AHFS Class:

• Corticosteroids 84:06.08

Generic Name(s):

• Fluocinolone Acetonide

• Fluocinonide

Fluocinolone acetonide and fluocinonide are synthetic fluorinated corticosteroids.

Fluocinolone acetonide and fluocinonide share the actions of the other topical corticosteroids and are used for the relief of the inflammatory manifestations of corticosteroid-responsive dermatoses.

Fluocinolone acetonide shampoo should be prepared by a pharmacist at the time of dispensing the shampoo; contents of the 12-mg capsule should be mixed with the shampoo base supplied by the manufacturer. The extemporaneously prepared shampoo is stable for 3 months from the time of compounding. The extemporaneously prepared shampoo must be shaken well prior to administration.

Topical fluocinolone acetonide or fluocinonide cream, gel, ointment, and solution are applied sparingly in thin films and rubbed gently into the skin 2-4 times daily depending on the severity of the condition. Occlusive dressings may be used for severe or resistant dermatoses.

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

For the treatment of moderate to severe atopic dermatitis in children 2 years of age or older, a thin film of fluocinolone acetonide 0.01% topical oil may be applied twice daily to affected areas for no longer than 4 weeks. The topical oil should not be applied to the face or diaper area. Application to intertriginous areas also should be avoided because of an increased risk of developing potentially irreversible adverse local effects (e.g., striae, atrophy, telangiectasia).

For the treatment of seborrheic dermatitis of the scalp in adults, no more than 30 mL of fluocinolone acetonide 0.01% shampoo is applied to the scalp once daily, lathered, and allowed to remain on the scalp for about 5 minutes. The hair and scalp are then rinsed thoroughly with water. Fluocinolone acetonide shampoo should not be used with occlusive dressings and patients should be warned that treated areas of the scalp should not be bandaged or otherwise covered or wrapped as to be occlusive, unless directed by a clinician.

For the treatment of psoriasis of the scalp in adults, a thin film of fluocinolone acetonide 0.01% topical oil should be applied to wet or dampened hair and scalp, massaged well, and covered with the manufacturer-supplied shower cap. The oil should be allowed 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.

Fluocinolone acetonide and fluocinonide share the toxic potentials of other topical corticosteroids, and the usual precautions of corticosteroid therapy should be observed.

Because fluocinolone acetonide 0.01% topical oil is formulated with 48% refined peanut oil, in which peanut protein is not detectable at 2.5 ppm, this formulation should be used 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, fluocinolone acetonide 0.01% topical oil should be discontinued and appropriate therapy instituted.

Patients should be advised to avoid contact of fluocinolone acetonide and fluocinonide preparations with the eyes since irritation may occur. If such contact occurs, the affected eye(s) should be flushed with copious amounts of water.

Pediatric Precautions

If fluocinolone acetonide or fluocinonide is used for topical treatment of corticosteroid-responsive dermatoses in children, the usual precautions associated with topical corticosteroid therapy in pediatric patients should be observed.

Safety and efficacy of fluocinolone acetonide 0.01% shampoo in infants and children have not been established. If fluocinolone acetonide or fluocinonide is used for topical treatment of corticosteroid-responsive dermatoses in children, 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 or older have been established in several open-label studies. In these studies, children 2-12 years of age with baseline body surface area involvement of 50% or greater had normal adrenocortical function (as determined by a cosyntropin test) following 4 weeks of fluocinolone acetonide 0.01% topical oil therapy; approximately 22% of children 2-5 years of age had low plasma cortisol concentrations prior to the cosyntropin test. The long-term safety of fluocinolone acetonide 0.01% topical oil in pediatric patients has not been established.

Because fluocinolone acetonide 0.01% topical oil is formulated with 48% refined peanut oil, the manufacturer recommends that this preparation be used with caution in children with known hypersensitivity to peanuts. In a clinical study evaluating the response of children with or without a history of hypersensitivity to peanuts, prick (intracutaneous) and patch test results were negative in all 13 children who were exposed to refined peanut oil, fluocinolone acetonide 0.01% topical oil, and a histamine/saline control, including 9 children who tested positive for peanut allergens on radioallergosorbent tests (RAST) prior to the trial. These children also tested negative on the prick (intracutaneous) and patch tests after receiving fluocinolone acetonide 0.01% topical oil twice daily for 2 weeks. However, one child with known hypersensitivity to peanuts experienced a flare of his atopic dermatitis during the 2 weeks of twice-daily administration of fluocinolone acetonide 0.01% topical oil.

Mutagenicity and Carcinogenicity

Studies have not been performed to date to evaluate the carcinogenic or mutagenic potential of fluocinolone acetonide and fluocinonide. However, some corticosteroids have exhibited mutagenic activity in various in vivo and in vitro microbial or mammalian test systems.

Pregnancy, Fertility, and Lactation

The teratogenic potential of topical corticosteroids in humans is not known; however, corticosteroids have been shown to produce teratogenic effects in animals when administered topically or systemically.

Chemistry and Stability

Chemistry

Fluocinolone acetonide and fluocinonide are synthetic fluorinated corticosteroids. Fluocinolone acetonide occurs as an anhydrous or dihydrate, white or practically white, crystalline powder and is insoluble in water, soluble in alcohol, and sparingly soluble in propylene glycol. Fluocinonide, the 21-acetate ester of fluocinolone acetonide, occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and slightly soluble in alcohol.

Stability

Fluocinolone acetonide and fluocinonide preparations should be stored in tight containers at a temperature less than 40°C, preferably between 15-30°C; freezing should be avoided.

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

Additional Information

For further information on chemistry, pharmacology, absorption, uses, cautions, methods of application, and use of occlusive dressings in therapy with fluocinolone acetonide and fluocinonide, see the Topical Corticosteroids General Statement 84:06.08. 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.