting of organophosphate insecticide poisoning in all pediatric age groups. Adverse events seen in pediatric patients treated with atropine are similar to those that occur in adult patients, although central nervous system effects are often seen earlier and at lower doses [see Adverse Reactions ( 6 )]. Overheating (atropine fever) caused by suppression of sweat gland activity may be more pronounced in infants and small children.
Extreme hyperthermia in a newborn has been reported with as little as 0.065 mg orally.
8.5Geriatric Use Geriatric patients may be more susceptible to the effects of atropine. Because of the longer half-life of atropine in geriatric patients, they may require less frequent doses after the initial dose [see Clinical Pharmacology ( 12.3 )].
🤰 Pregnancy ▾
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 in pregnant women. Adequate animal reproduction studies have not been conducted with atropine.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use A review of published literature supports the safety and effectiveness of atropine in the setting of organophosphate insecticide poisoning in all pediatric age groups. Adverse events seen in pediatric patients treated with atropine are similar to those that occur in adult patients, although central nervous system effects are often seen earlier and at lower doses [see Adverse Reactions ( 6 )]. Overheating (atropine fever) caused by suppression of sweat gland activity may be more pronounced in infants and small children.
Extreme hyperthermia in a newborn has been reported with as little as 0.065 mg orally.
🧓 Geriatric Use ▾
8.5Geriatric Use Geriatric patients may be more susceptible to the effects of atropine. Because of the longer half-life of atropine in geriatric patients, they may require less frequent doses after the initial dose [see Clinical Pharmacology ( 12.3 )].
🆘 Overdosage ▾
10 OVERDOSAGE Symptoms 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.
Treatment 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 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 ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Atropine competitively blocks the effects of acetylcholine, including excess acetylcholine due to organophosphorus poisoning, at muscarinic cholinergic receptors on smooth muscle, cardiac muscle, secretory gland cells, and in peripheral autonomic ganglia and the central nervous system.
12.2Pharmacodynamics Atropine reduces secretions in the mouth and respiratory passages, relieves airway constriction, and may reduce centrally-mediated respiratory paralysis. In severe organophosphorus 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 block and nodal rhythm.
Atropine will not act on the neuromuscular junction and has no effect on muscle paralysis or weakness, fasciculations or tremors. Atropine is not dependable in reversing the weakness or paralysis of the respiratory muscles. Severe difficulty in breathing requires artificial respiration in addition to the use of atropine.
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), may cause atropine “fever” due to suppression of sweat gland activity especially in infants and small children and may inhibit sweating, thereby causing hyperthermia, particularly in a warm environment or with exercise [see Warnings and Precautions ( 5.2 )].
12.3Pharmacokinetics Atropine is well absorbed after intramuscular administration. Following 1.67 mg atropine given intramuscularly to adults by the 2 mg ATROPEN delivery system, the peak concentration (C max ) is 9.6 ± 1.5 (mean ± SEM) ng/mL reached between 3-60 minutes (T max ). The protein binding of atropine is 14 to 22% in plasma.
Atropine is distributed throughout the various body tissues and fluids. Much of the drug is metabolized by enzymatic hydrolysis, particularly in the liver. Atropine has been reported to be excreted in human milk [see Use in Specific Populations ( 8.2 )] .
The unchanged drug excreted by urine is approximately 13 to 50%. Specific Populations Gender The AUC (0-inf) and C max values for atropine are 15% higher in females than males. The half-life of atropine is approximately 20 minutes shorter in females than males.
Geriatric The half-life of intravenous atropine is 3.0 ± 0.9 (mean ± SD) hours in adults and 10.0 ± 7.3 (mean ± SD) hours in geriatric patients (65 to 75 years of age). Pediatric The half-life of intravenous atropine in pediatric subjects under 2 years is 6.9 ± 3.3 (mean ± SD) hours; in children over 2 years, the half-life is 2.5 ± 1.2 (mean ± SD) hours. Renal and Hepatic Impairment The pharmacokinetics of atropine has not been evaluated in subjects with renal or hepatic impairment.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Atropine competitively blocks the effects of acetylcholine, including excess acetylcholine due to organophosphorus poisoning, at muscarinic cholinergic receptors on smooth muscle, cardiac muscle, secretory gland cells, and in peripheral autonomic ganglia and the central nervous system.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied ATROPEN is a prefilled single-dose autoinjector that contains a clear solution and is supplied in the following package configurations: Table 3: ATROPEN Package Configurations NDC Number Package Configuration Product Description Delivered Dose (atropine) NDC 11704-107-01 Carton of 1 ATROPEN 0.25 mg (yellow label) 0.21 mg/0.3 mL (equivalent to 0.25 mg/0.3 mL of atropine sulfate) NDC 11704-104-01 Carton of 1 ATROPEN 0.5 mg (blue label) 0.42 mg/0.7 mL (equivalent to 0.5 mg/0.7 mL of atropine sulfate) NDC 11704-105-01 Carton of 1 ATROPEN 1 mg (red label) 0.84 mg/0.7 mL (equivalent to 1 mg/0.7 mL of atropine sulfate) NDC 11704-106-01 Carton of 1 ATROPEN 2 mg (green label) 1.67 mg/0.7 mL (equivalent to 2 mg/0.7 mL of atropine sulfate) NDC 11704-101-01 (For military use only) 1 Autoinjector ATROPEN 2 mg 1.67 mg/0.7 mL (equivalent to 2 mg/0.
