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Inflammatory and pruritic dermatologic conditions: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Hypersensitivity to fluocinonide or any component of the formulation
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.
Refer to adult dosing.
Atopic dermatitis, psoriasis, and other inflammatory and pruritic dermatologic conditions:
Children and Adolescents: Topical: Cream, gel, ointment, solution (0.05%): Refer to adult dosing.
Children ≥12 years and Adolescents: Topical: Cream (0.1%): Refer to adult dosing.
There are no dosage adjustments provided in the manufacturers labeling.
There are no dosage adjustments provided in the manufacturers labeling.
For topical use only. Apply sparingly in a thin film. Rub in lightly. Avoid contact with eyes. Do not use tight fitting diapers or plastic pants in children needing treatment in the diaper area. 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 0.5% 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.
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)
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy
Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification
HPA axis suppression (ACTH stimulation test, AM plasma cortisol test, urinary free cortisol test); signs of bacterial or fungal infections.
Frequency not defined.
Central nervous system: Intracranial hypertension, localized burning
Dermatologic: Acne vulgaris, allergic dermatitis, atrophic striae, contact dermatitis, folliculitis, hypertrichosis, hypopigmentation, maceration of the skin, miliaria, perioral dermatitis, pruritus, skin atrophy, telangiectasia, xeroderma
Endocrine & metabolic: Cushings syndrome, glycosuria, growth suppression, HPA-axis suppression, hyperglycemia
Infection: Secondary infection
Local: Local irritation
Concerns related to adverse effects:
- Adrenal suppression: May cause hypercorticism 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.
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Adverse events have been observed with corticosteroids in animal reproduction studies. Topical corticosteroids are preferred over systemic for treating conditions, such as psoriasis or atopic dermatitis in pregnant women; high-potency corticosteroids are not recommended during the first trimester. Topical products are not recommended for extensive use, in large quantities, or for long periods of time in pregnant women (Bae 2011; Koutroulis 2011; Leachman 2006). Information specific to the use of fluocinonide during pregnancy is limited (Valkova 2006).
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.
Dependent on formulation, amount applied and nature of skin at application site; may be increased with inflammation or occlusion
Hepatic
Primarily urine; bile
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience stinging, dry skin, burning, or itching. Have patient report immediately to prescriber signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), signs of Cushing 's disease (weight gain in upper back or stomach; moon face; severe headache; or slow healing), signs of skin changes (pimples, stretch marks, slow healing, or hair growth), or skin irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.