Target species
Dogs.
Indications for use for each target species
Treatment of otitis externa associated with Malassezia pachydermatis.
Contraindications
Do not use in cases of hypersensitivity to the active substances, to other corticosteroids or to any of the excipients.
Do not use if the eardrum is perforated.
Do not use in dogs with generalised demodicosis.
Special warnings
Clean the ears before the initial treatment is applied. In clinical trials, saline only was used for ear cleaning before the first application of the veterinary medicinal product and ears were not cleaned again during the duration of the study (45 days).
If treatment with this veterinary medicinal product is discontinued, the ear canals should be cleaned before treatment with an alternative product is initiated.
Transient wetness of the inner and outer pinna may be observed after administration. This observation is attributed to presence of the veterinary medicinal product and is not of clinical concern. 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.
Special precautions for use
Special precautions for safe use in the target species:
Safety has not been established in dogs less than 2 months of age or weighing less than 1.4 kg.
Use of the veterinary medicinal product should be based on identification and susceptibility testing of the target pathogen. If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at the local/regional level.
Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies.
Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of fungi resistant to terbinafine and may decrease the effectiveness of treatment with other antifungal agents.
In case of parasitic or bacterial otitis externa, an appropriate acaricidal or antibiotic treatment should be implemented as appropriate.
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 corticosteroid preparations is known to trigger systemic effects, including suppression of adrenal function.
Decreased cortisol levels were observed after product instillation in tolerance studies using a related product (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 concurrent corticosteroid treatments should be avoided.
Use with caution in dogs with a 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 with 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.
XI: In very rare cases, eye disorders such as keratoconjunctivitis sicca and corneal ulcers have been reported in dogs treated with a related product, in the absence of eye contact with the product. Although a causal relationship with the product was not definitively established, owners should be recommended to monitor for ocular signs (such as squinting, redness and discharge) in the hours and days following the veterinary medicinal product application, and to promptly consult a veterinarian in case such signs appear.
GB: Owners should be recommended to monitor for ocular signs (such as squinting, redness and discharge) in the hours and days following the veterinary medicinal product application, and to promptly consult a veterinarian in case such signs appear.
The safety and efficacy of the veterinary medicinal product in cats has not been evaluated. Post- marketing surveillance of a related product shows that the use of the 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 the veterinary medicinal product, restraining the dog after administration) are needed to avoid exposure to the eyes.
Avoid hand-to-eye contact. In case of accidental ocular exposure, flush the eyes thoroughly with large amounts of water. If symptoms develop, seek medical advice and show the package leaflet or the label to the physician.
Although no potential for skin irritation was indicated by experimental studies, contact of the product with the skin should be avoided. In case of accidental skin contact with the product, either directly during application or indirectly via contact with the treated area, wash exposed skin thoroughly with water.
May be harmful after ingestion. Avoid ingestion of the product, including hand-to-mouth exposure.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Dogs:
Uncommon (1 to 10 animals / 1,000 animals treated): | Elevated liver enzymesa |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Deafness, impaired hearingb Conjunctivitis, keratoconjunctivitis sicca, corneal ulcer, blepharospasm, eye redness, ocular discharge Application site reactions (i.e. erythema, pain, pruritus, oedema, ulcer) Hypersensitivity reactions (including facial oedema, urticaria, shock)c |
a Mainly transient elevation of alanine aminotransferase
b Usually temporary. Mainly in elderly animals
c If hypersensitivity to any of the components occurs, the ear should be thoroughly washed
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 the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Betamethasone is known to be teratogenic in laboratory species.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Do not use during pregnancy and lactation.
Fertility:
Do not use in breeding animals.
Interaction with other medicinal products and other forms of interaction
Compatibility with ear cleaners, other than saline, has not been demonstrated.
Administration routes and dosage
Auricular use.
Administer one tube per affected ear. Repeat the administration after 7 days. The maximum clinical response may not be seen until 21 days after the second administration (28 days after the start of treatment).
Instructions for proper use:
It is recommended to clean and dry the external ear canal before the first administration of the veterinary medicinal product.
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.
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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
In a study using a related, similar product, 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, haematocrit, total protein, albumin and alanine aminotransferase. These findings were not associated with clinical signs.
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.
Withdrawal periods
Not applicable.