Easotic ear suspension for dogs 10 ml
Treatment of acute otitis externa associated with bacteria (Malassezia pachydermatis, gentamicin and fungi) in dogs
Easotic ear suspension for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF Easotic
Hydrocortisone aceponate 1.11 mg/ml
Miconazole as nitrate 15.1 mg/ml
Gentamicin as sulphate 1,505 IU/ml.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM OF Easotic
Ear drops, suspension.
A white suspension.
4. CLINICAL PARTICULARS OF Easotic
4.1 Target species
4.2 Indications for use, specifying the target species
Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole in particular Malassezia pachydermatis.
Do not use in case of hypersensitivity to the active substances or to any of the excipients, to corticosteroids, to other azole antifungal agents and to other aminoglycosides.
Do not use if the eardrum is perforated.
Do not use concurrently with substances known to cause ototoxicity. Do not use in dogs with generalised demodecosis.
4.4 Special warnings
Bacterial and fungal otitis is often secondary in nature and appropriate diagnosis should be used to determine the primary factors involved.
4.5 Special precautions for use
Special precautions for use in animals
If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted.
Use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing and take into account official and local antimicrobial policies.
Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria and fungi resistant to gentamicin and miconazole respectively and may decrease the effectiveness of treatment with aminoglycosides and azole antifungal agents, due to the potential for cross-resistance.
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 in order to avoid the risk of transmission of the infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus.
Gentamicin is known to be associated with ototoxicity when administered by the systemic route at higher doses.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental skin contact, it is recommended to wash thoroughly with water.
Avoid contact with eyes. In case of accidental contact, rinse with abundant quantities of water. In case of eye irritation, seek medical advice.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
4.6 Adverse reactions (frequency and seriousness)
Mild to moderate redness of the ear was common (2.4% of treated dogs). Papules were observed uncommonly
(less than 1% of treated dogs). In all cases, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy.
In very rare cases, the use of the veterinary medicinal product has been associated with hearing impairment, usually temporary, and primarily in geriatric dogs. If this occurs, treatment should be stopped. See section 4.5 of the SPC.
In very rare cases, type-I hypersensitivity reactions (facial swelling, allergic pruritus) have been observed. If this occurs, treatment should be stopped.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals)
uncommon (more than 1 but less than 10 animals in 1,000 animals)
rare (more than 1 but less than 10 animals in 10,000 animals)
very rare (less than 1 animal in 10,000 animals, including isolated reports.
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Systemic absorption of hydrocortisone aceponate, gentamicin sulphate and miconazole nitrate being negligible, it is unlikely for teratogenic, foetotoxic or maternotoxic effects to occur at the recommended dosage in dogs.
Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
Compatibility with ear cleaners has not been demonstrated.
4.9 Amounts to be administered and administration route
One ml contains 1.11 mg hydrocortisone aceponate, 15.1 mg miconazole (as nitrate) and 1,505 IU gentamicin (as sulphate).
It is recommended that the external ear canal should be cleaned and dried before treatment and excess hair around the treatment area be cut.
The recommended dosage is 1 ml of the veterinary medicinal product per infected ear once a day for five consecutive days.
Shake the bottle thoroughly before first administration and prime the pump.
Introduce the atraumatic canula in the ear canal. Administer one dose (1 ml) of the product in each affected ear. This dose is adequately delivered by one pump activation. The airless pump allows the product to be administered whatever the position of the bottle is.
1 dose / ear / day for 5 days
Whatever the size, Whatever the position
The product as presented allows treating a dog suffering from bilateral otitis.
To administer one dose (1 ml) of the product in the affected ear:
Take out one pipette from the box.
Shake the pipette thoroughly before use.
To open: hold up the pipette upright and break the top of the cannula.
Introduce the atraumatic cannula in the ear canal. Squeeze gently but firmly in the middle of the body of the pipette.
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.
The veterinary medicinal product should be used at room temperature (i.e. do not instil cold product).
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
At 3 and 5 times the recommended dose, no local or general adverse reactions were observed with the exception of some dogs showing erythema and papulae in the ear canal.
In dogs treated at the therapeutic dose for ten consecutive days, serum cortisol levels decreased from five days onward and returned to normal values within ten days after the end of treatment. However, serum cortisol response levels post ACTH stimulation remained in the normal range during the extended treatment period, indicating a preserved adrenal function.
4.11 Withdrawal period
5. PHARMACOLOGICAL PROPERTIES OF Easotic
Pharmacotherapeutic group: Otologicals, corticosteroids and antiinfectives in combination. ATCvet code: QS02CA03.
5.1 Pharmacodynamic properties
The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic):
Hydrocortisone aceponate belongs to the diester class of the glucocorticosteroids with a potent intrinsic glucocorticoid activity which means a relief of both inflammation and pruritus leading to an improvement of clinical signs observed in otitis externa.
Miconazole nitrate is a synthetic imidazole derivative with a pronounced antifungal activity.
Miconazole selectively inhibits the synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis. Mechanisms of resistance to azoles consist of either failure in antifungal accumulation or modification of target enzyme. No standardised in-vitro susceptibility breakpoints have been defined for miconazole; however, using the method by Diagnostics Pasteur, no resistant strains were found.
Gentamicin sulphate is an aminoglycoside bactericidal antibiotic which acts by inhibiting protein synthesis. Its spectrum of activity includes Gram-positive and Gram-negative bacteria, such as the following pathogenic organisms isolated from the ears of dogs: Staphylococcus intermedius, Pseudomonas aeruginosa, Proteus mirabilis, Escherichia coli, etc.
Since many bacterial strains may be involved in otitis externa in dogs, the mechanisms of resistance can vary. The bacterial resistance phenotypes to gentamicin are mainly based on three mechanisms: enzymatic modification of aminoglycosides, failure of intracellular penetration of the active substance and alteration of the aminoglycoside target.
Cross-resistance is mainly linked with efflux pumps which confer resistance to β-lactams, quinolones and tetracyclines depending on the specificity of the pump with its substrate.
Co-resistance has been described, i.e. gentamicin resistance genes are found to be physically linked to other antimicrobial resistance genes that are transferred between pathogens due to transferable genetic elements such as plasmids, integrons and transposons.
Gentamicin resistant bacteria isolated from the field between 2008 and 2010 in canine otitis before treatment
(determined according to CLSI guideline breakpoint ≥ 8 for all isolates except for Staphylococci ≥ 16 μg/ml) were low: 4.7%, 2.9% and 12.5% for Staphylococcus spp., Pseudomonas and Proteus spp. respectively. All Escherichia coli isolates were fully susceptible to gentamicin.
5.2 Pharmacokinetic particulars
After application of the veterinary medicinal product into the ear canal, absorption of miconazole and gentamicin through the skin is negligible.
Hydrocortisone aceponate belongs to the diesters’ class of glucocorticosteroids. The diesters are lipophilic components ensuring an enhanced penetration into the skin associated with low systemic bioavailability. The diesters are transformed inside the skin structures in C17 monoesters responsible for the potency of the therapeutic class. In laboratory animals, hydrocortisone aceponate is eliminated the same way as hydrocortisone (other name for endogenous cortisol) through urine and faeces.
6. PHARMACEUTICAL PARTICULARS OF Easotic
6.1 List of excipients
Do not mix with other veterinary medicinal products.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 18 months. Shelf life after first opening the immediate packaging: 10 days.
Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
6.4. Special precautions for storage
Do not store above 25 °C.