PrDermOtic®
Oil Ear Drops
(Fluocinolone Acetonide Otic Solution), 0.01% w/v
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.
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.
Fluocinolone Acetonide
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.
Oil, for Otic Use Only. Strength 0.01% w/v
A dropper is supplied with the package.
BEFORE you use DermOtic®Oil Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v, talk to your doctor or pharmacist if:
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.
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.
If swallowed, contact your doctor.
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.
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.
Keep tightly closed. Store at 25°C (77°F). Keep out of the reach of children and pets.
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.
