Acarexx

Name: Acarexx

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.

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.

Carton 12 x 2 ampules

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
Packaging
# Item Code Package Description
1 NDC:0010-4497-02 12 POUCH (POUCH) in 1 CARTON
1 NDC:0010-4497-01 2 AMPULE (AMPULE) 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 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.

Acarexx Overview

Ivermectin lotion is a no-comb,10-minute prescription treatment used to treat head lice infestations in adults and children 6 months of age and older.

Ivermectin is also available in tablet form. It is a prescription medication used to treat two types of roundworm parasites. It is usually taken as a single dose on an empty stomach with water.

Ivermectin is also available in a topical cream that is used to treat rosacea.

Ivermectin belongs to a group of drugs called antihelmintics. It works by killing the target parasite.

Common side effects of ivermectin lotion include eye redness and irritation, dandruff, and dry skin.

Common side effects of ivermectin tablets include loss of appetite, nausea, vomiting, and dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.

Acarexx Precautions

Oral:

Serious side effects have been reported with this medication, and certain precautions should be followed:

  • fever
  • blistering or peeling skin
  • rash
  • hives
  • itching

If treating specifically for the parasite loa loa (endemic in West or Central Africa), you may also experience certain serious adverse effects that should be addressed immediately if they occur. These effects have been seen very rarely following the use of ivermectin.

  • swelling of the eyes, face, arms, hands, feet, ankles, or lower legs
  • joint pain and swelling
  • painful and swollen glands of the neck, armpit or groin
  • rapid heartbeat
  • eye pain, redness, or tearing
  • swelling of the eye or eyelids
  • abnormal sensation in the eyes

Do not use ivermectin tablets if you are allergic to any of its ingredients.

Ivermectin tablets can cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up. Do not drive or operate heavy machinery until you know how this medication affects you.

Topical:

 Certain precautions should be followed when using ivermectin lotion:

  • Ivermectin lotion is for use on scalp hair and scalp only. Do not get ivermectin lotion in your eyes, mouth, or vagina.

Acarexx Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ivermectin lotion and tablets, there are no specific foods that you must exclude from your diet.

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