POM-V Prescription Required Companion Animal

Otomicol Ear Drops and Cutaneous Suspension for Dogs, Cats and Guinea Pigs

Active ingredients: Miconazole Nitrate, Polymyxin B Sulphate, Prednisolone Acetate

Form

Drops

Species

Cats Dogs Guinea pig

Manufacturer

KRKA, d.d., Novo mesto

VMD MA No.

01656/3072

What it's used for

 spp. Gram-negative bacteria  spp.  Yeasts and fungi   spp.  spp. 

Full indications, dosage and side effects ↓

View official SPC (PDF)

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Clinical information

Otomicol Ear Drops and Cutaneous Suspension for Dogs, Cats and Guinea Pigs — SPC Details

Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.

 spp.
Gram-negative bacteria
 spp.

Yeasts and fungi

 spp.
 spp.


Shake well before use (10 seconds).
Routes of administration:
Dogs, Cats: For instillation in the external auditory canal or for cutaneous application.
Guinea Pigs: For cutaneous application.
Infections of the external auditory canal (otitis externa):
Clean the auricle and external auditory canal and place 3 to 5 drops of the veterinary
medicinal product into the external auditory canal twice a day. Massage the auricle
and the external auditory canal gently to avoid causing pain to the animal, but
thoroughly to ensure proper distribution of the active substances.
Treatment should be continued without interruption until a few days after complete
disappearance of the clinical symptoms.
Infections of the skin and skin adnexa:
Apply a thin film of the veterinary medicinal product to the skin lesions to be treated
twice a day and rub well.
At the beginning of treatment, hair surrounding or covering the lesions must be
clipped; this should be repeated during treatment if necessary. Hygienic measures
such as cleaning the skin to be treated before the use of the product are essential for
successful therapy.
Treatment should be continued without interruption until a few days after complete
disappearance of the clinical symptoms.
In persistent cases (otitis externa or skin infections), treatment may be required for 2
to 3 weeks. If necessary, antimycotic therapy without glucocorticoid should be
continued.

Do not use in cases of hypersensitivity to the active substances or to any of the
excipients.
Do not use on large wounds.
Do not use in dogs or cats suffering from perforation of the tympanic membrane.

Dog, cat, guinea pig:
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Deafness
Undetermined frequency
(cannot be estimated from the
available data):
Local immune deficiency
2,3
Skin thinning
Delayed healing
Teleangiectasia
Increased vulnerability of the skin (with bleeding)
1
In animals treated for otitis externa, especially in older dogs. Treatment should be
discontinued.
With prolonged use due to the contained glucocorticoid.
Associated with increased susceptibility to infection.
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.

Do not use in cases of known resistance against polymyxin B or miconazole.
Cross-resistance has been shown between polymyxin B and colistin. Use of the
product should be carefully considered when susceptibility testing has shown
resistance to colistin because its effectiveness may be reduced.
Bacterial and fungal otitis is often secondary in nature. The underlying cause should
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 pathogen(s). If this is not possible, therapy should
be based on epidemiological information and knowledge of susceptibility of the target
pathogens at local/regional level.
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 case of otitis externa, before treatment with the veterinary medicinal product is
initiated, 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 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.
The veterinary medicinal product should not be used on the mammary glands of
lactating animals due to the possible oral intake by the offspring.
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. Personal protective equipment consisting of single use disposable
gloves should be worn when applying the veterinary medicinal product to animals. In
case of accidental spillage, skin or eyes should be rinsed immediately with plenty of
water.
Take care to avoid accidental ingestion, especially by a child. In case of accidental
ingestion, seek medical advice immediately and show the leaflet or the label to the
physician.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.

No data available.

Store below 25 C. Store in the original container in order to protect from light.

Not applicable.

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.