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Tropicamide

For mydriasis and cycloplegia for diagnostic procedures.

Prescription medicine Ophthalmic Safety alerts on record

How to use Tropicamide

Ce que dit la notice officielle. Si un médecin vous l'a prescrit, suivez l'ordonnance. La notice de votre boîte prime si elle est différente.

Pour qui

For mydriasis and cycloplegia for diagnostic procedures.

Comment le prendre et à quelle fréquence
  • For refraction, instill one or two drops of 1% solution in the eye(s), repeated in five minutes
  • If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect
  • For examination of fundus, instill one or two drops of 0.5% solution 15 or 20 minutes prior to examination
  • Individuals with heavily pigmented irides may require higher strength or more doses
  • Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours
  • However, in some cases, complete recovery may take up to 24 hours
  • To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Talk to a doctor first if

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.

Effets secondaires possibles

Ocular: Transient stinging, blurred vision, photophobia and superficial punctate 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 cardio-respiratory collapse in children have been reported with the use of anticholinergic drugs.

En cas d'oubli

Prenez-le dès que vous y pensez, sauf s'il est presque l'heure de la dose suivante. Dans ce cas, sautez la dose oubliée. Ne prenez jamais deux doses à la fois pour compenser. Vérifiez votre notice, certains médicaments font exception.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2022-06-29.

Marques dans le monde

Products with Tropicamide as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

TropicamideTROPICAMIDE 1 g/g · Powder · Medisca Inc.
NDC 38779-0273Label
TropicamideTROPICAMIDE 1 kg/kg · Powder · Bioxera Pharma Private Limited
NDC 53211-213Label
TropicamideTROPICAMIDE 1 kg/kg · Powder · Laurus Labs Limited
NDC 42385-114Label
TropicamideTROPICAMIDE 5 mg/mL · Solution/ Drops · Sandoz Inc
NDC 61314-354Label
TropicamideTROPICAMIDE 10 mg/mL · Solution/ Drops · Sandoz Inc
NDC 61314-355Label

Nigeria (NAFDAC)

NAFDACTrofrine Ophthalmic Solution B4-7805NAFDACVitrophen Ophthalmic Solution B4-9833

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron SU.S. FDA Class II
20 Nov 2025 · Fagron Compounding Services · OngoingIncorrect Product Formulation
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit U.S. FDA Class III
9 Jul 2025 · Imprimis NJOF, LLC · CompletedSub-Potent Drug: Subpotent assay results during stability testing.
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, LedgU.S. FDA Class III
24 Feb 2025 · Imprimis NJOF, LLC · OngoingSub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This isU.S. FDA Class III
10 Nov 2023 · Fagron Compounding Services · OngoingLabeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Tropicamide

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Encore 3 vérifications gratuites aujourd'hui Sources officielles : FDA américaine · EMA (UE) · NAFDAC · alertes OMS

Questions about Tropicamide

What is Tropicamide used for?

For mydriasis and cycloplegia for diagnostic procedures. (From the official U.S. FDA label.)

How do I take Tropicamide?

Follow your prescription or the leaflet in your pack. The official label says: For refraction, instill one or two drops of 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect. For examination of fundus, instill one or two drops of 0.5% solution 15 or 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher s…

Do I need a prescription for Tropicamide?

Usually yes. Tropicamide is a prescription medicine in most countries. Rules differ by country.

What brands contain Tropicamide?

Tropicamide is sold under names such as Mydriacyl, Paremyd, Mydcombi, Tropicamide. Brand names differ between countries.

How can I check that my Tropicamide is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.