Fluocinolone acetonide (topical)
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From MedlinePlus, U.S. National Library of Medicine
Corticosteroid
Dosing in kidney impairment
4 CONTRAINDICATIONS None None. 5 WARNINGS AND PRECAUTIONS Topical corticosteroids can produce reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria. Systemic absorption may require evaluation for hypothalamic-pituitary-adrenal (HPA) axis suppression. Modify use should HPA axis suppression develop.
Potent corticosteroids use on large areas, prolonged use or occlusive use may increase systemic absorption. Local adverse reactions may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely with occlusive use or more potent corticosteroids. ( 5.2 , 5.3 , 6.1 ) Children may be more susceptible to systemic toxicity from equivalent doses. ( 5.1 , 8.4 ) 5.1 Hypothalamic-Pituitary-Adrenal Axis Suppression Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency.
Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. [See Use in Specific Populations ] 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may occur with use of topical corticosteroids and may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.
Contraindications
None None ( 4 ).
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from fluocinolone acetonide topical oil, 0.01%. Therefore, fluocinolone acetonide topical oil, 0.01% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation
8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when fluocinolone acetonide topical oil, 0.01% is administered to a nursing woman.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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