Version May 2024
Atopic dermatitis:
Cream, gel, ointment, topical solution (0.05%): Children and Adolescents: Topical: Apply thin layer to affected area 2 to 4 times daily depending on the severity of the condition. Note: In children <12 years, NICE guidelines recommend applying only once or twice daily (Ref).
Cream (0.1%): Children ≥12 years and Adolescents: Topical: Apply a thin layer once daily to affected areas. Not recommended for use >2 consecutive weeks or >60 g/week total exposure. Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Corticosteroid-responsive dermatoses (including psoriasis):
Cream, gel, ointment, topical solution (0.05%): Children and Adolescents: Topical: Apply thin layer to affected area 2 to 4 times daily depending on the severity of the condition; may use occlusive dressings to manage psoriasis or recalcitrant conditions
Cream (0.1%): Children ≥12 years and Adolescents: Topical: Apply a thin layer once or twice daily to affected areas. Not recommended for use >2 consecutive weeks or >60 g/week total exposure. Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassess diagnosis.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Fluocinonide: Drug information")
Atopic dermatitis: Topical:
Cream, gel, ointment, solution (0.05%): Apply thin layer to affected area 2 to 4 times daily.
Cream (0.1%): Apply thin layer to affected areas once daily. Not recommended for use >2 consecutive weeks or >60 g/week total exposure. Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Psoriasis: Topical:
Cream, gel, ointment, solution (0.05%): Apply thin layer to affected area 2 to 4 times daily.
Cream (0.1%): Apply a thin layer once or twice daily to affected areas. Not recommended for use >2 consecutive weeks or >60 g/week total exposure. Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassess diagnosis.
Other inflammatory and pruritic dermatologic conditions besides atopic dermatitis or psoriasis: Topical:
Cream, gel, ointment, solution (0.05%): Apply thin layer to affected area 2 to 4 times daily.
Cream (0.1%): Apply thin layer to affected area once or twice daily. Not recommended for use >2 consecutive weeks or >60 g/week total exposure. Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassess diagnosis.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Endocrine & metabolic: HPA-axis suppression (4%)
Local: Application-site burning (2% to 7%)
Nervous system: Headache (3% to 4%)
Respiratory: Nasal congestion (≤1%), nasopharyngitis (≤1%)
Postmarketing:
Dermatologic: Acne vulgaris, exfoliation of skin, perioral dermatitis (Kosari 2009), skin rash, skin tightness, xeroderma
Hypersensitivity: Hypersensitivity reaction
Local: Application-site edema, application-site erythema, application-site irritation, application-site pain, application-site pruritus, local skin discoloration
Nervous system: Dizziness
Hypersensitivity to fluocinonide or any component of the formulation
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.
• Contact dermatitis: Allergic contact dermatitis can occur, it is usually diagnosed by failure to heal rather than clinical exacerbation.
• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert, 2002).
• Local effects: Local adverse reactions may occur (eg, skin atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection miliaria); may be irreversible. Local adverse reactions are more likely to occur with occlusive and/or prolonged use. If irritation develops, discontinued use and institute appropriate therapy.
• Skin infections: Concomitant skin infections may be present or develop during therapy; discontinue if dermatological infection persists despite appropriate antimicrobial therapy.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.
Special populations:
• Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.
Other warnings/precautions:
• Application site: Lower-strength formulations (0.05%) may be used cautiously on face or opposing skin surfaces that may rub or touch (eg, skin folds of the groin, axilla, and breasts); higher-strength (0.1%) should not be used on the face, groin, or axillae.
• Appropriate use: 0.1% cream: Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassess diagnosis. Do not use more than half of the 120 g tube per week. Should not be used in the treatment of rosacea or perioral dermatitis.
