PROTAZIL®
(1.56% diclazuril)
Antiprotozoal Pellets
Overview
PROTAZIL®
(1.56% diclazuril)
ANTIPROTOZOAL PELLETS
Alfalfa-based top-dress pellet for the treatment of equine protozoal myeloencephalitis (EPM) in horses.
- Safe, easy and effective, PROTAZIL® (1.56% diclazuril) Antiprotozoal Pellets start working fast against a disease where time matters
- First FDA-approved alfalfa-based, pelleted formulation containing diclazuril
- Rapid absorption and no loading dose required1
- Makes accurate dosing and administration easier and safer for horse owners
- Well-accepted by horses and consumed with no mess or fuss
- Administer as a daily top-dress at 1 mg/kg for 28 days
Indications
PROTAZIL (1.56% diclazuril) Antiprotozoal Pellets are indicated for the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona in horses.
Administration
Dose
PROTAZIL (1.56% diclazuril) is administered as a top-dress in the horse’s daily grain ration at a rate of 1 mg diclazuril per kg (0.45 mg diclazuril/lb) of body weight for 28 days. The quantity of PROTAZIL necessary to deliver this dose is 64 mg pellets per kg (29 mg pellets/lb) of body weight.
Administration
To achieve this dose, weigh the horse (or use a weight tape). Scoop up PROTAZIL to the level (cup mark) corresponding to the dose for the horse’s body weight using the following chart:
| Weight Range of Horse (lb) | mLs of Pellets |
|---|---|
| 275-524 | 20 |
| 525-774 | 30 |
| 775-1024 | 40 |
| 1025-1274 | 50 |
| 1275-1524 | 60 |
| 1525-1774 | 70 |
| 1775-2074 | 80 |
One 2.4-lb bucket of PROTAZIL will treat one 1274-lb horse for 28 days.
Contraindications
Use of PROTAZIL (1.56% diclazuril) Antiprotozoal Pellets is contraindicated in horses with known hypersensitivity to diclazuril.
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.
Resources
Keep your clinic up-to-date on the Merck Animal Health line of equine products.
References
1. Hunyadi L, Papich MG, Pusterla N. Pharmacokinetics of a low-dose and FDA-labeled dose of diclazuril administered orally as a pelleted top dressing in adult horses. J of Vet Pharmacology and Therapeutics (accepted) 2014, doi: 10.111/jvp.12176. The correlation between pharmacokinetic data and clinical effectiveness is unknown.