Prednisolone acetate

Overview

Prednisolone acetate is a prednisolone molecule bound to an acetate functional group by an ester bond. Prednisolone acetate was granted FDA approval in 1955.

Indication

Prednisolone acetate is indicated as an anti-inflammatory or immunosuppressive agent for allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, or infectious conditions. Prednisolone acetate is also indicated in organ transplant patients, as well as endocrine or neoplastic conditions.

Associated Conditions

Inflammation
Inflammatory Conditions
Ocular Infections, Irritations and Inflammations
Ocular Inflammation
Transplanted Organ Rejection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Phase 2 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis	2024/11/07	NCT06679153	Phase 2	Completed	VivaVision Biotech, Inc
Research on the Treatment of Severe Community-acquired Pneumonia in Children	2023/03/14	NCT05768204	Phase 4	Recruiting	Baoping XU
DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia	2022/11/17	NCT05620901	Early Phase 1	Completed	Lejla Vajzovic, MD, FASRS
The Efficacy and Safety of Docetaxel Combined With Platinum for Metastatic Hormone-sensitive Prostate Cancer	2022/07/18	NCT05461261	Phase 2	Recruiting	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing FLACS With Premium IOL	2021/04/28	NCT04863742	Phase 4	UNKNOWN	Sight Medical Doctors PLLC
Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections	2020/09/24	NCT04563299	Phase 4	Terminated	Retina Vitreous Associates of Florida
Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment	2020/07/09	NCT04464629	Phase 4	Terminated	Midwest Eye Institute
Dextenza for Post-operative Treatment of Pterygium	2020/04/17	NCT04351737	Phase 4	Completed	Brandon Eye Associates, PA
A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%	2020/02/18	NCT04273282	Phase 4	Completed	Research Insight LLC
Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study	2019/11/19	NCT04168112	Phase 4	Completed	Sight Medical Doctors PLLC

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Prednisolone Acetate	A-S Medication Solutions	50090-0561	OPHTHALMIC	10 mg in 1 mL	1/20/2016
PREDNISOLONE ACETATE	DIRECT RX	72189-055	OPHTHALMIC	10 mg in 1 mL	10/30/2019
PREDNISOLONE ACETATE	NuCare Pharmaceuticals,Inc.	68071-2222	OPHTHALMIC	10 mg in 1 mL	2/4/2022
Pred-Brom	Imprimis NJOF, LLC	71384-505	OPHTHALMIC	10 mg in 1 mL	1/19/2018
PREDNISOLONE ACETATE	Pacific Pharma, Inc.	60758-119	OPHTHALMIC	10 mg in 1 mL	4/4/2024
BLEPHAMIDE	Physicians Total Care, Inc.	54868-1157	OPHTHALMIC	2 mg in 1 g	3/4/2012
PRED MILD	Physicians Total Care, Inc.	54868-6355	OPHTHALMIC	1.2 mg in 1 mL	1/2/2013
Pred-Gati	ImprimisRx NJ	70261-502	OPHTHALMIC	10 mg in 1 mL	2/22/2018
BLEPHAMIDE	Physicians Total Care, Inc.	54868-0634	OPHTHALMIC	2 mg in 1 mL	11/15/2013
Prednisolone Acetate	REMEDYREPACK INC.	70518-4006	OPHTHALMIC	10 mg in 1 mL	2/2/2024

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
PRED FORTE OPHTHALMIC SUSPENSION 1%	ALLERGAN PHARMACEUTICALS IRELAND	SIN04661P	SOLUTION	10 mg/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
PREDNEFRIN FORTE phenylephrine hydrochloride/prednisolone acetate eye drops bottle	23235	AbbVie Pty Ltd	Medicine	A	10/14/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PREDNISOLONE/SULFACETAMIDE	pharma stulln inc.	02023814	Suspension - Ophthalmic	0.5 % / W/V	12/31/1994
TEVA-PREDNISOLONE	teva canada limited	00700401	Suspension - Ophthalmic	1 %	12/31/1986
SANDOZ PREDNISOLONE	Sandoz Canada, Inc.	01916203	Suspension - Ophthalmic	1 %	12/31/1993
BLEPHAMIDE S.O.P.	Allergan, Inc.	00307246	Ointment - Ophthalmic	0.2 %	12/31/1974
METIMYD OPH SUS	schering-plough canada inc	00177024	Suspension - Ophthalmic	5 MG / ML	12/31/1956
PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION USP 1%	bausch & lomb pharmaceuticals inc.	02234048	Suspension - Ophthalmic	1 %	N/A
SANDOZ PREDNISOLONE	Sandoz Canada, Inc.	01916181	Suspension - Ophthalmic	0.12 %	12/31/1993
DIOPTIMYD OINTMENT	steri-med pharma inc.	02023784	Ointment - Topical , Ophthalmic	5 MG / G	N/A
PRED FORTE	Abbvie Corporation	00301175	Suspension - Ophthalmic	1 % / W/V	12/31/1974
ODAN-CIDE	odan laboratories ltd	00630640	Solution - Ophthalmic	5 MG / ML	12/31/1985

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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