Auriotic Ear Drops and Cutaneous Suspension for Dogs and Cats
Active ingredients: Miconazole Nitrate, Polymyxin B Sulphate, Prednisolone Acetate
Form
Drops
Species
Manufacturer
VetViva Richter GmbH
VMD MA No.
57446/4016
What it's used for
spp. • spp. coli AN: 01435/2024 & 01436/2024 • pachydermatis spp. spp. spp. Treatment of Otodectes cynotis (ear mites) infestations where the...
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Auriotic Ear Drops and Cutaneous Suspension for Dogs and Cats — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
•
spp.
coli
AN: 01435/2024 & 01436/2024
•
pachydermatis
spp.
spp.
spp.
Treatment of Otodectes cynotis (ear mites) infestations where there is concurrent
infection with miconazole and polymyxin B sensitive pathogens.
At the beginning of treatment, hair surrounding or covering the lesions must be
clipped; this should be repeated during treatment if necessary.
Infections of the external auditory canal (otitis externa):
Clean the external ear canal and auricle and place 5 drops of the veterinary
medicinal product into the external auditory canal twice a day. Massage the ear and
the auditory canal thoroughly to ensure proper distribution of the active substances,
but gently enough to avoid causing pain to the animal.
Treatment should be continued without interruption until a few days after complete
disappearance of the clinical symptoms, at least for 7 - 10 days up to 14 days. The
success of the treatment should be verified by a veterinarian before discontinuing
treatment.
Skin infections (small localised superficial):
Apply a few drops of the veterinary medicinal product to the skin lesions to be treated
twice a day and rub well.
Treatment should be continued without interruption until a few days after complete
disappearance of the clinical symptoms, up to 14 days.
In some persistent cases (ear or skin infections), treatment may need to be continued
for 2 to 3 weeks. In cases where prolonged treatment is necessary repeated clinical
examinations including a re- assessment of the diagnosis are required.
corticosteroids, to other azole antifungal agents, or to any of the excipients,
miconazole is known,
Very rare
(<1 animal / 10 000 animals
treated, including isolated
reports):
Deafness
Undetermined frequency
(cannot be estimated from the
available data):
Other immune system disorders
2,3
;
Application site infection
, Application site
bleeding
2,4
;
Skin thinning
;
Delayed healing
, Systemic disorder
(e.g. Adrenal gland disorder
2,5
);
Telangiectasia
.
Especially in older dogs. In this case treatment should be discontinued.
After prolonged and extensive use of topical corticosteroid preparations.
Local immunosuppression including increased risk of infections
Increased vulnerability of the skin to bleeding.
Suppression of adrenal function.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
the marketing authorisation holder or the national competent authority via the
national reporting system. See the package leaflet for respective contact details.
be identified and treated.
Special precautions for safe use in the target species:
Use of the veterinary medicinal product should be based on identification and
susceptibility testing of the target bacteria and/or fungi isolated from the animal. If this
is not possible, therapy should be based on local (regional) epidemiological
information and knowledge of susceptibility of the target pathogens.
Use of the veterinary medicinal product should be in accordance with official, national
and regional antimicrobial policies.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG
category) should be used for first line treatment where susceptibility testing suggests
the likely efficacy of this approach.
In cases of persistent infestations with Otodectes cynotis (ear mites) systemic
treatment with an appropriate acaricide should be considered.
Before treating with the veterinary medicinal product, the integrity of the tympanic
membrane must be verified.
Systemic corticosteroid effects are possible, especially when the veterinary medicinal
product is used under an occlusive dressing, on extensive skin lesions, with
increased skin blood flow, or if the veterinary medicinal product is ingested by licking.
Oral ingestion of the veterinary medicinal product by treated animals or animals
having contact with treated animals should be avoided.
Avoid contact with eyes in animals. In case of accidental contact, rinse thoroughly
with water.
AN: 01435/2024 & 01436/2024
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
People with known hypersensitivity to prednisolone, polymyxin B or miconazole
should avoid contact with the veterinary medicinal product.
The veterinary medicinal product may cause irritation to skin and eyes. Avoid contact
with skin or eyes. Always wear single use disposable gloves when applying the
veterinary medicinal product to animals. In case of accidental spillage, skin or eyes
should be rinsed immediately with plenty of water. Wash hands after use.
Take care to avoid accidental ingestion. In case of accidental ingestion, seek medical
advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
After first opening do not store above 25 °C.
Keep the container in the outer carton.
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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