Atropine Sulfate
Generic: ATROPINE SULFATE
Basic Information
Manufacturer
Bausch & Lomb Incorporated
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
c0a56d60-0914-42b1-af59-c56afe93d18c
Indications & Usage
INDICATIONS AND USAGE For mydriasis and/or cycloplegia.
For cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract.
For cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract.
Warnings
WARNINGS In pediatric patients, use with extreme caution.
Excessive use in pediatric patients or in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning.
If this occurs, discontinue medication and use appropriate therapy as outlined in OVERDOSAGE .
Excessive use in pediatric patients or in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning.
If this occurs, discontinue medication and use appropriate therapy as outlined in OVERDOSAGE .
Adverse Reactions
ADVERSE REACTIONS Prolonged use may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis.
Severe reactions are manifested by hypotension with progressive respiratory depression.
Coma and death have been reported in the very young.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Severe reactions are manifested by hypotension with progressive respiratory depression.
Coma and death have been reported in the very young.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.