terbinafine

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 in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis).

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

Osurnia™

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

Otiserene®

For the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis).

DuOtic®

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)

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

Osurnia® (florfenicol, terbinafine, betamethasone acetate)

DuOtic™ is indicated for the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis).

DuOtic™(terbinafine and betamethasone acetate otic gel)

OSURNIA is a fixed combination of three active substances: florfenicol (antibacterial), terbinafine (antifungal) and betamethasone acetate (steroidal anti-inflammatory). Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis. Its spectrum of activity includes Gram-positive and Gram-negative bacteria. Terbinafine is an antifungal which selectively inhibits the early synthesis of ergosterol. Betamethasone acetate is a glucocorticosteroid with anti-inflammatory activity. OSURNIA dissolves in ear wax and is slowly eliminated from the ear mechanically. Ear inflammation can increase the percutaneous absorption of active substances in OSURNIA. In a laboratory study conducted in healthy dogs (see Animal Safety ), low plasma concentrations of florfenicol, terbinafine, and betamethasone acetate were measurable during the first 2-4 days after administration of 1× dose, and during the first 2-7 days after administration of 5× dose. No quantifiable plasma concentrations of any of the three active ingredients were observed in the pre-dose samples of most dogs prior to second and third administrations. Although total and peak exposure in the blood tended to be highly variable between dogs, systemic drug concentrations tended to increase in a less than dose-proportional manner as the administered dose increased from 1× to 5×.

Osurnia® (florfenicol, terbinafine, betamethasone acetate)

DuOtic™ is a fixed combination of two active ingredients: terbinafine (antifungal) and betamethasone acetate (steroidal anti-inflammatory). Terbinafine is an antifungal which selectively inhibits the early synthesis of ergosterol. Betamethasone acetate is a glucocorticosteroid with anti-inflammatory activity. DuOtic™ dissolves in ear wax and is slowly eliminated from the ear mechanically. Ear inflammation can increase the percutaneous absorption of active substances in DuOtic™. In a laboratory study conducted in healthy dogs administered Osurnia® (see Target Animal Safety ), low plasma concentrations of florfenicol, terbinafine, and betamethasone acetate were measurable during the first 2-4 days after administration of 1X dose, and during the first 2-7 days after administration of 5X dose. No quantifiable plasma concentrations of any of the three active ingredients were observed in the pre-dose samples of most dogs prior to second and third administrations. Although total and peak exposure in the blood tended to be highly variable between dogs, systemic drug concentrations tended to increase in a less than dose-proportional manner as the administered dose increased from 1X to 5X. The systemic exposure of terbinafine and betamethasone are not expected to be affected by the removal of florfenicol from the formulation.

DuOtic™(terbinafine and betamethasone acetate otic gel)

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)

Do not use in dogs with known tympanic perforation (see Precautions ). Do not use in dogs with a hypersensitivity to florfenicol, terbinafine or corticosteroids.

Osurnia® (florfenicol, terbinafine, betamethasone acetate)

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)

The following adverse reactions were reported during the course of a US field study for treatment of otitis externa in dogs treated with OSURNIA with 1 tube per affected ear(s) and repeated after 7 days: Frequency of Adverse Reaction by Treatment Adverse Reaction OSURNIA (n=190) Placebo (n=94) Elevated Alkaline Phosphatase 15 (7.9%) 3 (3.2%) Vomiting 7 (3.7%) 1 (1.1%) Elevated AST, ALT, ALPAspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP). Two dogs with pre-existing elevations in ALP were reported to have an increase in liver enzymes (ALP, ALT and/or AST) at study exit. Subsequent clinical chemistries returned to pre-treatment levels in one dog, while no follow-up was performed for the second dog. 2 (1.1%) 0 (0.0%) Weight loss (>10% body weight) 1 (0.53%) 0 (0.0%) Hearing Decrease/Loss 1 (0.53%) 1 (1.1%)

Osurnia® (florfenicol, terbinafine, betamethasone acetate)

The following adverse reactions were reported during the course of a US field study for treatment of otitis externa in dogs treated with DuOtic™ with 1 tube per affected ear(s) and repeated after 7 days: Number (%) of dogs with Adverse Reactions by Treatment Adverse Reaction DuOtic™ (n=120) Control (n=119) Elevated alanine aminotransferaseFour dogs were reported to have an increase in alanine aminotransferase at Study Exit. The levels reported in subsequent clinical chemistries returned to normal in three dogs, while no follow up was performed for the fourth dog. 4 (3.3%) 0 (0.0%) Conjunctivitis 1 (0.8%) 0 (0.0%) Ocular discharge 1 (0.8%) 2 (1.7%) Ear discharge 0 (0.0%) 1 (0.8%) Ear pruritus 3 (2.5%) 4 (3.4%)

DuOtic™(terbinafine and betamethasone acetate otic gel)

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)

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 tube) per affected ear(s) and repeat administration in 7 days.

Otic

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

Osurnia™

Administer one dose (1 dropperette) per affected ear.

Otic

SIMPLERA™

Administer one dose (1 tube) per affected ear once.

Otic

Otiserene®

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)

DuOtic™ should be administered by a veterinary professional. Wear eye protection when administering DuOtic™ (see Human Safety Warnings, Precautions, Post-approval Experience, and Target Animal Safety ). 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. Clean and dry the external ear canal before administering the initial dose of the product. Verify the tympanic membrane is intact prior to each administration (see Precautions, Contraindications, Target Animal Safety and Post-approval Experience ). Administer one dose (1 tube) per affected ear. Repeat administration in 7 days. Open tube by twisting the soft tip. Insert the flexible tip in the affected external ear canal and squeeze entire tube contents into the external ear canal. After application, gently massage the base of the ear to allow the gel to penetrate the lower part of the ear canal. Restrain 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 and Target Animal Safety ). Do not clean the ear canal for 45 days after the initial administration to allow contact of the gel with the ear canal. Cleaning the ear may affect product effectiveness (see Effectiveness ). If alternative otic therapies are required, it is recommended to clean the ear(s) before application of those therapies.

AURICULAR (OTIC)

DuOtic™(terbinafine and betamethasone acetate otic gel)

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)