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Pharmaceuticals
Protazil®
(1.56% diclazuril)
Indications

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

Purpose
Science
Administration

The Science of Convenient

  • Safe, easy and effective, Protazil® (1.56% diclazuril) starts 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

Important Safety Information
Use of Protazil® (1.56% dicazuril) is contraindicated in horses with known hypersensitivity to diclazuril. Safe use in horses used for breeding purposes, during pregnancy, or in lactating mares has not been evaluated. The safety of Protazil® (1.56% dicazuril) with concomitant therapies in horses has not been evaluated. For use in horses only. Do not use in horses intended for human consumption. Not for human use. Keep out of reach of children.

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.

Science

Additional Resources

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.

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.

CONTRAINDICATIONS Use of PROTAZIL® (1.56% diclazuril) Antiprotozoal Pellets is contraindicated in horses with known hypersensitivity to diclazuril.

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.

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.