DuOtic 10 mg / 1 mg Ear Gel for Dogs

Clean the ears before the initial treatment is applied. In clinical trials, saline only was
used for ear
cleaning before the first application of the veterinary medicinal product and ears
were not cleaned
again during the duration of the study (45 days).
If treatment with this veterinary medicinal product is discontinued, the ear canals
should be cleaned before treatment with an alternative product is initiated.
Transient wetness of the inner and outer pinna may be observed after
administration. This observation is attributed to presence of the veterinary medicinal
product and is not of clinical concern. Fungal
otitis is often secondary to other conditions. Appropriate diagnosis should be used,
and therapy of
causative conditions should be investigated before antimicrobial treatment is
considered.
In animals with a history of chronic or recurrent otitis externa, efficacy of the
veterinary medicinal
product may be affected if the underlying causes of the condition such as allergy or
anatomical
conformation of the ear are not addressed.

Special precautions for safe use in the target species:
Safety has not been established in dogs less than 2 months of age or weighing less
than 1.4 kg.
Use of the veterinary medicinal product should be based on identification and
susceptibility testing of the target pathogen. If this is not possible, therapy should be
based on epidemiological information
and knowledge of susceptibility of the target pathogens at the local/regional level.
Use of the veterinary medicinal product should be in accordance with official,
national and regional
antimicrobial policies.
Use of the veterinary medicinal product deviating from the instructions given in the
SPC may increase the prevalence of fungi resistant to terbinafine and may decrease
the effectiveness of treatment with
other antifungal agents.
In case of parasitic or bacterial otitis externa, an appropriate acaricidal or antibiotic
treatment should
be implemented as appropriate.
Before the veterinary medicinal product is applied, the external auditory canal must
be examined
thoroughly to ensure that the ear drum is not perforated (see section 3.3).
Prolonged and intensive use of topical corticosteroid preparations is known to trigger
systemic effects, including suppression of adrenal function (see section 3.10).
Decreased cortisol levels were observed after product instillation in tolerance studies
using a related
product (before and after ACTH stimulation), indicating that betamethasone is
absorbed and enters the systemic circulation. The finding was not correlated with
pathological or clinical signs and was
reversible.
Additional concurrent corticosteroid treatments should be avoided.
Use with caution in dogs with a suspected or confirmed endocrine disorder (i.e.
diabetes mellitus;
hypo- or hyper-thyroid disease, etc.).
The veterinary medicinal product may be irritating to eyes. Avoid accidental contact
with the dog’s
eyes. If accidental ocular exposure does occur, the eyes should be flushed
thoroughly with water for
10 to 15 minutes. If clinical signs develop, seek veterinary advice.
Owners should be recommended to monitor for ocular signs (such as squinting,
redness and discharge) in the hours and days following the veterinary medicinal
product application, and to promptly consult a veterinarian in case such signs
appear. See section