Plain Topical Corticosteroids
Wash hands before and after application. Use gloves if required by universal precautions. Apply sparingly in a thin film and rub gently into the cleansed, affected area. Use occlusive dressings only if specified by the physician.
Hairy areas: Use gel or solution. Part hair and apply small amount to the affected area and rub in gently. Until the medication has dried, protect from washing, clothing, or rubbing. Hair may be washed as usual but not immediately after applying the medication.
skin atrophy / Delayed / Incidence not known
increased intracranial pressure / Early / Incidence not known
papilledema / Delayed / Incidence not known
visual impairment / Early / Incidence not known
ocular hypertension / Delayed / Incidence not known
erythema / Early / 1.0-10.0
withdrawal / Early / Incidence not known
glycosuria / Early / Incidence not known
Cushing's syndrome / Delayed / Incidence not known
hyperglycemia / Delayed / Incidence not known
growth inhibition / Delayed / Incidence not known
adrenocortical insufficiency / Delayed / Incidence not known
pseudotumor cerebri / Delayed / Incidence not known
hypertension / Early / Incidence not known
hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
cataracts / Delayed / Incidence not known
skin ulcer / Delayed / Incidence not known
impaired wound healing / Delayed / Incidence not known
tolerance / Delayed / Incidence not known
contact dermatitis / Delayed / Incidence not known
maculopapular rash / Early / 1.0-10.0
xerosis / Delayed / 1.0-10.0
pruritus / Rapid / 1.0-10.0
skin irritation / Early / 1.0-10.0
hypertrichosis / Delayed / Incidence not known
purpura / Delayed / Incidence not known
telangiectasia / Delayed / Incidence not known
acneiform rash / Delayed / Incidence not known
miliaria / Delayed / Incidence not known
folliculitis / Delayed / Incidence not known
striae / Delayed / Incidence not known
infection / Delayed / Incidence not known
skin hypopigmentation / Delayed / Incidence not known
headache / Early / Incidence not known
Common Brand Names
Fluovix, Fluovix Plus, Lidex, Lidex -E, Vanos
Topical high-potency synthetic fluorinated corticosteroid
Used for moderate to severe corticosteroid-responsive dermatoses, including psoriasis
Avoid areas of thinner skin
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.Renal Impairment
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
Metyrapone: (Major) Medications which affect pituitary or adrenocortical function, including all corticosteroid therapy, should be discontinued prior to and during testing with metyrapone. Patients taking inadvertent doses of corticosteroids on the test day may exhibit abnormally high basal plasma cortisol levels and a decreased response to the test. Although systemic absorption of topical corticosteroids is minimal, temporary discontinuation of these products should be considered if possible to reduce the potential for interference with the test results.
Voriconazole: (Moderate) Monitor for potential adrenal dysfunction with concomitant use of voriconazole and fluocinonide. In patients taking corticosteroids, voriconazole-associated CYP3A4 inhibition of their metabolism may lead to corticosteroid excess and adrenal suppression. Corticosteroid exposure is likely to be increased. Voriconazole is a strong CYP3A4 inhibitor, and fluocinonide is a CYP3A4 substrate.
Fluocinonide/Fluovix/Fluovix Plus/Lidex/Lidex -E/Vanos Topical Cream: 0.05%, 0.1%
Fluocinonide/Lidex Topical Gel: 0.05%
Fluocinonide/Lidex Topical Ointment: 0.05%
Fluocinonide/Lidex Topical Sol: 0.05%
While in general corticosteroid dosage must be individualized and is highly variable depending on the nature and severity of the disease and on patient age and response, the area of skin where fluocinonide is applied should be limited.Adults
4 applications/day topically; Vanos 2 applications/day topically or 60 g/week for <=2 weeks.Elderly
4 applications/day topically; Vanos 2 applications/day topically or 60 g/week for <=2 weeks.Adolescents
4 applications/day topically; Vanos 2 applications/day topically or 60 g/week for <=2 weeks.Children
>= 12 years: 4 applications/day topically; Vanos 2 applications/day topically or 60 g/week for <=2 weeks.
>= 2 years and < 12 years: 4 applications/day topically; safety and efficacy of Vanos have not been established.
< 2 years: Safety and efficacy have not been established.
Mechanism Of Action
Topical corticosteroids exhibit anti-inflammatory, antipruritic, and vasoconstrictive properties. At the cellular level, corticosteroids induce peptides called lipocortins. Lipocortins antagonize phospholipase A2, an enzyme which causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine, liposomal enzymes and the complement system. Early anti-inflammatory effects of topical corticosteroids include the inhibition of macrophage and leukocyte movement and activity in the inflamed area by reversing vascular dilation and permeability. Later inflammatory processes such as capillary production, collagen deposition, keloid (scar) formation also are inhibited by corticosteroids. Clinically, these actions correspond to decreased edema, erythema, pruritus, plaque formation and scaling of the affected skin.
Fluocinonide is administered topically. It is unknown whether topically applied corticosteroids cross the placenta or are distributed into breast milk. Systemically absorbed fluocinonide is rapidly cleared as inactive metabolites via hepatic pathways. The unchanged parent compound and metabolites are excreted renally.Topical Route
The amount of fluocinonide absorbed following topical application is variable and dependent on the condition of the affected skin. Absorption is enhanced through application on abraded or inflamed skin, or when used on areas where the stratum corneum is thin such as the eyelids, genitalia, and face. In addition, application under occlusion, which increases skin hydration and temperature, enhances penetration through the stratum corneum. Although penetration through the epidermis is usually minimal, prolonged use of fluorinated adrenocorticoids, administration to large body surface areas, or application under occlusion can result in undesirable effects such as adrenal suppression (see Adverse Reactions).
Pregnancy And Lactation
There are no adequate and well-controlled studies of topical application of fluocinonide during pregnancy. Topical corticosteroids, including fluocinonide, should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women. Guidelines recommend mild to moderate potency agents over potent corticosteroids, which should be used in short durations. Fetal growth restriction and a significantly increased risk of low birthweight has been reported with use of potent or very potent topical corticosteroids during the third trimester, particularly when using more than 300 grams. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
It is not known whether topical administration of fluocinonide could result in sufficient systemic absorption to produce detectable quantities in breast milk. However, most dermatologists stress that topical corticosteroids can be safely used during lactation and breast-feeding. If applied topically, care should be used to ensure the infant will not come into direct contact with the area of application, such as the breast. Increased blood pressure has been reported in an infant whose mother applied a high potency topical corticosteroid ointment directly to the nipples. Consider therapy with less-potent topical agents, like hydrocortisone or triamcinolone, in nursing mothers requiring long-term therapy with a topical corticosteroid. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.