0 Items Login Store Rx Products News About Us Contact Us Canada – PrDermOtic® Oil Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v DIN 02300559 PrDermOtic® Oil Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v About This Medication 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 forms it comes in: Oil, for Otic Use Only. Strength 0.01% w/v A dropper is supplied with the package. 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. 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 it Keep tightly closed. Store at 25°C (77°F). Keep out of the reach of children and pets. Reporting Side Effects You can report any suspected side effects associated with the use of health products to Health Canada by: Visiting Adverse Reaction Reporting for information on how to report online, by mail or by fax; or Calling toll-free at 1-866-234-2345. 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. If you want more information about this medication Talk to your healthcare professional Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information in the link below. 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