Fluocinolone acetonide (topical)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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Overview
Fluocinolone acetonide (topical) is a corticosteroid that is FDA approved for the treatment of inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses. Common adverse reactions include burning,itching,irritation, dryness, folliculitis.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- Fluocinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.
Dosage
- Fluocinolone Acetonide Cream is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. In hairy sites, the hair should be parted to allow direct contact with the lesion.
- Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. Some plastic films may be flammable and due care should be exercised in their use. Similarly, caution should be employed when such films are used on children or left in their proximity, to avoid the possibility of accidental suffocation.
- If an infection develops, the use of the occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Fluocinolone acetonide (topical) in adult patients.
Non–Guideline-Supported Use
Indications
- Vitiligo
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Fluocinolone acetonide (topical) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Fluocinolone acetonide (topical) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluocinolone acetonide (topical) in pediatric patients.
Contraindications
- Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Warnings
There is limited information regarding Fluocinolone acetonide (topical) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
- The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Fluocinolone acetonide (topical) in the drug label.
Drug Interactions
Use in Specific Populations
Pregnancy
- Pregnancy Category C
- Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fluocinolone acetonide (topical) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Fluocinolone acetonide (topical) during labor and delivery.
Nursing Mothers
- It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
Pediatric Use
- Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalmic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
- HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
- Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
Geriatic Use
There is no FDA guidance on the use of Fluocinolone acetonide (topical) with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Fluocinolone acetonide (topical) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Fluocinolone acetonide (topical) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Fluocinolone acetonide (topical) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Fluocinolone acetonide (topical) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Fluocinolone acetonide (topical) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Fluocinolone acetonide (topical) in patients who are immunocompromised.
Administration and Monitoring
Administration
- Topical
Monitoring
There is limited information regarding Monitoring of Fluocinolone acetonide (topical) in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Fluocinolone acetonide (topical) in the drug label.
Overdosage
- Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.
Pharmacology
Mechanism of Action
Structure
- Fluocinolone Acetonide Cream USP is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16, 17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure:
- Fluocinolone Acetonide Cream USP 0.01% contains fluocinolone acetonide 0.1 mg/g in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax.
- Fluocinolone Acetonide Cream USP 0.025% contains fluocinolone acetonide 0.25 mg/g in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Fluocinolone acetonide (topical) in the drug label.
Pharmacokinetics
- The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
- Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION).
- Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, and Impairment of Fertility
- Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.
- Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
Clinical Studies
There is limited information regarding Clinical Studies of Fluocinolone acetonide (topical) in the drug label.
How Supplied
- Fluocinolone Acetonide Cream USP, 0.01% is supplied in
- 15 g Tube – NDC 52565-031-15
- 60 g Tube – NDC 52565-031-60
- Fluocinolone Acetonide Cream USP, 0.025% is supplied in
- 15 g Tube – NDC 52565-020-15
- 60 g Tube – NDC 52565-020-60
Storage
- Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F).
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Fluocinolone acetonide (topical) in the drug label.
Precautions with Alcohol
- Alcohol-Fluocinolone acetonide (topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- FLUOCINOLONE ACETONIDE
Look-Alike Drug Names
- A® — B®[1]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ "http://www.ismp.org". External link in
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