Fluocinolone acetonide

Overview

Fluocinolone acetonide, with the formula 6-alpha, 9-alpha-difluoro-16-alpha, 17 alpha-acetonide, is a corticosteroid that presents a high lipophilicity. It has been used extensively in dermatological preparations and it has also been investigated thoroughly for its use in implantable corticosteroid devices. This type of device containing fluocinolone acetonide was developed by Taro Pharmaceuticals and approved by FDA in May 2016.

Indication

Fluocinolone acetonide has been used extensively in different medical areas. -In dermatology, it is extensively used for the relief of inflammatory dermatosis, dermatitis, psoriasis, hypertrophic tissues, keloid tissues and atopic dermatitis. -It has been used in shampoo products as a low to medium potency corticosteroid for the treatment of seborrheic dermatitis of the scalp. -In ear drops, it is used as a low to medium potency corticosteroid for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older. -As an intravitreal implant, it is indicated for the treatment of diabetic macular edema with patients that have been previously treated with a course of corticosteroids and no clinically significant rise in intraocular pressure. -Fluocinolone acetonide was announced on October 15, 2018 to be FDA approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. -Some reports have indicated the use of fluocinolone acetonide as a vasoprotective agent and for its use in the treatment of first-degree hemorrhoids.

Associated Conditions

Acute Otitis Media (AOM)
Allergic Skin Reaction
Atopic Dermatitis
Blisters
Chronic Disease of Skin
Dermatosis
Diabetic Macular Edema (DME)
External Hemorrhoid
Fissure;Anal
Friction and Pressure Injuries
Hemorrhoids, Internal
Non-infectious Posterior Uveitis Chronic Uveitis
Otitis Externa
Perianal erythema
Pruritus
Psoriasis of the scalp
Purulent Wounds
Scab
Seborrheic dermatitis of the scalp
Skin Inflammation caused by Bacterial Infections
Skin Inflammation of the ear
Uveitis
Wound Infections
Anal eczema
Bacterial skin infections
Chronic eczematous otitis externa
Corticosteroid-responsive dermatoses

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 Mg) Intravitreal Implants Vs Observation for Prevention of VA Loss Due to Radiation Retinopathy	2023/05/06	NCT05844982	Phase 3	Recruiting	Jaeb Center for Health Research
A Study of YUTIQ® 0.18 mg Intravitreal Implant for the Management of Chronic Non-infectious Uveitis	2022/10/25	NCT05592717	N/A	Recruiting	Tianjin Medical University
The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment	2022/08/03	NCT05486468	Phase 3	Recruiting	Texas Retina Associates
A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery	2021/06/08	NCT04918121	Early Phase 1	Active, not recruiting	Sanjay Asrani
A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)	2020/07/14	NCT04469595	Phase 4	Active, not recruiting	Alimera Sciences
Imaging of Uveitis Patients Receiving Injectable Fluocinolone Acetonide Implant	2020/04/09	NCT04340505	N/A	Recruiting	The Cleveland Clinic
Combined Ranibizumab and Iluvien for Diabetic Macular Oedema	2018/12/21	NCT03784443	Phase 2	Withdrawn	Imperial College London
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa	2017/06/23	NCT03196973	Phase 3	Completed	Salvat
Fluocinolone Acetonide Insert (ILUVIEN®) for Diabetic Macular Edema (FAD) Study	2016/09/16	NCT02902744	Phase 4	Withdrawn	Johns Hopkins University
A Non-Randomized, Open-Label, Single Center Phase 4 Study of the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (Laser, Anti-VEGF) With or Without Intravitreal Corticosteroid Therapy	2015/06/15	NCT02472366	Phase 4	Completed	Alimera Sciences

