mometasone

For the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulase- positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Mometavet®

POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis).

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Posatex® Otic Suspension

Florfinasone™ Otic is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Florfinasone™ Otic

For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa) in dogs.

Mometamax Single™

INDICATIONS: Mometavet™ Otic Suspension is indicated for the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P . aeruginosa], coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).

MOMETAVETTM (gentamicin sulfate, mometasone furoate anhydrous, and clotriamzole Otic Suspension)

INDICATIONS: POSATEX® Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis).

Posatex® Otic Suspension (Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole, Suspension)

SIMPLERA is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

SIMPLERA™ (florfenicol, terbinafine, mometasone furoate)

PHARMACOLOGY: Gentamicin: Gentamicin sulfate is an aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive bacteria. In vitro tests have determined that gentamicin is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. In clinical trials, gentamicin was shown to have a range of activity against the following organisms commonly isolated from infected canine ears: Pseudomonas spp. (including P. aeruginosa), coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci. Mometasone: Mometasone furoate anhydrous is a synthetic adrenocorticoid characterized by a novel (2') furoate 17-ester having chlorine at the 9 and 21 positions, which have shown to possess high topical potency. Systemic absorption of mometasone furoate ointment was found to be minimal (2%) over 1 week when applied topically to dogs with intact skin. In a 6-month dermal toxicity study using 0.1% mometasone ointment on healthy intact skin in dogs, systemic effects typical of corticosteroid therapy were noted. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal, intact skin. Inflammation can increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Clotrimazole: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of dermatophytes and yeast. The primary action of clotrimazole is against dividing and growing organisms. I n vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp., and Malassezia pachydermatis. Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. In an induced otitis externa study using dogs infected with M alassezia pachydermatis, 1% clotrimazole in the vehicle formulation was effective both microbiologically and clinically in terms of reduction of exudate, odor and swelling. In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. These events began rapidly and extensively after addition of the drug. Clotrimazole is very poorly absorbed following dermal application. G e n t am i cin- M o m e t a s o n e - Clo t ri m a z o l e : By virtue of its three active ingredients, gentamicin, mometasone, and clotrimazole otic suspension has antibacterial, anti-inflammatory, and antifungal activity. In clinical field trials, gentamicin, mometasone, and clotrimazole otic suspension was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis. Gentamicin, mometasone, and clotrimazole otic suspension reduced discomfort, redness, swelling, exudate, and odor.

MOMETAVETTM (gentamicin sulfate, mometasone furoate anhydrous, and clotriamzole Otic Suspension)

CONTRAINDICATIONS: If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.

MOMETAVETTM (gentamicin sulfate, mometasone furoate anhydrous, and clotriamzole Otic Suspension)

CONTRAINDICATIONS: POSATEX® Otic Suspension is contraindicated in dogs with known or suspected hypersensitivity to quinolones, mometasone furoate monohydrate, or posaconazole. Do not use in dogs with known tympanic perforation (see PRECAUTIONS ).

Posatex® Otic Suspension (Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole, Suspension)

Do not use in dogs with known tympanic membrane perforation (see PRECAUTIONS ). SIMPLERA is contraindicated in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride, or mometasone furoate.

SIMPLERA™ (florfenicol, terbinafine, mometasone furoate)

Do not use in dogs with known tympanic membrane perforation (see Precautions ). Klentz is contraindicated in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride, or mometasone furoate.

Klentz™ (florfenicol, terbinafine, mometasone furoate)

WARNINGS: The use of these components has been associated with deafness or partial hearing loss in a small number of sensitive dogs (e.g, geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of Mometavet™ Otic Suspension immediately and flush the ear canal thoroughly with a non-toxic solution. Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs that received corticosteroids during pregnancy. Field and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. P RE C AUTIONS: Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact. Administration of recommended doses of Mometavet™ Otic Suspension beyond 7 days may result in delayed wound healing. If overgrowth of non-susceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted. Avoid ingestion. Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects. Use of corticosteroids, depending on dose, duration, and specific steroid, may result in endogenous steroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.

MOMETAVETTM (gentamicin sulfate, mometasone furoate anhydrous, and clotriamzole Otic Suspension)

Human Warnings: Klentz 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 Klentz should not handle this product. Not for use in humans. Keep this and all drugs out of the reach of children. Avoid skin contact. In case of accidental ingestion by humans, contact a physician immediately.

