Consumer Information for: DERMOTIC OIL EAR DROPS

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

DermOtic® Oil Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v is indicated for moderate to severe Chronic Eczematous External Otitis (inflammatory condition of the external ear) in adults and children 12 years and older. Not to be used on the face.

What it does

DermOtic® Oil Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v is a topical corticosteroid. When applied to the affected area, corticosteroid, DermOtic® Oil Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v, has anti-inflammatory action and is believed to interfere in the production of important mediators of inflammation, the prostaglandins and leucokotrienes, to help reduce the ear inflammation (swelling), redness, and itching.

When it should not be used
  • Do not use if hypersensitive (allergic) to any of the ingredients in this formulation. (See What the nonmedicinal ingredients are).
  • This product contains refined peanut oil.
  • Do not apply in the eye or eye area.
  • This medication should not be used if you have a perforated eardrum, or ear tubes, or untreated ear infection (bacterial or fungal or viral infections). Contact your doctor if you are not sure about an ear infection
What the medicinal ingredient is

Fluocinolone Acetonide

What the non-medicinal ingredients are

Refined Peanut Oil NF, Mineral Oil Light, Oleth-2, Isopropyl Myristate, Isopropyl Alcohol, Cream Fragrance, and Balsam Pine Fragrance. The peanut oil used in DermOtic® Oil Ear Drops is tested for residual protein through amino acid analysis; the acceptance criterion for total protein is no more than 0.5 parts per million.

What dosage form it comes in

Oil, for Otic Use Only. Strength 0.01% w/v A dropper is supplied with the package.

Warnings and precautions

Serious Warnings and Precautions

BEFORE you use DermOtic® Oil Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v, talk to your doctor or pharmacist if:

  • Do not use on the eye (or eye area), face, underarm or groin. In case of accidental eye contact, rinse thoroughly with water.”
  • This medication should not be used for any condition other than that for which it was prescribed.
  • If you develop any allergic reaction during product use, such as rash, intense itching (flare), raised skin area (wheal) or any other skin reaction, stop use of the product and contact your doctor.
Interactions with this medication

There are no known drug interactions with DermOtic® Oil Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v. No drug interaction studies have been conducted with this product.

Proper use of this medication

Usual Dose

Chronic Eczematous External Otitis in Adults and Children 12 Years and Older:

Using the supplied ear-dropper, apply 5 drops of DermOtic® Oil Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v 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 Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v into the ear. Keep head tilted for about a minute to allow DermOtic® Oil Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v to penetrate into the ear canal. Gently pat excess material dripping out of the ear using a clean cotton ball. Follow these instructions twice daily for 7 days in children, and 7 to 14 days in adults. If no improvement is seen within 1 week in your child, contact your child’s doctor. Do not use an ear plug, cotton or any other dressing in the ear while using this medication.


Overdose

If swallowed, contact your doctor.


Missed Dose

If a dose of this medication is missed, it is not necessary to make up the missed dose. Skip the missed dose and continue with the next scheduled dose. Do not double dose.

Side effects and what to do about them

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: (common) burning, itching, irritation, dryness, (uncommon) hair follicle infection, acne, skin lightening, rash around the mouth, allergic contact dermatitis, (rare) secondary infection, skin thinning, stretch mark, and bumps. If a raised area and flare type reactions (which may be limited to intense itching) or other manifestations of allergic reaction develop, DermOtic® Oil Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v should be discontinued immediately and appropriate therapy instituted. If side effects persist please contact your doctor or pharmacist.

Serious side effects, how often they happen and what to do about them
Symptom / effect There have been no reported Serious Side Effects during clinical trials or post-marking experience. If a serious side effect does occur, discontinue the drug and call your doctor or pharmacist. Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and talk with your doctor or pharmacist
Allergic Reaction: Flare up of existing condition     ✔

This is not a complete list of side effects. For any unexpected effects while taking DermOtic® Oil Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v, contact your doctor or pharmacist.

How to store

Keep tightly closed. Store at 25°C (77°F). Keep out of reach of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This leaflet is part III of a three-part “Product Monograph" published when DermOtic ® Oil Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about DermOtic ® Oil Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v. Contact your doctor or pharmacist if you have any questions about the drug.

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor: Hill Dermaceuticals, Inc.
At: 1-800-344-5707

This leaflet was prepared by Hill Dermaceuticals, Inc.
Last revised: November 27, 2018

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