Item Number: OTOXOLANE
Treatment of otitis externa of both bacterial and fungal origin respectively due to bacteria sensitive to marbofloxacin, and fungi especially Malassezia pachydermatis sensitive to clotrimazole. Dexamethasone acetate for anti-inflammatory and anti-pruritic activity. The product should be used based on susceptibility testing.
Dosage and administration
FOR AURICULAR USE ONLY
Apply ten drops into the ear once daily for 7 to 14 days.
After 7 days of treatment, the veterinary surgeon should evaluate the necessity to extend the treatment another week.
One drop of the preparation contains 71 µg marbofloxacin, 237 µg clotrimazole and 23.7 µg dexamethasone acetate.
Shake well for 30 seconds before use and squeeze gently to fill the dropper with the product.
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. When the product is intended for use in several dogs, use one dropper per dog.
The external ear canal should be meticulously cleaned and dried before treatment. Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated.
Contra-indications, warnings, etc
Do not use in dogs suffering from perforation of the tympanic membrane. Before treating with the product, the integrity of the tympanic membrane must be verified.
Do not use in cases of hypersensitivity to the active substances, to other azole antifungal agents or to any other fluoroquinolones or to any of the excipients.
Do not administer to pregnant or lactating bitches.
Avoid contact with eyes in animals. In case of accidental contact, rinse thoroughly with water.
Official and local antimicrobial policies should be taken in to account when the veterinary medicinal product is used. Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antibiotics.
Prolonged and intensive use of topical corticosteroid preparations is known to trigger local and systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed wound healing.
Quinolone class drugs have been associated with cartilage erosions in weight-bearing joints and other forms of arthropathy in immature animals of various species. The use of the product in young animals is not recommended.
Usual adverse reactions associated with corticosteroid drugs may be observed (changes in biochemical and haemotological parameters, such as increase in alkaline phosphatase, and of aminotransferase, some limited neutrophilia).
On rare occasions, the use of this combination may be associated with deafness, mainly in elderly dogs and mostly of a transient nature.
Changes in biochemical and haematological parameters (such as increase of alkaline phosphatase, aminotransferase, some limited neutrophilia, eosinopaenia, lymphopaenia) are observed with three fold the recommended dosage; such changes are not serious and will reverse once the treatment has stopped.
Wash hands carefully after applying the product.
Avoid contact with eyes. If splashed in the eye, rinse with large amounts of clean water.
If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention and show the package insert to the physician.
People with known hypersensitivity (allergy) to (fluoro)quinolones, (cortico)steroids or antifungals and to other ingredients in the product should take care to avoid contact with the product during administration.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Do not store above 30 °C.
Keep the bottles in the outer carton in order to protect from light.
Shelf-life of unopened packaging: 24 months.
Shelf life of opened packaging: 3 months.
Boxes containing: 10 ml LDPE bottle and dropper and 20 ml LDPE bottle with 2 droppers.
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