Klentz™ (florfenicol, terbinafine, mometasone furoate)

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

SIMPLERA™ (florfenicol, terbinafine, mometasone furoate)

A D VE R S E R E ACTIONS: Ge n tam i ci n : While aminoglycosides are absorbed poorly from skin, intoxication may occur when aminoglycosides are applied topically for prolonged periods of time to large wounds, burns, or any denuded skin, particularly if there is renal insufficiency. All aminoglycosides have the potential to produce reversible and irreversible vestibular, cochlear, and renal toxicity. M o m e t a s o n e : ALP (SAP) and ALT (SGPT) enzyme elevations, weight loss, anorexia, polydipsia, polyuria, neutrophilia, and lymphopenia have occurred following the use of parenteral, high-dose, and/or prolonged or systemic synthetic corticosteroids in dogs. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy. Clo t rima z o l e : The following have been reported occasionally in humans in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin not present before therapy. Mometavet™ Otic Suspension: In field studies following once-daily treatment with gentamicin, mometasone, and clotrimazole otic suspension, ataxia, proprioceptive deficits, and increased water consumption were observed in less than 1% of 164 dogs. In a field study following twice-daily treatment with gentamicin, mometasone, and clotrimazole otic suspension, inflammation of the pinna and diarrhea were observed in less than 1% of 141 dogs. To report suspected adverse drug events, for technical assistance, or to obtain a Safety Data Sheet (SDS), contact Dechra at (866) 933-2472. 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

MOMETAVETTM (gentamicin sulfate, mometasone furoate anhydrous, and clotriamzole Otic Suspension)

ADVERSE REACTIONS: In the field study, 143 dogs were treated with POSATEX® Otic Suspension. Of those, 1 dog with bilateral otitis externa developed hearing loss. POSATEX® Otic Suspension treatment was discontinued and the condition resolved after one week. To report suspected adverse reactions, call 1-800-224-5318. For a copy of the Material Safety Data Sheet (MSDS) call 1-800-770-8878.

Posatex® Otic Suspension (Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole, Suspension)

In a field study conducted in the United States (see Effectiveness ), there were no directly attributable adverse reactions in 146 dogs administered florfenicol, terbinafine, and mometasone furoate otic solution.

Klentz™ (florfenicol, terbinafine, mometasone furoate)

In a field study conducted in the United States (see Effectiveness ), there were no directly attributable adverse reactions in 146 dogs administered CLARO.

CLARO™ Elanco TM (florfenicol, terbinafine, mometasone furoate)

For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g tubes and bottles, 15 g tubes and bottles, and 30 g bottles (2 drops from the 215 g bottle) once daily in the ear canal. For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g tubes and bottles, 15 g tubes and bottles, and 30 g bottles (4 drops from the 215 g bottle) once daily in the ear canal. Therapy should continue for 7 consecutive days.

Otic

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Mometavet®

For dogs weighing less than 30 lbs. instill 4 drops of POSATEX Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs. or more, instill 8 drops once daily into the ear canal. Therapy should continue for 7 consecutive days. Four drops of POSATEX Otic Suspension delivers approximately 1.0 mg of orbifloxacin, 0.1 mg of mometasone furoate monohydrate, and 0.1 mg of posaconazole.

Otic

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Posatex® Otic Suspension

For dogs weighing less than 30 lbs, instill 4 drops from the 7.5g, 15g, or 30g bottle into the ear canal (2 drops from the 215g bottle) or, for dogs weighing 30 lbs or more, instill 8 drops from the 7.5g, 15g or 30g bottle into the ear canal (4 drops from the 215g bottle), once daily for 7 days.

Topical

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Mometamax™ Otic Suspension

Mometamax Single™ should be administered by veterinary personnel. The dose volume is 0.8 mL per affected ear. Verify the tympanic membrane is intact prior to administration.

Otic

Mometamax Single™

Administer one dose (1 dropperette) per affected ear. The duration of effect should last 30 days.

Otic

For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

CLARO™

Administer one dose (1 dropperette) per affected ear.

Otic

SIMPLERA™

SIMPLERA should be administered by veterinary personnel. Wear eye protection when administering SIMPLERA. (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 effect should last 30 days. Cleaning the ear after dosing may affect product effectiveness.

AURICULAR (OTIC)

SIMPLERA™ (florfenicol, terbinafine, mometasone furoate)

Klentz should be administered by veterinary personnel. Wear eye protection when administering Klentz. (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, twist the cap to open the dropperette. The cap does not come off the dropperette. 5. 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. 6. 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 ). 7. Repeat with other ear as prescribed. 8. The duration of the effect should last 30 days. Cleaning the ear after dosing may affect product effectiveness.

AURICULAR (OTIC)

Klentz™ (florfenicol, terbinafine, mometasone furoate)

DOS AGE AN D ADMINISTRATION: The external ear canal should be thoroughly cleaned and dried before treatment. Verify that the eardrum is intact. For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g tubes and bottles, 15 g tubes and bottles, and 30 g bottles (2 drops from the 215 g bottle) of Mometavet™ Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g tubes and bottles, 15 g tubes and bottles, and 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal. Therapy should continue for 7 consecutive days.

AURICULAR (OTIC)

MOMETAVETTM (gentamicin sulfate, mometasone furoate anhydrous, and clotriamzole Otic Suspension)

DOSAGE AND ADMINISTRATION: Shake well before use. For dogs weighing less than 30 lbs. instill 4 drops of POSATEX® Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs. or more, instill 8 drops once daily into the ear canal. Therapy should continue for 7 consecutive days.

AURICULAR (OTIC)

Posatex® Otic Suspension (Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole, Suspension)