DermOtic

Last updated on RxList: 7/21/2021
DermOtic Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is DermOtic?

DermOtic (fluocinolone acetonide oil) is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.

What Are Side Effects of DermOtic?

Side effects of DermOtic include:

Dosage for DermOtic

For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply a dose of 5 drops of DermOtic Oil into the affected ear. To apply, tilt head to one side so that the ear is facing up. Then gently pull the ear lobe backward and upward and apply 5 drops of DermOtic Oil into the ear. Keep head tilted for about a minute to allow DermOtic Oil to penetrate lower into the ear canal. Gently pat excess material dripping out of the ear using a clean cotton ball. Follow these instructions twice each day for 7 to 14 days.

DermOtic In Children

DermOtic Oil may be used twice daily for up to 2 weeks in pediatric patients 2 years of age and older with chronic eczematous external otitis. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. DermOtic Oil is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing DermOtic Oil for peanut-sensitive individuals.

What Drugs, Substances, or Supplements Interact with DermOtic?

DermOtic may interact with other medicines.

Tell your doctor all medications and supplements you use.

DermOtic During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using DermOtic; it is unknown how it would affect a fetus. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is unknown if topical administration of corticosteroids such as DermOtic could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in breast milk, caution should be exercised when DermOtic Oil is used while breastfeeding.

Consult your doctor before breastfeeding.

Additional Information

Our DermOtic (fluocinolone acetonide oil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Ear infection or acute otitis media is an infection of the middle ear. See Answer
DermOtic Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • severe irritation in or around your ear; or
  • signs of a skin infection--warmth, redness, swelling, sores, oozing.

Your skin can absorb topical steroid medicine, which may cause steroid side effects throughout the body. Tell your doctor if you have:

  • swelling, weight gain (especially in your face or your upper back and torso);
  • thinning skin, stretch marks, acne, increased facial hair;
  • memory problems, feeling irritable;
  • irregular menstrual periods, changes in sexual function; or
  • growth delay in a child.

Children can absorb larger amounts of this medicine through the skin and may be more likely to have side effects.

Common side effects may include:

  • burning, itching, irritation, or dryness;
  • rash around the ear in which this medicine was applied;
  • rash or irritation around your mouth;
  • acne, pimples, stretch marks;
  • lightened skin color; or
  • redness or crusting around your hair follicles.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for DermOtic (Fluocinolone Acetonide Oil Ear Drops)

SLIDESHOW

Ear Infection Symptoms, Causes, and Treatment See Slideshow
DermOtic Professional Information

SIDE EFFECTS

The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with Derma- Smoothe/FS® Topical Oil.

Read the entire FDA prescribing information for DermOtic (Fluocinolone Acetonide Oil Ear Drops)

© DermOtic Patient Information is supplied by Cerner Multum, Inc. and DermOtic Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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