OTIMIX PLUS ear drops, Suspension for dogs and cats

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Composition

Each ml contains

Active substances:

Miconazole nitrate                 23 mg

Polymyxin B sulfate                5,500 IU

Prednisolone acetate             5 mg

White suspension.

Target species

Dogs and cats.

Indications for use for each target species

Treatment of otitis externa and dermatitis in dogs and cats caused by the following microorganisms susceptible to polymyxin B and miconazole:

Gram-positive bacteria:

Staphylococcus spp.

Streptococcus spp.

Gram-negative bacteria:

Pseudomonas spp.

Escherichia coli

Yeasts and fungi:

Microsporum spp.     

Trichophyton spp.

Candida spp.

Malassezia pachydermatis

Adjunctive treatment of Otodectes cynotis infestation in cases of co-infection with pathogens susceptible to polymyxin B and miconazole.

Do not use in case of hypersensitivity to miconazole, polymyxin B or prednisolone, or to any of the excipients.

Do not use in animals with perforated eardrums (membrana tympani) since polymyxin B is known to be a potential ototoxic agent.

Special warnings

There is cross-resistance between polymyxin B and colistin and also between miconazole and other imidazole antifungals.

Special precautions for use

Special precautions for safe use in the target species:

The use of the product should be based on the result of cultivation and on the determination of susceptibility of the microorganisms isolated from the animal. If this is not possible, therapy should be based on local (regional) epidemiological information about susceptibility of the target pathogens.

When using the product, take into account official and local antimicrobial policies.

Polymyxin B belongs to category B according to the AMEG classification. These antimicrobials should only be considered for the treatment of clinical conditions where there are no antimicrobials in categories C or D that may be effective.

The use of the product deviating from the instructions given in this Summary of Product Characteristics (SPC) may increase the prevalence of bacteria resistant to polymyxin B and miconazole and reduce the effectiveness of therapy with other substances from the group of polymyxins and imidazole antifungals due to possible cross-resistance.

In cases of Otodectes cynotis (ear mite) infestation, systemic treatment with an appropriate acaricide should be considered.

Systemic effects of prednisolone may occur when using the product, especially when using the product under an impermeable bandage, on extensive skin lesions, with increased blood circulation in the skin or if the product is ingested by an animal.

Before administering the product, it is necessary to check that the eardrum (membrana tympani) is intact.

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.

Pregnant and breastfeeding women should administer the product with caution.

The product can cause skin and eye irritation, so avoid contact of the product with the skin and eyes. Avoid accidental ingestion of the product.

When handling the veterinary medicinal product, personal protective equipment consisting of protective gloves should be used.

In case of skin contact, wash the area immediately with plenty of water and soap. In case of contact with eyes, rinse immediately with plenty of water. If eye or skin irritation persists, or in case of accidental ingestion of the product, seek medical advice immediately and show the package leaflet or the label to the physician.

Do not smoke, drink or eat while handling the product.Wash hands after use.

Adverse events

Long-term and extensive use of topical preparations containing corticosteroids is known to trigger local immunosuppression including increased risk of infection, epidermal thinning and delayed healing, telangiectasia and increased skin vulnerability to bleeding, and systemic effects including suppression of adrenal function.
The conventional adverse effects of corticosteroids can occur (disturbance of biochemical parameters, such as increased cortisol and hepatic enzyme levels).

Very rare (< 1 animal / 10,000 animals treated, including isolated reports):

Deafness*

* especially in elderly dogs

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 the package leaflet for respective contact details.

Administration routes and dosage

Auricular or cutaneous administration. Shake well before use.

Ears:           After cleaning the auditory canal apply 3 to 5 drops of the product into the ear twice daily. To ensure optimal distribution of the product, massage the ear base well.

Continue the treatment without interruption for a few more days after the disappearance of clinical signs, at least 7 – 10 days, 14 days at most.       

Skin:           Apply a few drops of the product twice a day to cover the entire lesion and rub into the affected area with a gloved hand.

Continue the treatment without interruption for a few more days after the disappearance of clinical signs, up to 14 days.
In some persistent cases, a treatment duration of 2 – 3 weeks is recommended. In case of fungal infection, further treatment, if indicated, should be continued with corticosteroid-free preparations.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 3 months.

Special precautions for storage

Store below 25 °C.

Packaging

15 ml