VA Class:OP600
ATC Class:S01FA06
Tropicamide, a synthetic tertiary amine antimuscarinic, is a mydriatic and cycloplegic.
Tropicamide is an effective mydriatic drug for use prior to examination of the fundus. When complete cycloplegia is necessary, as in measurement of refractive errors, results with tropicamide have been variable. On the basis of some reports, the drug produces adequate cycloplegia only when two instillations are made and when refraction is performed 20-35 minutes following the second instillation. Other clinical studies confirm rapid recovery but indicate that two instillations of the drug are less satisfactory for cycloplegia than is homatropine or cyclopentolate. Because of its short duration of effect, tropicamide may be useful when a short period of cycloplegia is preferred.
Combination preparations containing tropicamide and hydroxyamphetamine hydrobromide are used to produce mydriasis for diagnostic purposes or when a short period of mydriasis is preferred. Combination preparations containing tropicamide and hydroxyamphetamine hydrobromide only produce partial cycloplegia since the low concentration (i.e., 0.25%) of tropicamide in the combinations only has partial cycloplegic action while hydroxyamphetamine hydrobromide has minimal cycloplegic action.
Tropicamide is applied topically to the eye. To avoid excessive systemic absorption, finger pressure should be applied on the lacrimal sac for 1-2 minutes following topical instillation of the solution. Care should be taken to avoid contamination of the solution container.
To produce mydriasis for funduscopic examination of the eye, 1 or 2 drops of a 0.5% solution of tropicamide may be instilled onto the eye(s) 15-20 minutes before examination. In patients with heavily pigmented irides, higher solution concentrations may be required.101 To produce cycloplegia for refraction, a 1% solution should be used; 1 or 2 drops of this solution may be instilled onto the eye(s) and repeated in 5 minutes. The examination must be performed within 30 minutes after the second instillation. If the patient is not examined within 20-30 minutes, an additional drop of the 1% solution should be instilled.
When a combination preparation containing tropicamide and hydroxyamphetamine hydrobromide is used to produce mydriasis, 1 or 2 drops of the solution may be instilled onto the eye(s).102 Patients with lighter irides may experience slightly greater mydriasis than patients with darker irides.102
Tropicamide may cause increased intraocular pressure. Other adverse ocular effects of tropicamide include transient stinging, blurred vision, photophobia, and superficial punctate keratitis. Adverse systemic effects reported with tropicamide include dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, CNS disturbances, and muscle rigidity. Serious cardiovascular events, including death, myocardial infarction, ventricular fibrillation, and hypotensive episodes, have rarely occurred after instillation of tropicamide in fixed combination with hydroxyamphetamine hydrobromide.
Precautions and Contraindications
When tropicamide is used as a fixed-combination preparation that includes hydroxyamphetamine hydrobromide, the cautions, precautions, and contraindications associated with hydroxyamphetamine must be considered in addition to those associated with tropicamide.102
Because of its relatively short duration of action, the danger of precipitating a rise in intraocular pressure is probably not as great with tropicamide as with other mydriatic and cycloplegic drugs. Nevertheless, dilation of the pupil causes the iris to crowd the angular space and thus tends to obstruct the access of fluid to the canal of Schlemm. The manufacturer of the fixed combination containing tropicamide with hydroxyamphetamine hydrobromide states that the preparation should not be used in patients with angle-closure glaucoma and it should not be used in the presence of a shallow anterior chamber unless gonioscopic observation of the chamber angle is possible.102 The possibility of undiagnosed glaucoma in some patients should be considered. To avoid induction of angle-closure glaucoma in susceptible patients, an estimation of the depth of the angle of the anterior chamber should be performed prior to use of tropicamide in fixed combination with hydroxyamphetamine hydrobromide.102 Patients with hypertension, hyperthyroidism, diabetes mellitus, or cardiac disorders (i.e., arrhythmias, chronic ischemic heart disease) should be closely monitored following topical application of ophthalmic solutions containing tropicamide in fixed combination with hydroxyamphetamine.102
The possibility that tropicamide-induced psychotic reactions and behavioral disturbances may occur in patients hypersensitive to anticholinergic drugs should be considered.
Tropicamide ophthalmic solution is contraindicated in patients with known hypersensitivity to the drug or any ingredient in the formulation.
Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with anticholinergic agents, and this should be considered. Tropicamide may cause potentially dangerous CNS disturbances in pediatric patients.
