EASOTIC Miconazole, Gentamicin and Hydrocortisone Aceponate Otic Suspension (Canada)

Company: Virbac

DIN 02424576

For Veterinary Use Only

Description

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

THERAPEUTIC CLASSIFICATION:

Anti-inflammatory, antifungal and antibacterial.

EASOTIC Miconazole, Gentamicin and Hydrocortisone Aceponate Otic Suspension 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 canister, prime the pump by depressing the pump 1 to 2 times to fill the clear canula (tip) with a full dose of product.

Carefully insert the canula into the external ear canal(s) and apply 1 mL (a single pump) of 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.

CAUTIONS:

Do not administer orally.

Concurrent administration of potentially ototoxic drugs should be avoided.

Use with caution in dogs with impaired hepatic or renal function.

As a class, aminoglycoside antibiotics are associated with ototoxicity, 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.

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

The safe use of EASOTIC Otic Suspension in dogs used for breeding purposes, during pregnancy, or in lactating bitches, has not been evaluated.

Not for ophthalmic use. Avoid contact with eyes.

Do not use in cats.

Warnings

Keep 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 aminoglycoside antibiotics, azole antifungals or hydrocortisone should not handle this product.

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

Adverse Reactions

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 Otic Suspension.

In very rare cases, the use of the veterinary medicinal product bas been associated with hearing impairment, usually temporary, and primarily in geriatric dogs.

Immediately discontinue use of EASOTIC Otic Suspension if hearing loss or signs of vestibular dysfunction are observed during treatment.

To report suspected adverse drug events, technical assistance or to obtain a Material Safety Data Sheet, call Virbac at 1-800-338-3659.

OTHER INFORMATION:

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 nitrate and gentamicin sulfate 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 efficacy 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 efficacy 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 EFFICACY), the minimum of 10 isolates from successfully treated cases was met for S. pseudintermedius and M. pachydermatis.

EFFICACY:

The efficacy of this drug was evaluated in a double-masked, placebo-controlled efficacy study conducted in the USA with one hundred fifty seven dogs with otitis externa. 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 albumin levels. Dogs in the 3X and 5X groups also had higher liver weights and greater food consumption.

STORAGE INFORMATION: Store at 15°C-30°C.

How Supplied

EASOTIC Otic Suspension is supplied in a polyethylene canister, with a soft applicator canula. Each canister contains 10 x 1 mL doses.

Manufactured by: Virbac Animal Health Inc., PO Box 162059, Fort Worth, Texas 76161 United States

Imported and distributed by: Virbac Canada Inc., 231 Shearson Crescent, Suite 209, Cambridge, ON, N1T 1J5.

1-800-338-3659

302159-02

09400

CPN: 1177072.1