Tropicamide is an ophthalmic cycloplegic and mydriatic agent. It is used for cycloplegic refraction and for dilating the pupil for diagnostic purposes. This drug was approved by the FDA in 1960.
Route-Specific Administration
Ophthalmic Administration
-Remove contact lenses prior to administration. Wash hands before and after use. Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch. To avoid excessive systemic absorption, apply finger pressure on the lacrimal sac for 2-3 minutes following topical application to the eye.
-To avoid contamination or the spread of infection, do not touch dropper tip to any surface and do not use dropper for more than one person.
-Advise patient not to drive or engage in potentially hazardous activities while pupils are dilated.
-Patients may be sensitive to light. Advise patient to protect eyes in bright illumination during dilation.
-When using in children, parents should be warned not to allow any of the preparation to get into the child's mouth. Parents should wash their hands and their child's hands following administration.
Increased intraocular pressure, blurred vision, transient stinging, photophobia with or without corneal staining, and superficial punctate keratitis have been reported with tropicamide administration.
Non-ocular adverse reactions that may occur following the administration of tropicamide include xerostomia, sinus tachycardia, headache, nausea, vomiting, pallor, allergic reactions, CNS disturbances, and muscle rigidity. Psychotic reactions, behavioral disturbances, and cardiorespiratory collapse have been reported in pediatric patients and some adults with the use of anticholinergic drugs.
Tropicamide is contraindicated in patients with a hypersensitivity to any component of the formulation. Hypersensitivity to anticholinergics may result in behavioral disturbances and psychotic reactions.
Tropicamide ophthalmic solution is for topical use only and should never be injected.
Tropicamide is contraindicated in patients with primary glaucoma or a tendency toward narrow angle glaucoma (closed-angle glaucoma). An estimation of the depth of the angle of the anterior chamber should be made prior to the administration of tropicamide to avoid inducing closed-angle glaucoma.
Tropicamide contains benzalkonium chloride, which may be absorbed by contact lenses. Users of soft contact lenses should not administer tropicamide while wearing these lenses.
No differences in safety or efficacy have been identified between geriatric and younger patients. However, increased intraocular pressure may be present in the elderly.
Use tropicamide cautiously in children. The risk of precipitating CNS disturbances in children is possible with the use of tropicamide. Psychotic reactions, behavioral disturbances, and cardiorespiratory collapse have been reported in children being treated with anticholinergics. The safety and efficacy of tropicamide have not been established in infants and neonates.
It is unknown if tropicamide can cause fetal harm when administered during pregnancy or if it can affect reproductive capacity. Therefore, administer tropicamide to a pregnant woman only if clearly needed.
It is not known whether tropicamide is excreted in human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
For cycloplegia induction for refraction:
NOTE: Heavily pigmented irises may require larger doses than lightly pigmented irises.
Ophthalmic dosage:
Adults, Adolescents, and Children: Instill 1 or 2 drops of a 1% solution into the eye(s), then repeat in 5 minutes. If the patient has not been seen within 20 to 30 minutes, an additional drop to prolong mydriasis may be used.
Neonates and Infants: Safety and efficacy have not been established.
For mydriasis induction for examination of the fundus:
NOTE: Heavily pigmented irises may require larger doses than lightly pigmented irises.
Ophthalmic dosage:
Adults, Adolescents, and Children: Instill 1 or 2 drops of a 0.5% solution 15 to 20 minutes before examination.
Neonates and Infants: Safety and efficacy have not been established.
Maximum Dosage Limits:
-Adults
1% solution: 5 drops/day/eye.
0.5% solution: 2 drops/day/eye
-Geriatric
1% solution: 5 drops/day/eye.
0.5% solution: 2 drops/day/eye
-Adolescents
1% solution: 5 drops/day/eye.
0.5% solution: 2 drops/day/eye
-Children
1% solution: 5 drops/day/eye.
0.5% solution: 2 drops/day/eye
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Tropicamide products.
Tropicamide has an anticholinergic effect that blocks the responses of the iris sphincter muscle and the ciliary body muscle to cholinergic stimulation, resulting in mydriasis. The 0.5% solution may be useful for producing mydriasis with little cycloplegia. Administration of the 1% solution also paralyzes accommodation.
Tropicamide is administered ophthalmically.
-Route-Specific Pharmacokinetics
Other Route(s)
Ophthalmic route
The 1% tropicamide solution has a rapid onset of action producing the maximum mydriatic and cycloplegic effects within 15-60 minutes following topical application to the eye. The duration of both effects is normally 3-8 hours. However, mydriasis may persist for 24 hours in selected patients.