Fluocinolone (Synalar) Contraindications and Precautions
- acne rosacea
- acne vulgaris
- ophthalmic administration
- perioral dermatitis
- breast-feeding
- children
- corticosteroid hypersensitivity
- Cushing’s syndrome
- diabetes mellitus
- elderly
- fungal infection
- herpes infection
- hypothalamic-pituitary-adrenal (HPA) suppression
- infection
- measles
- occlusive dressing
- ocular exposure
- peanut oil hypersensitivity
- pregnancy
- skin abrasion
- skin atrophy
- varicella
- viral infection
Fluocinolone (Synalar) Contraindications and Precautions
Systemic absorption of topical corticosteroids such as fluocinolone can produce reversible hypothalamic-pituitary-adrenal (HPA) suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. To minimize risk of HPA axis suppression, patients should be treated for no more than 2 weeks at a time and only small areas should be treated. Conditions that increase systemic absorption include use over large surface areas, prolonged use, use in areas where the epidermal barrier is disrupted (i.e., skin abrasion), and the use of occlusive dressings. Fluocinolone and other fluorinated topical corticosteroids should be used cautiously on areas of the body that have a thin layer of skin. Absorption of topical steroids is markedly increased when these agents are applied to areas such as the axilla, eyelids, face, scalp, or scrotum. Patients applying fluocinolone to a large surface area or to areas under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.
Care should be taken to avoid ocular exposure to topical fluocinolone; ophthalmic administration of topical fluocinolone is contraindicated.
Children and infants may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. To minimize risk of hypothalamic-pituitary-adrenal (HPA) axis suppression, patients should be treated for no more than 2 weeks at a time and only small areas should be treated. If children are being treated in the diaper area, tight-fitting diapers or plastic pants should be avoided as these garments may act as an occlusive dressing and increase systemic absorption of the drug. Derma-Smoothe/FS® is not recommended for the treatment of diaper dermatitis and should not be applied to this area. Administration of topical corticosteroids should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy in children may interfere with growth and development.
Topical corticosteroids should be used with caution in individuals with dermatological infections; the normal inflammatory response to local infections can be masked by fluocinolone. Application of topical corticosteroids to areas of infection, including tuberculosis of the skin, dermatologic fungal infection, and cutaneous or systemic viral infection (e.g., herpes infection, measles, varicella), should be initiated or continued only if the appropriate antiinfective treatment is instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Fluocinolone intravitreal implants (Retisert™) are contraindicated for use in ophthalmic viral infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, as well as ophthalmic bacterial and fungal infections.
High-potency topical corticosteroids should not be used to treat acne vulgaris, acne rosacea, or perioral dermatitis. Fluocinolone may aggravate these conditions. Topical corticosteroids may delay the healing of non-infected wounds, such as venous stasis ulcers.
Topical corticosteroids should be used with caution in patients with diabetes mellitus. Exacerbation of diabetes may occur with systemic absorption of the topical corticosteroid. Use of topical corticosteroids may further delay healing of skin ulcers in diabetic patients.
Topical corticosteroids should be used for brief periods, or under close medical supervision in patients with evidence of pre-existing skin atrophy. Elderly patients may be more likely to have preexisting skin atrophy secondary to aging. Purpura and skin lacerations that may raise the skin and subcutaneous tissue from deep fascia may be more likely to occur with the use of topical corticosteroids in geriatric patients. Use of lower potency topical corticosteroids also may be necessary in some patients.
Fluocinolone is classified as FDA pregnancy risk category C. There are no adequate and well-controlled studies in pregnant women. However, corticosteroids have been shown to be teratogenic in animals when administered systemically at relatively low dosages. Some corticosteroids have been shown to be teratogenic after dermal application in animals. Thus, topical fluocinolone should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
It is not known whether topical corticosteroids are distributed into breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant during breast-feeding. Nevertheless, caution should be exercised when topical corticosteroids are administered to a woman during lactation.
Derma-Smoothe/FS® contains peanut oil. Caution should be used when using this product in patients with peanut oil hypersensitivity as hypersensitivity reactions have been reported. If wheal and flare type reactions, which may be limited to pruritus, or other manifestations of hypersensitivity develop, the products should be discontinued immediately. In one study, topical fluocinolone 0.01% in peanut oil was well tolerated even in patients with peanut allergic sensitivity. Another article concurred.
Although true corticosteroid hypersensitivity is rare, patients who have demonstrated a prior hypersensitivity reaction to fluocinolone should not receive any form of fluocinolone. It is possible, though also rare, that such patients will display cross-hypersensitivity to other corticosteroids. It is advisable that patients who have a hypersensitivity reaction to any corticosteroid undergo skin testing, which, although not a conclusive predictor, may help to determine if hypersensitivity to another corticosteroid exists. Such patients should be carefully monitored during and following the administration of any corticosteroid.
[ Last revised: 4/13/2005 7:55:00 PM ]
References
. Butani L. Corticosteroid-induced hypersensitivity reactions. Ann Allergy Asthma Immunol 2002;89:439 - 45.
. Paller AS, Nimmagadda S, Schachner L, et al. Fluocinolone acetonide 0.01% in peanut oil: therapy for childhood atopic dermatitis, even in patients who are peanut sensitive. J Am Acad Dermatol 2003;48:569 - 77.
. Yunginger JW, Calobrisi SD. Investigation of the allergenicity of a refined peanut oil-containing topical dermatologic agent in persons who are sensitive to peanuts. Cutis 2001;68:153 - 5.
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