Otoxolan Ear Drops, Suspension for Dogs

Composition

Each ml of suspension contains:

Active substances:

Marbofloxacin 3.0 mg

Clotrimazole 10.0 mg

Dexamethasone acetate 1.0 mg

(equivalent to Dexamethasone 0.9 mg)

Excipients:

Off yellow, opalescent, viscous suspension.

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Pharmacological properties

4.1 ATCvet code: QS02CA06

4.2 Pharmacodynamics

The veterinary medicinal product combines three active ingredients, marbofloxacin, clotrimazole and dexamethasone.

Marbofloxacin, a synthetic bactericidal agent belonging to the fluoroquinolone family that acts by inhibiting DNA gyrase. It exhibits a broad spectrum of activity against Gram-positive bacteria (e.g. Staphylococcus intermedius) and against Gram-negative organisms (Pseudomonas aeruginosa, Escherichia coli and Proteus mirabilis). In the European literature susceptibility data (MIC50 values) for canine and feline otitis pathogens are presented:

Susceptibility breakpoints have been determined as ≤ 1 µg/ml for sensitive, 2 µg/ml for intermediate and ≥ 4 µg/ml for resistant bacterial strains.

Marbofloxacin is not active against anaerobes. Resistance to fluoroquinolones occurs by chromosomal mutation with three mechanisms: decrease of the bacterial wall permeability, expression of efflux pump or mutation of enzymes responsible for molecule binding.

Clotrimazole, an anti-fungal agent that belongs to the imidazole family and which acts by causing changes in membrane permeability, allowing intracellular compounds to leak from the cell and thus inhibiting cellular molecular synthesis. It exhibits a wide spectrum of activity and is aimed, in particular, at Malassezia pachydermatis;

Dexamethasone acetate, a synthetic glucocorticoid exhibiting anti-inflammatory and anti-pruritic activity.

4.3 Pharmacokinetics

Pharmacokinetics studies in dogs at the therapeutic dosage have shown that: Marbofloxacin plasma concentrations peak at 0.06 µg/ml on the 14th day of treatment.

Marbofloxacin bonds weakly to plasma proteins (< 10% in dogs) and is eliminated slowly, mainly in the active form, predominantly in urine (2/3) and in faeces (1/3). Clotrimazole absorption is extremely poor (plasma concentration < 0.04 µg/ml). Dexamethasone acetate plasma concentration reaches 1.25 ng/ml on the 14th day of treatment. Dexamethasone resorption is not increased by the inflammatory process induced by otitis.

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Target species

Dogs.

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Indications

Treatment of otitis externa of both bacterial and fungal origin respectively due to bacteria sensitive to marbofloxacin, and fungi especially Malassezia pachydermatis sensitive to clotrimazole.

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Dosage

For auricular use.

Apply ten drops into the ear once daily for 7 to 14 days.

After 7 days of treatment, the veterinary surgeon should evaluate the necessity to extend the treatment another week.

One drop of the preparation contains 71 µg marbofloxacin, 237 µg clotrimazole and 23.7 µg dexamethasone acetate.

The external ear canal should be meticulously cleaned and dried before treatment. Shake well for 30 seconds before use and squeeze gently to fill the dropper with the veterinary medicinal product.

After application, the base of the ear may be massaged briefly and gently to allow the preparation to penetrate to the lower part of the ear canal.

When the veterinary medicinal product is intended for use in several dogs, use one dropper per dog.

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Contraindications

Do not use in dogs suffering from perforation of the tympanic membrane.

Do not use in cases of hypersensitivity to the active substances, to other azole antifungal agents or to any other fluoroquinolones or to any of the excipients.

Do not use in animals, where resistance of causative agents to marbofloxacin and/or clotrimazole is known.

See section 3.7.

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Adverse reactions

Dogs:

Rare (1 to 10 animals / 10,000 animals treated): Deafness1

Undetermined frequency (cannot be estimated from the available data): Changes in biochemical and haematological parameters (e.g., Elevated serum alkaline phosphatase (ALP), Elevated alanine aminotransferase (ALT)/Elevated aspartate aminotransferase (AST), Neutrophilia)2

1Mainly in elderly dogs and mostly of a transient nature.

2Associated with corticosteroid drugs.

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.

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Warnings

Special precautions for safe use in the target species:

Before treating with the veterinary medicinal product, the integrity of the tympanic membrane must be verified.

Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria and/or fungi isolated from the animal. If this is not possible, therapy should be based on local (regional) epidemiological information about susceptibility of the target pathogens.

Official and local antimicrobial policies should be taken in to account when the veterinary medicinal product is used.

Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population.

It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antibiotics.

Quinolone class drugs have been associated with cartilage erosions in weight- bearing joints and other forms of arthropathy in immature animals of various species. The use of the product in young animals is not recommended.

Prolonged and intensive use of topical corticosteroid preparations is known to trigger local and systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed wound healing.

Avoid contact with eyes in animals. In case of accidental contact, rinse thoroughly with water.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity (allergy) to (fluoro)quinolones, (cortico)steroids, antifungals, or any of the excipients should avoid contact with the veterinary medicinal product.

Avoid contact of the skin and eyes with the veterinary medicinal product. In case of accidental spillage onto skin or eyes, rinse the affected area with large amounts of water.

Take care to avoid accidental ingestion. 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.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

Do not use during pregnancy and lactation.

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Interactions

None known.

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Overdose

Changes in biochemical and haematological parameters (such as increase of alkaline phosphatase, aminotransferase, some limited neutrophilia, eosinopaenia, lymphopaenia) are observed with three fold the recommended dosage; such changes are not serious and will reverse once the treatment has stopped.

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Special warnings

Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

Box containing 1 x 10 ml LDPE bottle with an LDPE dropper and HDPE screw cap, and a thermoplastic elastomer dropper with cap.

Box containing 1 x 20 ml LDPE bottle with an LDPE dropper and HDPE screw cap, and 2 thermoplastic elastomer droppers with caps.

Box containing 1 x 30 ml LDPE bottle with an LDPE dropper and HDPE screw cap, and 3 thermoplastic elastomer droppers with caps.

Not all pack sizes may be marketed.

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Storage

Do not store above 30 °C.

Keep the bottles in the outer carton in order to protect from light.

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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.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

UK(NI): Vm 01656/3081

UK(GB): Vm 01656/5081

8 DATE OF FIRST AUTHORISATION

23 December 2016

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

September 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved: 29 September 2026

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Registration holder

KRKA d.d., Novo mesto

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