Easotic Otic: Product Information

EASOTIC OTIC- hydrocortisone aceponate, miconazole nitrate and gentamicin suspension
Virbac AH, Inc.

(hydrocortisone aceponate, miconazole nitrate, gentamicin sulfate)
Otic Suspension for Dogs
Anti-inflammatory, antifungal, and antibacterial

Rx

For Otic Use in Dogs Only

CAUTION

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

DESCRIPTION

EASOTIC® Otic Suspension contains 1.11 mg/mL hydrocortisone aceponate, 17.4 mg/mL miconazole nitrate and 1.5 mg/mL gentamicin (as sulfate). The inactive ingredient is a semi-liquid petroleum jelly.

INDICATIONS

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

DOSAGE AND ADMINSTRATION

Verify that the tympanic membrane is intact. Shake well before each use.

Priming the canister: Prior to the first use of the dosing container, press firmly on the pump several times until the product fills the nozzle (canula tip) with a full dose of product.

Carefully insert the canula into the affected external ear canal(s) and apply 1 mL (a single pump) of Otic Suspension once per day for 5 days. Wash hands after usage.

CONTRAINDICATIONS

Do not use in dogs with known tympanic membrane perforation.

EASOTIC Otic Suspension is contraindicated in dogs with known or suspected hypersensitivity to corticosteroids, imidazole antifungals, or aminoglycoside antibiotics.

WARNINGS

Human Warnings: Not for use in humans. Keep this and all drugs out of reach of children. In case of accidental skin contact, wash area thoroughly with water. Avoid contact with eyes.

Humans with known or suspected hypersensitivity to hydrocortisone, aminoglycoside antibiotics, or azole antifungals should not handle this
product.

In case of accidental ingestion by humans, contact a physician immediately. Physicians may contact a Poison Control Center for advice concerning cases of ingestion by humans.

Animal Warnings: As a class, aminoglycoside antibiotics are associated with ototoxicty, vestibular dysfunction and renal toxicity. The use of EASOTIC Otic Suspension in a dog with a damaged tympanic membrane can result in damage to the structures of the ear associated with hearing
and balance or in transmission of the infection to the middle or inner ear. Immediately discontinue use of EASOTIC Otic Suspension if hearing loss or signs of vestibular dysfunction are observed during treatment (see ADVERSE REACTIONS).

PRECAUTIONS

Do not administer orally.

Concurrent administration of potentially ototoxic drugs should be avoided.

Use with caution in dogs with impaired hepatic or renal function (see ANIMAL SAFETY).

Long-term use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hyperadrenocorticism in dogs (see ANIMAL SAFETY).

The safe use of EASOTIC Otic Suspension 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 adverse reactions reported in 145 dogs administered EASOTIC Otic Supsension.

In foreign market experience, reports of hearing loss and application site erythema have been received. In most reported cases, the hearing loss and erythema were transient and resolved with discontinuation of EASOTIC® suspension.

To report suspected adverse drug events, contact Virbac AH, Inc at 1-800-338-3659 or the FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

For technical assistance or to obtain a Safety Data Sheet, call Virbac at 800-338-3659 or visit us at us.virbac.com.

PHARMACOLOGY

Hydrocortisone aceponate is a glucocorticoid with anti-inflammatory effects. Miconazole nitrate is an imidazole antifungal. Gentamicin sulfate is an aminoglycoside antibiotic.

In the target animal safety study, hydrocortisone aceponate, miconazole and gentamicin were shown to be systemically absorbed from the ears of healthy dogs (see ANIMAL SAFETY); increased systemic absorption may be observed in inflamed ears.

MICROBIOLOGY

The compatibility and additive effect of each of the components in EASOTIC® Otic Suspension 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 and from dogs enrolled in the clinical effectiveness study for EASOTIC Otic Suspension determined that miconazole nitrate and gentamicin sulfate 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 hydrocortisone aceponate to the combination did not impair antimicrobial activity to any clinically-significant extent.

In a field study (see EFFECTIVENESS), the minimum of 10 isolates from successfully treated cases was met for S. pseudintermedius and M. pachydermatis.

