The compatibility and additive effect of each of the components in CLARO® solution was demonstrated in a component effectiveness and non-interference study. An 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. No consistent synergistic or antagonistic effect of the two antimicrobials was demonstrated. The addition of mometasone furoate to the combination did not impair antimicrobial activity to any clinically significant extent. In a field study (see EFFECTIVENESS), at least 10 isolates from successfully treated cases were obtained for S. pseudintermedius and M. pachydermatis.
In a well-controlled, double-masked field study, CLARO® was evaluated against a vehicle control in 221 dogs with otitis externa. One hundred and forty six dogs were treated with CLARO® and 75 dogs were treated with the vehicle control. All dogs were evaluated for safety. Treatment (1 mL) was administered once on Day 0 to the affected ear(s). Prior to treatment, the ear(s) was cleaned with saline. The dogs were evaluated on Days 0, 7, 14, and 30. Blood work and urinalysis were obtained on Day 0 pre-treatment and Day 30 at study completion. Four clinical signs associated with otitis externa were evaluated: erythema, exudate, swelling, and ulceration. Success was based on clinical improvement at Day 30. 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).
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). No clinically relevant treatment-related findings were noted in hearing tests, body weight, weight gain, or food consumption. 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 ACTH-stimulation, decreased adrenal weight and atrophy of the adrenal cortex, increased liver weight with hepatocellular enlargement/cytoplasmic change, and decreased thymus weight. Other potentially treatment-related effects included mild changes to AST, total protein, inorganic phosphorus, creatinine, and calcium.
Store between 20°C – 25°C (68°F – 77°F), excursions are permitted 15°C – 30°C (59°F – 86°F).
CLARO® solution is supplied in a single-use dropperette in a blister.
Each dropperette contains one 1 mL dose.
CLARO® is available in cartons of two, ten, or twenty dropperettes.
Elanco US Inc
Shawnee, KS 66216
Made in Germany
CLARO, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
©2020 Elanco or its affiliates.
Approved by FDA under NADA # 141-440
Otic Solution for use in dogs only
Do Not Use in Cats.
CAUTION: Federal (U.S.A.) law restricts this
drug to use by or on the order of a licensed
Approved by FDA under NADA # 141-440
Net Contents: 2 x 1 mL
single dose dropperettes
See package insert for complete safety and
administration information prior to use.
| CLARO |
florfenicol, terbinafine, mometasone furoate solution
|Labeler — Elanco US Inc. (966985624)|
|KVP Pharma Veterin Produkte GmbH||320324445||ANALYSIS, LABEL, MANUFACTURE, PACK|
|Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd.||421271589||API MANUFACTURE|
|Symbiotec Pharmalab Private Limited||650328805||API MANUFACTURE|
|Aurobindo Pharma Limited||918917647||API MANUFACTURE|
|Gedeon Richter Plc.||644781932||API MANUFACTURE|
Revised: 05/2021 Elanco US Inc.
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