Acarexx Otic Suspension

This page contains information on Acarexx Otic Suspension for veterinary use.
The information provided typically includes the following:
  • Acarexx Otic Suspension Indications
  • Warnings and cautions for Acarexx Otic Suspension
  • Direction and dosage information for Acarexx Otic Suspension

Acarexx Otic Suspension

This treatment applies to the following species:
Manufacturer: Boehringer Ingelheim

(0.01% Ivermectin)

Otic Suspension

NADA 141-174, Approved by FDA

Acarexx Otic Suspension Caution

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

Description

Chemical name: Ivermectin is a mixture of 5-0-demethyl-22,23-dihydroavermectin A1a (component B1a) and 5-0-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl) avermectin A1b (component B1b). Empirical formula: B1a = C48H74O14, B1b = C47H72O14. Molecular weight: B1a = 875.10, B1b = 861.07.

Acarexx Otic Suspension Indications

Acarexx (0.01% ivermectin) Otic Suspension is indicated for the treatment of adult ear mite (Otodectes cynotis) infestations in cats and kittens four weeks of age or older. Effectiveness against eggs and immature stages has not been proven.

Dosage: Acarexx suspension is administered topically in the ear canal at an ivermectin concentration of 0.01%. One dose of 0.5 mL is applied in each ear. Repeat treatment one time if necessary, based upon the ear mite life cycle and the response to treatment.

Administration: Tear foil pouch at the notch to remove the two plastic ampules. Use one ampule per ear. Shake well before use. Snap off the cap of the ampule and place the tip into the external ear canal. Squeeze the entire contents of one ampule into the ear and massage the base of the ear to distribute the medication. Repeat the procedure in the other ear using the second ampule. In clinical field trials, ears were not cleaned and many animals still had debris in their ears at the end of the study. Cleaning the ears prior to administration of Acarexx suspension is not necessary to provide effectiveness.

Human Warnings: Not for human use. Keep out of reach of children.

Precautions

The safe use of Acarexx suspension in cats used for breeding purposes, during pregnancy, or in lactating queens, has not been evaluated.

Adverse Reactions

In approximately 1% of 80 cats and kittens, pain associated with the pinna and vomiting were observed following treatment with Acarexx suspension.

To report suspected adverse reactions, to obtain a Material Safety Data Sheet or for technical assistance, call 1-866-638-2226.

Effectiveness

One treatment with Acarexx suspension was 92% effective in treating adult ear mite (Otodectes cynotis) infestations after seven days in a dose titration/confirmation study. In a well-controlled clinical field trial, one treatment of Acarexx suspension was 94% effective in clearing cats and kittens of adult ear mite infestations within 7 to 10 days.

Safety: In two Target Animal Safety studies, Acarexx suspension was proven to be safe in kittens four weeks of age or older. Four-week-old kittens were administered Acarexx suspension at dose rates of 1X, 3X and 5X the recommended dose for three or six consecutive days and no adverse reactions were observed, except one kitten treated at 1X the dose had histologic evidence of minimal, chronic dermal inflammation of the ear. In a well-controlled clinical field trial, Acarexx suspension was used safely in cats and kittens receiving other frequently used veterinary products such as flea control products, vaccines, anthelmintics, antibiotics and steroids.

Storage

Store below 77°F (25°C). Protect from freezing.

How Supplied

Acarexx Otic Suspension is packaged in two polypropylene ampules per foil pouch, which are packaged 12 foil pouches per display carton. Each ampule is filled to deliver 0.5 mL of 0.01% ivermectin otic suspension per ear.

Manufactured for: Boehringer Ingelheim Vetmedica, Inc., St. Joseph, MO 64506 U.S.A.

Acarexx is a registered trademark of Boehringer Ingelheim Vetmedica, Inc.

© 2013 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.

449701-02

Code 449711

Revised 07/2013

83664909

83663228, R.1

NAC No.: 1028173.2

BOEHRINGER INGELHEIM VETMEDICA, INC.
2621 NORTH BELT HIGHWAY, ST. JOSEPH, MO, 64506-2002
Telephone:   800-325-9167
Fax:   816-236-2717
Website:   www.bevaccinesmart.com
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Every effort has been made to ensure the accuracy of the Acarexx Otic Suspension information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-09-05

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