EFFECTIVENESS

The effectiveness of this drug was evaluated in 157 dogs with otitis externa. The study was a double-masked field study with a placebo control. One hundred and four dogs were treated with EASOTIC Otic Suspension and 53 dogs were treated with the placebo control. Treatment was administered once daily for 5 consecutive days to the affected ear(s). The dogs were evaluated at 4 different intervals over the course of 1 month to determine response to therapy. The 6 clinical signs evaluated were: malodor, aural discharge, pruritus, erythema, swelling and pain. The individual clinical scores were assigned based on the severity of each sign. Success was based on clinical improvement at Day 28 ±2 days. The success rates of the 2 groups were significantly different (p=0.0179); 68.5% of dogs administered EASOTIC Otic Suspension were successfully treated, compared to 21.8% of the dogs in the placebo control group.

ANIMAL SAFETY

In the target animal safety study, EASOTIC Otic Suspension was administered at 0X, 1X, 3X and 5X the recommended dose for 15 consecutive days (3 times the recommended treatment duration) in laboratory Beagles, with 8 dogs per group. Hypersensitivity reactions in the external ear canal and inner pinnae were seen in all EASOTIC Otic Suspension groups and included mild to severe aural erythema (3X group), papules and ulceration (1X and 5X groups), otitis externa (3X and 5X groups), and otitis media (5X group). Renal tubular crystals were present in the cortex and medulla (0X, 1X, 3X, and 5X groups) and mild renal tubular basophilia and atrophy were present in one 5X group dog. Baseline cortisol values and the cortisol response to ACTH stimulation were lower in treated dogs compared to the control dogs. The ACTH stimulation test results are consistent with systemic absorption of topical corticosteroids causing suppression of the hypothalamic-pituitary-adrenal axis. Dogs in the 3X and 5X groups demonstrated elevations in AST and ALP, while dogs in the 1X, 3X, and 5X groups had elevated cholesterol, total protein, and albuminlevels. Dogs in the 3X and 5X groups also had higher liver weights and greater food consumption.

STORAGE INFORMATION

Store at temperatures between 20o C-25o C (68o F-77o F), with excursions permitted between 15o C-30o C (59o F-86o F).

HOW SUPPLIED

EASOTIC Otic Suspension is supplied in a polyethylene canister, with a soft applicator canula.

Each canister contains ten 1 mL doses.

Made in the U.S.A.

Distributed by:
Virbac AH, Inc.
P.O. Box 162059
Fort Worth, TX 76161 USA

Approved by FDA under NADA # 141-330
Revision Date 04/2020

© 2020 Virbac Corporation. All Rights Reserved. EASOTIC is a registred trademark of Virbac S.A. 302076-04

image description

EASOTIC OTIC
hydrocortisone aceponate, miconazole nitrate, and gentamicin sulfate suspension
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-360
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACEPONATE (HYDROCORTISONE) HYDROCORTISONE ACEPONATE 1.11 mg in 1 mL
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 17.4 mg in 1 mL
GENTAMICIN (GENTAMICIN) GENTAMICIN 1.5 mg in 1 mL
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51311-360-10 10 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141330 01/30/2020
Labeler — Virbac AH, Inc. (131568396)
Establishment
Name Address ID/FEI Operations
Virbac Corporation 829166276 manufacture, label, pack
Establishment
Name Address ID/FEI Operations
FUJIAN FUKANG PHARMACEUTICAL CO., LTD. 528180884 api manufacture
Establishment
Name Address ID/FEI Operations
HOVIONE FARMACIENCIA, S.A. 449818434 api manufacture
Establishment
Name Address ID/FEI Operations
FDC Limited 650441301 api manufacture
Establishment
Name Address ID/FEI Operations
Eurofins BioPharma Product Testing Torronto, Inc. 257266387 analysis
Establishment
Name Address ID/FEI Operations
Alcami Carolinas Corporation 117877975 analysis

Revised: 01/2022 Virbac AH, Inc.

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2022. All Rights Reserved.