Otoxolan

1 x 10 ml

Ear drops, suspension

Active substance

Clotrimazole : 10 mg/ml

Marbofloxacin : 3 mg/ml

Dexamethasone (Dexamethasone acetate) : 1 mg/ml

ATC code

QS02CA06 Dexamethasone (Corticosteroids - moderately potent (group II)) and antiinfectives

QS02CA Corticosteroids and antiinfectives in comb.

QS02C Corticosteroids and antiinfectives in comb.

QS02 Otologicals

QS Sensory organs

Species

Dogs.

Indications

Treatment of otitis externa of both bacterial and fungal origin respectively due to bacteria sensitive to marbofloxacin, and fungi especially Malassezia pachydermatis sensitive to clotrimazole.

Dose to be administered and administration route

For auricular use.

Apply ten drops into the ear once daily for 7 to 14 days.

After 7 days of treatment, the veterinary surgeon should evaluate the necessity to extend the treatment another week.

One drop of the preparation contains 71 µg marbofloxacin, 237 µg clotrimazole and 23.7 µg dexamethasone acetate.

The external ear canal should be meticulously cleaned and dried before treatment. Shake well for 30 seconds before use and squeeze gently to fill the dropper with the veterinary medicinal product.

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.

When the veterinary medicinal product is intended for use in several dogs, use one dropper per dog.

Adverse reactions

Dogs:

Rare

(1 to 10 animals / 10,000 animals treated):

Deafness¹

Undetermined frequency (cannot be estimated from the available data):

Changes in biochemical and haematological parameters (e.g., Elevated serum alkaline phosphatase (ALP), Elevated alanine aminotransferase (ALT)/Elevated aspartate aminotransferase (AST), Neutrophilia)²

¹Mainly in elderly dogs and mostly of a transient nature. ²Associated with corticosteroid drugs.

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 also section 16 of the package leaflet for contact details.