atropine sulfate injection, USP Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION.
ATROPINE SULFATE INJECTION, for intravenous use
Initial U.S. Approval: 1960

INDICATIONS AND USAGE

Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life threatening muscarinic effects. (1)

DOSAGE AND ADMINISTRATION

•
For intravenous administration (2.1)
•
Titrate according to heart rate, PR interval, blood pressure and symptoms (2.1)
•
Adult dosage
-
Antisialagogue or for antivagal effects: Initial single dose of 0.5 mg to 1 mg (2.2)
-
Antidote for organophosphorus or muscarinic mushroom poisoning: Initial single dose of 2 mg to 3 mg, repeated every 20-30 minutes (2.2)
-
Bradyasystolic cardiac arrest: 1 mg dose, repeated every 3-5 minutes if asystole persists (2.2)
•
Patients with Coronary Artery Disease: Limit the total dose to 0.03 mg/kg to 0.04 mg/kg (2.4)

DOSAGE FORMS AND STRENGTHS

•
0.05 mg/mL injection in Ansyr™ Plastic Syringe (3)
•
0.1 mg/mL injection in Ansyr™ Plastic Syringe (3)
•
0.1 mg/mL injection in LifeShield™ Abboject™ Glass Syringe (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

  • Tachycardia (5.1)
  • Glaucoma (5.2)
  • Pyloric obstruction (5.3)
  • Worsening urinary retention (5.4)
  • Viscid bronchial plugs (5.5)

ADVERSE REACTIONS

Most adverse reactions are directly related to atropine's antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur with chronic administration of therapeutic doses. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Mexiletine: Decreases rate of mexiletine absorption. (7.1)

Revised: 6/2020

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION.
ATROPINE SULFATE INJECTION, for intravenous use
Initial U.S. Approval: 1960

INDICATIONS AND USAGE

Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life threatening muscarinic effects. (1)

DOSAGE AND ADMINISTRATION

•
For intravenous administration (2.1)
•
Titrate according to heart rate, PR interval, blood pressure and symptoms (2.1)
•
Adult dosage
-
Antisialagogue or for antivagal effects: Initial single dose of 0.5 mg to 1 mg (2.2)
-
Antidote for organophosphorus or muscarinic mushroom poisoning: Initial single dose of 2 mg to 3 mg, repeated every 20-30 minutes (2.2)
-
Bradyasystolic cardiac arrest: 1 mg dose, repeated every 3-5 minutes if asystole persists (2.2)
•
Patients with Coronary Artery Disease: Limit the total dose to 0.03 mg/kg to 0.04 mg/kg (2.4)

DOSAGE FORMS AND STRENGTHS

•
0.05 mg/mL injection in Ansyr™ Plastic Syringe (3)
•
0.1 mg/mL injection in Ansyr™ Plastic Syringe (3)
•
0.1 mg/mL injection in LifeShield™ Abboject™ Glass Syringe (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

  • Tachycardia (5.1)
  • Glaucoma (5.2)
  • Pyloric obstruction (5.3)
  • Worsening urinary retention (5.4)
  • Viscid bronchial plugs (5.5)

ADVERSE REACTIONS

Most adverse reactions are directly related to atropine's antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur with chronic administration of therapeutic doses. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Mexiletine: Decreases rate of mexiletine absorption. (7.1)

Revised: 6/2020

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