MilbeMite (Canada)

(milbemycin oxime 0.1% ear solution)

FOR VETERINARY USE ONLY

DIN 02246889

A topical medication for the treatment of otoacariasis caused by Otodectes cynotis, in dogs and cats, puppies and kittens.

Introduction

Elanco Canada Limited encourages you to take the time to read the package insert which describes the use of MILBEMITE (milbemycin oxime) for the treatment of ear mite infestations due to Otodectes cynotis in dogs and cats.

MILBEMITE is only available through veterinarians.

Description

MILBEMITE is available as a liquid in dispensing tubes for administration to dogs

and cats, puppies and kittens 2 weeks of age or older. Each plastic tube contains 0.25 mL of MILBEMITE as 0.1% solution of milbemycin oxime. Milbemycin oxime consists of the oxime derivatives of 5-didehydromilbemycins in the ratio of approximately 80% A₄ (C₃₂H₄₅NO₇, MW 555.71) and 20% A₃ (C₃₁H₄₃NO₇, MW541.68).

MilbeMite Indications

MILBEMITE is indicated for treatment of parasitic infestations of the external ear by removal of the ear mite, Otodectes cynotis, in dogs, cats, puppies, and kittens two (2) weeks of age or older.

Ear Mite Disease In Dogs And Cats

Otodectes cynotis is an ear mite that infests the external ear canal and skin of dogs and cats causing intense irritation. Otodectic otitis is manifested by copious production of dark cerumen. The animal may rub and scratch its ears and shake its head violently causing damage to the external ear possibly resulting in aural hematoma. Protracted infestation with Otodectes cynotis may cause rupture of the tympanic membrane leading to disease of the middle ear or central nervous system.

Animals with ear mite disease may infest other animals in the household.

Dosage

MILBEMITE should be administered according to the following schedule.

Recommended Dosage Schedule

Note: a small amount of residual volume (0.05 mL) will remain in the dispensing tube.

Administration

Open the tube by pressing cap down firmly to break seal. Remove cap and check to be sure tip of tube is open.

Ear cleaning is recommended prior to treatment. MILBEMITE should be administered as one tube per ear in cats, and 2 tubes per ear in dogs, as a single treatment. Follow-up evaluation should be performed 7-10 days post treatment. In a small number of cases, retreatment may be indicated based on follow-up examinations. It is important to treat all affected pets in the household.

Contra-indications

Do not use if the eardrum is perforated.

MilbeMite Cautions

This product has not been tested in puppies or kittens less than two weeks of age.

The use of MILBEMITE in cats and dogs with perforated tympanic membranes has not been evaluated. The integrity of the tympanic membrane should be confirmed before administering this product.

Many animals treated for otoacariasis have concurrent otitis externa involving secondary yeast or bacterial infections. Otodectes cynotis causes primary inflammation and pruritus of the external ear canal and predisposes to these secondary infections. Therefore, cats and dogs with otoacariasis complicated by secondary yeast and/or bacterial infections may require supportive therapy in addition to a treatment with an acaricide.

Warnings

Keep out of reach of children. If accidentally swallowed, call a physician.

Pharmacology

Milbemycin oxime, the active ingredient of MILBEMITE, is a macrocyclic lactone derivative which is believed to act by interfering with invertebrate neurotransmission.

Safety & Efficacy

Safety: Multiple studies were conducted to evaluate the safety of a 0.1% milbemycin oxime solution for the treatment of ear mite infestations (Otodectes cynotis) in adult dogs and cats. In each study, repeated topical doses at 1, 3 or 5x the recommended dose did not produce adverse effects, including when the product was used in microfilaria (Dirofilaria immitis) positive dogs. In addition, no measurable levels of the milbemycin were detected in whole blood of the dogs and cats dosed at 5x. Oral daily dosing of 3x the recommended oral dose of milbemycin oxime has been proven safe in over 75 different breeds of dogs including collies, pregnant females, breeding males and females, and puppies over two weeks of age.

Efficacy: The clinical efficacy of milbemycin oxime 0.1% was evaluated in a placebo-controlled dose confirmation study of client-owned cats and dogs. Ears were examined for clinical signs of mite infestation (i.e. evidence of excessive ear exudate, head shaking, pruritus, erythema, and/or alopecia). Otodectes cynotis infestation was diagnosed by direct microscopic visualization of ear swab debris. Test or placebo treatment was administered to both ears of the animal following the pre-treatment examination. Animals’ ears were examined by ear swab microscopy at 7-10 days and at 28-35 days post-treatment.

In dogs, eighty-six (86.2) percent of the milbemycin oxime treated group were ear mite negative at 7-10 days post treatment. This percentage increased to 93.1% at 28-35 days post treatment.

In cats, ninety-nine percent (99%) of the milbemycin oxime treated group were ear mite negative at 7-10 days post treatment. This 99% efficacy was maintained through the next evaluation at 28-35 days post treatment.

In summary, these studies demonstrate that milbemycin oxime provides safe and effective removal of ear mites in dogs and cats.

Presentation

MILBEMITE is supplied as individual white polypropylene tubes, paired in a foil overlay envelope. There are 2 tubes of 0.25 mL each in one foil pouch, then 10 pouches in an outer box.

Storage Conditions

MILBEMITE should be stored at room temperature between 15°C and 25°C. Use product immediately after opening.

Elanco Canada Limited, Research Park Centre, 150 Research Lane, Suite 120, Guelph, Ontario N1G 4T2

MilbeMite, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

01Oct2019

CPN: 1231062.6