/// QUARTERLY BEAT / DECEMBER 2021
QUARTERLY BEAT / DECEMBER 2021 ///
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they leave. Once the client has returned home, as their pet’s ear improves and the animal grows accustomed to being rewarded for having the pinnae manipulated, the client will gain confidence in performing maintenance ear cleanings once we confirm the resolution of infection at the recheck exam. Client compliance is hugely important in veterinary medicine, and like many dermatologic diseases, a simple ear infection is never truly the only problem. Claro® allows for treatment of S. pseudintermedius, Malassezia spp. or both, while I get to work finding and addressing common underlying causes, such as food or environmental allergies, hypothyroidism or autoimmune disorders. By using Claro® as part of a multifaceted approach, I can clear the current infection, get the client on board with my long-term recommendations, improve patient temperament in the clinic and at home, and satisfy every member of the patient care team. PRECAUTIONS: For use in dogs only. Do not use in cats (see POST APPROVAL EXPERIENCE). CLARO® has been associated with rupture of the tympanic membrane. Reevaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment. Signs of internal ear disease such as head tilt, vestibular signs, ataxia, nystagmus, facial paralysis, and keratoconjunctivitis sicca have been reported (see POST APPROVAL EXPERIENCE) with the use of CLARO®. Wear eye protection when administering CLARO®. (See Human Warnings, PRECAUTIONS, POST APPROVAL EXPERIENCE).
Antibacterial, antifungal, and anti-inflammatory For Otic Use in Dogs Only CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: 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. INDICATIONS: CLARO® is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ). DOSAGE AND ADMINISTRATION: CLARO® should be administered by veterinary personnel. Wear eye protection when administering CLARO®. ( see Human Warnings, PRECAUTIONS, POST APPROVAL EXPERIENCE). Splatter may occur if the dog shakes its head following administration. Persons near the dog during administration should also take steps to avoid ocular exposure. Shake before use. Verify the tympanic membrane is intact prior to administration. ( see CONTRAINDICATIONS, PRECAUTIONS, POST APPROVAL EXPERIENCE). Administer one dose (1 dropperette) per affected ear. 1. Clean and dry the external ear canal before administering the product. 2. Verify the tympanic membrane is intact prior to administration. 3. Remove single dose dropperette from the package. 4. While holding the dropperette in an upright position, remove the cap from the dropperette. 5. Turn the cap over and push the other end of the cap onto the tip of the dropperette. 6. Twist the cap to break the seal and then remove cap from the dropperette. 7. Screw the applicator nozzle onto the dropperette. 8. 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. 9. Gently massage the base of the ear to allow distribution of the solution. Restrain the dog to minimize post application head shaking to reduce potential for splatter of product and accidental eye exposure in people and dogs ( see POST APPROVAL EXPERIENCE) . 10. Repeat with other ear as prescribed. 11. The duration of the effect should last 30 days. Cleaning the ear after dosing may affect product effectiveness. CONTRAINDICATIONS: Do not use in dogs with known tympanic membrane perforation (see PRECAUTIONS ). CLARO® is contraindicated in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride, or mometasone furoate. WARNINGS: Human Warnings: CLARO® may cause eye injury and irritation ( see PRECAUTIONS, POST APPROVAL EXPERIENCE). If contact with eyes occurs, flush copiously with water for at least 15 minutes. If irritation persists, contact a physician. Humans with known hypersensitivity to any of the active ingredients in CLARO® should not handle this product. PRECAUTIONS: For use in dogs only. Do not use in cats ( see POST APPROVAL EXPERIENCE) . Wear eye protection when administering CLARO® and restrain the dog to minimize post application head shaking. Reducing the potential for splatter of product will help prevent accidental eye exposure in people and dogs and help to prevent ocular injury ( see DOSAGE AND ADMINISTRATION, Human Warnings, POST APPROVAL EXPERIENCE) . Proper patient selection is important when considering the benefits and risks of using CLARO®. The integrity of the tympanic membrane should be confirmed before administering the product. CLARO® has been associated with rupture of the tympanic membrane. Reevaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment. Signs of internal ear disease such as head tilt, vestibular signs, ataxia, nystagmus, facial paralysis, and keratoconjunctivitis sicca have been reported ( see POST APPROVAL EXPERIENCE) with the use of CLARO®. Do not administer orally. 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. ADVERSE REACTIONS: In a field study conducted in the United States (see EFFECTIVENESS ), there were no directly attributable adverse reactions in 146 dogs administered CLARO®. POST APPROVAL EXPERIENCE (2019) : The following adverse events are based on post-approval adverse drug experience reporting for CLARO®. