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standards of non-Merck sources.
Pronunciation
(floo oh SIN oh nide)
Generic Available (U.S.)
Yes
Index Terms
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Anti-inflammatory, antipruritic; treatment of plaque-type psoriasis (up to 10% of body surface area) [high-potency topical corticosteroid]
Use: Dental
Relief of inflammatory and pruritic manifestations (high potency topical corticosteroid)
Pregnancy Risk Factor
C
Pregnancy Considerations
Teratogenic effects have been observed in animals administered potent topical corticosteroids. Topical products are not recommended for extensive use, in large quantities, or for long periods of time in pregnant women.
Lactation
Excretion unknown/not recommended
Breast-Feeding Considerations
It is not known if topical application will result in detectable quantities in breast milk.
Contraindications
Hypersensitivity to fluocinonide or any component of the formulation; viral, fungal, or tubercular skin lesions, herpes simplex
Warnings/Precautions
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's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's 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:
• Pediatrics: Use of the 0.1% cream in children <12 years of age is not recommended. Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing's 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 cream (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.
• Duration of therapy: Use of the 0.1% cream for >2 weeks is not recommended.
Adverse Reactions
Frequency not defined.
Cardiovascular: Intracranial hypertension
Dermatologic: Acne, allergic dermatitis, contact dermatitis, dry skin, folliculitis, hypertrichosis, hypopigmentation, maceration of the skin, miliaria, perioral dermatitis, pruritus, skin atrophy, striae, telangiectasia
Endocrine & metabolic: Cushing's syndrome, growth retardation, HPA axis suppression, hyperglycemia
Local: Burning, irritation
Renal: Glycosuria
Miscellaneous: Secondary infection
Metabolism/Transport Effects
None known.
Drug Interactions
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination
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. Risk C: 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. Risk C: Monitor therapy
Telaprevir: Corticosteroids may decrease the serum concentration of Telaprevir. Telaprevir may increase the serum concentration of Corticosteroids. Management: Concurrent use of telaprevir and systemic corticosteroids is not recommended. When possible, consider alternatives. If used together, employ extra caution and monitor closely for excessive corticosteroid effects and diminished telaprevir effects. Risk D: Consider therapy modification
Mechanism of Action
Fluorinated topical corticosteroid considered to be of high potency. The mechanism of action for all topical corticosteroids is not well defined, however, is felt to be a combination of three important properties: anti-inflammatory activity, immunosuppressive properties, and antiproliferative actions.
Pharmacodynamics/Kinetics
Absorption: Dependent on strength of product, amount applied, and nature of skin at application site; ranges from ~1% in areas of thick stratum corneum (palms, soles, elbows, etc) to 36% in areas of thin stratum corneum (face, eyelids, etc); increased in areas of skin damage, inflammation, or occlusion
Distribution: Throughout local skin; absorbed drug into muscle, liver, skin, intestines, and kidneys
Metabolism: Primarily in skin; small amount absorbed into systemic circulation is primarily hepatic to inactive compounds
Excretion: Urine (primarily as glucuronide and sulfate, also as unconjugated products); feces (small amounts as metabolites)
Dosage
Children and Adults: Pruritus and inflammation: Topical (0.05% cream): Apply thin layer to affected area 2-4 times/day depending on the severity of the condition. Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.
Children ≥12 years and Adults: Plaque-type psoriasis (Vanos™): Topical (0.1% cream): Apply a thin layer once or twice daily to affected areas (limited to <10% of body surface area). Note: Not recommended for use >2 consecutive weeks or >60 g/week total exposure. Discontinue when control is achieved.
Dental Usual Dosing
Pruritus and inflammation: Children and Adults: Topical (0.05% cream): Apply thin layer to affected area 2-4 times/day depending on the severity of the condition. Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.
Patient Education
For external use only. Do not use for eyes, mucous membranes, or open wounds. Before using, wash and dry area gently. Apply in a thin layer (may rub in lightly). Apply light dressing (if necessary) to area being treated. Do not use occlusive dressing unless so advised by prescriber. Avoid prolonged or excessive use around sensitive tissues or genital or rectal areas. Avoid exposing treated area to direct sunlight. Inform prescriber if condition worsens (redness, swelling, irritation, signs of infection, or open sores) or fails to improve.
Geriatric Considerations
Due to age-related changes in skin, limit use of topical corticosteroids.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
None reported
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, topical:
Vanos®: 0.1% (30 g, 60 g, 120 g)
Cream, anhydrous, emollient, topical: 0.05% (15 g, 30 g, 60 g, 120 g)
Cream, aqueous, emollient, topical: 0.05% (15 g, 30 g, 60 g)
Gel, topical: 0.05% (15 g, 30 g, 60 g)
Ointment, topical: 0.05% (15 g, 30 g, 60 g)
Solution, topical: 0.05% (20 mL, 60 mL)
Pricing: U.S. (www.drugstore.com)
Cream (Fluocinonide)
0.05% (15): $23.10
0.05% (30): $24.02
0.05% (60): $17.99
Cream (Fluocinonide-E)
0.05% (15): $17.99
0.05% (30): $15.99
0.05% (60): $16.99
Cream (Vanos)
0.1% (30): $204.38
0.1% (60): $343.20
Gel (Fluocinonide)
0.05% (15): $19.99
0.05% (30): $33.99
0.05% (60): $49.99
Ointment (Fluocinonide)
0.05% (15): $26.99
0.05% (30): $32.99
0.05% (60): $49.99
Solution (Fluocinonide)
0.05% (20): $31.99
0.05% (60): $51.99
References
Goedert JJ, Vitale F, Lauria C, et al, “Risk Factors for Classical Kaposi's Sarcoma,” J Natl Cancer Inst, 2002, 94(22):1712-8.
International Brand Names
Lexi-Comp.com
Last full review/revision March 2012
Content last modified March 2012
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