Medically reviewed by Drugs.com. Last updated on Jul 23, 2020.
(floo oh SIN oh lone)
- Fluocinolone Acetonide
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)
Brand Names: U.S.
- Corticosteroid, Otic
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.
Use: Labeled Indications
Relief of chronic eczematous external otitis
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
Chronic eczematous external otitis: Otic: Five drops into the affected ear twice daily for 1 to 2 weeks
Refer to adult dosing.
Chronic eczematous external otitis: Children ≥2 years and Adolescents: Otic: 5 drops into the affected ear twice daily for 1 to 2 weeks
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.
Store a controlled room temperature of 20°C to 25°C (68°F to 77°F).
There are no known significant interactions.
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
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.
Dosage form specific issues:
• Peanut oil: DermOtic Oil contains peanut oil; use caution in peanut-sensitive individuals.
Signs of bacterial or fungal infection
Pregnancy Risk Factor
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.
What is this drug used for?
• It is used to treat ear infections.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Severe application site irritation
• Skin changes like acne, stretch marks, slow healing, or hair growth
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
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