Fluocinolone Acetonide (Topical) (Monograph)

Brand names: Capex, Derma-Smoothe/FS, Lidex, Lidex-E, Synalar, Synemol
Drug class: Corticosteroids

Medically reviewed by Drugs.com on Oct 10, 2024. Written by ASHP.

Introduction

Synthetic fluorinated corticosteroids.

Uses for Fluocinolone Acetonide (Topical)

Corticosteroid-responsive Dermatoses

Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Generally most effective in acute or chronic dermatoses (e.g., seborrheic or atopic dermatitis, localized neurodermatitis, anogenital pruritus, psoriasis, late phase of allergic contact dermatitis, inflammatory phase of xerosis).

Topical therapy generally preferred over systemic therapy; fewer associated adverse systemic effects.

Topical therapy generally only controls manifestations of dermatoses; eliminate cause if possible.

Topical efficacy may be increased by using a higher concentration or occlusive dressing therapy. (See Administration with Occlusive Dressing under Dosage and Administration.)

Response may vary from one topical corticosteroid preparation to another.

Anti-inflammatory activity may vary considerably depending on the vehicle, drug concentration, site of application, disease, and individual patient.

Fluocinonide 0.05% cream, ointment, and gel are considered to have high-range potency.

Fluocinolone acetonide 0.025% ointment is considered to have high-range potency.

Fluocinolone acetonide 0.025% cream is considered to have medium potency.

Fluocinolone acetonide 0.01% shampoo is considered to have low–medium potency.

Fluocinolone acetonide 0.01% solution is considered to have low potency.

Fluocinolone Acetonide (Topical) Dosage and Administration

General

• Consider location of the lesion and the condition being treated when choosing a dosage form.

• Creams are suitable for most dermatoses, but ointments also may provide some occlusion and usually are used for the treatment of dry, scaly lesions.

• Lotions probably are best for treatment of weeping eruptions, especially in areas subject to chafing (e.g., axilla, foot, groin). Lotions, gels, and aerosols may be used on hairy areas, particularly the scalp.

• Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercially available products with another vehicle may decrease effectiveness.

• Patients applying a topical corticosteroid to a large surface area and/or to areas under occlusion should be evaluated periodically for evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression by appropriate endocrine testing (e.g., ACTH stimulation, plasma cortisol, urinary free cortisol).

Administration

Topical Administration

For dermatologic use only; avoid contact with eyes. If such contact occurs, flush the affected eye(s) with copious amounts of water.

The area of skin to be treated may be thoroughly cleansed before topical application to reduce the risk of infection; however, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating.

Apply cream, gel, ointment, or solution sparingly in a thin film and rub gently into the affected area.

Fluocinolone acetonide shampoo should be prepared by a pharmacist at the time of dispensing; contents of the 12-mg capsule should be mixed with the shampoo base supplied by the manufacturer.

The extemporaneously prepared shampoo must be shaken well prior to administration.

Apply ≤30 mL of shampoo to the scalp once daily, lather, and allow to remain on the scalp for about 5 minutes; then rinse the hair and scalp thoroughly with water.

After a favorable response is achieved, frequency of application or concentration (strength) may be decreased to the minimum necessary to maintain control and to avoid relapse; discontinue if possible.

Administration with Occlusive Dressing

Occlusive dressings may be used for severe or resistant dermatoses (e.g., psoriasis). (See Occlusive Dressings under Cautions.) However, the manufacturer states that fluocinolone acetonide shampoo should not be used with occlusive dressings; treated areas of the scalp should not be bandaged or otherwise covered or wrapped as to be occlusive, unless directed by a clinician.

Soak or wash the affected area to remove scales; apply a thin film of cream, lotion, or ointment; rub gently into the lesion; and apply another thin film. Cover affected area with a thin, pliable plastic film and seal it to adjacent normal skin with adhesive tape or hold in place with a gauze or elastic bandage.

If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape. For added moisture in dry lesions, apply cream, ointment, or lotion and cover with a dampened cloth before the plastic film is applied or briefly soak the affected area in water before application of the drug and plastic film.

Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion.

Frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of the corticosteroid are essential at each dressing change.

Occlusive dressing usually is left in place for 12–24 hours and therapy is repeated as needed. Although occlusive dressing may be left in place for 3–4 days at a time in resistant conditions, most clinicians recommend intermittent use of occlusive dressings for 12 hours daily to reduce the risk of adverse effects (particularly infection) and systemic absorption and for greater convenience.

The drug and an occlusive dressing may be used at night, and the drug or a bland emollient may be used without an occlusive dressing during the day.

