Version May 2024
Steroid-responsive otic infection: Otic solution (drops): Instill 2 to 3 drops into affected ear(s) 2 times/day; generally limit duration to 10 days.
Steroid-responsive dermatoses/infection: Topical: Apply in a thin layer to affected area 2 to 3 times/day; generally limit duration to 7 days.
There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.
There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.
Refer to adult dosing.
Children >2 years and Adolescents: Refer to adult dosing.
There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.
There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Central nervous system: Peripheral neuropathy
Dermatologic: Acne vulgaris, atrophic striae, burning sensation of skin, dyschromia, pruritus, skin atrophy, skin irritation, skin rash, telangiectasia
Endocrine & metabolic: HPA-axis suppression (rare; potentially associated with excessive/prolonged use), thyrotoxicosis
Hematologic & oncologic: Purpura
Hypersensitivity: Hypersensitivity reaction
Infection: Secondary infection
Ophthalmic: Optic atrophy
Hypersensitivity to clioquinol, flumethasone, or any component of the formulation; viral infection of the skin; tuberculosis, syphilis, rosacea, acne vulgaris, or perioral dermatitis; suspected or verified perforation of eardrum (otic solution); application to eyes; application to ulcerated areas (topical); use in children <2 years of age
Concerns related to adverse effects:
• Adrenal suppression: Systemic absorption of topical corticosteroids 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.
• Iodine intolerance: Use with caution in patients with iodine intolerance.
• 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 (Goedert 2002).
• Optic atrophy: Known to cause serious and irreversible optic atrophy.
• Peripheral neuropathy: Known to cause serious and peripheral neuropathy with muscular weakness, sensory loss, spastic paraparesis, and blindness.
• 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.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Renal impairment: Use with caution in patients with renal impairment.
• Thyroid disease: Use with caution in patients with thyroid abnormalities.
Special populations:
• Pediatric: Topical application poses a potential risk of toxicity to infants and children; striae has been reported with use of some corticosteroids in infants and children. Children may absorb proportionally larger amounts of corticosteroids 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: Do not apply to large areas or denuded skin or use occlusive dressing; may result in increased protein-bound iodine values irritate sensitized skin.
• Appropriate response: Discontinue therapy if no response within 1 week.
Not available in the US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Locacorten Vioform: Clioquinol 3% and flumethasone 0.02% (30 g) [contains cetyl alcohol]
Solution, Otic:
Locacorten Vioform: Clioquinol 1% and flumethasone pivalate 0.02% (10 mL, 11 mL)
Otic solution: Thorough cleaning of the external ear prior to and during therapy either by wiping or gentle syringing is essential.
Topical cream: Avoid use of occlusive dressings. Cleanse affected area before application; can stain skin and fabrics; for external use only; avoid contact with eyes and mucous membranes.
Topical: Cream: For external use only; avoid contact with eyes and mucous membranes. Apply a thin layer to clean, dry affected area(s); do not apply to ulcerated areas. Avoid use of occlusive dressings. May stain skin, hair, nails and fabrics.
Otic solution: Thorough cleaning of the external ear prior to and during therapy either by wiping or gentle syringing is essential. Do not use if eardrum is perforated.
Note: Not approved in the US
Otic solution: Treatment of otitis externa; otomycosis due to Aspergillus niger
Topical cream: Treatment of corticosteroid-responsive dermatoses complicated by infection with bacterial and/or fungal agents
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Nirmatrelvir and Ritonavir: May increase the serum concentration of Corticosteroids (Topical). Risk C: Monitor therapy
Adverse events have been observed with corticosteroids in animal reproduction studies.
Observe affected area for increased irritation
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. Flumethasone is an intermediate potency fluorinated corticosteroid. Clioquinol chelates bacterial surface and trace metals needed for bacterial growth
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