Coraxis Topical Solution: Product Information

CORAXIS TOPICAL SOLUTION- moxidectin solution
Bayer HealthCare, LLC Animal Health Division

(moxidectin)

Topical Solution for Dogs

Once-a-month topical solution for the prevention of heartworm disease caused by Dirofilaria immitis, as well as the treatment and control of intestinal hookworm, roundworm and whipworm infections in dogs and puppies that are at least 7 weeks of age and that weigh at least 3 lbs.

WARNING

DO NOT ADMINISTER THIS PRODUCT ORALLY
For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals.
Children should not come in contact with application sites for two (2) hours after application.

(See Contraindications, Warnings, Human Warnings, and Adverse Reactions, for more information)

CAUTION:

Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

CORAXIS™ (2.5% moxidectin) is a colorless to yellow, ready-to-use solution packaged in single dose applicator tubes for topical treatment of dogs. The formulation and dosage schedule are designed to provide a minimum of 1.1 mg/lb (2.5 mg/kg) moxidectin based on body weight.

Moxidectin is a semisynthetic macrocyclic lactone endectocide derived from the actinomycete Streptomycetes cyaneogriseus noncyanogenus. The chemical name for moxidectin is [6R,23E,25S(E)]-5-O-Demethyl-28-deoxy-25-(1,3-dimethyl-1-butenyl)-6,28-epoxy-23-(methoxyimino) milbemycin B.

INDICATIONS:

CORAXIS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis. CORAXIS is also indicated for the treatment and control of the following intestinal parasites:

Intestinal Parasite

Intestinal Stage

Adult

Immature

Adult

Fourth Stage

Larvae

Hookworm

Species

Ancylostoma

caninum

X

X

X

Uncinaria

stenocephala

X

X

X

Roundworm

Species

Toxocara canis

X

X

Toxascaris

leonina

X

Whipworm

Trichuris vulpis

X

CONTRAINDICATIONS:

Do not administer this product orally. (See WARNINGS.)

Do not use this product (containing 2.5% moxidectin) on cats.

WARNINGS:

For the first 30 minutes after application:

Ensure that dogs cannot lick the product from application sites on themselves or other treated dogs, and separate treated dogs from one another and from other pets to reduce the risk of accidental ingestion.

Ingestion of this product by dogs may cause serious adverse reactions including depression, salivation, dilated pupils, incoordination, panting, and generalized muscle tremors.

In avermectin sensitive dogs,a the signs may be more severe and may include coma and death.b

a Some dogs are more sensitive to avermectins due to a mutation in the ABCB1 gene (formerly MDR1 gene). Dogs with this mutation may develop signs of severe avermectin toxicity if they ingest this product. The most common breeds associated with this mutation include Collies and Collie crosses.

b Although there is no specific antagonist for avermectin toxicity, even severely affected dogs have completely recovered from avermectin toxicity with intensive veterinary supportive care.

HUMAN WARNINGS:

Not for human use. Keep out of the reach of children.

Children should not come in contact with application sites for two (2) hours after application. Causes eye irritation. Harmful if swallowed. Do not get in eyes or on clothing. Avoid contact with skin. Exposure to the product has been reported to cause headache; dizziness; and redness, burning, tingling, or numbness of the skin. Wash hands thoroughly with soap and warm water after handling.

If contact with eyes occurs, hold eyelids open and flush with copious amounts of water for 15 minutes. If eye irritation develops or persists, contact a physician. If swallowed, call poison control center or physician immediately for treatment advice. Have person sip a glass of water if able to swallow. Do not induce vomiting unless told to do so by the poison control center or physician. People with known hypersensitivity to benzyl alcohol or moxidectin should administer the product with caution. In case of allergic reaction, contact a physician. If contact with skin or clothing occurs, take off contaminated clothing. Wash skin immediately with plenty of soap and water. Call a poison control center or physician for treatment advice.

The Safety Data Sheet (SDS) provides additional occupational safety information. For a copy of the Safety Data Sheet (SDS) or to report adverse reactions call Bayer Veterinary Services at 1-800-422-9874. For consumer questions call 1-800-255-6826.

PRECAUTIONS:

Do not dispense dose applicator tubes without complete safety and administration information.

Use with caution in sick, debilitated, or underweight animals. The safety of CORAXIS has not been established in breeding, pregnant, or lactating dogs. The safe use of CORAXIS has not been established in puppies and dogs less than 7 weeks of age or less than 3 lbs body weight.

Prior to administration of CORAXIS , dogs should be tested for existing heartworm infection. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms.CORAXIS is not effective against adult D. immitis. (See ANIMAL SAFETY – Safety Study in Heartworm-Positive Dogs.)

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