ATROPEN Auto-Injector .25 mg/.3mL

atropine · INJECTION · Meridian Medical Technologies LLC

No Recall HistoryCurrently in Shortage

Plain English

ATROPEN Auto-Injector is a injection containing atropine at .25 mg/.3mL, taken intramuscular. Manufactured by Meridian Medical Technologies LLC.

Key Facts

Brand Name: ATROPEN Auto-Injector
Generic Name: atropine
NDC Code (Product): 11704-107
Manufacturer: Meridian Medical Technologies LLC
Strength: .25 mg/.3mL
Dosage Form: INJECTION
Route: INTRAMUSCULAR
Marketing Status
Application #: NDA017106
Drug Class: Anticholinergic [EPC]; Cholinergic Muscarinic Antagonist [EPC]
Marketing Start: 09/17/2004

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective620 reports

off label use569 reports

diarrhoea560 reports

hypotension496 reports

nausea482 reports

death446 reports

fatigue428 reports

dyspnoea412 reports

bradycardia386 reports

vomiting368 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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 & 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 ) 2.1 Important 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 …

Contraindications

4 CONTRAINDICATIONS None. None.

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 ) 7.1 Pralidoxime 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. 7.2 Barbiturates Barbiturates are potentiated by the anticholinesterases; therefore, barbiturates should be used cautiously in the treatment of convulsions resulting from exposure to atropine.

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 repo…

Frequently Asked Questions

What is ATROPEN Auto-Injector used for?

ATROPEN Auto-Injector contains atropine. It is a injection taken intramuscular. Consult your doctor for specific uses.

Is ATROPEN Auto-Injector a controlled substance?

ATROPEN Auto-Injector is not classified as a controlled substance by the DEA.

What is the generic name for ATROPEN Auto-Injector?

The generic name for ATROPEN Auto-Injector is atropine. There are 12 other brand versions of atropine.

What is the NDC code for ATROPEN Auto-Injector .25 mg/.3mL?

The NDC (National Drug Code) for ATROPEN Auto-Injector .25 mg/.3mL is 11704-107, listed by Meridian Medical Technologies LLC.

Product NDC

11704-107

Package NDC

11704-107-01

Other Atropine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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