Version May 2024
Chronic eczematous external otitis: Otic: 5 drops into the affected ear twice daily for 7 to 14 days.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Fluocinolone (otic): Pediatric drug information")
Chronic eczematous external otitis: Children ≥2 years and Adolescents: Otic: 5 drops into the affected ear twice daily for 1 to 2 weeks.
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. Frequency not defined.
Dermatologic: Acneiform eruptions, allergic contact dermatitis, burning, dryness, erythema, folliculitis, irritation, itching, hypopigmentation, keratosis pilaris, miliaria, skin atrophy, striae
Otic: Ear infection
Hypersensitivity to fluocinolone or any component of the formulation; Note: Contains peanut oil
Canadian labeling: Additional contraindications (not in US labeling): Absent or perforated tympanic membrane; tympanostomy tube (ear tube) is present; untreated ear infections (bacterial, fungal, or viral infections); application to the eye or around the eye
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. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.
• Contact dermatitis: Allergic contact dermatitis can occur, it is usually diagnosed by failure to heal rather than clinical exacerbation.
• Infection: Steroids may mask infection; prolonged use may result in secondary infections due to immunosuppression.
• Systemic effects: Adverse systemic effects may occur when used on large areas of the body, denuded areas, or for prolonged periods of time. Infants and children may be more susceptible to systemic toxicity from equivalent doses due to larger skin surface to body mass ratio.
Special populations:
• Pediatric: 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 syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.
Dosage form specific issues:
• Peanut oil: Products may contain peanut oil; use caution in peanut-sensitive individuals.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Oil, Otic, as acetonide:
DermOtic: 0.01% (20 mL) [contains isopropyl alcohol, peanut oil]
Flac: 0.01% (20 mL) [contains isopropyl alcohol, peanut oil]
Generic: 0.01% (20 mL)
Yes
Oil (DermOtic Otic)
0.01% (per mL): $1.68
Oil (Flac Otic)
0.01% (per mL): $11.00
Oil (Fluocinolone Acetonide Otic)
0.01% (per mL): $4.45 - $10.95
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.
Oil, Otic, as acetonide:
DermOtic: 0.01% (20 mL) [contains isopropyl alcohol, peanut oil]
Otic: For external ear use only; avoid contact with eyes. Use supplied ear dropper for administration. To apply drops, tilt head to one side so that the ear is facing up. Pull the ear lobe backward and upward and apply drops into the ear. Keep head tilted for about a minute to allow the drops to penetrate lower into the ear canal. Gently pat excess material dripping out of the ear using a clean cotton ball. Do not use occlusive dressings.
For otic use only. Tilt head to one side so that the ear is facing up. Gently pull the ear lobe backward and upward during instillation of drops. Keep head tilted for ~1 minute after instillation.
Chronic eczematous external otitis: Relief of chronic eczematous external otitis in pediatric patients ≥2 years of age and adults.
Fluocinolone may be confused with fluocinonide
None known.
There are no known significant interactions.
Adverse events have been observed with corticosteroids in animal reproduction studies. In general, the use of topical corticosteroids during pregnancy is not considered to have significant risk; however, intrauterine growth retardation in the infant has been reported (rare). The use of large amounts or for prolonged periods of time should be avoided.
Systemic corticosteroids are excreted in human milk. It is not known if sufficient quantities of fluocinolone are absorbed following topical administration to produce detectable amounts in breast milk.
Signs of bacterial or fungal infection
A synthetic fluorinated corticosteroid of low-to-moderate potency. The mechanism of action for all topical corticosteroids is not well defined, however, is believed to be a combination of anti-inflammatory, antipruritic, and vasoconstrictive properties.
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