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No consistent synergistic or antagonistic effect of the two antimicrobials was demonstrated. The compatibility and additive effect of each of the components in CLARO solution was demonstrated in a component effectiveness and non-interference study in vitro study of organisms collected from clinical cases of otitis externa in dogs enrolled in the clinical effectiveness study determined that florfenicol and terbinafine hydrochloride inhibit the growth of bacteria and yeast commonly associated with otitis externa in dogs. Mometasone furoate is a glucocorticosteroid with anti-inflammatory activity. Terbinafine is an antifungal which selectively inhibits the early synthesis of ergosterol. Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis. Clinical PharmacologyĬLARO Otic Solution is a fixed combination of three active substances: florfenicol (antibiotic), terbinafine (antifungal) and mometasone furoate (steroidal anti-inflammatory). To report suspected adverse drug events or for technical assistance, contact Elanco Canada Limited at 1-80. Neurological disorders: ataxia, nystagmus By system, these clinical signs were reported for CLARO rarely (1 -10 reports per 10,000 doses sold) or very rarely (<1 report per 10,000 doses sold) and include:Įar and labyrinth disorders: ear discharge, head shake, ear infectionĪpplication site disorders: application site erythema The adverse events listed here reflect reporting and not necessarily causality.īy system, adverse events are listed in decreasing order of frequency. It is generally recognized that this results in significant under-reporting. Adverse ReactionsĪlthough all adverse reactions are not reported, the following information is based on voluntary post-approval drug experience reporting. Humans with known hypersensitivity to florfenicol, terbinafine hydrochloride, or mometasone furoate should not handle this product.
#Claro otic skin
In case of accidental skin contact, wash area thoroughly with water. In case of accidental contact with eyes, rinse with abundant quantities of water and seek medical attention. When handling this product, special cautions should be taken to avoid oral exposure and direct contact with eyes or skin. In case of accidental ingestion, contact a physician immediately. If any eye irritation is seen after treatment, seek veterinary care. In case of exposure to the eye, rinse with abundant quantities of water. The safe use of CLARO in dogs used for breeding purposes, during pregnancy or lactation has not been evaluated.ĬLARO should be used with caution in dogs with impaired hepatic function (see ANIMAL SAFETY).Ĭaution should be used to prevent the medication from getting into the eyes of the dog being treated. Use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hyperadrenocorticism in dogs (see ANIMAL SAFETY). Reevaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment. The integrity of the tympanic membrane should be confirmed before administering the product. The use of CLARO in dogs with perforated tympanic membranes has not been evaluated. Contraindicationsĭo not use in dogs with known tympanic membrane perforation (see CAUTIONS).ĭo not use in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride, mometasone furoate, other corticosteroids or any excipients. Gently massage the base of the ear to allow distribution of the solution.Ĭleaning the ear after dosing may affect product effectiveness. Screw the applicator nozzle onto the dropperette.ĩ. Twist the cap to break the seal and then remove cap from the dropperette.ħ. Turn the cap over and push the other end of the cap onto the tip of the dropperette.Ħ. While holding the dropperette in an upright position, remove the cap from the dropperette.ĥ.
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Remove single dose dropperette from the package.Ĥ. Verify the tympanic membrane is intact prior to administration.ģ.
![claro-otic claro-otic](https://s3.amazonaws.com/cdn.revivalanimal.com/images/large/17157-629.jpg)
Clean and dry the external ear canal before administering the product.Ģ. The duration of effect should last 30 days.ġ. Care should be taken to prevent accidental exposure to the eyes (See CAUTIONS and WARNINGS).Īdminister one dose (1 dropperette) per affected ear. Dosage and AdministrationĬLARO should be administered by veterinary personnel in clinic. Claro IndicationsĬLARO is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius). Florfenicol, Terbinafine hydrochloride, and Mometasone furoate Otic SolutionĬLARO contains 16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride) and 2.2 mg/mL mometasone furoate.Īntibiotic, antifungal and anti-inflammatory.