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Fluocinolone (Topical) (Monograph)

Brand names: Capex, Derma-Smoothe/FS, Lidex, Lidex-E, Synalar, Synemol
Drug class: Corticosteroids
ATC class: D07AC04
VA class: DE200
CAS number: 67-73-2

Medically reviewed by Drugs.com on Jan 19, 2024. Written by ASHP.

Introduction

Synthetic fluorinated corticosteroids.b c d e

Uses for Fluocinolone (Topical)

Corticosteroid-responsive Dermatoses

Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.a c d e f

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).a

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

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

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

Response may vary from one topical corticosteroid preparation to another.a

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

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

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

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

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

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

Fluocinolone (Topical) Dosage and Administration

General

Administration

Topical Administration

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

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.a

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

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.b f

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

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

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.a

Administration with Occlusive Dressing

Occlusive dressings may be used for severe or resistant dermatoses (e.g., psoriasis).b c d e (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.b

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.a 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.a

If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape.a 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.a

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.a

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.a

Occlusive dressing usually is left in place for 12–24 hours and therapy is repeated as needed.a 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.a

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.a

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

Dosage

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

Pediatric Patients

Administer the least amount of topical preparations that provides effective therapy.a c d e (See Pediatric Use under Cautions.)

Corticosteroid-responsive Dermatoses
Topical

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

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.a

Adults

Corticosteroid-responsive Dermatoses
Topical

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

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

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.b 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.b

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

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.a

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.b

Cautions for Fluocinolone (Topical)

Contraindications

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.f

Peanut Hypersensitivity

Fluocinolone acetonide 0.01% topical oil is formulated with 48% refined peanut oil.b Use this formulation with caution in individuals with known hypersensitivity to peanuts.b 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.b

General Precautions

Hypothalamic-Pituitary-Adrenal Axis Suppression.

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

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.c d e f

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

HPA-axis function recovery generally is prompt and complete following drug discontinuance.a c d e f

Rarely, glucocorticosteroid insufficiency may require systemic corticosteroid therapy.a c d e f

Systemic Effects

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

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.a

Infants and children may be more susceptible to adverse systemic effects.a c d e (See Pediatric Use under Cautions.)

Local Effects

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

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

If irritation occurs, discontinue drug and institute appropriate therapy.c d e f

Skin Infection

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

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.a g In addition, consider the cautions, precautions, and contraindications associated with the anti-infective.a g

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

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).a However, most clinicians believe topical corticosteroids can be used with caution if the infection is treated.a

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.a c (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.a c (See Local Effects under Cautions.)

Do not use occlusive dressings on weeping or exudative lesions.a

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

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

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

Specific Populations

Pregnancy

Category C.c d e f

Lactation

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

Pediatric Use

Safety and efficacy of fluocinolone actonide shampoo not established.b f

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.b However, the long-term safety of the topical oil in pediatric patients has not been established.b

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.c d e

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

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,a c d e especially when topical corticosteroids are applied to >20% of body surface area.a The risk of adrenal suppression appears to increase with decreasing age.a (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.a c d e f

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

Intracranial hypertension has occurred in children; manifestations include bulging fontanelles, headaches, and bilateral papilledema.a c d e f

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

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.a

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.c d e f

Drug Interactions

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Corticosteroids

Potential pharmacologic interaction with other corticosteroid-containing preparationsa

Nitroblue-tetrazolium test for bacterial infection

Concurrent use of corticosteroids reportedly may result in false-negative resultsa

Fluocinolone (Topical) Pharmacokinetics

Absorption

Bioavailability

Topically applied fluocinolone acetonide and fluocinonide can be absorbed through normal intact skin.a c d e f

Percutaneous penetration can be altered by using different vehicles.c d e f

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).a c d e

Distribution

Extent

Not known whether topical fluocinolone acetonide or fluocinonide is distributed into milk.c d e f

Elimination

Metabolism

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

Elimination Route

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

Stability

Storage

Topical

Cream, Gel, Ointment, Solution, and Shampoo

Tight containersb f at 15–30°C.c d f Do not freeze.b Protect from excessive heat (above 40°C).e

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

Actions

Advice to Patients

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

Fluocinolone Acetonide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

0.025%*

Synalar (with parabens and propylene glycol)

Medicis

Synemol Emollient Cream

Medicis

For shampoo

0.01%

Capex Shampoo

Galderma

Oil

0.01%

Derma-Smoothe/FS (with isopropyl alcohol)

Hill

Ointment

0.025%*

Fluocinolone Acetonide Ointment

Fougera

Synalar

Medicis

Solution

0.01%*

Synalar (with propylene glycol)

Medicis

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

Fluocinonide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

0.05%*

Fluocinonide E Emollient Cream

Alpharma

Lidex (with propylene glycol)

Medicis

Lidex-E Emollient Cream (with propylene glycol)

Medicis

Gel

0.05%*

Fluocinonide Gel

Fougera

Lidex Gel (with propylene glycol)

Medicis

Ointment

0.05%*

Lidex (with propylene glycol)

Medicis

Solution

0.05%*

Lidex (with alcohol 35% and propylene glycol)

Medicis

AHFS DI Essentials™. © Copyright 2024, Selected Revisions January 29, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

a. AHFS Drug Information McEvoy GK, ed. Topical Corticosteroids General Statement. Bethesda, MD: American Society of Health-System Pharmacists.

b. AHFS Drug Information. McEvoy GK, ed. Fluocinolone Acetonide/Fluocinonide. Bethesda, MD: American Society of Health-System Pharmacists.

c. Taro. Fluocinonide gel 0.05% prescribing information. Hawthorne, NY; 1997 Jan.

d. Taro. Fluocinonide ointment 0.05% prescribing information. Hawthorne, NY; 1998 Aug.

e. Taro. Fluocinonide topical solution 0.05% prescribing information. Bramalea, ON, Canada; 1998 Feb.

f. Hill. Capex (fluocinolone acetonide) shampoo 0.01% prescribing information. Sanford, FL; 2000 Jul.

g. AHFS Drug Information. McEvoy GK, ed. Neomycin Sulfate. Bethesda, MD: American Society of Health-System Pharmacists.