Atropine Injection, 2 Mg

Generic Name: atropine injection, 2 mg

Anticholinergic [EPC]Over-the-Counter (OTC)

Brand Names:

N/a

The Atropine prefilled autoinjector is a single dose, self-contained unit designed for self or caregiver administration. Each 2 mg Atropine autoinjector delivers 1.67 mg atropine (equivalent to 2 mg atropine sulfate) in 0.7 mL of sterile pyrogen-free solution for intramuscular injection. Each 2 mg autoinjector also contains the following inactive ingredients: 3.27 mg citric acid monohydrate (buffer), 12.47 mg glycerin, 2.8 mg phenol, and 3.05 mg sodium citrate dihydrate (buffer).

Overview

The Atropine prefilled autoinjector is a single dose, self-contained unit designed for self or caregiver administration. Each 2 mg Atropine autoinjector delivers 1.67 mg atropine (equivalent to 2 mg atropine sulfate) in 0.7 mL of sterile pyrogen-free solution for intramuscular injection. Each 2 mg autoinjector also contains the following inactive ingredients: 3.27 mg citric acid monohydrate (buffer), 12.47 mg glycerin, 2.8 mg phenol, and 3.05 mg sodium citrate dihydrate (buffer).

Uses

Atropine is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds). Atropine, a cholinergic muscarinic antagonist, is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds) (1).

Dosage

Important Administration Information Three (3) Atropine autoinjectors should be available for use in each patient at risk for nerve agent or organophosphate insecticide poisoning; one (1) for mild symptoms plus two (2) more for severe symptoms [see Dosage and Administration (2.2)]. Only administer Atropine to patients experiencing symptoms of organophosphorus poisoning in a situation where exposure is known or suspected. The Atropine autoinjector is intended as an initial treatment of the muscarinic symptoms of insecticide or nerve agent poisonings as soon as symptoms appear; definitive medical care should be sought immediately.

Side Effects

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.

Interactions

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. Barbiturates Barbiturates are potentiated by the anticholinesterases; therefore, barbiturates should be used cautiously in the treatment of convulsions resulting from exposure to Atropine. Pralidoxime : may potentiate the effect of atropine (7.1).

Warnings

Cardiovascular 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. Atropine should be used with caution in patients with known cardiovascular disease or cardiac conduction problems. None. None (4)

Storage

How Supplied The 2 mg Atropine autoinjector provides atropine base 1.67 mg/0.7 mL (equivalent to atropine sulfate 2 mg/0.7 mL) in a sterile solution for intramuscular injection. The 2 mg Atropine autoinjector is supplied as 480 self-contained single-dose autoinjectors per box (NDC 71053-592-01).

Frequently Asked Questions

What is Atropine Injection, 2 Mg used for?

Atropine is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds). Atropine, a cholinergic muscarinic antagonist, is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds) (1).

What are the side effects of Atropine Injection, 2 Mg?

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.

What are the important warnings for Atropine Injection, 2 Mg?

Cardiovascular 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. Atropine should be used with caution in patients with known cardiovascular disease or cardiac conduction problems. None. None (4)

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.