Mydriacyl

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Mydriacyl

Classes

Mydriatics and Cycloplegics

Adverse Reactions
Severe

keratitis / Delayed / Incidence not known

Moderate

photophobia / Early / Incidence not known
blurred vision / Early / Incidence not known
sinus tachycardia / Rapid / Incidence not known

Mild

headache / Early / Incidence not known
xerostomia / Early / Incidence not known
pallor / Early / Incidence not known
vomiting / Early / Incidence not known
nausea / Early / Incidence not known

Common Brand Names

Mydral, Mydriacyl, Ocu-Tropic, Ophthalmicmyd, Tropicacyl

Dea Class

Rx

Description

Ophthalmic cycloplegic and mydriatic agent
Used for cycloplegic refraction and for dilating the pupil for diagnostic purposes
Contraindicated for use in glaucoma

Dosage And Indications
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.

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.

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

There are no drug interactions associated with Tropicamide products.

How Supplied

Mydral/Mydriacyl/Ocu-Tropic/Ophthalmicmyd/Tropicacyl/Tropicamide Ophthalmic Sol: 0.5%, 1%

Maximum Dosage
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.

Mechanism Of Action

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.[42357]

Pharmacokinetics

Tropicamide is administered ophthalmically.

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.

Pregnancy And Lactation
Pregnancy

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.[42356] 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.