pharmacopeia
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/api/v1/drug/tropicamide

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Cholinergic Antagonists; Cholinergic Muscarinic Antagonists.

CholinergicCholinergic Muscarinic

Indications

Sourced from openFDA
  • For mydriasis and cycloplegia for diagnostic procedures.

Contraindications

Sourced from openFDA
  • Contraindicated in persons showing hypersensitivity to any component of this preparation.contraindicated

Dosage & administration

Sourced from openFDA

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.

Warnings & precautions

Sourced from openFDA

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

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Dec 6, 1974ANDAANDA084305Sandoz
  • Dec 6, 1974ANDAANDA084306Alcon Labs Inc
  • Jul 27, 1994ANDAANDA040064Bausch And Lomb
  • Jul 27, 1994ANDAANDA040067Bausch And Lomb
  • Dec 12, 2019ANDAANDA207524Somerset Theraps Llc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,602 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use16310%
  2. 2Vision Blurred1589.9%
  3. 3Eye Pain1137.1%
  4. 4Headache1006.2%
  5. 5Visual Acuity Reduced986.1%
  6. 6Drug Ineffective895.6%
  7. 7Visual Impairment845.2%
  8. 8Nausea764.7%
  9. 9Dizziness704.4%
  10. 10Toxic Anterior Segment Syndrome694.3%
  11. 11Cataract684.2%
  12. 12Endophthalmitis674.2%
  13. 13Vitreous Floaters664.1%
  14. 14Fatigue654.1%
  15. 15Eye Irritation623.9%

Literature

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Recent PubMed references pinned to Tropicamide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 67 ClinicalTrials.gov registrations naming Tropicamide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Tropicamide work?
Mechanism-of-action classes: Cholinergic Antagonists; Cholinergic Muscarinic Antagonists.
What is Tropicamide used for?
According to FDA labeling, Tropicamide carries indications including: For mydriasis and cycloplegia for diagnostic procedures.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Tropicamide?
Tropicamide is classified as Anticholinergics, Anticholinergic, Cholinergic Antagonists, Cholinergic Muscarinic Antagonists, Decreased Parasympathetic Acetylcholine Activity, Pupillary Dilation.
What are the brand names for Tropicamide?
Tropicamide is marketed under brand names including Mydcombi, Mydriacyl, Paremyd.
What are the contraindications for Tropicamide?
Tropicamide labeling lists contraindications including: Contraindicated in persons showing hypersensitivity to any component of this preparation.. Always consult the full prescribing information and a clinician.
Note. Data for tropicamide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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