atropine sulfate

FDA Drug Profile — Atropine, Atropine Sulfate, ATROPINE, Isopto Atropine, atropine sulfate

atropine sulfate is listed in the FDA National Drug Code directory with 10 NDC codes, marketed under brand names including Atropine, Atropine Sulfate, ATROPINE. Available dosage forms: solution/ drops, injection, solution, solution, powder.

Drug Details

Generic Name
atropine sulfate
Brand Names
Atropine, Atropine Sulfate, ATROPINE, Isopto Atropine, atropine sulfate
Application Number
ANDA214752
Sponsor
Amneal Pharmaceuticals NY LLC
NDC Codes
10
Dosage Forms
SOLUTION/ DROPS, INJECTION, SOLUTION, SOLUTION, POWDER
Routes
OPHTHALMIC, INTRAVENOUS
Active Ingredients
ATROPINE SULFATE

Indications and Usage

INDICATIONS & USAGE 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.

Warnings

WARNINGS 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.