Fluocinonide topical

General

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

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

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

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

• 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).c d e f (See Hypothalamic-Pituitary-Adrenal Axis Suppresion and also Systemic Effects, under Cautions.)

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

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.)

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

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

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

Adults

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

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

• 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.a c d e f

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

• 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.a c d e f (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.c d e f

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

• 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.c d e

• 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. (See Cautions.)

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

Fluocinonide is a steroid. It prevents the release of substances in the body that cause inflammation.

Fluocinonide topical (for the skin) is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Fluocinonide topical may also be used for purposes not listed in this medication guide.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

Avoid getting this medicine in your eyes. If contact does occur, rinse with water. Do not use fluocinonide topical on broken or infected skin. Also avoid using this medicine in open wounds.

Avoid applying fluocinonide topical to the skin of your face, underarms, or groin area without your doctor's instruction. This medicine should not be used to treat rosacea.

Do not use fluocinonide topical to treat any condition that has not been checked by your doctor.

Usual Adult Dose for Dermatitis:

0.05% cream, gel, ointment: Apply a thin layer to affected area two to four times a day

0.1% cream: Apply a thin layer to affected area once or twice a day

Comments:
-Occlusive dressings may be used; however, if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-Treatment should be limited to 2 consecutive weeks and no more than 60 g per week should be used.

Uses: Relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses

Usual Adult Dose for Eczema:

0.05% cream, gel, ointment: Apply a thin layer to affected area two to four times a day

0.1% cream: Apply a thin layer to affected area once or twice a day

Comments:
-Occlusive dressings may be used; however, if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-Treatment should be limited to 2 consecutive weeks and no more than 60 g per week should be used.

Uses: Relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses

Usual Adult Dose for Atopic Dermatitis:

0.1% cream: Apply a thin layer to affected area once a day

Comments:
-Occlusive dressings may be used; however, if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-Treatment should be limited to 2 consecutive weeks and no more than 60 g per week should be used.

Use: Relief of the inflammatory and pruritic manifestations of atopic dermatitis

Usual Adult Dose for Psoriasis:

0.1% cream: Apply a thin layer to affected area once or twice a day

Comments:
-Occlusive dressings may be used; however, if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-Treatment should be limited to 2 consecutive weeks and no more than 60 g per week should be used.

Use: Relief of the inflammatory and pruritic manifestations of psoriasis

Usual Pediatric Dose for Dermatitis:

12 years or older:
0.05% cream, gel, ointment: Apply a thin layer to affected area two to four times a day

0.1% cream: Apply a thin layer to affected area once or twice a day

Comments:
-Occlusive dressings may be used; however, if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-Treatment should be limited to 2 consecutive weeks and no more than 60 g per week should be used.

Uses: Relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses

Usual Pediatric Dose for Eczema:

12 years or older:
0.05% cream, gel, ointment: Apply a thin layer to affected area two to four times a day

0.1% cream: Apply a thin layer to affected area once or twice a day

Comments:
-Occlusive dressings may be used; however, if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-Treatment should be limited to 2 consecutive weeks and no more than 60 g per week should be used.

Uses: Relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses

Usual Pediatric Dose for Psoriasis:

12 years or older:
0.1% cream: Apply a thin layer to affected area once or twice a day

Comments:
-Occlusive dressings may be used; however, if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-Treatment should be limited to 2 consecutive weeks and no more than 60 g per week should be used.

Use: Relief of the inflammatory and pruritic manifestations of psoriasis

Usual Pediatric Dose for Atopic Dermatitis:

12 years or older:
0.1% cream: Apply a thin layer to affected area once a day

Comments:
-Occlusive dressings may be used; however, if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-Treatment should be limited to 2 consecutive weeks and no more than 60 g per week should be used.

Use: Relief of the inflammatory and pruritic manifestations of atopic dermatitis

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: corticosteroids taken by mouth (e.g., prednisone), drugs that lower the immune system (e.g., cyclosporine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.