Otoxolan ear drops for dogs (Aurizon analog), 10 ml

Otoxolan (marbofloxacin, clotrimazole, dexamethasone acetate) ear solution

Description

Viscous, almost yellow, opalescent suspension.

Storage

1 ml of the drug contains active ingredients:

• marbofloxacin – 3.0 mg;
• clotrimazole – 10.0 mg;
• dexamethasone acetate – 1.0 mg.

Excipients: propyl gallate (E 310).

Pharmacological properties

ATC vet classification code QS02 – veterinary drugs used in otology. QS02CA06 – GCS (dexamethasone) and antibacterial drugs in combination.

Otoxolan is a combined preparation containing three active substances: marbofloxacin, clotrimazole and dexamethasone.

Marbofloxacin is a synthetic bactericidal agent belonging to the group of fluoroquinolones, the mechanism of action of which is to suppress the activity of the DNA-gyrase enzyme of a bacterial cell. It has a wide spectrum of activity against gram-positive bacteria (Staphylococcus intermedius) and against gram-negative organisms (Pseudomonas aeruginosa, Escherichia coli and Proteus mirabilis). The European literature presents sensitivity data (MIC50 values ​​(minimum inhibitory concentration)) of otitis media in cats and dogs:

Sensitivity control points were determined, namely: MIC of marbofloxacin ≤ 1 mgc/ml – bacterial strains are sensitive, 2 mgq/ml – moderately sensitive bacterial strains, ≥ 4 mgc/ml – resistant bacterial strains.

Clotrimazole is a synthetic imidazole derivative with a pronounced fungicidal effect on dermatophytes (Epidermophytion floccosum, Microsporum spp., Trichophyton spp.), yeast and yeast-like fungi (Candida spp., Cryptococcus neoformans, Torulosis spp., Aspergillus spp., Cladosporium spp., Madurella spp. . and others), as well as other pathogenic fungi (Malassezia pachydermatis and others). It inhibits the biosynthesis of ergostyrene and changes the lipid composition of the membrane, which leads to the death of the fungal cell.

Dexamethasone acetate is a synthetic glucocorticoid that has anti-inflammatory and anti-allergic effects.

Pharmacokinetic studies of the drug in dogs at therapeutic doses have shown that the highest plasma concentration of marbofloxacin is achieved at 0.06 μg / ml on the 14th day of treatment. Marbofloxacin binds poorly to plasma proteins (<10% in dogs) and is also slowly eliminated, mostly in active form, mainly in urine (2/3) and feces (1/3).

Clotrimazole is absorbed very slowly (plasma concentration <0.04 µg/ml).

The concentration of dexamethasone acetate in plasma reaches 1.25 ng / ml on the 14th day of treatment. Resorption of dexamethasone does not increase due to the inflammatory process caused by otitis media.

Application

Treatment of dogs suffering from otitis externa when affected by bacteria sensitive to marbofloxacin and fungi, especially Malassezia pachydermatis, which are sensitive to clotrimazole.

Dosage

For external use only – instillation into the ear. Before using the drug, it is necessary to thoroughly clean and dry the external ear canal, and also shake the vial with the drug thoroughly for 30 seconds and gently squeeze out to fill the pipette.

The recommended dose is ten drops in the ear once a day for 7-14 days.

After 7 days of treatment, the veterinarian should evaluate the need to continue treatment for another week.

One drop of the drug contains 71 micrograms of marbofloxacin, 237 micrograms of clotrimazole and 23.7 micrograms of dexamethasone acetate.

After the introduction of the drug, the ear is carefully and gently massaged so that the drug can penetrate into the lower part of the ear canal.

If the drug is intended for use in several dogs, a separate pipette is used for each individual dog.

Contraindications

Do not administer to animals hypersensitive to the active ingredients, other azole antifungals, any other fluoroquinolones, or any of the excipients.

Do not use in animals with perforated eardrum.

Do not administer to pregnant or lactating animals.

Warning

Special precautions for use

The drug should be used after determining the sensitivity of microorganisms to marbofloxacin.

By its nature, bacterial and fungal otitis is often a secondary disease. The root cause of the disease should be identified and treated.

Special warnings

The purpose of the drug should be carried out according to the results of in vitro determination of the sensitivity of microorganisms to maobofloxacin. The use of components of the drug may cause temporary deafness or partial hearing loss in sensitive dogs or older dogs.

Before using the drug, you should check the integrity of the eardrum.

Prolonged and intensive use of topical corticosteroids is known to cause local and systemic effects, including adrenal suppression, thinning of the epidermis, and delayed wound healing.

The quinolone class of drugs cause cartilage erosions in support joints and other forms of arthropathy in young animals of various species. It is not recommended to use the drug in young animals.

Special warnings for persons and service personnel

Wash hands thoroughly after applying the drug.

Avoid contact with eyes. In case of contact with eyes, rinse with plenty of clean water.

If symptoms persist on the skin or eyes, or the drug is accidentally swallowed, you should consult a doctor and show him the package insert for this drug.

Persons with hypersensitivity (allergy) to fluoroquinolones, corticosteroids or antifungal drugs, as well as other substances that make up the drug, should avoid contact with the drug during its use.

Storage

Dry dark place, inaccessible to children, at a temperature from 15 ºС to 30 ºС.

Shelf life – 24 months.

After opening the container – 3 months.

For use in veterinary medicine!