Tropicamide
Anticholinergic [EPC]
What it is used for
INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures. Clinical selection for Tropicamide should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC. Class context: Anticholinergic [EPC]. Confirm site-specific dose, duration and monitoring before prescribing.
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.
Possible side effects
ADVERSE REACTIONS Ocular: Transient stinging, blurred vision, photophobia and superficial punctate 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 cardio-respiratory collapse in children have been reported with the use of anticholinergic drugs.
Storage
HOW SUPPLIED 3mL and 15mL in plastic dispensers. 1% - 3 mL: NDC 61314-355-01 1% - 15 mL: NDC 61314-355-02 STORAGE: Store at 8° to 27°C (46° to 80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed. Revised: 11-2021
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