In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion. (See Occlusive Dressings under Cautions.)

Dosage

Available as fluocinolone acetonide and fluocinonide; dosage expressed in terms of the salt and the base, respectively.

Pediatric Patients

Administer the least amount of topical preparations that provides effective therapy.

Corticosteroid-responsive Dermatoses

Topical

Apply cream, gel, ointment, or solution sparingly 2–4 times daily depending on the severity of the condition.

For the treatment of moderate to severe atopic dermatitis in children ≥2 years of age, apply a thin film of fluocinolone acetonide 0.01% topical oil twice daily to affected areas for no longer than 4 weeks.

Adults

Corticosteroid-responsive Dermatoses

Topical

Apply cream, gel, ointment, or solution sparingly 2–4 times daily depending upon severity of condition.

For the treatment of atopic dermatitis, apply fluocinolone acetonide 0.01% topical oil as a thin film 3 times daily.

For the treatment of psoriasis of the scalp, apply a thin film of fluocinolone acetonide 0.01% topical oil to wet or dampened hair and scalp, massage well, and cover with the manufacturer-supplied shower cap. Allow oil to remain on the scalp overnight or for a minimum of 4 hours following application before being washed off with regular shampoo and rinsed thoroughly with water.

For the treatment of seborrheic dermatitis of the scalp, apply ≤30 mL of fluocinolone acetonide 0.01% shampoo to the scalp once daily.

Prescribing Limits

Pediatric Patients

Corticosteroid-responsive Dermatoses

Topical

For the treatment of moderate to severe atopic dermatitis in children ≥2 years of age, maximum 4 weeks of therapy.

Adults

Corticosteroid-responsive Dermatoses

Topical

For the treatment of seborrheic dermatitis of the scalp, maximum 30 mL of fluocinolone acetonide 0.01% shampoo applied to the scalp once daily.

Cautions for Fluocinolone Acetonide (Topical)

Contraindications

• Known hypersensitivity to fluocinolone acetonide, fluocinonide, or any ingredient in the formulation.

Warnings/Precautions

Sensitivity Reactions

Allergic contact dermatitis may manifest as failure to heal rather than irritation as occurs with other topical preparations that do not contain corticosteroids; confirm with diagnostic patch testing.

Peanut Hypersensitivity

Fluocinolone acetonide 0.01% topical oil is formulated with 48% refined peanut oil. Use this formulation with caution in individuals with known hypersensitivity to peanuts. If wheal and flare type reactions (which may be limited to pruritus) or other manifestations of hypersensitivity reactions develop, discontinue use of this formulation and institute appropriate therapy.

General Precautions

Hypothalamic-Pituitary-Adrenal Axis Suppression.

Topically applied corticosteroids can be absorbed in sufficient amounts to reversibly suppress the HPA axis.

Perform periodic HPA-axis evaluation by appropriate testing (e.g., ACTH stimulation, morning plasma cortisol, urinary free cortisol), especially in patients applying a topical corticosteroid to a large surface area or to areas under occlusion.

If HPA-axis suppression occurs, withdraw the drug, reduce the frequency of application, and/or substitute a less potent corticosteroid.

HPA-axis function recovery generally is prompt and complete following drug discontinuance.

Rarely, glucocorticosteroid insufficiency may require systemic corticosteroid therapy.

Systemic Effects

Systemic absorption following topical administration may result in manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Risk of adverse systemic effects increased with use of a high-potency topical corticosteroid, especially if applied to large areas of the body, for prolonged periods of time, with an occlusive dressing, and/or concurrently with other corticosteroid-containing preparations.

Infants and children may be more susceptible to adverse systemic effects.

Local Effects

Possible adverse local reactions (e.g., irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, miliaria); may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.

Prolonged use of topical corticosteroids may cause atrophy of the epidermis and subcutaneous tissue; these effects are most likely to occur (even with short-term use) in intertriginous (e.g., axilla, groin), flexor, and facial areas.

If irritation occurs, discontinue drug and institute appropriate therapy.

Skin Infection

If concurrent skin infection is present or develops, initiate appropriate anti-infective therapy. If infection does not respond promptly, discontinue topical corticosteroid therapy until the infection has been controlled.

When topical corticosteroids and topical anti-infectives are used concomitantly, consider that the corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; or suppress hypersensitivity reactions to ingredients in the formulation. In addition, consider the cautions, precautions, and contraindications associated with the anti-infective.

Do not use occlusive dressings in patients with primary skin infection.

