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Tropicamide (Ophthalmic)


VA CLASSIFICATION
Primary: OP600
Secondary: DX900

Commonly used brand name(s): I-Picamide; Minims Tropicamide; Mydriacyl; Mydriafair; Ocu-Tropic; Opticyl; Spectro-Cyl; Tropicacyl.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Diagnostic aid (cycloplegic; mydriatic)—

cycloplegic—

mydriatic—

Indications

Accepted

Mydriasis, in diagnostic procedures or
Refraction, cycloplegic—Indicated for mydriasis and cycloplegia in diagnostic procedures, such as measurement of refractive errors and examination of the fundus of the eye. {07} {19}

Mydriasis, preoperative or
Mydriasis, postoperative—Indicated when a short-acting mydriatic is needed for some preoperative and postoperative states.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    284.36 {09}

Mechanism of action/Effect:

Tropicamide is an anticholinergic agent that blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to stimulation by acetylcholine. The 0.5% solution produces dilation of the pupil (mydriasis); the 1% solution produces paralysis of accommodation (cycloplegia) as well as mydriasis. {07} {19}

Onset of action:

Rapid. {07} {19}

Time to peak effect:

Within 20 to 40 minutes. {18}

Duration of action:


Short {07} {18} {19}:

Cycloplegia (residual): 2 to 6 hours.

Mydriasis (residual): Approximately 7 hours.



Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans. {07}

Studies have not been done in animals. {04} {07} {19}

Breast-feeding

Problems in humans have not been documented.

Pediatrics

An increased susceptibility to tropicamide and similar drugs (such as atropine) has been reported in infants and young children and in children with blond hair, blue eyes, Down's syndrome, spastic paralysis, or brain damage; therefore, tropicamide should be used with great caution in these patients. In addition, this medication may cause psychotic reactions, behavioral disturbances, and cardiorespiratory collapse, especially in children. {04} {07} {19}


Geriatrics


Geriatric patients are more susceptible to the effects of tropicamide and similar drugs (such as atropine), thus increasing the potential for systemic side effects. Also, tropicamide should be used with caution in the elderly because of possible undiagnosed predisposition to angle-closure glaucoma. {07} {19}

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Brain damage, in children
Down's syndrome (mongolism), in children and adults
» Glaucoma, angle-closure, predisposition to{04}{07}{19}
Sensitivity to tropicamide{07}
Spastic paralysis, in children


Side/Adverse Effects

Note: An increased susceptibility to tropicamide and similar drugs (such as atropine) has been reported in infants, young children, children with blond hair or blue eyes, adults and children with Down's syndrome, children with brain damage or spastic paralysis, and the elderly. In addition, cardiorespiratory collapse has been reported in children and some adults. {07}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Signs of systemic absorption
    
Behavioral disturbances or psychotic reaction{04}{19} (unusual behavior, especially in children)
    
clumsiness or unsteadiness
    
confusion
    
fast heartbeat{04}{07}{19}
    
flushing or redness of face
    
hallucinations (seeing, hearing, or feeling things that are not there)
    
increased thirst or dryness of mouth{04}{07}{19}
    
skin rash
    
slurred speech
    
swollen stomach in infants
    
unusual drowsiness, tiredness, or weakness



Those indicating need for medical attention only if they continue or are bothersome
    
Blurred vision{04}{07}{19}
    
headache{19}
    
increased sensitivity of eyes to light{04}{07}{19}
    
stinging of eyes when medication is applied{04}{07}{19}




Overdose
For specific information on the agents used in the management of tropicamide ophthalmic overdose, see:
   • Physostigmine (Systemic) monograph.
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Treatment of overdose
Specific treatment—Physostigmine is used as an antidote to the systemic effects of this medication.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Tropicamide (Ophthalmic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to tropicamide





Use in children—Infants and young children and children with blond hair or blue eyes may be especially sensitive to the effects of tropicamide and similar drugs (such as atropine); this may increase the chance of side effects during treatment; in addition, medication may be more likely to cause psychotic reactions, behavioral disturbances, and cardiorespiratory collapse in children






Use in the elderly—Geriatric patients are more susceptible to the effects of tropicamide and similar drugs (such as atropine), thus increasing the potential for systemic side effects
Other medical problems, especially predisposition to angle-closure glaucoma

Proper use of this medication
Proper administration technique

» Importance of nasolacrimal pressure, especially in infants {07} {19}

Washing hands immediately after application to remove any medicine that may be on them; if applying medication to infants or children, washing their hands also, and not letting any medication get into their mouths {07} {19}

Preventing contamination: Not touching applicator tip to any surface; keeping container tightly closed {07} {19}

» Importance of not using more medication than the amount prescribed

» Proper dosing
Missed dose: Applying as soon as possible; if almost time for next dose, skipping missed dose and going back to regular dosing schedule; not doubling doses

» Proper storage

Precautions while using this medication
» Medication causes blurred vision and increased sensitivity of the eyes to light; not driving until you can see clearly; wearing sunglasses that block ultraviolet light to protect eyes from sunlight and other bright lights; checking with physician if these effects continue longer than 24 hours after discontinuation of medication {04} {07} {19}


