FDA
Atropine Sulfate
The FDA lists this product in 32 strengths and forms.
Indications
Atropine sulfate is given parenterally as a preanesthetic medication to decrease salivation and bronchial secretions. It is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. For ureteral and biliary colic, atropine sulfate given with morphine may be indicated. Atropine sulfate is indicated for relaxation of the upper gastrointestinal tract and colon during hypotonic radiography. Atropine is used as an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain species of aminata and in poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare “nerve gases”.
Large doses relieve the muscarine-like symptoms and some of the central nervous system manifestations.
Contraindications
Conditions at which inhibition of postganglionic cholinergic nerves are undesirable, such as glaucoma and tachycardia. Also contraindicated in asthma, because the parenteral dose which might relieve asthma would have an excessive drying effect upon mucous plugs in the bronchi. Prostatic hypertrophy, while not a contraindication, requires special attention to signs of urinary retention.
Warnings and precautions
Atropine is a highly potent drug and due care is essential to avoid overdosage, especially with intravenous administration. Pediatric populations are more susceptible than adults to the toxic effects of anticholinergic agents. Atropine I.V. decreased the rate of mexiletine absorption without altering the relative oral bioavailability; this delay in mexiletine absorption was reversed by the combination of atropine and intravenous metoclopramide during pretreatment for anesthesia.
Atropine is not removed by dialysis. This drug is effective in very low dosage and overdose may cause permanent damage or death, especially in children. This product contains Benzyl Alcohol which has been associated with a fatal gasping syndrome in infants and neonates.
Adverse reactions
Individual tolerance varies greatly, but these systemic doses are likely to produce the following effects: A scarlatiniform rash may occur. Atropine may produce fever, particularly in children, through inhibition of heat loss by evaporation. Although large doses of atropine may cause an alarming condition, recovery is usual. ADVERSE EVENT TABEL
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- ATROPINE SULFATE EQ 0.36MG BASE/INH · Aerosol, meteredNDA020056-001 · Discontinued
- ATROPINE SULFATE 1% · Solution/dropsANDA214752-001 · Prescription
- ATROPINE SULFATE 1% · Solution/dropsNDA206289-001 · Prescription
- ATROPINE SULFATE 1% · Solution/dropsNDA213581-001 · Prescription
- ATROPINE SULFATE 1MG/ML (1MG/ML) · SolutionANDA215969-002 · Prescription
- ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) · SolutionANDA215969-001 · Prescription
- ATROPINE SULFATE 1% · Solution/dropsANDA219013-001 · Prescription
- ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) · SolutionANDA216120-001 · Prescription
- ATROPINE SULFATE 1MG/ML (1MG/ML) · SolutionANDA216120-002 · Prescription
- ATROPINE SULFATE 1MG/ML (1MG/ML) · SolutionANDA217345-002 · Prescription
- ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) · SolutionANDA217345-001 · Prescription
- ATROPINE SULFATE 1MG/10ML (0.1MG/ML) · SolutionANDA214970-001 · Prescription
- ATROPINE SULFATE 8MG/20ML (0.4MG/ML) · SolutionANDA215005-001 · Prescription
- ATROPINE SULFATE 1MG/10ML (0.1MG/ML) · SolutionANDA215342-002 · Prescription
- ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) · SolutionANDA215342-001 · Prescription
- ATROPINE SULFATE 1% · Solution/drops
Official product information
This product has no Drugs@FDA application number in our table. DailyMed holds the labels the manufacturers submit.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Atropine Sulfate
- Application
- LABEL-ATROPINE SULFATE
- NDC
- 51662-1311-1