7 mL of atropine sulfate)
16.2Storage and Handling Store between 20ºC to 25ºC (68ºF 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. After the ATROPEN autoinjector has been activated, the empty container should be disposed of properly. It cannot be refilled, nor can the protruding needle be retracted.
📦 Storage and Handling ▾
16.2Storage and Handling Store between 20ºC to 25ºC (68ºF 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. After the ATROPEN autoinjector has been activated, the empty container should be disposed of properly. It cannot be refilled, nor can the protruding needle be retracted.
📋 Description ▾
11 DESCRIPTION Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration. When activated, the ATROPEN 0.25 mg autoinjector delivers 0.21 mg atropine base (equivalent to 0.25 mg atropine sulfate) in 0.3 mL of sterile pyrogen-free solution containing citrate buffer, sodium chloride, and Water for Injection. The pH range is 4.0 to 5.0.
When activated, the ATROPEN 0.5 mg autoinjector delivers 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg autoinjector delivers 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg autoinjector delivers 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg ATROPEN autoinjector delivers atropine in 0.7 mL of sterile pyrogen-free solution containing 12.5 mg glycerin, 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 to 5.0.
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 1 αH ,5 αH -Tropan-3α-ol (±) tropate (ester). Its empirical formula is C 17 H 23 NO 3 and its structural formula is as follows: Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Instructions for Use ). Administration Information Appropriate steps must be taken to ensure that users understand the indications for and use of ATROPEN, including review of symptoms of poisoning and operation of ATROPEN [see Dosage and Administration ( 2 )] . Protection against Organophosphorus Poisoning Individuals should not rely solely upon atropine to provide complete protection from chemical nerve agents and insecticide poisoning.
Primary protection against exposure to chemical nerve agents and insecticide poisoning is the wearing of protective garments including masks designed specifically for this use. Seek Definitive Medical Care If feasible and appropriate, advise patients that ATROPEN is an initial emergency treatment, that they need additional care at a healthcare facility. Avoid Overheating If feasible and appropriate, advise the patient to avoid a hot environment and excessive physical activity since atropine can inhibit sweating which can lead to overheating and heat injury.
Manufactured by: Meridian Medical Technologies ® , LLC St. Louis, MO 63146
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Atropine is well absorbed after intramuscular administration. Following 1.67 mg atropine given intramuscularly to adults by the 2 mg ATROPEN delivery system, the peak concentration (C max ) is 9.6 ± 1.5 (mean ± SEM) ng/mL reached between 3-60 minutes (T max ). The protein binding of atropine is 14 to 22% in plasma.
Atropine is distributed throughout the various body tissues and fluids. Much of the drug is metabolized by enzymatic hydrolysis, particularly in the liver. Atropine has been reported to be excreted in human milk [see Use in Specific Populations ( 8.2 )] .
The unchanged drug excreted by urine is approximately 13 to 50%. Specific Populations Gender The AUC (0-inf) and C max values for atropine are 15% higher in females than males. The half-life of atropine is approximately 20 minutes shorter in females than males.
Geriatric The half-life of intravenous atropine is 3.0 ± 0.9 (mean ± SD) hours in adults and 10.0 ± 7.3 (mean ± SD) hours in geriatric patients (65 to 75 years of age). Pediatric The half-life of intravenous atropine in pediatric subjects under 2 years is 6.9 ± 3.3 (mean ± SD) hours; in children over 2 years, the half-life is 2.5 ± 1.2 (mean ± SD) hours. Renal and Hepatic Impairment The pharmacokinetics of atropine has not been evaluated in subjects with renal or hepatic impairment.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Atropine reduces secretions in the mouth and respiratory passages, relieves airway constriction, and may reduce centrally-mediated respiratory paralysis. In severe organophosphorus 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 block and nodal rhythm.
