Tropicamide (Monograph)

Brand names: Mydral, Mydriacyl, Tropicacyl
Drug class: Mydriatics
ATC class: S01FA06
VA class: OP600
Chemical name: Benzeneacetamide, N-ethyl-α-(hydroxymethyl)-N-(4-pyridinylmethyl)-
Molecular formula: C₁₇H₂₀N₂O₂
CAS number: 1508-75-4

Introduction

Mydriatic and cycloplegic; synthetic tertiary amine antimuscarinic.

Uses for Tropicamide

Ophthalmologic Examination

Used to produce mydriasis and cycloplegia prior to diagnostic procedures (e.g., examination of the fundus).

Efficacy may differ slightly in patients with light and dark irides (see Dosage under Dosage and Administration and see Actions).

Used in fixed-combination with hydroxyamphetamine hydrobromide when a short period of mydriasis or only partial cycloplegia is preferred.

Tropicamide Dosage and Administration

General

• Prior to use of tropicamide in fixed combination with hydroxyamphetamine hydrobromide, estimate the depth of the angle of the anterior chamber to avoid induction of angle-closure glaucoma in susceptible patients.

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.

For ophthalmic use only; not for injection.

Avoid contamination of the solution container.

To avoid excessive systemic absorption, apply finger pressure on the lacrimal sac for 2–3 minutes after topical instillation of tropicamide.

Dosage

In patients with heavily pigmented irides, higher tropicamide concentrations may be required.

Solution concentrations of 0.5 and 1% produce mydriasis; the 1% concentration also produces cycloplegia. The 0.5% concentration may be useful for producing mydriasis with only slight cycloplegia.

Pediatric Patients

Ophthalmologic Examination

Mydriasis with Minimal Cycloplegia (e.g., for Fundus Examination)

Ophthalmic

1 or 2 drops of a 0.5% solution into the eye(s) 15–20 minutes before examination.

Tropicamide 0.25% in fixed combination with hydroxyamphetamine hydrobromide 1%: 1 or 2 drops into the conjunctival sac of the eye(s).

Cycloplegia for Refraction

Ophthalmic

1 or 2 drops of a 1% solution into the eye(s); repeat in 5 minutes. Perform the examination within 30 minutes after the second instillation. If patient is not examined within 20–30 minutes, instill an additional drop of the 1% solution.

Adults

Ophthalmologic Examination

Mydriasis with Minimal Cycloplegia (e.g., for Fundus Examination)

Ophthalmic

1 or 2 drops of a 0.5% solution into the eye(s) 15–20 minutes before examination.

Tropicamide 0.25% in fixed combination with hydroxyamphetamine hydrobromide 1%: 1 or 2 drops into the conjunctival sac of the eye(s).

Cycloplegia for Refraction

Ophthalmic

1 or 2 drops of a 1% solution into the eye(s); repeat in 5 minutes. Perform the examination within 30 minutes after the second instillation. If patient is not examined within 20–30 minutes, instill an additional drop of the 1% solution.

Special Populations

Tropicamide alone or in fixed combination with hydroxyamphetamine hydrobromide: No special population dosage recommendations at this time.

Cautions for Tropicamide

Contraindications

• Known hypersensitivity to tropicamide or any ingredient in the formulation.

• Tropicamide/hydroxyamphetamine fixed combination: Angle-closure glaucoma or narrow angles where mydriasis may precipitate attack of angle-closure glaucoma.

Warnings/Precautions

Warnings

CNS Effects

Risk of CNS disturbances, including psychotic reactions and behavioral disturbances; may be dangerous in pediatric patients (see Pediatric Use under Cautions).

Intraocular Pressure

Mydriatics may cause a transient increase in IOP. Consider the possibility of undiagnosed glaucoma in some patients. (See Contraindications.)

Sensitivity Reactions

Anticholinergic Sensitivity

Consider risk of psychotic reactions and behavioral disturbances in patients who are hypersensitive to anticholinergic drugs. (See CNS Effects and also Pediatric Use under Cautions.)

General Precautions

Use of Fixed Combinations

When tropicamide is used in fixed combination with hydroxyamphetamine hydrobromide, consider the cautions, precautions, and contraindications associated with hydroxyamphetamine hydrobromide.

Concomitant Diseases

When tropicamide is used in fixed combination with hydroxyamphetamine hydrobromide, closely monitor patients with hypertension, hyperthyroidism, diabetes mellitus, cardiac disorders (i.e., arrhythmias, chronic ischemic heart disease), glaucoma, or increased IOP following topical application.

Specific Populations

Pregnancy

Category C.

Lactation

Not known if tropicamide is distributed into milk. Exercise caution if used in nursing women.

Pediatric Use

May rarely cause potentially dangerous CNS disturbances in pediatric patients. (See CNS Effects under Cautions.)

Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse have been reported in pediatric patients with use of anticholinergic agents.

Tropicamide/hydroxyamphetamine fixed combination: Safety and efficacy not established.

Geriatric Use

Tropicamide: No overall differences in safety and efficacy relative to younger adults.

Tropicamide/hydroxyamphetamine fixed combination: No overall differences in safety and efficacy relative to younger adults. Consider possibility of undiagnosed glaucoma in geriatric patients. Monitor geriatric patients closely following topical application since glaucoma or increased IOP may be precipitated in these patients. (See Contraindications.)

Common Adverse Effects

Ocular: Increased IOP, transient stinging, blurred vision, superficial punctate keratitis, photophobia.

Systemic: Mouth dryness, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, CNS disturbances, muscle rigidity.

Drug Interactions

Specific Drugs

Tropicamide Pharmacokinetics

Absorption

Onset

Tropicamide: Maximum mydriatic effect appears in about 20–40 minutes.

Tropicamide: Maximum cycloplegia occurs within 20–35 minutes.

Tropicamide/hydroxyamphetamine fixed combination: Mydriasis occurs within 15 minutes and peaks in about 60 minutes.

Duration

Tropicamide: Mydriatic effects last about 6–7 hours; however, complete recovery from mydriasis may require up to 24 hours in some individuals.

Tropicamide: Cycloplegia persists for 50 minutes to 6 hours.

Tropicamide/hydroxyamphetamine: Mydriasis, inhibition of pupillary light response, and partial cycloplegia generally last for about 3 hours; recovery begins in about 90 minutes, and total recovery usually occurs in 6–8 hours. However, recovery may require up to 24 hours in some individuals. Patients with light irides may experience slightly greater mydriasis than patients with dark irides.

Distribution

Extent

Not known if tropicamide is distributed into milk.

Stability

Storage

Ophthalmic

Solution

Tightly closed containers at 8–27°C. Avoid excessive heat. Do not refrigerate.

Tropicamide/hydroxyamphetamine: 20–25°C. Protect from light.

Actions

• Blocks responses of the sphincter muscle of the iris and the accommodative ciliary muscle of the lens to cholinergic stimulation, thereby producing mydriasis and cycloplegia.

• Paralyzes accommodation (cycloplegia) in higher concentrations (e.g., 1%).

• Both the 0.5 and 1% concentrations of tropicamide induce mydriasis; the 0.5% concentration may be useful for producing mydriasis with only slight cycloplegia.

Advice to Patients

• Advise patients not to drive or engage in other hazardous activities while pupils are dilated.

• Importance of protecting eyes in bright illumination during dilation since sensitivity to light may occur.

• If contact lenses are worn, importance of removing lenses prior to tropicamide administration.

• Importance of learning and adhering to proper administration techniques to avoid contamination of the dropper tip.

• Advise parents to prevent the child from getting the solution into his or her mouth and to wash their own hands and the child’s hands following administration.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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