EASOTIC® Otic suspension
(hydrocortisone aceponate, miconazole nitrate, gentamicin sulfate) Anti- inflammatory, antifungal, and anti- bacterial
For Otic Use in Dogs Only
CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian.
BRIEF SUMMARY: Please consult package insert for complete product information.
INDICATIONS EASOTIC®
suspension is indicated for the
treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
CONTRAINDICATIONS Do not use in dogs with known tympanic membrane perforation.
EASOTIC®
with known or suspected hypersensitivity to corticosteroids,
antifungals, aminoglycoside antibiotics.
WARNINGS Human Warnings: Not for use in humans. Keep this and all drugs out of reach of children.
Humans with known or suspected hypersensitivity to hydrocortisone, aminoglycoside antibiotics, or azole antifungals should not handle this product.
Animal Warnings: As a class, aminoglycoside antibiotics are associated with ototoxicity, vestibular dysfunction and renal toxicity. The use of EASOTIC® 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® 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® 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, there were no adverse reactions reported in 145 dogs administered EASOTIC®
suspension.
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, or for technical assistance contact Virbac at 800-338-3659 .
ANIMAL SAFETY Aural administration of EASOTIC®
suspension
to 12 week old Beagle dogs at 1, 3,and 5 times the recommended dose (1mL/ear/day) for 15 days (three times the treatment length) was associated with alterations of the hypothalamic- pituitary-adrenal axis as evidenced by the ACTH stimulation results. Other findings considered to be related to treatment include the development of aural hyperemia; the presence of renal tubular crystals and possibly renal tubular basophilia and atrophy; elevated liver weights; the development of otitis externa and media; and elevations in alanine aminotransferase, alkaline phosphatase, total protein, albumin, and cholesterol levels.
STORAGE INFORMATION: Store at tempera- tures between 20º C-25º C (68º F-77º F), with excursions permitted between 15º C-30º C (59º F-86º F).
HOW SUPPLIED: EASOTIC® suspension is
supplied in a polyethylene canister, with a soft applicator canula.
Distributed by: Virbac AH, Inc., Fort Worth, TX 76137 USA NADA 141-330, Approved by FDA.
© 2013 Virbac AH, Inc. All Rights Reserved. Rev 8/2011
For information call 800-338-3659 © 2013 Virbac AH, Inc. All Rights Reserved. EASOTIC is a registered trademark of Virbac SA in the US.
Ease and otic together at last.
Precise dosing in any position.
Three Powerful Actives including Hydrocortisone Aceponate (HCA) -
® To learn more, visit
www.virbacvet.com
One pump, once daily,
for 5 days for any size dog.
suspension is contraindicated in dogs imidazole
or Flexible Nozzle:
Gentle on sensitive canine ears.
Unique Airless Delivery System:
Introducing the new blueprint for easy, effective treatment of otitis externa.
®
Passionate About Animal Health
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