Tropicamide

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
Brands: Mydral, Mydriacyl, Paremyd, Tropicacyl

Introduction

Mydriatic and cycloplegic; synthetic tertiary amine antimuscarinic.101 102 a

Uses for Tropicamide

Ophthalmologic Examination

Used to produce mydriasis and cycloplegia prior to diagnostic procedures (e.g., examination of the fundus).101 a

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Efficacy may differ slightly in patients with light and dark irides (see Dosage under Dosage and Administration and see Actions).101 102

Used in fixed-combination with hydroxyamphetamine hydrobromide when a short period of mydriasis or only partial cycloplegia is preferred.102 a

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.102 a

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.101 102 a

For ophthalmic use only; not for injection.101 102

Avoid contamination of the solution container.101 102 a

To avoid excessive systemic absorption, apply finger pressure on the lacrimal sac for 2–3 minutes after topical instillation of tropicamide.101 a

Dosage

In patients with heavily pigmented irides, higher tropicamide concentrations may be required.101 102

Solution concentrations of 0.5 and 1% produce mydriasis; the 1% concentration also produces cycloplegia.101 a The 0.5% concentration may be useful for producing mydriasis with only slight cycloplegia.101

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.101 a

Tropicamide 0.25% in fixed combination with hydroxyamphetamine hydrobromide 1%: 1 or 2 drops into the conjunctival sac of the eye(s).102 a

Cycloplegia for Refraction
Ophthalmic

1 or 2 drops of a 1% solution into the eye(s); repeat in 5 minutes.101 a Perform the examination within 30 minutes after the second instillation.101 a If patient is not examined within 20–30 minutes, instill an additional drop of the 1% solution.101 a

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.101 a

Tropicamide 0.25% in fixed combination with hydroxyamphetamine hydrobromide 1%: 1 or 2 drops into the conjunctival sac of the eye(s).102 a

Cycloplegia for Refraction
Ophthalmic

1 or 2 drops of a 1% solution into the eye(s); repeat in 5 minutes.101 a Perform the examination within 30 minutes after the second instillation.101 a If patient is not examined within 20–30 minutes, instill an additional drop of the 1% solution.101 a

Special Populations

Tropicamide alone or in fixed combination with hydroxyamphetamine hydrobromide: No special population dosage recommendations at this time.101 102

Cautions for Tropicamide

Contraindications

  • Known hypersensitivity to tropicamide or any ingredient in the formulation.101 102 a

  • Tropicamide/hydroxyamphetamine fixed combination: Angle-closure glaucoma or narrow angles where mydriasis may precipitate attack of angle-closure glaucoma.102 a

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).101 102 a

Intraocular Pressure

Mydriatics may cause a transient increase in IOP.101 102 a Consider the possibility of undiagnosed glaucoma in some patients.a (See Contraindications.)

Sensitivity Reactions

Anticholinergic Sensitivity

Consider risk of psychotic reactions and behavioral disturbances in patients who are hypersensitive to anticholinergic drugs.101 102 a (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.102

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.102 a

Specific Populations

Pregnancy

Category C.101 102

Lactation

Not known if tropicamide is distributed into milk.101 102 Exercise caution if used in nursing women.101 102

Pediatric Use

May rarely cause potentially dangerous CNS disturbances in pediatric patients.101 102 (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.101 102 a

Tropicamide/hydroxyamphetamine fixed combination: Safety and efficacy not established.102

Geriatric Use

Tropicamide: No overall differences in safety and efficacy relative to younger adults.101

Tropicamide/hydroxyamphetamine fixed combination: No overall differences in safety and efficacy relative to younger adults.102 Consider possibility of undiagnosed glaucoma in geriatric patients.a Monitor geriatric patients closely following topical application since glaucoma or increased IOP may be precipitated in these patients.102 a (See Contraindications.)

Common Adverse Effects

Ocular: Increased IOP,101 a transient stinging,101 a blurred vision,101 a superficial punctate keratitis,101 photophobia.101 a

Systemic: Mouth dryness,101 a tachycardia,101 a headache,101 a allergic reactions,101 nausea,101 vomiting,101 pallor,101 CNS disturbances, muscle rigidity.101

Interactions for Tropicamide

Specific Drugs

Drug

Interaction

Carbachol

Tropicamide may interfere with ocular antihypertensive action of carbachol101

Cholinesterase inhibitors (ophthalmic)

Tropicamide may interfere with ocular antihypertensive action of ophthalmic cholinesterase inhibitors101

Pilocarpine

Tropicamide may interfere with ocular antihypertensive action of pilocarpine101

Tropicamide Pharmacokinetics

Absorption

Onset

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

Tropicamide: Maximum cycloplegia occurs within 20–35 minutes.a

Tropicamide/hydroxyamphetamine fixed combination: Mydriasis occurs within 15 minutes and peaks in about 60 minutes.102 a

Duration

Tropicamide: Mydriatic effects last about 6–7 hours;a however, complete recovery from mydriasis may require up to 24 hours in some individuals.101

Tropicamide: Cycloplegia persists for 50 minutes to 6 hours.a

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.102 a However, recovery may require up to 24 hours in some individuals.102 a Patients with light irides may experience slightly greater mydriasis than patients with dark irides.102

Distribution

Extent

Not known if tropicamide is distributed into milk.101 102

Stability

Storage

Ophthalmic

Solution

Tightly closed containers at 8–27°C.101 Avoid excessive heat.101 Do not refrigerate.101

Tropicamide/hydroxyamphetamine: 20–25°C.102 Protect from light.102

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.101 102 a

  • Paralyzes accommodation (cycloplegia) in higher concentrations (e.g., 1%).101

  • 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.101

Advice to Patients

  • Advise patients not to drive or engage in other hazardous activities while pupils are dilated.101 102

  • Importance of protecting eyes in bright illumination during dilation since sensitivity to light may occur.101 102

  • If contact lenses are worn, importance of removing lenses prior to tropicamide administration.101

  • Importance of learning and adhering to proper administration techniques to avoid contamination of the dropper tip.101 102

  • 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.101 102

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.101 102

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.101 102

  • Importance of informing patients of other important precautionary information.101 (See Cautions.)

Preparations

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

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

Tropicamide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.5%*

Mydral

OCuSOFT

Mydriacyl (with benzalkonium chloride)

Alcon

Tropicacyl (with benzalkonium chloride)

Akorn

Tropicamide Ophthalmic Solution (with benzalkonium chloride)

Bausch & Lomb, Falcon

1%*

Mydral

OCuSOFT

Mydriacyl (with benzalkonium chloride)

Alcon

Tropicacyl (with benzalkonium chloride)

Akorn

Tropicamide Ophthalmic Solution (with benzalkonium chloride)

Bausch & Lomb, Falcon

Tropicamide Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.25% with Hydroxyamphetamine Hydrobromide 1%

Paremyd (with benzalkonium chloride)

Akorn

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

101. Alcon Pharmaceuticals. Mydriacyl(tropicamide) ophthalmic solution prescribing information. Fort Worth, TX; 2004 Feb.

102. Akorn. Paremyd (tropicamide and hydroxyamphetamine hydrobromide) ophthalmic solution prescribing information. Buffalo Grove, IL; 2006 Oct.

a. AHFS Drug Information 2008. McEvoy GK, ed. Tropicamide. Bethesda, MD; American Society of Health-System Pharmacists; 2008:2913-4.

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