Coraxis Topical Solution: Product Information (Page 3 of 4)

ANIMAL SAFETY:

In a controlled, double-masked, field safety study, a topical solution containing 2.5% moxidectin + 10% imidacloprid was administered to 128 dogs of various breeds, 3 months to 15 years of age, weighing 4 to 157 pounds. The moxidectin + imidacloprid topical solution was used safely in dogs concomitantly receiving ACE inhibitors, anticonvulsants, antihistamines, antimicrobials, chondroprotectants, corticosteroids, immunotherapeutics, MAO inhibitors, NSAIDs, ophthalmic medications, sympathomimetics, synthetic estrogens, thyroid hormones, and urinary acidifiers. Owners reported the following signs in their dogs after application of moxidectin + imidacloprid topical solution: pruritus, flaky/greasy residue at the treatment site, medicinal odor, lethargy, inappetence and hyperactivity. (See ADVERSE REACTIONS.)

Safety Study in Puppies: A solution containing 2.5% moxidectin + 10% imidacloprid was applied topically at 1, 3 and 5x the recommended dose to 7-week-old Beagle puppies once every 2 weeks for 6 treatments on days 0, 14, 28, 42, 56, and 70. Loose stools and diarrhea were observed in all groups, including the controls, throughout the study. Vomiting was seen in one puppy from the 1x treatment group (day 57), in two puppies from the 3x treatment group (days 1 and 79), and in one puppy from the 5x treatment group (day 1). Two puppies each in the 1x, 3x and 5x groups had decreased appetites within 24 hours post-dosing. One puppy in the 1x treatment group had pruritus for one hour following the fifth treatment. A puppy from the 5x treatment group displayed rapid, difficult breathing from 4 to 8 hours following the second treatment.

Dermal Dose Tolerance Study: A solution containing 2.5% moxidectin + 10% imidacloprid was administered topically to 8-month-old Beagle dogs once at 10x the recommended dose. One dog showed signs of treatment site irritation after application. Two dogs vomited, one at 6 hours and one at 6 days post-treatment. Increased RBC, hemoglobin, activated partial thromboplastin and direct bilirubin were observed in the treated group. Dogs in the treated group did not gain as much weight as the control group.

Safety Study in Heartworm-Positive Dogs: A solution containing 2.5% moxidectin + 10% imidacloprid was administered topically at 1 and 5x the recommended dose every 14 days for 3 treatments to dogs with adult heartworm infections and circulating microfilariae. At 5x, one dog was observed vomiting three hours after the second treatment. Hypersensitivity reactions were not seen in the 5x treatment group. Microfilariae counts decreased with treatment.

Oral Safety Study in Beagles: A solution containing 2.5% moxidectin + 10% imidacloprid was administered once orally at the recommended topical dose to 12 dogs. Six dogs vomited within 1 hour of receiving the test article, 2 of these dogs vomited again at 2 hours, and 1 dog vomited again at 18 hours post-dosing. One dog exhibited shaking (nervousness) 1 hour post-dosing. Another dog exhibited abnormal neurological signs (circling, ataxia, generalized muscle tremors and dilated pupils with a slow pupillary light response) starting at 4 hours post-dosing through 18 hours post-dosing. Without treatment, this dog was neurologically normal at 24 hours and had a normal appetite by 48 hours post-dosing. (See CONTRAINDICATIONS.)

Dermal Safety Study in Ivermectin-Sensitive Collies: A solution containing 2.5% moxidectin + 10% imidacloprid was administered topically at 3 and 5x the recommended dose every 28 days for 3 treatments to Collies which had been pre-screened to confirm avermectin sensitivity. No clinical abnormalities were observed.

Oral Safety Study in Ivermectin-Sensitive Collies: A solution containing 2.5% moxidectin + 10% imidacloprid was administered orally to 5 pre-screened ivermectin-sensitive Collies. The Collies were asymptomatic after ingesting 10% of the minimum labeled dose. At 40% of the minimum recommended topical dose, 4 of the dogs experienced neurological signs indicative of avermectin toxicity including depression, ataxia, mydriasis, salivation, muscle fasciculation and coma, and were euthanized. (See CONTRAINDICATIONS.)

STORAGE INFORMATION:

Store at temperatures between 4°C (39°F) and 25°C (77°F), avoiding excess heat or cold.

HOW SUPPLIED:

Applications Per Package
6 x 0.4 mL tubes
6 x 1.0 mL tubes
6 x 2.5 mL tubes
6 x 4.0 mL tubes
6 x 5.0 mL tubes

NADA # 141-417, Approved by FDA
Made in Italy
©2018 Bayer HealthCare LLC
Bayer (reg’d), the Bayer Cross (reg’d) and Coraxis ™ are trademarks of Bayer.

86572354
LV1808

August, 2018
Bayer logo

Bayer HealthCare LLC
Animal Health DivisionP.O. Box 390, Shawnee Mission, Kansas 66201 U.S.A.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 88.1-110 lbs dogs

CORAXIS (moxidectin) Topical Solution for Dogs, 88.1-110 lbs dogs label
(click image for full-size original)

6 Pack
88.1 — 110 lbs

CORAXISTM
(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 hookworm, roundworm and whipworm infections in dogs and puppies that are at least 7 weeks of age and weigh 88.1 to 110 lbs.

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

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)

Each tube contains 125 mg of moxidectin in a 2.5% moxidectin solution.

Keep this and all drugs out of reach of children.

6 PACK
SIX 5.0 mL TUBES

NADA # 141-417Approved by FDA

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 55.1-88 lbs dogs

CORAXIS (moxidectin) Topical Solution for Dogs, 55.1-88 lbs dogs label
(click image for full-size original)

6 Pack
55.1 — 88 lbs

CORAXISTM
(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 hookworm, roundworm and whipworm infections in dogs and puppies that are at least 7 weeks of age and weigh 55.1 to 88 lbs.

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

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)

Each tube contains 100 mg of moxidectin in a 2.5% moxidectin solution.

Keep this and all drugs out of reach of children.

6 PACK
SIX 4.0 mL TUBES

NADA # 141-417Approved by FDA

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 20.1-55 lbs dogs

CORAXIS (moxidectin) Topical Solution for Dogs, 20.1-55 lbs dogs label
(click image for full-size original)

6 Pack
20.1 — 55 lbs

CORAXISTM
(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 hookworm, roundworm and whipworm infections in dogs and puppies that are at least 7 weeks of age and weigh 20.1 to 55 lbs.

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

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)

Each tube contains 62.5 mg of moxidectin in a 2.5% moxidectin solution.

Keep this and all drugs out of reach of children.

6 PACK
SIX 2.5 mL TUBES

NADA # 141-417Approved by FDA

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