Coraxis Topical Solution: Product Information (Page 2 of 4)

ADVERSE REACTIONS:

Since CORAXIS contains 2.5% moxidectin, studies that demonstrated the safe use of a topical solution containing 2.5% moxidectin + 10% imidacloprid were acceptable to demonstrate the safety of CORAXIS.

Field Studies: Following treatment with a topical solution containing 2.5% moxidectin + 10% imidacloprid or an active control, dog owners reported the following post-treatment reactions:

OBSERVATION

Moxidectin + Imidacloprid

n = 128

Active Control

n = 68

Pruritus

19 dogs (14.8%)

7 dogs (10.3%)

Residue

9 dogs (7.0%)

5 dogs (7.4%)

Medicinal Odor

5 dogs (3.9%)

None observed

Lethargy

1 dog (0.8%)

1 dog (1.5%)

Inappetence

1 dog (0.8%)

1 dog (1.5%)

Hyperactivity

1 dog (0.8%)

None observed

During a field study of a topical solution containing 2.5% moxidectin + 10% imidacloprid using 61 dogs with pre-existing flea allergy dermatitis, one (1.6%) dog experienced localized pruritus immediately after product application, and one investigator noted hyperkeratosis at the application site of one dog (1.6%).

Laboratory Effectiveness Studies: One dog in a laboratory effectiveness study experienced weakness, depression and unsteadiness between 6 and 9 days after application of a topical solution containing 2.5% moxidectin + 10% imidacloprid. The signs resolved without intervention by day 10 post- application. The signs in this dog may have been related to peak serum levels of moxidectin, which vary between dogs, and occur between 1 and 21 days after product application.

The following clinical observations also occurred in laboratory effectiveness studies following application of a topical solution containing 2.5% moxidectin + 10% imidacloprid and may be directly attributed to the drug or may be secondary to the intestinal parasite burden or other underlying conditions in the dogs: diarrhea, bloody stools, vomiting, anorexia, lethargy, coughing, ocular discharge and nasal discharge. Observations at the application sites included damp, stiff or greasy hair, the appearance of a white deposit on the hair, and mild erythema, which resolved without treatment within 2 to 48 hours.

Foreign Market Experience: Because the following events were reported voluntarily during post-approval use of the product containing 2.5% moxidectin + 10% imidacloprid in foreign markets, it is not always possible to reliably establish a causal relationship to drug exposure. Adverse events associated with CORAXIS (2.5% moxidectin) are expected to be similar.

The following adverse events were reported in humans: eye irritation, allergic reactions, skin irritation, skin tingling, sore throat and chemical odor. Adverse events reported in dogs topically treated with a topical solution containing 2.5% moxidectin + 10% imidacloprid included: vomiting, diarrhea, bloody diarrhea, salivation, poor appetite, lethargy, weakness, restlessness, agitation, disorientation, ataxia, muscle tremors, seizures, panting, labored breathing, acute pulmonary edema, hives, rash, swollen face and ears, pruritus, erythema, alopecia, hot spots, local discomfort and discoloration of the hair at the application site. Accidental oral ingestion in dogs caused salivation, vomiting, muscle tremor, seizures, mydriasis, ataxia, lethargy, disorientation, agitation and poor appetite.

Adverse events in cats topically treated with imidacloprid + moxidectin for dogs included application site and skin reactions, vomiting, lethargy, agitation and neurologic signs.

To report a suspected adverse reaction, call 1-800-422-9874.

DOSAGE AND ADMINISTRATION:

The recommended minimum dose is 1.1 mg/lb (2.5 mg/kg) moxidectin, once-a-month, by topical administration.

Do not apply to irritated skin.

1.
Remove one dose applicator tube from the package. As specified in the following table, administer the entire contents of the CORAXIS tube that correctly corresponds with the body weight of the dog.
* Dogs over 110 lbs. should be treated with the appropriate combination of CORAXIS tubes.

Dog Weight

(lbs)

CORAXIS

Volume

(mL)

Moxidectin

(mg)

3–9

CORAXIS 9

0.4

10

9.1–20

CORAXIS 20

1.0

25

20.1–55

CORAXIS 55

2.5

62.5

55.1–88

CORAXIS 88

4.0

100

88.1–110*

CORAXIS 110

5.0

125

Instructions for CORAXIS administration
(click image for full-size original)
2.
While holding the tube in an upright position, remove the cap from the tube.
3.
Turn the cap over and push the other end of cap onto the tip of the tube.
4.
Twist the cap to break the seal and then remove cap from the tube.
Instructions for CORAXIS administration
(click image for full-size original)
5.
The dog should be standing for application. Part the hair on the back of the dog between the shoulder blades until the skin is visible. For dogs weighing 20 lbs or less, place the tip of the tube on the skin and apply the entire contents directly on the exposed skin at one spot between the shoulder blades. For dogs weighing more than 20 lbs, place the tip of the tube on the skin and apply the entire contents directly on the exposed skin at 3 or 4 spots on the top of the backline from the base of the neck to the upper back in an area inaccessible to licking. Do not apply an amount of solution at any one location that could run off the side of the dog.

Do not let this product get in your dog’s mouth or eyes. Do not allow the dog to lick any of the application sites for 30 minutes. In households with multiple pets, keep each treated dog separated from other treated dogs and other pets for 30 minutes after application to prevent licking the application sites. (See WARNINGS.)

Stiff hair, a damp appearance of the hair, pink skin or a slight powdery residue may be observed at the application site on some animals. This is temporary and does not affect the safety and effectiveness of the product.

Shampooing 90 minutes after treatment does not reduce the effectiveness of CORAXIS in the prevention of heartworm disease.

Heartworm Prevention: For prevention of heartworm disease, CORAXIS should be administered at one-month intervals. CORAXIS may be administered year-round or at a minimum should start one month before the first expected exposure to mosquitoes and should continue at monthly intervals until one month after the last exposure to mosquitoes. If a dose is missed and a 30-day interval between doses is exceeded, administer CORAXIS immediately and resume the monthly dosing schedule. When replacing another heartworm preventative product in a heartworm prevention program, the first treatment with CORAXIS should be given within one month of the last dose of the former medication.

Treatment and Control of Intestinal Nematode Infections: For the treatment and control of intestinal hookworm infections caused by Ancylostoma caninum and Uncinaria stenocephala (adults, immature adults and fourth-stage larvae) and roundworm infections caused by Toxocara canis (adults and fourth-stage larvae), and Toxascaris leonina (adults), and whipworm infections caused by Trichuris vulpis (adults), CORAXIS should be administered once as a single topical dose.

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