Mydriacyl®
Tropicamide 0.5%, 1% · ophthalmic solution
Mydriatics/Cycloplegics
Approved uses
Cycloplegic refraction
1 or 2 drops of 1% in the eye(s), repeated in 5 minutes.
Cycloplegic shift averages 0.11 D less than cyclopentolate 1%, judged clinically insignificant.
Mydriasis for fundus examination
1 or 2 drops of 0.5% instilled 15 or 20 minutes before examination; heavily pigmented irides may require the higher strength or more doses.
Mydriasis begins in 15 to 30 minutes and reverses in 4 to 8 hours, up to 24 hours in some patients.
OFF-LABELNot in the FDA label for this product
Accommodative spasm (pseudomyopia)
1% BID, tapered against symptomatic response over about 2 months, alongside a single vision plus lens.
Case report · n=2
Evidence is a case report of 2 patients in Nepal with sudden fluctuating myopic refraction that shifted hyperopic under cycloplegia; both were managed with 1% twice daily plus a single vision plus lens and avoidance of triggering near work, with the dose tapered against symptomatic response and no recurrence reported over the follow-up. Case report level only: no control group, no comparison with cyclopentolate or atropine, and no dose-finding data.
Contraindications
Hypersensitivity to any component of this preparation.
Available FormsOphthalmic solution, 1% (3 mL, 15 mL) in plastic DROP-TAINER dispensers
Mechanism of ActionAnticholinergic that blocks the response of the iris sphincter and the ciliary muscle to cholinergic stimulation, dilating the pupil; the 1% strength also paralyzes accommodation, while 0.5% produces mydriasis with only slight cycloplegia. Acts in 15 to 30 minutes with roughly 3 to 8 hours of activity, and complete recovery from mydriasis requires 24 hours in some patients.
Warnings & Precautions
- CNS disturbances: May be dangerous in pediatric patients; psychotic reactions and behavioral disturbances from anticholinergic hypersensitivity should be considered.
- Intraocular pressure elevation: Mydriatics may produce a transient rise.
- Systemic absorption: The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption.
- Contact lenses: Remove before use.
- Cholinergic drug interference: May interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
- Route restriction: Topical ophthalmic use only, not for injection.
Common Side Effects
- Ocular: Transient stinging, blurred vision, photophobia, superficial punctate keratitis; increased intraocular pressure reported following mydriatics.
- Systemic: Dry mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, CNS disturbances, muscle rigidity.
- Anticholinergic class effects: Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children.
Pregnancy & LactationPregnancy: No animal reproduction studies have been conducted and fetal harm is unknown; give only if clearly needed.
Lactation: Excretion in human milk is unknown; exercise caution in a nursing woman.
Pediatric UseMay rarely cause CNS disturbances that may be dangerous in pediatric patients.