Osurnia Ear Gel for Dogs

Composition

Each dose (1.2 g) contains:

Active substances:

Terbinafine: 10 mg

Florfenicol: 10 mg

Betamethasone acetate: 1 mg equivalent to betamethasone base 0.9 mg

Excipients:

Off-white to slightly yellow translucent gel.

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Pharmacological properties

4.1 ATCvet code:

QS02CA90

4.2 Pharmacodynamics

The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic):

Betamethasone acetate belongs to the diesters class of the glucocorticosteroids with a potent intrinsic glucocorticoid activity which relieves both inflammation and pruritus leading to an improvement of clinical signs observed in otitis externa.

Terbinafine is an allylamine with a pronounced fungicidal activity. It selectively inhibits the early synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis (MIC90 of 2 mcg/ml). Terbinafine has a different mode of action than azole antifungals, therefore there is no cross resistance with azole antifungals.

Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis. Its spectrum of activity includes Gram-positive and Gram-negative bacteria including Staphylococcus pseudintermedius (MIC90 of 8 mcg/ml).

Due to the high antimicrobial concentrations achieved in the ear canal and the multifactorial nature of otitis externa, in vitro susceptibility may not be directly correlated with clinical success.

4.3 Pharmacokinetics

The formulation dissolves in ear wax and is slowly eliminated from the ear mechanically.

Systemic absorption of all active substances was determined in multiple-dose studies after placing the veterinary medicinal product into both ear canals of healthy mixed breed dogs. Absorption occurred primarily during the first two to four days after administration, with low plasma concentrations (1 to 42 ng/ml) of active substances.

The extent of percutaneous absorption of topical medications is determined by many factors including the integrity of the epidermal barrier. Inflammation can increase the percutaneous absorption of veterinary medicinal products.

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Target species

Dogs.

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Indications

Treatment of acute otitis externa and acute exacerbation of recurrent otitis externa associated with Staphylococcus pseudintermedius and Malassezia pachydermatis.

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Dosage

Auricular use.

Administer one tube per infected ear. Repeat the administration after 7 days. The maximum clinical response may not be seen until 21 days after the second administration.

Instructions for proper use:

It is recommended to clean and dry the external ear canal before the first administration of the veterinary medicinal product. It is recommended not to repeat ear cleaning until 21 days after the second administration of the product. If treatment with this veterinary medicinal product is discontinued, the ear canals should be cleaned before treatment with an alternative product is initiated.

1. Open the tube by twisting the soft tip.

2. Introduce this flexible soft tip into the ear canal.

3. Apply the veterinary medicinal product into the ear canal by pressing it between two fingers.

4. After application, the base of the ear may be massaged briefly and gently to facilitate even distribution of the veterinary medicinal product into the ear canal.

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Contraindications

Do not use if the eardrum is perforated.

Do not use in dogs with generalised demodicosis.

Do not use in pregnant or breeding animals (see section 3.7).

Do not use in cases of hypersensitivity to the active substances, to other corticosteroids or to any of the excipients.

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Adverse reactions

Dogs:

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

Deafnessa, Impaired hearinga

Application site erythema, Application site pain, Application site pruritus, Application site oedema, Application site ulcer

Hypersensitivity reactions (e.g. facial oedema, urticaria and shock)

Eye disorders (e.g. neurogenic keratoconjunctivitis sicca, keratoconjunctivitis sicca, corneal ulcer, blepharospasm, eye redness and ocular discharge)b

Ataxia, Facial paralysis, Nystagmus

Internal ear disorder (mainly head tilt)

a Usually temporary and mainly in elderly animals.

b See also section 3.5 - special precautions for use in animals.

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:

If hypersensitivity to any of the components occurs, the ear should be thoroughly washed.

The safety of the veterinary medicinal product has not been established in dogs less than 2 months of age or weighing less than 1.4 kg.

Whenever possible the use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing.

Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to florfenicol and fungi resistant to terbinafine and may decrease the effectiveness of treatment with other antibiotics and antifungal agents.

In case of parasitic otitis, an appropriate acaricidal treatment should be implemented.

Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum is not perforated.

Prolonged and intensive use of topical corticosteroids preparation is known to trigger systemic effects, including suppression of adrenal function (see section 3.10).

Decreased cortisol levels were observed after product instillation in tolerance studies (before and after ACTH stimulation), indicating that betamethasone is absorbed and enters the systemic circulation. The finding was not correlated with pathological or clinical signs and was reversible.

Additional corticosteroid treatments should be avoided.

