ACAREXX- ivermectin suspension

Acarexx by

Drug Labeling and Warnings

Acarexx by is a Animal medication manufactured, distributed, or labeled by Boehringer Ingelheim Vetmedica, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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.

SPL UNCLASSIFIED SECTION

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

Principal Display Panel – Laminate pouch

NDC: 0010-4497-01

Acarexx®

(0.01% ivermectin)

Otic Suspension

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

Net Contents: Two ampules per pouch

Each ampule contains 0.5 mL of 0.01% ivermectin otic suspension.

NADA 141-174, Approved by FDA

Principal Display Panel – Display Carton

NDC: 0010-4497-02

Acarexx®

(0.01% ivermectin)

Otic Suspension

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

Net Contents: 12 foil pouches containing 2 ampules per pouch. Each ampule contains 0.5 mL of 0.01% ivermectin otic suspension.

NADA 141-174, Approved by FDA

INGREDIENTS AND APPEARANCE

ACAREXX 
ivermectin suspension

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 0010-4497
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)	IVERMECTIN	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ALCOHOL (UNII: 3K9958V90M)
CHOLESTEROL (UNII: 97C5T2UQ7J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0010-4497-02	12 in 1 CARTON
1	NDC: 0010-4497-01	2 in 1 POUCH
1		0.5 mL in 1 AMPULE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141174	08/28/2017

Labeler - Boehringer Ingelheim Vetmedica, Inc. (007134091)