Side/adverse effects
Signs of potential side effects, especially systemic absorption


General Dosing Information
Although some manufacturers recommend a dose of 2 drops of an ophthalmic solution at appropriate intervals, the conjunctival sac will usually hold only 1 drop. {11}

When used for refraction, an additional drop should be instilled if the examination cannot be performed within 20 to 30 minutes following instillation of the second drop of tropicamide solution. {04} {19}

More frequent instillation or use of a stronger solution may be required to produce adequate cycloplegia in eyes with brown or hazel irides than in eyes with blue irides. {04} {19}

To avoid excessive systemic absorption, patient should apply digital pressure to the lacrimal sac during and for 2 or 3 minutes following instillation of the medication. {07} {19}


Ophthalmic Dosage Forms

TROPICAMIDE OPHTHALMIC SOLUTION USP

Usual adult and adolescent dose
Cycloplegic refraction
Topical, to the conjunctiva, 1 drop of a 1% solution, repeated once in five minutes. {04} {07} {19}

For examination of fundus of eye
Topical, to the conjunctiva, 1 drop of a 0.5% solution fifteen to twenty minutes prior to examination. {04} {07} {19}


Usual pediatric dose
Cycloplegic refraction
Topical, to the conjunctiva, 1 drop of a 0.5 or 1% solution, repeated once in five minutes.

For examination of fundus of eye
See Usual adult and adolescent dose .


Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


0.5% (Rx) [Mydriacyl{07}{19} (benzalkonium chloride) (sodium chloride) (edetate disodium) (hydrochloric acid or sodium hydroxide)] [Mydriafair{13}] [Ocu-Tropic{08}{20}] [Opticyl{16}] [Spectro-Cyl] [Tropicacyl{10}{21} (benzalkonium chloride 0.1%)][Generic]{02}{12}{18}


1% (Rx) [I-Picamide{01}] [Mydriacyl{07}{19} (benzalkonium chloride)] [Mydriafair] [Ocu-Tropic{08}{20}] [Opticyl{16}] [Spectro-Cyl] [Tropicacyl{10}{21} (benzalkonium chloride)][Generic]{02}{12}{18}

Canada—


0.5% (Rx) [Mydriacyl{23} (benzalkonium chloride)] [Tropicacyl{14}]


1% (Rx) [Minims Tropicamide{22}] [Mydriacyl{23} (benzalkonium chloride)] [Tropicacyl]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • For the eye.
   • Keep container tightly closed. {19}



Revised: 07/14/1995



References
  1. I-Picamide package insert (American Pharm). In: PDR Physicians' desk reference for ophthalmology. 17th ed. 1989. Montvale, NJ: Medical Economics Data, 1989: 106.
  1. Tropicamide generic package inserts (B&L; Steris Labs). In: PDR Physicians' desk reference for ophthalmology. 19th ed. 1991. Montvale, NJ: Medical Economics Data, 1991: 254.
  1. Open.
  1. Mydriacyl package insert (Alcon). In: PDR Physicians' desk reference for ophthalmology. 19th ed. 1991. Montvale, NJ: Medical Economics Data, 1991: 223.
  1. Open.
  1. Open.
  1. Mydriacyl (Alcon). In: PDR Physicians' desk reference for ophthalmology. 23rd ed. 1995. Montvale, NJ: Medical Economics Data Production Company, 1995: 230.
  1. Ocu-Tropic (Ocumed). In: PDR Physicians' desk reference for ophthalmogy. 23rd ed. 1995. Montvale, NJ: Medical Economics Data Production Company, 1995: 329.
  1. The United States pharmacopeia. The national formulary. USP 22nd revision (January 1, 1990). NF 17th ed (January 1, 1990). Rockville, MD: The United States Pharmacopeial Convention, Inc., 1990.
  1. Tropicacyl (Akorn). In: PDR Physicians desk reference for ophthalmology. 23rd ed. 1995. Montvale, NJ: Medical Economics Data Production Company, 1995: 201.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1992: 477a.
  1. Tropicamide package insert (Bausch & Lomb—US), Rev 10/92, Rec 8/93.
  1. Mydriafair package insert (Pharmafair—US), Rev 7/83, Rec 3/89.
  1. Tropicacyl package insert (Akorn). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 26th ed. Ottawa: Canadian Pharmaceutical Association, 1991: 1257.
  1. Open.
  1. Opticyl (Optopics). In: Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1993 October: 487.
  1. Open.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons, Inc., 1992: 486a.
  1. Mydriacyl package insert (Alcon). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Montvale, NJ: Medical Economics Data, 1993: 224.
  1. Ocu-Tropic package insert (Ocumed). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Montvale, NJ: Medical Economics Data, 1993: 303.
  1. Tropicacyl package insert (Akorn). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Montvale, NJ: Medical Economics Data, 1993: 207.
  1. Minims Tropicamide 1% package insert (Smith & Nephew). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 730.
  1. Mydriacyl package insert (Alcon). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 765.
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