FDA

Atropine Sulfate

Approved 29 Nov 2024Intravenous, Intramuscular, Subcutaneous, Intraosseous, EndotrachealSolution

The FDA lists this product in 32 strengths and forms.

Indications

Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life threatening muscarinic effects. (1)

Contraindications

None. None. (4)

Warnings and precautions

Hypersensitivity (5.1) Worsening of Ischemic Heart Disease (5.2) Acute Glaucoma (5.3) Pyloric obstruction (5.4) Complete urinary retention (5.5) Viscid plugs (5.6)

5.1Hypersensitivity

Atropine may cause anaphylaxis.

5.2Worsening of Ischemic Heart Disease

In patients with ischemic heart disease, the total dose should be restricted to 2 to 3 mg (maximum 0.03 to 0.04 mg/kg) to avoid atropine-induced tachycardia, increased myocardial oxygen demand and the potential for worsening cardiac ischemia or increasing infarction size.

5.3Acute Glaucoma

Atropine may precipitate acute glaucoma.

5.4Pyloric Obstruction

Atropine may convert partial organic pyloric stenosis into complete obstruction.

5.5Complete Urinary Retention

Atropine may lead to complete urinary retention in patients with prostatic hypertrophy.

FDA

Atropine Sulfate

Approved 29 Nov 2024Intravenous, Intramuscular, Subcutaneous, Intraosseous, EndotrachealSolution

The FDA lists this product in 32 strengths and forms.

Official labelAsk Osler about it

Indications

Contraindications

None. None. (4)

Warnings and precautions

Hypersensitivity (5.1) Worsening of Ischemic Heart Disease (5.2) Acute Glaucoma (5.3) Pyloric obstruction (5.4) Complete urinary retention (5.5) Viscid plugs (5.6)

5.1Hypersensitivity

Atropine may cause anaphylaxis.

5.2Worsening of Ischemic Heart Disease

5.3Acute Glaucoma

Atropine may precipitate acute glaucoma.

5.4Pyloric Obstruction

Atropine may convert partial organic pyloric stenosis into complete obstruction.

5.5Complete Urinary Retention

Atropine may lead to complete urinary retention in patients with prostatic hypertrophy.

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Limited available data with Atropine Sulfate Injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes ( see Data ). There are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events ( see Clinical Considerations ). Animal reproduction studies have not been conducted with Atropine Sulfate Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. Clinical Considerations Disease -associated maternal and/or embryo/fetal risk Severe or life-threatening muscarinic events such as acute organophosphate poisoning and symptomatic bradycardia are medical emergencies in pregnancy which can be fatal if left untreated.

Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of atropine on the fetus. Data Human Data No adequate and well-controlled studies are available regarding use of atropine in pregnant women. In a cohort study of 401 pregnancies in the first trimester and 797 pregnancies in the second or third trimester, atropine use was not associated with an increased risk of congenital malformation.

In a surveillance study, 381 newborns were exposed to atropine during the first trimester; 18 major birth defects were observed when 16 were expected. No specific pattern of major birth defects was identified. In another surveillance study of 50 pregnancies in the first trimester, atropine use was not associated with an increased risk of malformations. Methodological limitations of these observational studies including the inability to control for the dosage and timing of atropine exposure, underlying maternal disease, or concomitant maternal drug use, cannot definitively establish or exclude any drug-associated risk during pregnancy.

Atropine Sulfate

Indications

Contraindications

Warnings and precautions

5.1Hypersensitivity

5.2Worsening of Ischemic Heart Disease

5.3Acute Glaucoma

5.4Pyloric Obstruction

5.5Complete Urinary Retention

Two medicines in one question?

Atropine Sulfate

Indications

Contraindications

Warnings and precautions

5.1Hypersensitivity

5.2Worsening of Ischemic Heart Disease

5.3Acute Glaucoma

5.4Pyloric Obstruction

5.5Complete Urinary Retention

Two medicines in one question?

5.6Viscid Plugs

5.7Benzyl Alcohol

Interactions

7.1Mexiletine Atropine Sulfate

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Composition

Strengths and forms

Official product information

At a glance