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Fluocinolone Acetonide Topical Solution USP, 0.01%	Bryant Ranch Prepack	72162-1271	TOPICAL	0.1 mg in 1 mL	3/11/2024
fluocinolone acetonide	Bryant Ranch Prepack	72162-1434	TOPICAL	0.01 mg in 100 mL	3/12/2024
Derma-Smoothe/FS	Royal Pharmaceuticals	68791-101	TOPICAL	0.11 mg in 1 mL	4/15/2018
FLUOCINOLONE ACETONIDE 0.025% / LIDOCAINE HCL MONOHYDRATE 1%	Sincerus Florida, LLC	72934-1083	TOPICAL	0.025 g in 100 g	5/20/2019
Fluocinolone Acetonide Oil	Rising Pharmaceuticals, Inc.	64980-329	AURICULAR (OTIC)	0.11 mg in 1 mL	10/25/2018
Fluocinolone Acetonide	Lupin Pharmaceuticals,Inc.	43386-069	TOPICAL	0.1 mg in 1 mL	2/21/2019
Fluocinolone Acetonide	Amneal Pharmaceuticals LLC	65162-703	TOPICAL	0.11 mg in 118.28 mL	12/18/2023
Neo-Synalar	Medimetriks Pharmaceuticals	43538-940	TOPICAL	0.25 mg in 1 g	1/10/2023
YUTIQ	EyePoint Pharmaceuticals, Inc	71879-136	INTRAOCULAR	0.18 mg in 1 1	12/13/2023
Fluocinolone Acetonide	Amneal Pharmaceuticals LLC	65162-702	AURICULAR (OTIC)	0.11 mg in 20 mL	12/18/2023

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
FLUNOLONE-V CREAM 0.25 mg/g	ATLANTIC LABORATORIES CORPN LTD	SIN04897P	CREAM	0.25 mg/g	7/5/1990
SUPRICORT CREAM 0.025% w/w	GLENMARK PHARMACEUTICALS LTD	SIN03907P	CREAM	0.025% w/w	2/21/1990
TRI-LUMA CREAM	HILL DERMACEUTICALS, INC., G. Production Inc.	SIN12607P	CREAM	0.1 mg/g	10/19/2004
CETRAXAL PLUS EAR DROPS SOLUTION	Laboratorios Salvat S.A.	SIN14597P	SOLUTION	0.25mg	8/29/2014

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
FLUOCINOLONE CREAM 0.0125% (VIDA)	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	9/25/2000
FLUOCINOLONE ACETONIDE OINT 0.03%	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	10/25/1986
CINO-N CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	3/5/1987
SYNCO-CFN CREAM	N/A	EUROPHARM LABORATOIRES COMPANY LIMITED	N/A	N/A	7/15/1993
NEO-CINOLONE CREAM	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	5/18/1984
UNI-CINOLONE CREAM 0.025%	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	10/14/1992
FLUOCINOLONE CREAM 0.0125% W/W	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	7/13/2015
CATELONE-N CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	3/5/1987
FLU-N CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	5/19/1979
FLUOCINOLONE CREAM 0.025% (VIDA)	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	9/25/2000

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ILUVIEN fluocinolone acetonide 190 mcg intravitreal implant in applicator	306543	Specialised Therapeutics Alim Pty Ltd	Medicine	A	8/6/2019

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SYNALAR CREAM 0.025%	medicis canada ltd.	00030422	Cream - Topical	0.025 %	12/31/1970
SYNALAR CREAM MILD 0.01%	medicis canada ltd.	00030414	Cream - Topical	0.01 %	12/31/1967
DERMA SMOOTHE/FS LIQ 0.01%	Hill Dermaceuticals Inc	00873292	Emulsion - Topical	0.01 %	12/31/1991
SYNALAR BI-OTIC SOLUTION	medicis canada ltd.	00189499	Solution - Otic	0.25 MG / ML	12/31/1986
SYNALAR ONT REGULAR 0.025%	syntex inc.	00030406	Ointment - Topical	.025 %	12/31/1963
FS SHAMPOO-0.01%	Hill Dermaceuticals Inc	02129078	Shampoo - Topical	.01 %	12/31/1994
SYNALAR OINTMENT MILD 0.01%	medicis canada ltd.	00030392	Ointment - Topical	0.01 %	12/31/1968
RETISERT	bausch & lomb inc	02306980	Implant - Intravitreal	0.59 MG	9/13/2012
FLUODERM ONT 0.01%	Taro Pharmaceuticals Inc	00716804	Ointment - Topical	.1 MG / G	12/31/1979
OTIXAL	medexus pharmaceuticals inc.	02459655	Solution - Otic	0.025 % / W/V	5/8/2017

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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