Fluocinonide (topical)
Looking up MedlinePlus…
From MedlinePlus, U.S. National Library of Medicine
Boxed warning
Important: For skin use only. Do not get Fluocinonide Cream USP, 0.1% in your eyes, mouth, or vagina. Not for use on the face, groin, or underarms.
Corticosteroid
Dosing in kidney impairment
4 CONTRAINDICATIONS None. None 5 WARNINGS AND PRECAUTIONS Fluocinonide cream USP, 0.1% has been shown to suppress the HPA axis. Systemic absorption of fluocinonide cream USP, 0.1% may produce reversible hypothalamic-pituitaryadrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia and unmask latent diabetes Systemic absorption may require evaluation for 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 with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation and allergic contact dermatitis and may be more likely to occur with occlusive use or more potent corticosteroids Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 ) 5.1 Effect on Endocrine System Systemic absorption of topical corticosteroids, including fluocinonide cream USP, 0.1%, can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.
Contraindications
None. None ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Therefore, fluocinonide cream USP, 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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.
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 breast milk. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.