Description

EASOTIC Otic Suspension

Hydrocortisone, Miconazole, Gentamicin Otic Suspension for Dogs

Manufactured by: Virbac AH

Dosage form: Suspension

Presentation: 

10 ml (10 doses of 1 ml each)

Polyethylene canister, with a soft applicator canula.

Ingredients & Composition:

Each ml of suspension contains
Hydrocortisone aceponate 1.11 mg
Miconazole nitrate         17.4 mg
Gentamicin (as sulfate)   1.5 mg
Inactive ingredient: semi-liquid petroleum jelly

Description / Action: 

Easotic Suspension is the cutaneous hydrocortisone suspension with antifungal and antibiotic combination for dogs. Hydrocortisone has potent anti-inflammatory effects. Miconazole nitrate is an imidazole antifungal. Centamicin sulfate is an aminoglycoside antibiotic.

Additive effect and compatibility of the components was demonstrated on organisms collected from clinical cases of otitis externa in dogs. Gentamicin and miconazole effectively inhibit the growth of yeast and bacteria commonly associated with otitis externa in dogs.

The addition of hydrocortisone aceponate to the combination did not impair antimicrohial activity to any clinically-significant extent.

Six clinical signs malodor, aural discharge, pruritus, erythema, swelling and pain were evaluated in dogs with otitis externa and successfully treated.

Class: Topical Corticosteroid, Anti-inflammatory, antifungal, and antibacterial

Indication / Uses:

Indicated for the treatment of otitis externa (acute/recurrent) associated with susceptible strains of

• • Yeast (Malassezia Pachydermatis) and
  • Bacteria (Staphylococcus pseudintermedius)

Dosage and administration:

Shake the canister well for at least 30 seconds before use. The ball bearings inside the canister ensures thorough mixing of contents. Remove the clear cap before use. (If using first time then press firmly on the pump several times until product fills the nozzle (canula tip) with a full dose of product).

Insert the canula into the affected external ear canal and apply 1 ml

(1 pump = 1 ml)

Gentle massage to the ear may help in medication passage into your dog’s ear. Wipe the nozzle clear of debris, replace the cap, and store upright.

Frequency: Once daily for 5 days

Species: For Otic Use in Dogs Only

Benefits:

• It delivers potent active ingredients acts locally with minimal or low risk of systemic side effects. After absorption in systemic circulation hydrocortisone aceponate is converted into less potent metabolite, hydrocortisone.
• Hydrocortisone aceponate is a unique new-generation di-ester steroid having a strongly positive benefit/risk ratio.
• Contains proven antimicrobial and antifungal agents.
• Its ergonomically designed applicator makes administration easier/ less frustrating and enhances client compliance.
• Flexible and ergonomic nozzle design does not irritate inflamed and sensitive ears

• Provides rapid and sustained treatment of ear problems like otitis externa with 5 once-daily doses.

Over-dosage / Side effects / Contraindications /Warnings:

Don’t use if tympanic membrane is not intact. Administration of suspension in perforated tympanic membrane may result into damage of internal ear structure associated with hearing and balance and can also transmit the ear infection to the inner ear or middle ear.

Gentamicin as an aminoglycoside is associated with renal toxicity, ototoxicty, and vestibular dysfunction. Increased systemic absorption of HCA may be observed in inflamed ears. In the case if you notice hearing loss or signs of vestibular dysfunction immediately discontinue use. In some cases hearing loss with erythema at application site has been reported but it has been found to be transient and resolved with discontinuation of use.

Avoid concurrent administration of potentially ototoxic drugs and use with caution in dogs with history of impaired hepatic or renal function.

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

Contraindicated in dogs with known or suspected hypersensitivity to imidazole antifungals, corticosteroids, or aminoglycoside class of antibiotics.

Pharmaceutical precautions / Instructions: 

Not for use in humans. Store at temperatures between 20° C-25° C (68° F-77° F), with excursions permitted between 1 5° C-30° C (59° F-86° F). Do not administer orally. Keep this reaching out of the children. Shake well before each use. Wash hands after use. Wash area thoroughly with water in case of accidental skin contact. Avoid contact with eyes. In case of accidental ingestion by humans, contact a physician immediately. Humans with known or suspected hypersensitivity to any of its components like hydrocortisone, aminoglycoside antibiotics, or azole antifungals should not handle this product.

Safety: Age / Pregnancy/ Withdrawal:

Safety for use in dogs intended for breeding purposes, during pregnancy, or in lactating bitches, has not been evaluated for this product.

In the target animal safety study, EASOTIC Otic Suspension was administered at 0X, 1 X, 3X and 5X the recommended dose for 15 days consecutively (3 times the recommended treatment duration) in laboratory Beagles, with 8 dogs per group. Irrespective of the dosage hypersensitivity reactions in the external ear canal and inner pinnae were seen in all groups. It included mild to severe aural erythema in 3X group, papules and ulceration in 1X and 5X groups, otitis externa in 3X and 5X groups, and otitis media in 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. Elevations in AST and ALP in the dogs of 3X and 5X groups were seen, while dogs in the 1X, 3X, and 5X groups had elevated total protein, cholesterol and albumin levels. Greater food consumption and higher liver weights in the 3X and 5X group dogs were recorded.

Substitute: Updating Soon

Also see Otisoothe Solution,