Atropine will not act on the neuromuscular junction and has no effect on muscle paralysis or weakness, fasciculations or tremors. Atropine is not dependable in reversing the weakness or paralysis of the respiratory muscles. Severe difficulty in breathing requires artificial respiration in addition to the use of atropine.
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), may cause atropine “fever” due to suppression of sweat gland activity especially in infants and small children and may inhibit sweating, thereby causing hyperthermia, particularly in a warm environment or with exercise [see Warnings and Precautions ( 5.2 )].
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No adequate studies regarding the carcinogenic potential of atropine have been conducted. Mutagenesis Studies to assess the mutagenic potential of atropine have not been conducted. Impairment of Fertility In studies in which male rats were orally administered atropine (62.5 to 125 mg/kg) for one week prior to mating and throughout a 5-day mating period with untreated females, a dose-related decrease in fertility was observed.
A no-effect dose for male reproductive toxicity was not established. The lowest dose tested was 300 times (on a mg/m 2 basis) the dose of atropine in a single application of ATROPEN (2 mg). Fertility studies of atropine in females have not been conducted.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No adequate studies regarding the carcinogenic potential of atropine have been conducted. Mutagenesis Studies to assess the mutagenic potential of atropine have not been conducted. Impairment of Fertility In studies in which male rats were orally administered atropine (62.5 to 125 mg/kg) for one week prior to mating and throughout a 5-day mating period with untreated females, a dose-related decrease in fertility was observed.
A no-effect dose for male reproductive toxicity was not established. The lowest dose tested was 300 times (on a mg/m 2 basis) the dose of atropine in a single application of ATROPEN (2 mg). Fertility studies of atropine in females have not been conducted.
📄 Patient Package Insert ▾
Instructions for Use ATROPEN (at-ROW-pen ) (atropine injection) for intramuscular use Self and Caregiver Instructions for Use of ATROPEN Important: Follow these instructions only when ready to use ATROPEN . If possible, a healthcare provider or someone who has been trained to identify and treat the symptoms of nerve agent and insecticide poisoning should give the ATROPEN injection. If a healthcare provider is not available during an emergency, a patient or caregiver might need to give the ATROPEN injection.
Individuals should not rely only on ATROPEN for protection from nerve agent and insecticide poisoning. Exposed persons and caregivers need to wear clothing to protect their skin and goggles and masks to protect their face and eyes when available, to avoid exposure. Step 1 Choose the Correct Dose Adults and children weighing over 90 pounds (41 kg) (generally over 10 years of age 2 mg ATROPEN ( green label ) 2 mg Children weighing 40 pounds to 90 pounds (18 kg to 41 kg) (generally 4 to 10 years of age) 1 mg ATROPEN (red label) 1 mg Children weighing 15 pounds to 40 pounds (7 kg to 18 kg) (generally 6 months to 4 years of age) 0.5 mg ATROPEN (blue label) 0.5 mg Infants weighing less than 15 pounds (7 kg) (generally less than 6 months of age) 0.25 mg ATROPEN (yellow label) 0.25 mg Caution : When the ATROPEN is activated, the needle will quickly extend from the green tip and black tip.
Keep your fingers away from the green tip and black tip . Step 2 Decide if Symptoms are Mild or Severe If nerve agent or insecticide exposure is known or suspected, you may see the following mild and severe symptoms. You may not have all of the symptoms or see all symptoms in others exposed to a nerve agent or certain insecticide poisoning: Mild Symptoms Severe Symptoms - Blurred vision and sore eyes - Excessive, unexplained teary eyes - Excessive, unexplained runny nose - Increase saliva or sudden drooling - Chest tightness or breathing problems - Shaking (tremors) throughout the body or muscle twitching - Nausea and vomiting - Unexplained wheezing, coughing or increase in mucus (phlegm) coming from the lungs - Sudden stomach cramping - Fast heartbeat (tachycardia) or slow heartbeat (bradycardia) - Strange or confused behavior - Severe breathing problems or a large amount of fluid (secretions) coming from the lungs - Severe muscle twitching and general weakness - Problems controlling urine or stool (bowel movement) - Seizures (convulsions) - Passing out (unconsciousness) Symptoms in infants and young children: The mild symptoms excessive, unexplained teary eyes, excessive, unexplained runny nose and increased saliva or sudden drooling , and the severe symptom problems controlling urine or stool (bowel movement) are sometimes seen in healthy infants and young children.
