POM-V Prescription Required Companion Animal

Otomicol Ear Drops and Cutaneous Suspension for Dogs and Cats

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

Form

Drops

Species

Cats Dogs

Manufacturer

KRKA, d.d., Novo mesto

VMD MA No.

01656/5072

What it's used for

For the treatment of primary and secondary infections of skin (eczema, dermatitis, pyoderma) and skin adnexa (hair, claws, sweat glands), as well as for th...

Full indications, dosage and side effects ↓

View official SPC (PDF)

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1

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2

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Prescription required

Your vet must provide a written prescription on request. You can then purchase from any licensed online retailer.

Clinical information

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

Source: VMD Summary of Product Characteristics (SPC). Last updated 26 Mar 2026.

For the treatment of primary and secondary infections of skin (eczema, dermatitis,
pyoderma) and skin adnexa (hair, claws, sweat glands), as well as for the treatment
of otitis externa, caused by infections with the following miconazole and polymyxin B
sensitive pathogens:
Gram-positive bacteria
Staphylococcus spp.
Streptococcus spp.
Gram-negative bacteria
Pseudomonas spp.
Escherichia coli
Yeasts and fungi
Malassezia pachydermatis
Candida spp.

Issued: June 2024
AN: 01259/2023
Microsporum spp.
Trichophyton spp.
For the topical treatment of otitis externa caused by the ear mite Otodectes cynotis.

Do not use in animals with perforated ear drums since Polymyxin B is known to be a
potential ototoxic agent.
Do not use in cases of hypersensitivity to the active substances or to any of the
excipients.

Dog, cat:
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 the national competent authority via the
national reporting system. See also section 16 of the package leaflet for contact
details.

As the product is a prescription only medicine, treatment should be closely
supervised by a veterinary practitioner.

Special precautions for use in animals
For external use only.
Due to the likely variability (temporal, geographical) in the emergence of bacterial
resistance to polymyxin B, bacteriological sampling and sensitivity testing
(antibiogram) is recommended. If there is overgrowth of resistance bacteria and/or
fungi, treatment with this product should be discontinued and treatment with an
appropriate alternative should be initiated.
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.
Other precautions:
Not applicable.

Issued: June 2024
AN: 01259/2023

Do not use concomitantly with medicines that induce ototoxicity.

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

Issued: June 2024
AN: 01259/2023

Polymyxin B sulfate 5500 IU (equivalent to 0.5293 mg polymyxin B sulfate)
Excipients:
For the full list of excipients, see section

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.