Fluocinolone (Otic)

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Keep using fluocinolone as you have been told by your doctor or other health care provider, even if you feel well.
• Wash your hands before and after use.
• For the ear only.
• Keep out of your eyes.
• Lie on your side with problem ear up.
• For children younger than 3 years of age, pull the outer ear outward and downward.
• For children 3 years of age and older, pull the outer ear outward and upward.
• Put drops in ear without touching dropper to ear. Stay on side for 2 minutes or put cotton plug in ear.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

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:

• Skin irritation.
• Burning.
• Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Refer to adult dosing.

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.

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