Topical corticosteroids may be absorbed percutaneously. The extent of absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, prolonged duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children. Hypothalamic-pituitary-adrenal (HPA) suppression may occur, particularly in younger children or in patients receiving high doses for prolonged periods; acute adrenal insufficiency (adrenal crisis) may occur with abrupt withdrawal after long-term therapy or with stress. Infants and small children may be more susceptible to HPA axis suppression or other systemic toxicities due to larger skin surface area to body mass ratio; use with caution in pediatric patients.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Vanos: 0.1% (30 g, 60 g, 120 g)
Generic: 0.05% (15 g, 30 g, 60 g, 120 g); 0.1% (30 g, 60 g, 120 g)
Gel, External:
Generic: 0.05% (15 g, 30 g, 60 g)
Ointment, External:
Generic: 0.05% (15 g, 30 g, 60 g)
Solution, External:
Generic: 0.05% (20 mL, 60 mL)
Yes
Cream (Fluocinonide Emulsified Base External)
0.05% (per gram): $3.21
Cream (Fluocinonide External)
0.05% (per gram): $2.88 - $3.04
0.1% (per gram): $0.54 - $20.44
Cream (Vanos External)
0.1% (per gram): $32.82
Gel (Fluocinonide External)
0.05% (per gram): $3.97 - $7.73
Ointment (Fluocinonide External)
0.05% (per gram): $4.72
Solution (Fluocinonide External)
0.05% (per mL): $0.80 - $2.74
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External:
Lidemol: 0.05% (30 g, 100 g) [contains cetyl alcohol, propylene glycol]
Lidex: 0.05% (60 g, 400 g)
Lyderm: 0.05% (15 g, 60 g, 400 g) [contains propylene glycol]
Tiamol: 0.05% (25 g, 100 g) [contains cetyl alcohol, propylene glycol]
Topactin Emollient: 0.05% ([DSC])
Generic: 0.05% ([DSC])
Gel, External:
Lidex: 0.05% (60 g)
Lyderm: 0.05% (15 g, 60 g) [contains edetate (edta) disodium, propylene glycol]
Ointment, External:
Lidex: 0.05% (60 g)
Lyderm: 0.05% (15 g, 60 g) [contains edetate (edta) disodium, propylene glycol]
Topical: For topical use only. Apply sparingly in a thin film. Rub in lightly. Avoid contact with eyes; generally not for routine use on the face, underarms, or groin area. Unless otherwise directed by health care professional, do not use with occlusive dressing; do not use on skin covered by diapers or plastic pants. Wash hands after application (unless hands are part of the treatment area).
Topical: For topical use only. Apply sparingly in a thin film. Rub in lightly. Avoid contact with eyes. Wash hands after application (unless hands are part of the treatment area).
Lower-strength formulations (0.05%) may be used cautiously on face or opposing skin surfaces that may rub or touch (eg, skin folds of the groin, axilla, and breasts); higher-strength (0.1%) should not be used on the face, groin, or axillae. Occlusive dressings significantly increase percutaneous absorption and may be used with fluocinonide 0.05% for the management of psoriasis or recalcitrant conditions only as determined by healthcare provider (monitor; adverse events may be increased).
Store at room temperature; avoid excessive heat.
Fluocinonide 0.05%: Cream, gel, ointment, topical solution: Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (FDA approved in pediatric patients [age not specified] and adults)
Fluocinonide 0.1% cream: Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (FDA approved in ages ≥12 years and adults)
Fluocinonide may be confused with flunisolide, fluocinolone
Lidex may be confused with Lasix, Videx
KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).
None known.
There are no known significant interactions.
Topical corticosteroids may be used for the treatment of corticosteroid-responsive dermatosis, such as atopic dermatitis, in patients planning a pregnancy (Vestergaard 2019).
Systemic bioavailability of topical corticosteroids is variable (eg, integrity of skin, use of occlusion) and may be further influenced by trimester of pregnancy (Chi 2017). In general, the use of topical corticosteroids is not associated with a significant risk of adverse pregnancy outcomes. However, there may be an increased risk of low-birth-weight infants following maternal use of potent or very potent topical products, especially in high doses, although this risk is likely to be low (Andersson 2021; Chi 2015; Chi 2017).
When first-line treatments, such as emollients, are insufficient, topical corticosteroids may be used for the treatment of atopic dermatitis in pregnant patients (Vestergaard 2019). Topical corticosteroids are classified by potency; the medication and formulation (eg, cream, gel, and/or salt form) contribute to the potency classification (Oakley 2021; Stacey 2021; Tadicherla 2009). In general, use of the least potent product in limited amounts is recommended during pregnancy. Mild to moderate potency corticosteroids are preferred; potent to very potent topical corticosteroids should only be used as alternative therapy in limited amounts under obstetrical care. Pregnant patients should avoid application of topical corticosteroids to areas with high percutaneous absorption (eg, arm pit, skin folds, vulva) (Chi 2017) and caution should be used when applying to areas prone to striae formation (eg, abdomen, breast, thighs) (Vestergaard 2019).
Growth in pediatric patients; assess HPA axis suppression (eg, ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test)
Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Fluocinonide is fluorinated corticosteroid considered to be of high potency.
Absorption: Dependent on formulation, amount applied, and nature of skin at application site; may be increased with inflammation or occlusion
Metabolism: Hepatic
Excretion: Primarily urine; bile
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