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.
The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to
reduce excessive systemic absorption.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
There have been no long-term studies done using tropicamide in animals to evaluate carcinogenic
Pregnancy Category C
Animal reproduction studies have not been conducted with tropicamide. It is
also not known whether tropicamide can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity. Tropicamide should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human
milk, caution should be exercised when tropicamide is administered to a nursing woman.
Tropicamide may rarely cause CNS disturbances which may be dangerous in pediatric patients.
Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children
have been reported with the use of anticholinergic drugs (see WARNINGS). Keep this and all
medications out of the reach of children.
No overall differences in safety or effectiveness have been observed between elderly and younger