Tropicamide

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Tropicamide
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]

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Overview

Tropicamide is an antimuscarinic that is FDA approved for the procedure of causing mydriasis and cycloplegia. Common adverse reactions include blurred vision, burning sensation in eye.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Tropicamide is indicated for mydriasis and cycloplegia for diagnostic procedures.

  • Dosage:
  • For examination of fundus: 1 to 2 drops 0.5% solution in the eye(s) 15 to 20 min prior to exam
  • For mydriasis induction: refractive procedures, 1 to 2 drops 1% solution in the eye(s), may be repeated in 5 min

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Tropicamide in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tropicamide in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Tropicamide is indicated for mydriasis and cycloplegia for diagnostic procedures.

  • Dosage:
  • For examination of fundus: 1 to 2 drops 0.5% solution in the eye(s) 15 to 20 min prior to exam
  • For mydriasis induction: refractive procedures, 1 to 2 drops 1% solution in the eye(s), may be repeated in 5 min

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Tropicamide in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tropicamide in pediatric patients.

Contraindications

  • Contraindicated in persons showing hypersensitivity to any component of this preparation.

Warnings

  • FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION.
  • This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered.
  • Mydriatics may produce a transient elevation of intraocular pressure.
  • Remove contact lenses before using.

Adverse Reactions

Clinical Trials Experience

Ocular

Transient stinging, blurred vision, photophobia and superficial punctuate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydriatics.

Non-Ocular

Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.

Postmarketing Experience

There is limited information regarding Tropicamide Postmarketing Experience in the drug label.

Drug Interactions

Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C Animal reproduction studies have not been conducted with tropicamide. It is also not known whether tropicamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tropicamide should be given to a pregnant woman only if clearly needed.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tropicamide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Tropicamide during labor and delivery.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tropicamide is administered to a nursing woman.

Pediatric Use

Tropicamide may rarely cause CNS disturbances which may be dangerous in pediatric patients. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs. Keep this and all medications out of the reach of children.

Geriatic Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Gender

There is no FDA guidance on the use of Tropicamide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Tropicamide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Tropicamide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Tropicamide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Tropicamide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Tropicamide in patients who are immunocompromised.

Administration and Monitoring

Administration

Topical (Ophthalmic drops)

Monitoring

There is limited information regarding Tropicamide Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Tropicamide and IV administrations.

Overdosage

There is limited information regarding Tropicamide overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Tropicamide structure.png
Tropicamide
Systematic (IUPAC) name
N-ethyl-3-hydroxy-2-phenyl-N- (pyridin-4-ylmethyl) propanamide
Identifiers
CAS number 1508-75-4
ATC code S01FA06
PubChem 5593
DrugBank DB00809
Chemical data
Formula C17H20N2O2 
Mol. mass 284.353 g/mol
Pharmacokinetic data
Bioavailability ?
Protein binding 45%
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

C

Legal status
Routes topical eye drops

Mechanism of Action

This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, dilating the pupil (mydriasis). The stronger preparation (1%) also paralyzes accommodation.

Structure

The active ingredient is represented by the chemical structure:

Tropicamide chemical structure.png

Pharmacodynamics

This preparation acts in 15-30 minutes, and the duration of activity is approximately 3-8 hours. Complete recovery from mydriasis in some individuals may require 24 hours.

Pharmacokinetics

There is limited information regarding Tropicamide Pharmacokinetics in the drug label.

Nonclinical Toxicology

There have been no long-term studies done using tropicamide in animals to evaluate carcinogenic potential.

Clinical Studies

There is limited information regarding Tropicamide Clinical Studies in the drug label.

How Supplied

Tropicamide Ophthalmic Solution USP, 0.5% and 1% are supplied as sterile solutions in plastic dropper bottles:

  • 0.5% NDC 17478-101-12 (15 mL)
  • 1% NDC 17478-102-12 (15 mL)
  • 1% NDC 17478-102-20 (2 mL)

Storage

Store at 20° to 25°C (68° to 77°F)

Images

Drug Images

Package and Label Display Panel

Tropicamide 5 mg in 1 ml FDA package label.png
Tropicamide 10 mg in 1 ml FDA package label.png
Tropicamide 0.5%.png
This image of the FDA label is provided by the National Library of Medicine.
Tropicamide 1%.png
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

  • Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in potentially hazardous activities while pupils are dilated.
  • Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation.
  • Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration.

Precautions with Alcohol

Alcohol-Tropicamide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • Mydral [1]
  • Mydriacyl
  • Ocu-Tropic
  • Tropicacyl

Look-Alike Drug Names

There is limited information regarding Tropicamide Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. "FDA LABEL: TROPICAMIDE- tropicamide solution/ drops".




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