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Protazil (1.56% diclazuril) Antiprotozoal Pellets for Horses

Item# IWM037984
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Description

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.

Ingredients

Active Ingredients:

Diclazuril, 1.56%

Directions

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:

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. 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).

FAQ

Protazil is a diclazuril-based anti-protozoal top-dress pellet for the treatment of EPM caused by S. neurona in horses
  • Diclazuril is an FDA-approved anti-protozoal drug used for the treatment of EPM in horses
  • Diclazuril has proved safe and effective in treating horses naturally infected with EPM
  • Protazil is the only EPM treatment available in an alfalfa-based, pelleted, top-dress, formula
  • Protazil is easier to administer than a paste EPM treatment product
  • Protazil is voluntarily consumed by most horses when administered on their daily grain ration
  • Protazil offers convenient dosing with an easy-to-use calibrated scoop
  • Protazil is the only FDA-approved diclazuril-based EPM treatment product on the market
  • Protazil is the only EPM treatment product in an alfalfa-based, pelleted, top-dress formula, making accurate dosing and administration easier
  • Protazil is a more affordable FDA-approved EPM treatment option
  • The alfalfa-based pellet formulation helps ensure voluntary consumption by the horse
  • Equine protozoal myeloencephalitis (EPM) is a neurologic disease of horses
  • EPM is caused primarily by the infection with the protozoan parasite Sarcocystis neurona (S. neurona); a few cases are caused by the protozoan parasite Neospora hughesi
  • Horses accidentally ingest the protozoan parasites when consuming feed and/or water contaminated by infected opossum feces
  • It is estimated that approximately 50 percent of horses in many regions of the U.S. have been exposed to S. neurona
  • Horses in some regions of the U.S. may have an exposure rate closer to 70 percent to 80 percent
  • However, less than 1 percent of horses actually develop clinical signs of EPM
  • In a large field safety study of 214 privately owned EPM-positive horses of various genders, breeds and ages, Protazil was administered for 28 days at doses of 1, 5 and 10 milligrams of diclazuril per kilogram of body weight (mg/kg)
  • Adverse events were reported for two of the 214 horses. In the first case, a horse was enrolled showing severe neurologic signs. Within 24 hours of dosing, the horse was recumbent, biting, and exhibiting signs of dementia. The horse died, and no cause of death was determined. In the second case, the horse began walking stiffly approximately 13 days after the start of dosing. The referring veterinarian reported that the horse had been fed grass clippings and possibly had laminitis
  • Protazil is simply poured on top of the horse's daily grain ration, increasing client compliance and voluntary consumption by the horse and avoiding the tubes and mess of other treatment products
  • Each container of Protazil comes with an easy-to-use calibrated scoop that can be adjusted for the weight of each individual horse
Currently, Protazil is not labeled for preventive treatment
The safe use of Protazil in horses used for breeding purposes, during pregnancy, or in lactating mares has not been evaluated
Protazil is sold exclusively to licensed veterinarians and is available in 2- and 10-pound containers

Reviews

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5.0
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100% Recommend this product (1 of 1 responses)
By Tracy
Frederick, MD
Great Price!!
October 5, 2018
Being the owner of a horse that needs expensive meds for the rest of her life, I was thrilled to find that Entirely Pets Pharmacy carried both of her drugs at GREAT prices !!
Merchant Response:Tracy, You are a good horse parent. Happy to be of help. You both take care!

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