Use with precaution in dogs with suspected or confirmed endocrine disorder (i.e. diabetes mellitus; hypo- or hyper-thyroid disease, etc.).

The veterinary medicinal product may be irritating to eyes. Avoid accidental contact to the dog’s eyes. If accidental ocular exposure does occur, the eyes should be flushed thoroughly with water for 10 to 15 minutes. If clinical signs develop, seek veterinary advice.

Owners should be recommended to monitor ocular signs (such as squinting, redness and discharge) in the hours and days following the product application, and to promptly consult a veterinarian in case such signs appear.

See section 3.6 for details on ocular adverse events in dogs.

The safety and efficacy of the veterinary medicinal product in cats has not been evaluated. Post-marketing surveillance shows that the use of the veterinary medicinal product in cats can be associated with neurological signs (including Horner’s syndrome with protrusion of membrane nictitans, miosis, anisocoria, and internal ear disorders with ataxia and head tilt) and systemic signs (anorexia and lethargy). The use of the veterinary medicinal product in cats should therefore be avoided.

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

The veterinary medicinal product may be irritating to eyes. Accidental eye exposure may occur when the dog shakes its head during or just after administration. To avoid this risk for the owners, it is recommended that this veterinary medicinal product is administered only by veterinarians or under their close supervision. Appropriate measures (e.g. wearing safety glasses during administration, massaging the ear canal well after administration to ensure even distribution of product, restraining the dog after administration) are needed to avoid exposure to the eyes. In case of accidental ocular exposure, flush the eyes thoroughly with water for 10 to 15 minutes. If symptoms develop, seek medical advice immediately and show the package leaflet or the label to the physician.

In case of accidental skin contact, wash exposed skin thoroughly with water. In case of accidental ingestion by humans, 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.

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:

Laboratory studies have shown evidence of teratogenic effects associated with betamethasone in laboratory species.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation in pregnant and lactating bitches.

Do not use during pregnancy and lactation.

Fertility:

Do not use in breeding animals.

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Interactions

Compatibility with ear cleaners, other than sodium chloride solution, has not been demonstrated.

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Overdose

Auricular administration of five times the recommended dose, one week apart, for 5 consecutive weeks (a total six administrations of 5 tubes per ear or 10 tubes per dog) to mixed breed dogs weighing 10 to 14 kg resulted in clinical signs of wetness of the inner and outer pinna (attributed to presence of the product).

There were no clinical signs associated with unilateral vesicle formation within the epithelium of the tympanic membrane (also observed after six administrations, one week apart, of 1 tube per ear or 2 tubes per dog), unilateral mucosal ulceration in the lining of the middle ear cavity or decrease in serum cortisol response below normal reference range in ACTH stimulation testing. The decreased adrenal and thymus weights accompanied by atrophy of the adrenal cortex and lymphoid depletion of the thymus correlated with the decreased cortisol levels and were consistent with the pharmacologic effects of betamethasone. These findings are considered reversible.

Reversibility of the epithelial tympanic membrane blistering is also likely through epithelial migration, a natural self-cleaning and self–repair mechanism for the tympanic membrane and ear canal.

Additionally, dogs showed slightly elevated red blood cell count, hematocrit, total protein, albumin and alanine aminotransferase. These findings were not associated with clinical signs.

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Special warnings

Clean the ears before the initial treatment is applied. Ear cleaning should not be repeated until 21 days after the second administration. In clinical trials, sodium chloride solution only was used for ear cleaning.

Transient wetness of the inner and outer pinna can be observed. This observation is attributed to presence of product and is not of clinical concern. Bacterial and fungal otitis is often secondary to other conditions. Appropriate diagnosis should be used, and therapy of causative conditions should be investigated before antimicrobial treatment is considered.

In animals with a history of chronic or recurrent otitis externa, efficacy of the veterinary medicinal product may be affected if the underlying causes of the condition such as allergy or anatomical conformation of the ear are not addressed.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

Single-use multi-layered aluminium and polyethylene tube with a polypropylene thermoplastic elastomer tip.

Cardboard box containing 2, 12, 20 or 40 tubes (each tube containing 2.05 g of product of which a single dose of 1.2 g can be extracted).

Not all pack sizes may be marketed.

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Storage

Store in a refrigerator (2 °C – 8 °C).

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

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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

Vm 50406/5054

8 DATE OF FIRST AUTHORISATION

31 July 2014

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

November 2025

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: 13 November 2025

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Registration holder

Dechra Regulatory B.V.

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