Detailed description Suspension to be dropped into the dog's ear
Composition: List of active substance(s) and other component(s): Hydrocortisone aceponate ………………………….. 1.11 mg/ml Miconazole Nitrate ………………………………………. 15.1 mg/ml Gentamicin sulfate …………………………………….. 1505 IU/ml
Indications: Treatment of acute otitis externa and acute recurrent otitis externa caused by gentamicin-susceptible bacteria and miconazole-susceptible fungi, in particular Malassezia pachydermatis.
Target species: Dogs.
Usage and dosage method: by instillation in the ear. 1 ml contains 1.11 mg hydrocortisone aceponate, 15.1 mg miconazole (as nitrate) and 1505 IU gentamicin (as sulfate). Before the treatment, it is recommended to clean the outer ear, dry it and trim the excess hair. The recommended dose is 1 ml of the veterinary medicine per ear once a day for five consecutive days. Before the first drop, shake the vial well and firmly release the pump by pressing on the top. Insert the cannula into the ear canal. Inject one dose (1 ml) of the drug into each infected ear. The given dose is taken by pressing the pump once. Thanks to the hermetic pump system, the drug can be instilled regardless of the position of the vial. This presentation provides an opportunity to treat a dog with bilateral otitis media.
After instillation, massage the base of the ear for a short time and carefully so that the medicine penetrates deep into the ear canal.
The veterinary medicine should be used at room temperature (ie, do not instill a cold medicine).
Side Effects: Mild to moderate ear redness, seen in 2.4% of treated dogs. Papules may occur less frequently (less than 1% of treated dogs). In all cases, treatment with the veterinary drug was not discontinued and all dogs returned to normal without specific treatment.
In very rare cases, the use of veterinary medicine can cause hearing loss (partial hearing loss or deafness), especially in older dogs.
The frequency of side effects is determined as follows:
Very common (side effects observed in more than 1 in 10 treated animals) Common (1 to 10 cases per 100 treated animals) Uncommon (1 to 10 cases per 1,000 treated animals) Rare (1 to 10 cases per 10,000 treated animals) Very rare (less than 1 in 10,000 treated animals, including isolated cases). If you experience any side effects, including those not listed in this summary, or if you believe that the product has not been effective, please notify your veterinarian.
Contraindications: Do not use in case of hypersensitivity to the active substance or any of the excipients, corticosteroids or other azole antifungals or other aminoglycosides. In case of hypersensitivity to any of the components, stop treatment and start appropriate therapy. Do not use in case of perforation of the tympanic membrane.
Do not use together with substances that have an ototoxic effect.
Special precautions: Special precaution(s): Bacterial and fungal otitis are often secondary. A proper diagnosis should be made to determine what the causative factors are.
Special precautions for use in animals: in case of hypersensitivity to one of the components, treatment should be stopped and appropriate therapy should be prescribed. Before use, infectious microbes should be determined and their sensitivity to antibiotics should be determined.
In case of parasitic otitis, appropriate acaricidal treatment should be performed. Before using the veterinary medicinal product, carefully inspect the ear canal to ensure that the tympanic membrane is not perforated to avoid the risk of transmission of infection to the middle ear and damage to the vestibular and cochlear apparatus. Gentamicin is known to have an ototoxic effect when administered systemically at doses higher than therapeutic doses.
Pregnancy and lactation: the safety of the veterinary medicinal product during pregnancy and lactation has not been established. Given that the systemic absorption of hydrocortisone aceponate, gentamicin sulfate, and miconazole nitrate is negligible, it is unlikely that the drug will have teratogenic, fetotoxic, or maternal toxic effects at recommended doses. The drug should only be used after a benefit/risk assessment by a responsible veterinarian.
Interactions with other drugs or other types of interactions: compatibility with ear cleaners has not been determined.
Overdose (symptoms, emergency procedures, antidotes): At 3-5 times the recommended dose, no local or general side effects were observed, except for a few dogs that developed ear canal e.g.