Aurizon (Canada)

Marbofloxacin-Clotrimazole-Dexamethasone Otic Suspension

VETERINARY USE ONLY

DIN 02353970

Ear drops for dogs

Each drop of AURIZON contains 71µg marbofloxacin, 237µg clotrimazole and 23.7µg dexamethasone acetate.

Aurizon Indications

For the treatment of canine otitis externa associated with yeast (Malassezia pachydermatis) sensitive to clotrimazole and bacteria (Staphylococcus spp. (including S. intermedius), Pseudomonas aeruginosa, Proteus spp. and Streptococcus spp.) sensitive to marbofloxacin.

Pharmacology

AURIZON combines three active ingredients:

- marbofloxacin, a synthetic bactericidal agent belonging to the fluoroquinolones family that acts by inhibiting DNA gyrase.

- clotrimazole, an anti-fungal agent that belongs to the imidazole family and which acts by causing changes in membrane permeability, allowing intracellular compounds to leak from the cell and thus inhibiting cellular molecular synthesis.

- dexamethasone acetate, a synthetic glucocorticoid exhibiting anti-inflammatory and anti-pruritic activity.

When AURIZON was applied to healthy dog ears, marbofloxacin was absorbed percutaneously resulting in a mean plasma concentration of 0.06µg/mL on the 14^th day of treatment, which is 5.8 times less than the mean minimal plasma concentration observed after 7 days of marbofloxacin oral administration at the therapeutic dose of 2mg/kg. Clotrimazole was poorly absorbed and was not detectable (<0.04µg/mL) in the plasma of treated dogs. Dexamethasone mean plasma concentration on the 14^th day of treatment was 1.25ng/mL. In an induced otitis model study, the inflammatory process did not increase the absorption of dexamethasone.

Microbiology

Marbofloxacin is active in vitro against a wide variety of gram-positive and gram-negative bacteria isolated from domestic animals, including the following organisms isolated from infected canine ears: Staphylococcus spp. (including S. intermedius), Pseudomonas aeruginosa, Proteus spp. and Streptococcus spp.

Clotrimazole exhibits a wide spectrum of in vitro antifungal activity, including against the yeast Malassezia pachydermatis frequently isolated from otitic ears in dogs.

Aurizon Dosage And Administration

The external ear canal should be meticulously cleaned and dried before treatment. Shake well before use. Avoid the introduction of contamination during use.

Apply 10 drops into the ear once daily for 7 to 14 days.

After 7 days, a veterinarian should evaluate the necessity to extend the treatment an additional week.

After application, the base of the ear should be massaged briefly and gently to allow the preparation to penetrate to the lower part of the ear canal.

When the product is intended for use in several dogs, use one cannula per dog.

Adverse Reactions

On rare occasions, the use of this product may be associated with deafness or partial hearing loss, mainly in elderly dogs and mostly of transient nature. Localized skin reactions characterized by transient erythema and inflammation at the site of application are rarely reported.

Prolonged and intensive use of topical corticosteroid preparations is known to trigger local and systemic effects, including suppression of adrenal function, clinical signs such as polyuria and polydipsia, thinning of the epidermis and delayed wound healing.

Usual adverse reactions associated with corticosteroid drugs may be observed (changes in biochemical and hematological parameters, such as increase of alkaline phosphatase, and aminotransferase, some limited neutrophilia and lymphopenia).

Contraindications

Do not use in dogs suffering from perforation of the tympanic membrane.

Do not use in dogs with known hypersensitivity to any of the ingredients.

Do not use in pregnant or lactating bitches and in breeding animals.

Aurizon Cautions

Before treating with AURIZON, the integrity of the tympanic membrane must be verified. Treatment must be discontinued if hearing loss or vestibular dysfunction are observed during treatment. Owners should be advised of the potential for adverse reactions (and associated clinical signs) and to contact their veterinarian immediately if any sign of adverse reactions is observed.

The use of fluoroquinolones in animals with central nervous system disorders has, in rare instances, been associated with convulsive seizures. Fluoroquinolones have been associated with arthropathies in immature animals.

Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population. It is prudent to reserve fluoroquinolones for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antibiotics.

Warnings

Keep out of reach of children.

Avoid contact with eyes. If splashed in the eye, rinse with copious amounts of water. Wash hands carefully after applying the product.

Persons with known hypersensitivity to compounds in the product should avoid contact with the product.

Storage

Store between 15°C and 25°C. Stable for 60 days after opening.

Revision date: 2022-09-26

Vetoquinol N.-A. Inc., 2000, ch. Georges, Lavaltrie, QC, Canada J5T 3S5

1022 A

Net	Code
10 mL	992972
20 mL	992973

CPN: 1234329.3