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Name:Acarexx
Manufacturer:Boehringer Ingelheim Vetmedica, Inc.
Category:Animal Drugs


Acarexx®(0.01% ivermectin)Otic Suspension

ACAREXX - ivermectin suspension 
Boehringer Ingelheim Vetmedica, Inc.

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Acarexx®
(0.01% ivermectin)
Otic Suspension

NADA 141-174, Approved by FDA

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-O-demethyl-22,23-dihydroavermectin A1a (component B1a) and 5-O-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.

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 86°F (30°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.

© 2010 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.

449701L-00-1002
Code 449711
Revised 02/10

Laminate Pouch - Front side

Picture of front of laminate pouch.

Laminate Pouch - Back side

Picture of back of laminate pouch.

Carton 12 x 2 ampules

Picture of 12 x 2 ampule carton.

ACAREXX 
ivermectin suspension
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0010-4497
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVERMECTIN (IVERMECTIN) IVERMECTIN 0.1 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0010-4497-02 12 POUCH ( POUCH) in 1 CARTON contains a POUCH (0010-4497-01)
1 NDC:0010-4497-01 2 AMPULE ( AMPULE) in 1 POUCH This package is contained within the CARTON (0010-4497-02) and contains a AMPULE
1 0.5 mL in 1 AMPULE This package is contained within a POUCH (0010-4497-01) and a CARTON (0010-4497-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141174 05/28/2010

Labeler - Boehringer Ingelheim Vetmedica, Inc. (007134091)
Registrant - Boehringer Ingelheim Vetmedica, Inc. (007134091)
Establishment
Name Address ID/FEI Operations
AAI Pharma Services Corp 832394733 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Lancaster Laboratories, Inc. 069777290 ANALYSIS

Revised: 11/2010 Boehringer Ingelheim Vetmedica, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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