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Atropine Sulfate Injection, USP
For intravenous use
INDICATIONS AND USAGE
Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Tachycardia: When the recurrent use of atropine is essential in patients with coronary artery disease, the total dose should be restricted to 2 to 3 mg (max 0.03 to 0.04 mg/kg) to avoid the detrimental effects of atropine-induced tachycardia on myocardial oxygen demand.
Acute Glaucoma: Atropine may precipitate acute glaucoma.
Pyloric Obstruction: Atropine may convert partial organic pyloric stenosis into complete obstruction.
Complete Urinary Retention: Atropine may lead to complete urinary retention in patients with prostatic hypertrophy.
Viscid Plugs: Atropine may cause inspissation of bronchial secretions and formation of viscid plugs in patients with chronic lung disease.
Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur. Anhidrosis can produce heat intolerance. Constipation and difficulty in micturition may occur in elderly patients. Hypersensitivity reactions have been observed.
Mexiletine: Atropine Sulfate Injection decreased the rate of mexiletine absorption.
USE IN SPECIFIC POPULATIONS
Pregnancy: It is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity.
Nursing Mothers: Trace amounts of atropine was found in breast milk. The clinical impact is not known.
Pediatric Use: Recommendations for use in pediatric patients are not based on clinical trials.
Geriatric Use: Dose selection for an elderly patient should be cautious.
The fatal adult dose of atropine is not known. In pediatric populations, 10 mg or less may be fatal.
Atropine is not removed by dialysis.
Pharmacokinetics - Specific Populations
The elimination half-life of atropine is more than doubled in children under two years and the elderly (>65 years old) compared to other age groups.
For additional safety information, please see Full Prescribing Information.
You are encouraged to report adverse drug events to American Regent Inc., at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or by calling 1-800-FDA-1088.
REF – 0845 9/2021