Easotic
Active substance
ATC code
Species
Dogs.
Indications
Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole in particular Malassezia pachydermatis.
Dose to be administered and administration route
Auricular use.
One ml contains 1.11 mg hydrocortisone aceponate, 15.1 mg miconazole (as nitrate) and 1,505 IU gentamicin (as sulphate).
It is recommended that the external ear canal should be cleaned and dried before treatment and excess hair around the treatment area be cut.
The recommended dosage is 1 ml of the veterinary medicinal product per infected ear once a day for five consecutive days.
Multi-dose container:
Shake the bottle thoroughly before first administration and prime the pump by pressing it. Introduce the atraumatic canula in the ear canal. Administer one dose (1 ml) of the product in each affected ear. This dose is adequately delivered by one pump activation. The airless pump allows the product to be administered whatever the position of the bottle is.
The product as presented allows treating a dog suffering from bilateral otitis.
Single-dose container:
To administer one dose (1 ml) of the product in the affected ear:
• Take out one pipette from the box.
• Shake the pipette thoroughly before use.
• To open: hold up the pipette upright and break the top of the cannula.
• Introduce the atraumatic cannula in the ear canal. Squeeze gently but firmly in the middle of the body of the pipette.
After application, the base of the ear may be massaged briefly and gently to allow the preparation to penetrate to the lower part of the ear canal.
The veterinary medicinal product should be used at room temperature (i.e. do not instil cold product).
Adverse reactions
Dogs:
Common (1 to 10 animals / 100 animals treated): | Application site reddening (ear) 1,2 |
Uncommon (1 to 10 animals / 1,000 animals treated): | Application site papule 2 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Impaired Hearing 3,4, Deafness 3,4 Hypersensitivity reactions (facial swelling, allergic pruritus) 4 |
1 Mild to moderate.
2 Recovering without specific therapy.
3 Primarily in geriatric dogs.
Complete recovery was confirmed in 70% of post marketing cases with an adequate follow-up, otherwise hearing improvement was observed in most dogs.
Recovery has been observed between one week and up to two months after onset of signs. 4 If the adverse reaction occurs, treatment should be stopped.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
