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Fluocinolone Ointment (Fluocinolone Acetonide Topical) - Summary

 
 



SUMMARY

FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025%

Fluocinolone Acetonide Ointment contains Fluocinolone Acetonide USP (Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-. It has an empirical formula of C24H30F2O6 and a molecular weight of 452.49 (CAS Registry Number 67-73-2). Each gram of the ointment contains 0.25 mg Fluocinolone Acetonide in a base containing White Petrolatum.

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.


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NEWS HIGHLIGHTS

Media Articles Related to Fluocinolone Ointment (Fluocinolone Topical)

Seborrheic Dermatitis
Source: MedicineNet Eye Care Specialty [2017.08.09]
Title: Seborrheic Dermatitis
Category: Diseases and Conditions
Created: 3/16/2012 12:00:00 AM
Last Editorial Review: 8/9/2017 12:00:00 AM

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Published Studies Related to Fluocinolone Ointment (Fluocinolone Topical)

A randomized controlled trial of the efficacy and safety of a fixed triple combination (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) compared with hydroquinone 4% cream in Asian patients with moderate to severe melasma. [2008.09]
BACKGROUND: Melasma is an acquired, chronic hypermelanosis for which therapy remains a challenge. OBJECTIVES: To compare the efficacy and safety of a triple combination [TC: fluocinolone acetonide 0.01%, hydroquinone (HQ) 4%, tretinoin 0.05%] vs. HQ 4% after 8 weeks of treatment of moderate to severe facial melasma in Asian patients... CONCLUSIONS: Efficacy in Asians and patient satisfaction were superior with the fixed TC than with HQ 4%.

Cost-effectiveness of a fixed combination of hydroquinone/tretinoin/fluocinolone cream compared with hydroquinone alone in the treatment of melasma. [2007.02]
BACKGROUND: A once-daily fixed combination of hydroquinone, tretinoin, and fluocinolone acetonide (Tri-luma) is a newly available treatment for melasma. OBJECTIVE: To assess cost-effectiveness of triple combination therapy (TCT) applied once daily and hydroquinone alone applied twice daily in the U.S., Argentina, Brazil, Chile, and Colombia from a payer's perspective... CONCLUSION: TCT had a 30% better rate of complete clearing than hydroquinone with a lower cost in the U.S. and an incremental cost in other countries. In every country, cost per primary success was lower for TCT than for hydroquinone. Results were robust to varying assumptions of success rates and quantity used.

Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. [2006.06]
PURPOSE: To report the interim 34-week safety and efficacy results of a 3-year study to evaluate an investigational intravitreal fluocinolone acetonide (FA) implant in patients with noninfectious posterior uveitis. DESIGN: Prospective, dose-masked, dose-randomized, historically controlled, multicenter trial in patients with unilateral or bilateral disease. PARTICIPANTS: A total of 278 patients with recurrent noninfectious posterior uveitis were randomized to receive a 0.59-mg (n = 110) or 2.1-mg (n = 168) implant. In patients with bilateral disease, the more severely affected eye received the implant... CONCLUSIONS: The FA implant significantly reduced uveitis recurrences, improved VA, and decreased the need for adjunctive therapy in the studied patient population. The most common side effects included increased intraocular pressure and cataract progression.

Effect of fluocinolone acetonide on human dental pulp cells: cytotoxicity, proliferation, and extracellular matrix formation. [2011.02]
INTRODUCTION: The goal of vital pulp therapy is to maintain pulp vitality and function. Fluocinolone acetonide is a potent topical glucocorticoid used in the treatment of skin disorders and oral lesions that could possibly be used to resolve inflammation and stimulate the healing process of inflamed dental pulp. The purpose of this study was to investigate the effects of fluocinolone acetonide (0.1-50 mumol/L) on cytotoxicity, cell proliferation, and fibronectin and type I collagen synthesis in human dental pulp cells (HDPCs)... CONCLUSIONS: Low concentrations (0.1-10 mumol/L) of fluocinolone acetonide might have the potential to stimulate healing of inflamed dental pulp. Copyright A(c) 2011 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Cost-effectiveness of a hydroquinone/tretinoin/fluocinolone acetonide cream combination in treating melasma in the United States. [2010.09]
BACKGROUND: Melasma, a disorder of facial hyperpigmentation, presents a treatment obstacle to many physicians. Combination therapy with hydroquinone, tretinoin, and fluocinolone acetonide has proven effective, but it is generally more expensive than other treatments. OBJECTIVE: To assess the cost-effectiveness of daily triple combination therapy (TCT) compared with daily use of each possible pair of agents (dyads) and twice daily use of hydroquinone (HQ) alone from a payer's perspective... CONCLUSION: TCT consistently had the lowest cost per primary success in all the analyses performed. Furthermore, ICERs were low, indicating that TCT's superior efficacy is attained at marginal cost increases. Our results indicate that TCT is the most cost-effective treatment when compared with any of its dyads or with hydroquinone alone.

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Clinical Trials Related to Fluocinolone Ointment (Fluocinolone Topical)

Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment [Completed]
The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.

Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant [Recruiting]

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant [Terminated]
This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants [Completed]
This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.

Pilot Study of a Fluocinolone Acetonide Intravitreal Insert (FA-i) to Treat Intermediate-, Posterior-, or Panuveitis [Enrolling by invitation]
The purpose of this study is to determine the tolerability, safety, and benefits of an investigational drug,Fluocinolone Acetonide Intravitreal Insert (FA-i), in people who have posterior uveitis. The study drug, Fluocinolone Acetonide, is currently used in a surgical implant, Retisert, which is approved by the U. S. Food and Drug Administration (FDA) to treat non-infectious posterior uveitis . The study drug is able to be inserted in an ophthalmology (eye)clinic whereas Retisert must be surgically implanted in the Operating Room. Two doses of fluocinolone acetonide will be used in this study to determine if either strength of fluocinolone acetonide can effectively treat uveitis and if so, which strength works better. Or, it is possible that both strengths may work about the same but one strength may have fewer side effects.

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Page last updated: 2017-08-09

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