Some manufacturers state that topical corticosteroids are contraindicated in patients with tuberculosis of the skin, dermatologic fungal infections, and cutaneous or systemic viral infection (including vaccinia and varicella and herpes simplex of the eye or adjacent skin). However, most clinicians believe topical corticosteroids can be used with caution if the infection is treated.

Occlusive Dressings

Adverse systemic corticosteroid effects may occur with use of occlusive dressings on large areas of the body and for prolonged periods of time; monitor accordingly. (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also Systemic Effects, under Cautions.)

Adverse local reactions may occur more frequently with the use of occlusive dressings, especially with prolonged therapy. (See Local Effects under Cautions.)

Do not use occlusive dressings on weeping or exudative lesions.

Do not use occlusive dressings in patients with primary skin infection.

Remove occlusive dressings covering large areas if body temperature increases; thermal homeostasis may be impaired.

Use plastic occlusive material with care to avoid the risk of suffocation.

Specific Populations

Pregnancy

Category C.

Lactation

Not known whether topical fluocinolone acetonide or fluocinonide is distributed into milk. Caution advised if these preparations are used.

Pediatric Use

Safety and efficacy of fluocinolone actonide shampoo not established.

Safety and efficacy of fluocinolone acetonide 0.01% topical oil in the management of moderate to severe stable atopic dermatitis in children ≥2 years of age have been established. However, the long-term safety of the topical oil in pediatric patients has not been established.

Tight-fitting diapers or plastic pants should not be used on a child being treated with the drug in the diaper area, since they may constitute occlusive dressings.

The topical oil should not be applied to the face or diaper area.

Children are more susceptible to topical corticosteroid-induced HPA-axis suppression and Cushing’s syndrome than mature individuals because of a greater skin surface area-to-body weight ratio, especially when topical corticosteroids are applied to >20% of body surface area. The risk of adrenal suppression appears to increase with decreasing age. (See Systemic Effects under Cautions.)

Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol concentrations, and lack of response to corticotropin (ACTH) stimulation.

Children also are at greater risk of glucocorticosteroid insufficiency during and/or after withdrawal of treatment.

Intracranial hypertension has occurred in children; manifestations include bulging fontanelles, headaches, and bilateral papilledema.

Striae has been reported in children treated inappropiately with topical corticosteroids.

Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic efficacy; chronic topical corticosteroid therapy may interfere with growth and development.

Common Adverse Effects

Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, miliaria.

Drug Interactions

Specific Drugs and Laboratory Tests

Fluocinolone Acetonide (Topical) Pharmacokinetics

Absorption

Bioavailability

Topically applied fluocinolone acetonide and fluocinonide can be absorbed through normal intact skin.

Percutaneous penetration can be altered by using different vehicles.

Percutaneous penetration also can be increased by use of occlusive dressings and by presence of inflammation and/or other disease of the epidermal barrier (e.g., psoriasis, eczema).

Distribution

Extent

Not known whether topical fluocinolone acetonide or fluocinonide is distributed into milk.

Elimination

Metabolism

Once absorbed through the skin, topically applied corticosteroids are metabolized primarily in the liver.

Elimination Route

Topical corticosteroids and metabolites are excreted by the kidneys and, to a lesser extent, in bile.

Stability

Storage

Topical

Cream, Gel, Ointment, Solution, and Shampoo

Tight containers at 15–30°C. Do not freeze. Protect from excessive heat (above 40°C).

The extemporaneously prepared shampoo is stable for 3 months from the time of compounding.

Actions

• Produces anti-inflammatory, antipruritic, and vasoconstrictor actions, possibly resulting in part from steroid receptor binding.

• Precise mechanism of action for topical anti-inflammatory activity is unknown; therapeutic benefit in the management of corticosteroid-responsive dermatoses mediated primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions.

• Anti-inflammatory effects may occur through induction of phospholipase A₂ inhibitory proteins (lipocortins); decreased arachidonic acid release from membrane phospholipids. Decreased arachidonic acid precursors may downregulate biosynthesis of potent inflammatory mediators (e.g., prostaglandins, leukotrienes).

Advice to Patients

• Importance of using only as directed, only for the disorder for which it was prescribed, and for no longer than prescribed; avoid contact with the eyes and only apply externally as directed. (See Topical Administration under Dosage and Administration.)

• Importance of informing patients that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a clinician.

• Importance of reporting any local adverse reactions, especially those occurring under occlusive bandage, to a clinician.

• Importance of informing parents of children that if fluocinolone topical preparations are applied in the diaper area, that tight-fitting diapers or plastic pants should not be used since they may act as an occlusive dressing.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

• Importance of informing patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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