In infants and young children, these symptoms are seen less often than the other mild and severe symptoms listed above. Symptoms must be looked at together when nerve agent or insecticide exposure is known or suspected. The severe symptoms severe muscle twitching and general weakness can happen in infants.
Infants may become drowsy or pass out, with muscle floppiness instead of muscle twitching, soon after exposure to nerve agents or insecticides. Step 3 Treating Mild Symptoms First Dose: Give 1 dose of ATROPEN (1 injection) if you get 2 or more mild symptoms of nerve agent or insecticide exposure. Give the injection in the outer thigh.
Ask a caregiver to check your symptoms to see if they continue or get worse. Get medical help right away . Additional Doses: If, any time after the first injection of ATROPEN, the exposed person gets any of the severe symptoms listed above, give 2 more doses of ATROPEN (2 injections) in the outer thigh quickly one right after the other.
Use a new ATROPEN for each injection. If you have given yourself the first injection, someone else should give you the second and third ATROPEN injections, if possible. Treating Severe Symptoms If you get any of the s… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
Principal Display Panel - 0.25 mg Carton Label NDC 11704-107-01 MERIDIAN MEDICAL TECHNOLOGIES™ ATROPEN ® (atropine injection) 0.25 mg Single-Dose Auto-Injector for Intramuscular Use Only Rx Only For use in Nerve Agent and Insecticide Poisoning Each auto-injector delivers an injection of 0.21 mg/0.3 mL atropine (equivalent to 0.25 mg atropine sulfate), 1.5 mg citric acid monohydrate, 2.0 mg sodium citrate dihydrate and 2.0 mg sodium chloride. Principal Display Panel - 0.25 mg Carton Label
Principal Display Panel - 0.5 mg Carton Label NDC 11704-104-01 MERIDIAN MEDICAL TECHNOLOGIES™ ATROPEN ® (atropine injection) 0.5 mg Single-Dose Auto-Injector for Intramuscular Use Rx Only for use in Nerve Agent and Insecticide Poisoning Each auto-injector delivers an injection of 0.42 mg/0.7mL atropine (equivalent to 0.5 mg atropine sulfate), 12.5 mg glycerin, 2.4 mg citric acid monohydrate, 2.4 mg sodium citrate dihydrate and 2.8 mg phenol. Principal Display Panel - 0.5 mg Carton Label
Principal Display Panel - 1 mg Carton Label NDC 11704-105-01 MERIDIAN MEDICAL TECHNOLOGIES™ ATROPEN ® (atropine injection) 1 mg Single-Dose Auto-Injector for Intramuscular Use Rx Only for use in Nerve Agent and Insecticide Poisoning Each auto-injector delivers an injection of 0.84 mg/0.7mL atropine (equivalent to 1 mg atropine sulfate), 12.5 mg glycerin, 2.7 mg citric acid monohydrate, 2.7 mg sodium citrate dihydrate and 2.8 mg phenol. Principal Display Panel - 1 mg Carton Label
Principal Display Panel - 2 mg Carton Label NDC 11704-106-01 MERIDIAN MEDICAL TECHNOLOGIES™ ATROPEN ® (atropine injection) 2 mg Single-Dose Auto-Injector for Intramuscular Use Rx Only for use in Nerve Agent and Insecticide Poisoning Each auto-injector delivers an injection of 1.67 mg/0.7mL atropine (equivalent to 2 mg atropine sulfate), 12.5 mg glycerin, 3.3 mg citric acid monohydrate, 3.0 mg sodium citrate dihydrate and 2.8 mg phenol. Principal Display Panel - 2 mg Carton Label
Principal Display Panel - 2 mg Auto-Injector Label NDC 11704-101-01 MERIDIAN MEDICAL TECHNOLOGIES™ St. Louis, MO 63146 1-833-739-0945 Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]. Keep from freezing.
NSN 6505-00-926-9083 ATROPEN ® (atropine injection) 2 mg Single-Dose Auto-Injector for Intramuscular Use in Nerve Agent and Insecticide Poisoning Each auto-injector delivers an injection of 1.67 mg/0.7 mL atropine (equivalent to 2 mg atropine sulfate). 1 Remove Yellow Safety 2 Place Green End on outer thigh and push hard till injector functions Rx Only 0002208 NDC 11704-101-01 Principal Display Panel - 2 mg Auto-Injector Label
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
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) | ✓ 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. |