Tropicamide
Generic: TROPICAMIDE
Basic Information
Manufacturer
Somerset Therapeutics, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
378b5fe2-4b5d-4c87-a7d6-fd0caa6402af
Indications & Usage
INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures.
Warnings
WARNINGS FOR TOPICAL OPHTHALMIC USE ONLY.
NOT FOR INJECTION.
This preparation may cause CNS disturbances which may be dangerous in pediatric patients.
The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered.
Mydriatics may produce a transient elevation of intraocular pressure.
Remove contact lenses before using.
NOT FOR INJECTION.
This preparation may cause CNS disturbances which may be dangerous in pediatric patients.
The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered.
Mydriatics may produce a transient elevation of intraocular pressure.
Remove contact lenses before using.
Adverse Reactions
ADVERSE REACTIONS Ocular: Transient stinging, blurred vision, photophobia and superficial punctuate keratitis have been reported with the use of tropicamide.
Increased intraocular pressure has been reported following the use of mydriatics.
Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.
Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.
Increased intraocular pressure has been reported following the use of mydriatics.
Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.
Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.