Tropicamide

Overview

Tropicamide is an alkaloid atropine‐derived anticholinergic drug and a non‐selective antagonist of muscarinic acetylcholine (mACh) receptors. Usually available in ophthalmic formulations, tropicamide is used to cause mydriasis and cycloplegia for eye exams or ocular procedures. It is also used in combination with hydroxyamphetamine for the same indication. Oral tropicamide has been investigated as a potential drug to relieve sialorrhea in patients with Parkinson's Disease.

Indication

Tropicamide is indicated to induce mydriasis (dilation of the pupil) for diagnostic procedures and in conditions where short-term pupil dilation is desired, either as monotherapy or in combination with hydroxyamphetamine or phenylephrine. It provides clinically significant mydriasis with partial cycloplegia.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy of the MydCombi on Pupillary Dilation in Pediatric and Adult Patients	2024/04/15	NCT06366217	Phase 4	Not yet recruiting	University of California, San Francisco
Cycloplegic Refraction in Pediatric Patients With Esotropia	2023/10/11	NCT06077682	Phase 4	Recruiting	Islamic Hospital, Jordan
Retinal Oxygenation Estimation Trial With Mantis Photonics Hyperspectral Camera	2022/10/04	NCT05566626	Not Applicable	ENROLLING_BY_INVITATION	Mantis Photonics AB
Cycloplegic Refraction Among Children	2022/07/05	NCT05442801	Phase 4	Completed	Islamic Hospital, Jordan
Wearing-Off Period of Pharmacological Dilation and Anisocoria	2022/02/14	NCT05238233	Phase 4	Completed	Prisma Health-Upstate
Effect of Tropicamide 0.5% vs Tropicamide 1% on Intraocular Pressure of Diabetic Patients	2021/06/21	NCT04932213	Phase 3	Completed	Semnan University of Medical Sciences
Efficacy and Safety of Mydriatic Microdrops Compared With Standard Drops for Retinopathy of Prematurity (ROP) Screening: a Pilot Randomized Clinical Trial	2020/11/10	NCT04623684	Phase 4	Completed	Aristotle University Of Thessaloniki
Performance of Rigid Gas Permeable (RGP) Scleral Contact Lenses With a Passive Artificial Iris	2019/08/01	NCT04040790	Not Applicable	Terminated	University Ghent
The Effect of Brimonidine	2019/05/22	NCT03959176	Phase 4	Completed	Wake Forest University Health Sciences
Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation	2018/11/23	NCT03751631	Phase 3	Completed	Eyenovia Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Tropicamide	Bausch & Lomb Incorporated	24208-585	OPHTHALMIC	10 mg in 1 mL	9/1/2023
Tropicamide	Akorn	17478-101	OPHTHALMIC	5 mg in 1 mL	5/20/2022
Tropicamide	Sandoz Inc	61314-355	OPHTHALMIC	10 mg in 1 mL	12/16/2020
Tropicamide	Somerset Therapeutics, LLC	70069-121	OPHTHALMIC	10 mg in 1 mL	4/26/2023
Tropicamide	Akorn	17478-102	OPHTHALMIC	10 mg in 1 mL	5/20/2022
Tropicamide	Sandoz Inc	61314-354	OPHTHALMIC	5 mg in 1 mL	10/23/2020
Tropicamide	Bausch & Lomb Incorporated	24208-590	OPHTHALMIC	5 mg in 1 mL	9/1/2023
Mydriacyl	Alcon Laboratories, Inc.	0065-0355	OPHTHALMIC	10 mg in 1 mL	1/28/2019
MYDCOMBI	Eyenovia, Inc.	81046-0111	OPHTHALMIC	0.08 mg in 0.008 mL	5/9/2023
Mydriatic-4	Imprimis NJOF, LLC	71384-632	OPHTHALMIC	10 mg in 1 mL	5/1/2018

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
MINIMS TROPICAMIDE EYE DROPS 1% w/v	LABORATOIRE CHAUVIN SA	SIN04202P	SOLUTION	1% w/v	4/20/1990
MYDRIACYL STERILE OPHTHALMIC SOLUTION 1%	ALCON-COUVREUR NV	SIN04715P	SOLUTION	10.0mg/ml	6/13/1990

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Minims Tropicamide 1% 10mg/mL eye drops tube	32289	Bausch & Lomb Australia Pty Ltd	Medicine	A	10/30/1991
MYDRIACYL tropicamide 1% eye drops bottle	25357	Alcon Laboratories Australia Pty Ltd	Medicine	A	10/15/1991
Minims Tropicamide 0.5% 5mg/mL eye drops tube	32288	Bausch & Lomb Australia Pty Ltd	Medicine	A	10/30/1991
MYDRIACYL tropicamide 0.5% eye drops bottle	25356	Alcon Laboratories Australia Pty Ltd	Medicine	A	10/15/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
R.O.-TROPAMIDE	richmond pharmaceuticals inc.	00896446	Liquid - Ophthalmic	10 MG / ML	12/31/1992
TROPICAMIDE	pharma stulln inc.	02023679	Solution - Ophthalmic	1 %	12/31/1994
TROPICAMIDE	pharma stulln inc.	02023660	Solution - Ophthalmic	0.5 %	12/31/1994
TROPICAMIDE 1% - LIQ OPH 10MG/ML	rivex ophthalmics inc.	02212919	Liquid - Ophthalmic	10 MG / ML	9/15/1997
PMS-TROPICAMIDE OPH SLTN 1%	Pharmascience Inc	00872946	Drops - Ophthalmic	1 %	12/31/1992
ODAN-TROPICAMIDE	odan laboratories ltd	00627704	Solution - Ophthalmic	0.5 %	12/31/1985
MYDRIACYL	Alcon Canada Inc	00001007	Solution - Ophthalmic	1 % / W/V	12/31/1969
DIOPHENYL-T SOLUTION	Sandoz Canada, Inc.	02023717	Solution - Ophthalmic	0.8 %	12/31/1994
PHENYLTROPE OPH SOLN	Sandoz Canada, Inc.	00629693	Solution - Ophthalmic	0.8 %	12/31/1985
MINIMS TROPICAMIDE	bausch & lomb inc	02148536	Drops - Ophthalmic	1 % / W/V	12/31/1995

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
FYDRANE 0,2 MG/ML + 3,1 MG/ML + 10 MG/ML SOLUCION INYECTABLE	Laboratoires Thea	80177	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
MINIMS TROPICAMIDA 10 MG/ML COLIRIO EN SOLUCION EN ENVASE UNIDOSIS	Bausch + Lomb Ireland Limited	88867	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized
MYDRIASERT 0,28 mg/5,4 mg INSERTO OFTALMICO	Laboratoires Thea	70710	INSERTO OFTÁLMICO	Diagnóstico Hospitalario	Commercialized
COLIROFTA TROPICAMIDA 10 MG/ML COLIRIO EN SOLUCION	Alcon Healthcare S.A.	57050	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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