No overall differences in efficacy or safety of tropicamide have been observed between geriatric and younger patients.101 The possibility of undiagnosed glaucoma in geriatric patients should be considered, since tropicamide in fixed combination with hydroxyamphetamine is contraindicated in patients with known or suspected angle-closure glaucoma.102 Therefore, geriatric patients should be monitored closely following topical application of ophthalmic solutions containing tropicamide since glaucoma or increased intraocular pressure may be precipitated in these patients.
Studies have not been performed to date to evaluate the carcinogenic potential of tropicamide.101
Pregnancy, Fertility, and Lactation
Animal reproduction studies have not been performed with tropicamide. It is not known whether tropicamide can cause fetal harm when administered to pregnant women. Tropicamide should be used during pregnancy only when clearly needed.
There is no adequate information on whether tropicamide may affect fertility in humans.
It is not known whether tropicamide is distributed into milk.101 Because many drugs are distributed into milk, tropicamide should be used with caution in nursing women.101
Tropicamide may interfere with the ocular antihypertensive effects of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.101
Tropicamide is a mydriatic and cycloplegic drug that shares the pharmacologic effects of atropine on the eye. Following topical application to the eye, tropicamide blocks the action of acetylcholine resulting in relaxation of the cholinergically innervated sphincter muscle of the iris. Adrenergic innervation to the radial muscle is therefore unopposed and the pupil becomes dilated. Cholinergic stimulation of the accommodative ciliary muscle of the lens also is blocked. Anticholinergic effects of tropicamide in the eye produce dilation of the pupil (mydriasis) and paralysis of accommodation (cycloplegia). Tropicamide tends to have greater mydriatic than cycloplegic effect. This is clinically important since the presence of tropicamide-induced mydriasis does not necessarily indicate sufficient cycloplegia.
The maximum mydriatic effect appears in about 20-40 minutes. Maximum cycloplegia occurs within 20-35 minutes. Mydriasis generally lasts about 6-7 hours and cycloplegia persists for 50 minutes to 6 hours. Complete recovery from mydriasis may require up to 24 hours in some individuals.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
When the commercially available combination preparation containing tropicamide 0.25% and hydroxyamphetamine hydrobromide 1% is used, the mydriatic effect apparently is increased compared with that produced by either drug alone.102 Following application of this preparation, mydriasis occurs within 15 minutes, maximum mydriatic effect appears in about 60 minutes, and clinically important 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, but may not occur for up to 24 hours in some patients.102
Tropicamide is a synthetic tertiary amine antimuscarinic. Tropicamide is an amide-type derivative of tropic acid. The drug is prepared by esterifying tropic acid with acetyl chloride and then converting the resulting tropic acid acetate to the corresponding acid chloride by reaction with thionyl chloride. Condensation of the acid chloride with 4-[(ethylamino)methyl]pyridine in the presence of an appropriate dehydrochlorinating agent results in tropicamide acetate ester which saponifies readily to tropicamide.
Tropicamide occurs as a white or practically white, crystalline powder that is odorless or has not more than a slight odor. The drug is slightly soluble in water but its solubility is increased in acid media. Tropicamide ophthalmic solution is a sterile aqueous solution of the drug; hydrochloric acid and/or sodium hydroxide are added to adjust the pH to 4-5.8. The ophthalmic solution also contains edetate disodium (disodium EDTA), sodium chloride, and benzalkonium chloride as a preservative.
Tropicamide ophthalmic solutions should be stored in tightly closed containers at 8-27°C; the solutions should not be refrigerated nor stored at high temperatures. The fixed-combination preparation containing tropicamide with hydroxyamphetamine hydrobromide should be protected from light and stored at 20-25°C.102
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.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Solution | 0.5%* | Mydral® | OCuSOFT |
Mydriacyl® | Alcon | |||
Tropicacyl® | Akorn | |||
Tropicamide Ophthalmic Solution | ||||
1%* | Mydral® | OCuSOFT | ||
Mydriacyl® | Alcon | |||
Tropicacyl® | Akorn | |||
Tropicamide Ophthalmic Solution |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Solution | 0.25% with Hydroxyamphetamine Hydrobromide 1% | Paremyd® | Akorn |
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions January 1, 2009. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
Only references cited for selected revisions after 1984 are available electronically.
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.