MedPath

Fluocinolone acetonide

Generic Name
Fluocinolone acetonide
Brand Names
Capex, Derma-Smoothe/FS, Derma-smoothe FS, Dermotic, Flac, Iluvien, Neo-synalar, Otixal, Otovel, Retisert, Synalar, Tri-luma, Yutiq
Drug Type
Small Molecule
Chemical Formula
C24H30F2O6
CAS Number
67-73-2
Unique Ingredient Identifier
0CD5FD6S2M

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.

Background

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

FDA Approved Products

Fluocinolone Acetonide
Manufacturer:Cosette Pharmaceuticals, Inc.
Route:TOPICAL
Strength:0.25 mg in 1 g
Approved: 2023/11/22
NDC:0713-0224
Fluocinolone Acetonide
Manufacturer:Quagen Pharmaceuticals LLC
Route:TOPICAL
Strength:0.11 mg in 1 mL
Approved: 2023/02/26
NDC:70752-158
fluocinolone acetonide
Manufacturer:Bryant Ranch Prepack
Route:TOPICAL
Strength:0.01 mg in 100 mL
Approved: 2024/03/12
NDC:72162-1434
Fluocinolone Acetonide Topical Solution USP, 0.01%
Manufacturer:Encube Ethicals Private Limited
Route:TOPICAL
Strength:0.1 mg in 1 mL
Approved: 2020/12/02
NDC:21922-003
Fluocinolone acetonide
Manufacturer:Bryant Ranch Prepack
Route:TOPICAL
Strength:0.01 mg in 100 mL
Approved: 2023/07/17
NDC:63629-8656

Singapore Approved Products

FLUNOLONE-V CREAM 0.25 mg/g
Manufacturer:ATLANTIC LABORATORIES CORPN LTD
Form:CREAM
Strength:0.25 mg/g
Online:Yes
Approved: 1990/07/05
Approval:SIN04897P
SUPRICORT CREAM 0.025% w/w
Manufacturer:GLENMARK PHARMACEUTICALS LTD
Form:CREAM
Strength:0.025% w/w
Online:Yes
Approved: 1990/02/21
Approval:SIN03907P
TRI-LUMA CREAM
Manufacturer:HILL DERMACEUTICALS, INC., G. Production Inc.
Form:CREAM
Strength:0.1 mg/g
Online:Yes
Approved: 2004/10/19
Approval:SIN12607P
CETRAXAL PLUS EAR DROPS SOLUTION
Manufacturer:Laboratorios Salvat S.A.
Form:SOLUTION
Strength:0.25mg
Online:Yes
Approved: 2014/08/29
Approval:SIN14597P

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