Target Species
Dogs.
Indications for use
Treatment of acute otitis externa and acute exacerbations of recurrent otitis externa, associated with bacteria susceptible to orbifloxacin and fungi susceptible to posaconazole, in particular Malassezia pachydermatis.
Contraindications
Do not use if the eardrum is perforated.
Do not use in case of hypersensitivity to the active substances, to any of the ingredients, to corticosteroids, to other azole antifungal agents or to other fluoroquinolones.
Do not use during the whole or part of the pregnancy.
Special warnings for each target species
Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated.
Special precautions for use
Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population. It is prudent to reserve fluoroquinolones for the treatment of clinical conditions, which have responded poorly or are expected to respond poorly to other classes of antibiotics.
Use of the product should be based on susceptibility testing of isolated bacteria, and/or other appropriate diagnostic tests.
Quinolone class veterinary medicinal products have been associated with cartilage erosions in weight-bearing joints and other forms of arthropathy in immature animals of various species. Therefore do not use in animals less than 4 months of age.
Prolonged and intensive use of topical corticosteroids preparation is known to trigger local and systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed healing. See section 4.10.
Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum is not perforated in order to avoid the risk of transmission of the infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus.
Operator warnings
Wash hands carefully after applying the veterinary medicinal product. Avoid skin contact. In case of accidental exposure, rinse the affected area with copious quantities of water.
Adverse Reactions
Mild erythematous lesions have been observed.
The use of auricular preparations may be associated with hearing impairment, usually temporary, and primarily in geriatric dogs.
Use during pregnancy or lactation
Do not use during the whole or part of the pregnancy.
The use of the veterinary medicinal product is not recommended during lactation.
Laboratory studies in puppies have shown evidence of arthropathy after systemic administration of orbifloxacin. Fluoroquinolones are known to cross the placenta and to be distributed into milk.
Studies to determine the effect of orbifloxacin on fertility in dogs have not been conducted.
Do not use in breeding animals.
Interactions
No clinical data available.
Amounts to be administered and administration route
Auricular use.
One drop contains 267 µg orbifloxacin, 27 µg mometasone furoate and 27 µg posaconazole.
The external ear canal should be meticulously cleaned and dried before treatment. Excess hair around the treatment area should be cut.
Shake well before use.
Dogs weighing less than 2 kg, apply 2 drops to the ear once a day.
Dogs weighing 2 - 15 kg, apply 4 drops to the ear once a day.
Dogs weighing 15 kg or more, apply 8 drops to the ear once a day.
Treatment should continue for 7 consecutive days.
After application, the base of the ear may be massaged briefly and gently to allow the veterinary medicinal product to penetrate the lower part of the ear canal.
Overdose
Administration of the recommended dose (4 drops per ear) 5 times daily for 21 consecutive days to dogs weighing 7.6 to 11.4 kg bodyweight caused a slight decrease in serum cortisol response after adrenocorticotropic hormone (ACTH) administration in an ACTH stimulation test. Discontinuation of treatment will result in a complete return to normal adrenal response.
Withdrawal periods
Not applicable.