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. In humans , accidental exposure leading to corneal ulcers and other ocular injuries such as eye irritation and redness have been reported. Exposure occurred when the dog shook its head after application of CLARO®. Skin irritation has also been reported. In dogs , the adverse events reported are presented below in decreasing order of reporting frequency: Ear discharge, head shaking, ataxia, internal ear disorder (head tilt and vestibular), deafness, emesis, nystagmus, pinnal irritation and ear pain, keratoconjunctivitis sicca, vocalization, corneal ulcer, cranial nerve disorder (facial paralysis), tympanic membrane rupture. CLARO® is not approved for use in cats . The adverse events reported following extra-label use in cats are presented below in decreasing order of reporting frequency: Ataxia, anorexia, internal ear disorder (head tilt and vestibular), Horner’s syndrome (third eyelid prolapse and miosis), nystagmus, lethargy, anisocoria, head shake, emesis, tympanic rupture, and deafness. To report suspected adverse drug events and/or obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, contact Elanco 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/reportanimalae. Information for Dog Owners: Owners should be aware that adverse reactions may occur following administration of CLARO® and should be instructed to observe the dog for signs such as ear pain and irritation, vomiting, head shaking, head tilt, incoordination, eye pain and ocular discharge (see POST APPROVAL EXPERIENCE ). Owners should be advised to contact their veterinarian if any of the above signs are observed. Owners should also be informed that splatter may occur if the dog shakes its head following administration of CLARO® which may lead to ocular exposure. Eye injuries, including corneal ulcers, have been reported in humans and dogs associated with head shaking and splatter following administration. Owners should be careful to avoid ocular exposure (see PRECAUTIONS, POST APPROVAL EXPERIENCE ) CLARO ® (florfenicol, terbinafine, mometasone furoate) Otic Solution for use in dogs only Do Not Use in Cats.
Feline Thyroid Disease: What’s the TSH?
STEFANIE DEMONACO , DVM, MS, DACVIM Assistant Professor, Small Animal Internal Medicine Virginia-Maryland College of Veterinary Medicine
Did you miss Dr. Stefanie DeMonaco’s YouTube LIVE event on the use of TSH on the diagnosis of feline thyroid disease? Click below to watch it and read what you need to know!
hyperthyroidism can have tT4 fluctuating in and out of the reference range, and NTI can lower tT4 into the reference range. In those cases, measuring TSH with free T4 (fT4) can aid in the diagnosis. One of the limitations of using fT4 in cats with NTI is that 20% of cats will have a falsely elevated fT4, 1 further confounding the diagnosis of hyperthyroidism. TSH is commonly used in humans and dogs for the diagnosis of thyroid disease, but until most recently, has not been routinely used in cats. The current assay that is widely available uses canine TSH assay (cTSH) to measure feline TSH. The limitation of this assay is the lowest detection limit (<0.03 ng/dL), as this does not differentiate low-normal concentrations from those below the reference interval. A closer look at cTSH in hyperthyroid and euthyroid cats highlights how the lower limit of detection obscures the diagnosis of hyperthyroidism. Serum cTSH was undetectable in most – if not all – hyperthyroid cats, but it was also undetectable in one-third of euthyroid cats. The overlap of undetectable cTSH concentrations between hyperthyroid and euthyroid cats is a limiting factor in the diagnosis of hyperthyroidism. The accuracy of cTSH improves when measured in combination with tT4 and fT4. A tT4 concentration within the upper-third of the reference range with high serum fT4 and undetectable TSH is suggestive of hyperthyroidism. When considering cTSH for the diagnosis of thyroid disease, it is important to understand how NTI impacts the concentration in order to appropriately interpret the test. There are few studies that have evaluated cTSH in cats
The use of thyroid-stimulating hormone (TSH) in the diagnosis of feline thyroid disease has recently become more routine in clinical practice. Concurrent nonthyroidal illness (NTI) in hyperthyroid cats and those with mild hyperthyroidism can be problematic to diagnose when total T4 (tT4) concentration is within the reference interval. Concurrent TSH can be helpful in supporting the diagnosis. In addition to screening for hyperthyroidism, TSH has become part of the routine diagnosis of feline iatrogenic hypothyroidism that can occur after treatment for hyperthyroidism. The current use and best practices of TSH in cats with hyper- and hypothyroidism will be discussed. Use of TSH to diagnose hyperthyroidism Feline hyperthyroidism is the most common endocrinopathy in aged cats. Diagnosis is typically made by documenting an increased tT4 concentration in a cat with compatible clinical signs of hyperthyroidism. However, 10% of hyperthyroid cats will have a high-normal tT4 concentration due to early hyperthyroidism or NTI. 1 This occurs because cats with early
BRITTANY LANCELLOTTI, DVM, DACVD
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