claro otic insert

Human Warnings: Not for use in humans. Behavior and Stress Training and Solutions. Administer one dose (1 dropperette) per affected ear. Reevaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment.Use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hyperadrenocorticism in dogs (see ANIMAL SAFETY).Use with caution in dogs with impaired hepatic function (see ANIMAL SAFETY).The safe use of CLARO® in dogs used for breeding purposes, during pregnancy, or in lactating bitches has not been evaluated. Remove single dose dropperette from the package. The integrity of the tympanic membrane should be confirmed before administering the product. While holding the dropperette in an upright position, remove the cap from the dropperette. Of the 183 dogs included in the effectiveness evaluation, 72.5% of dogs administered CLARO® solution were successfully treated, compared to 11.1% of the dogs in the vehicle-control group (p=0.0001). Screw the applicator nozzle onto the dropperette. The dogs were evaluated on Days 0, 7, 14, and 30. 8. Screw the applicator nozzle onto the dropperette. CLARO® should be administered by veterinary personnel in clinic. Caution should be used to prevent the medication from getting into the eyes of the dog being treated. Treatment (1 mL) was administered once on Day 0 to the affected ear(s). The safe use of CLARO® in dogs used for breeding purposes, during pregnancy or lactation has not been evaluated. purified water, propylene carbonate, propylene glycol, ethyl alcohol, and polyethylene glycol. Every effort has been made to ensure the accuracy of the Claro information published above. Clean and dry the external ear canal before administering the product. Florfenicol, Terbinafine hydrochloride, and Mometasone furoate Otic Solution. - image 02, CLARO (florfenicol, terbinafine, mometasone furoate) Otic Solution label - image 04. The addition of mometasone furoate to the combination did not impair antimicrobial activity to any clinically significant extent. Antibiotic, antifungal and anti-inflammatory. Turn the cap over and push the other end of the cap onto the tip of the dropperette. Keep this and all drugs out of reach of children. CLARO ® Otic Solution is a fixed combination of three active substances: florfenicol (antibacterial), terbinafine (antifungal), and mometasone furoate (steroidal anti-inflammatory). CLARO® administration was associated with post-treatment ear wetness or clear aural exudate, increased absolute neutrophil count, decreased absolute lymphocyte and eosinophil counts, suppression of the adrenal cortical response to adrenocorticotropic hormone (ACTH) stimulation, decreased adrenal weight and atrophy of the adrenal cortex, increased liver weight with hepatocellular enlargement/cytoplasmic change, and decreased thymus weight.

In case of accidental skin contact, wash area thoroughly with water. In a field study (see EFFECTIVENESS), at least 10 isolates from successfully treated cases were obtained for S. pseudintermedius and M. pachydermatis. CLARO® Otic Solution is a fixed combination of three active substances: florfenicol (antibacterial), terbinafine (antifungal), and mometasone furoate (steroidal anti-inflammatory). Antibacterial, antifungal, and anti-inflammatoryFor Otic Use in Dogs Only. 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: Ear and labyrinth disorders: ear discharge, head shake, ear infection, Application site disorders: application site erythema, Neurological disorders: ataxia, nystagmus. Although all adverse reactions are not reported, the following information is based on voluntary post-approval drug experience reporting.

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. CLARO® 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. 5. CLARO ® is available in cartons of two, ten, or twenty dropperettes. If any eye irritation is seen after treatment, seek veterinary care. When handling this product, special cautions should be taken to avoid oral exposure and direct contact with eyes or skin. CLARO® should be administered by veterinary personnel. 6. Get all the latest info on sales, offers, events, and more when you sign up for our newsletter. 3. Bayer, the Bayer Cross and CLARO are registered trademarks of Bayer. CLARO® 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. CLARO ® solution is supplied in a single-use dropperette in a blister. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. In a target animal safety study, CLARO® was administered aurally to 12-week-old Beagle puppies (4 dogs/sex/group) at 0X, 1X, 3X, and 5X the recommended dose once every 2 weeks for a total dosing period of 28 days (3 times the treatment duration). CLARO™ Otic Solution is a fixed combination of three active substances: florfenicol (antibacterial), terbinafine (antifungal), and mometasone furoate (steroidal anti-inflammatory). Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis. Reevaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment. Administer one dose (1 dropperette) per affected ear. Four clinical signs associated with otitis externa were evaluated: erythema, exudate, swelling, and ulceration. Select one or more newsletters to continue. Verify the tympanic membrane is intact prior to administration. Gently massage the base of the ear to allow distribution of the solution. Do not administer orally. should be administered by veterinary personnel. 9. The product labeling information includes all published material associated to a drug. 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). In case of accidental skin contact, wash area thoroughly with water. Gently massage the base of the ear to allow distribution of the solution. All dogs were evaluated for safety. Twist the cap to break the seal and then remove cap from the dropperette. In case of accidental ingestion, contact a physician immediately. CLARO ® Otic Solution is a fixed combination of three active substances: florfenicol (antibiotic), terbinafine (antifungal) and mometasone furoate (steroidal anti-inflammatory). Use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hyperadrenocorticism in dogs (see ANIMAL SAFETY). In case of exposure to the eye, rinse with abundant quantities of water.

It is generally recognized that this results in significant under-reporting. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Humans with known hypersensitivity to florfenicol, terbinafine hydrochloride, or mometasone furoate should not handle this product. CLARO® is supplied in a single-use dropperette in a blister. CLARO® 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.Inactive ingredients include purified water, propylene carbonate, propylene glycol, ethyl alcohol, and polyethylene glycol.

The integrity of the tympanic membrane should be confirmed before administering the product.

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. Terbinafine is an antifungal which selectively inhibits the early synthesis of ergosterol. CLARO® is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius). Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis. CLARO® should be used with caution in dogs with impaired hepatic function (see ANIMAL SAFETY). Reevaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment. In a well-controlled, double-masked field study, CLARO® was evaluated against a vehicle control in 221 dogs with otitis externa. You must have JavaScript enabled in your browser to utilize the functionality of this website. Available for Android and iOS devices. Use with caution in dogs with impaired hepatic function (see ANIMAL SAFETY on label). Claro Otic Solution Animal Product Label Images Screw the applicator nozzle onto the dropperette - image 01 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. In case of accidental ingestion by humans, contact a physician immediately. The use of CLARO® in dogs with perforated tympanic membranes has not been evaluated. Keep out of reach of children. CLARO® is available in cartons of 2 or 10 dropperettes. Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis. No clinically relevant treatment-related findings were noted in hearing tests, body weight, weight gain, or food consumption. Bayer Inc., 2920 Matheson Blvd East, Mississauga, ON L4W 5R6, Copyright © 2020 Animalytix LLC. Mometasone furoate is a glucocorticosteroid with anti-inflammatory activity. Shake before use.CLARO® should be administered by veterinary personnel.Administer one dose (1 dropperette) per affected ear. Data sources include IBM Watson Micromedex (updated 2 Nov 2020), Cerner Multum™ (updated 2 Nov 2020), ASHP (updated 30 Sep 2020) and others. CLARO® is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius). 1. The use of CLARO® in dogs with perforated tympanic membranes has not been evaluated.

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