Protazil (1.56% diclazuril) Antiprotozoal Pellets for Horses

Protazil, diclazuril 1.56%, is an alfalfa-based antiprotozoal pellet indicated for the treatment of equine protozoal myeloencephalitis EPM caused by S. neurona in horses. It is labeled for a dosage rate of 1 mg/kg for 28 consecutive days. For use in horses only.

Key Benefits

• First FDA-approved alfalfa-based, pelleted formulation containing diclazuril
• Effective treatment for equine protozoal myeloencephalitis (EPM)
• Rapid absorption and no loading dose required
• Easy and accurate dosing making administration safer for horse owners
• Palatable taste loved by horses

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

Indications

PDF: EPM Recovery Starts with Protazil by Merck

Protazil is a registered trademark of Intervet Inc., d/b/a Merck Animal Health, a subsidiary of Merck & Co. Inc.

Active Ingredients:

Diclazuril, 1.56%

View Protazil Drug Facts Sheet.

Dosage:

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 weigh tape)). Scoop up Protazil® to the level (cup mark) corresponding to the dose for the horse’s body weight using the following chart:

One 2.4-lb bucket of Protazil® will treat one 1274-lb horse for 28 days. One 10-lb bucket of Protazil® will treat five 1100-lb horses for 28 days.

Caution:

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

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.

Adverse Reactions

There were no adverse effects noted in the field study which could be ascribed to diclazuril. To report suspected adverse reactions, to obtain a MSDS, or for technical assistance call 1-800-224-5318.

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 (2.27mg/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 top-dress 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.

Storage:

Store between 15°C to 30°C (59°F to 86°F).