Indications

PROTAZIL (1.56% diclazuril) Antiprotozoal Pellets are indicated for the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona in horses.

precautions

Animal Safety

PROTAZIL^® (1.56% diclazuril) Antiprotozoal Pellets were administered to 30 horses (15 males and 15 females, ranging from 5 to 9 months of age) in a target animal safety study. Five groups of 6 horses each (3 males and 3 females) received 0, 5 (5X), 15 (15X), 25 (25X) or 50 (50X) mg diclazuril/kg (2.27 mg/lb) body weight/day for 42 consecutive days as a top-dress on the grain ration of the horse.

The variables measured during the study included: clinical and physical observations, body weights, food and water consumption, hematology, serum chemistry, urinalysis, fecal analysis, necropsy, organ weights, gross and histopathologic examinations. The safety of diclazuril top-dress administered to horses at 1 mg/kg once daily cannot be determined based solely on this study because of the lack of an adequate control group (control horses tested positive for the test drug in plasma and CSF). However, possible findings associated with the drug were limited to elevations in BUN, creatinine, and SDH and less than anticipated weight gain. Definitive test article-related effects were decreased grain/top-dress consumption in horses in the 50 mg/kg group.

In a second target animal safety study, PROTAZIL (1.56% diclazuril) Antiprotozoal Pellets were administered to 24 horses (12 males and 12 females, ranging from 2 to 8 years of age). Three groups of 4 horses/sex/group received 0, 1, or 5 mg diclazuril/kg body weight/day for 42 days as a topdress on the grain ration of the horse. The variables measured during the study included physical examinations, body weights, food and water consumption, hematology, and serum chemistry. There were no test article-related findings seen during the study.

Precautions

The safe use of PROTAZIL (1.56% diclazuril) Antiprotozoal Pellets in horses used for breeding purposes, during pregnancy, or in lactating mares has not been evaluated. The safety of PROTAZIL (1.56% diclazuril) Antiprotozoal Pellets with concomitant therapies in horses has not been evaluated.

Warnings

For use in horses only. Do not use in horses intended for human consumption. Not for human use. Keep out of reach of children.

Important Safety Information

PROTAZIL is contraindicated in horses with known hypersensitivity to diclazuril. The safety of Protazil in horses used for breeding purposes, during pregnancy, or in lactating mares, and use with concomitant therapies in horses has not been evaluated. Do not use in horses intended for human consumption. Not for human use. For complete safety information, refer to the product label.