(florfenicol, Terbinafine, Mometasone Furoate), Bayer Healthcare, Llc Animal Health Division.
Description Claro® (florfenicol, terbinafine, mometasone furoate) Otic Solution features the only FDA-approved, veterinarian-administered, single-dose treatment regimen for canine otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius). Cleaning the ear after dosing may affect product effectiveness. The duration of effect should last 30 days. Human Warnings: Not for use in humans. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis. In a field study conducted in the United States (see EFFECTIVENESS), there were no directly attributable adverse reactions in 146 dogs administered CLARO®.To report suspected adverse drug events and/or obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, contact Bayer HealthCare at 1-800-422-9874.For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth. Select one or more newsletters to continue. CLARO® is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius). One hundred and forty six dogs were treated with CLARO® and 75 dogs were treated with the vehicle control. Care should be taken to prevent accidental exposure to the eyes (See CAUTIONS and WARNINGS). CLARO™ Otic Solution is a fixed combination of three active substances: florfenicol (antibacterial), terbinafine (antifungal), and mometasone furoate (steroidal anti-inflammatory). CLARO® is supplied in a single-use dropperette in a blister. Do not use in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride, mometasone furoate, other corticosteroids or any excipients.
9. Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. CLARO ® is available in cartons of two, ten, or twenty dropperettes. 1.
Insert the tapered tip of the dropperette into the affected external ear canal and squeeze to instill the entire contents (1 mL) into the affected ear. The safe use of CLARO® in dogs used for breeding purposes, during pregnancy or lactation has not been evaluated. If any eye irritation is seen after treatment, seek veterinary care. CLARO® should be used with caution in dogs with impaired hepatic function (see ANIMAL SAFETY). CLARO® should be administered by veterinary personnel. Remove single dose dropperette from the package. Twist the cap to break the seal and then remove cap from the dropperette. Screw the applicator nozzle onto the dropperette. Humans with known hypersensitivity to florfenicol, terbinafine hydrochloride, or mometasone furoate should not handle this product. CLARO ® Otic Solution is a fixed combination of three active substances: florfenicol (antibacterial), terbinafine (antifungal), and mometasone furoate (steroidal anti-inflammatory). 5. Mometasone furoate is a glucocorticosteroid with anti-inflammatory activity. We comply with the HONcode standard for trustworthy health information -, 905-282-5550 or 800-62BAYER (800-622-2937), Direction and dosage information for Claro. Verify the tympanic membrane is intact prior to administration.
CLARO ® solution is supplied in a single-use dropperette in a blister. CLARO ® Otic Solution is a fixed combination of three active substances: florfenicol (antibacterial), terbinafine (antifungal), and mometasone furoate (steroidal anti-inflammatory). Do not administer orally.The use of CLARO® in dogs with perforated tympanic membranes has not been evaluated. Success was based on clinical improvement at Day 30. 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. All dogs were evaluated for safety. Reevaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment.
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