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Fluocinolone (Otic)

Medically reviewed by Drugs.com. Last updated on Jul 23, 2020.

Pronunciation

(floo oh SIN oh lone)

Index Terms

  • Fluocinolone Acetonide

Dosage Forms

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.

  • DermOtic
  • Flac

Pharmacologic Category

  • Corticosteroid, Otic

Pharmacology

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

Contraindications

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

Dosing: Adult

Chronic eczematous external otitis: Otic: Five drops into the affected ear twice daily for 1 to 2 weeks

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Chronic eczematous external otitis: Children ≥2 years and Adolescents: Otic: 5 drops into the affected ear twice daily for 1 to 2 weeks

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.

Storage

Store a controlled room temperature of 20°C to 25°C (68°F to 77°F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

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

Warnings/Precautions

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.

Monitoring Parameters

Signs of bacterial or fungal infection

Pregnancy Risk Factor

C

Pregnancy Considerations

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.

Patient Education

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:

• Burning

• Itching

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.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

More about fluocinolone otic

Consumer resources

Professional resources

Other brands: DermOtic Oil, Flac

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