Texas Equine Veterinary Association

• 26 • Antioxidants, such as Vitamin E, are oen recommended for horses with neurological and neuromuscular conditions. A balanced diet and focus on the horse's wellbeing, including reducing stress, are important for optimal recovery. Compounding: e can of worms not to open Prescribing a compounded drug for EPM when an FDA-approved treatment is available puts not just the health of the horse at risk, but also your veterinary license. Compounded products have not been evaluated by the FDA for safety and effectiveness and are not FDA-approved for use in animals. As recent events have demonstrated, incorrectly formulated compounded products can result in lethal toxicity to horses and legal nightmares for the prescribing veterinarian. It is simply not worth the risk. Take-home message When it comes to EPM, time matters. e sooner you treat the disease with an FDA-approved product the better the horse's chance of recovery. In fact, horses treated with an anticoccidial drug are 10 times more likely to improve than untreated horses. 2 Supportive care, including anti-inflammatories and vitamin E supplementation may also be beneficial to the horse. Steer clear of compounded EPM treatments, which are illegal at best and lethal at worst. It is not worth the risk to your license or patients. Important Safety Information Use of Protazil® (1.56% diclazuril) Antiprotozoal Pellets 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. e safety of Protazil® (1.56% diclazuril) Antiprotozoal Pellets 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. Please refer to Marquis® and ReBalance® product labels for important safety information. Copyright © 2021 Intervet Inc., d/b/a Merck Animal Health, a subsidiary of Merck & Co., Inc. Marquis and ReBalance brand marks are the property of their respective manufacturers. 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 erapeutics (accepted) 2014, doi: 10.111/jvp.12176. e correlation between pharmacokinetic data and clinical effectiveness is unknown 2 Reed SM, et al. Equine Protozoal Myeloencephalitis: An Updated Consensus State- ment with a Focus on Parasite Biology, Diagnosis, Treatment and Prevention. J Vet Intern Med 2016;30:491–502. A word on immunomodulators... Oen, I am asked whether immunomodulators can play a role in helping EPM patients. ere are no studies showing the benefit of immunomodulators for EPM, and I recommend them on a case-by- case basis, especially if the horse experiences a relapse. KEY POINT: It is illegal to prescribe a compounded product for the treatment of EPM if an FDA-approved option is available. Doing so could result in the loss of your veterinary license. (detomidine hydrochloride) Sedative and Analgesic For Use in Horses Only Sterile Solution 10 mg/mL CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. INDICATIONS: Dormosedan® is indicated for use as a sedative and analgesic to facilitate minor surgical and diagnostic procedures in mature horses and yearlings. It has been used successfully for the following: to calm fractious horses, to provide relief from abdominal pain, to facilitate bronchoscopy, bronchoalveolar lavage, nasogastric intubation, nonreproductive rectal palpations, suturing of skin lacerations, and castrations. Additionally, an approved, local infiltration anesthetic is indicated for castration. CONTRAINDICATIONS: Dormosedan® should not be used in horses with pre-existing AV or SA block, with severe coronary insufficiency, cerebrovascular disease, respiratory disease, or chronic renal failure. Intravenous potentiated sulfonamides should not be used in anesthetized or sedated horses as potentially fatal dysrhythmias may occur. Information on the possible effects of detomidine hydrochloride in breeding horses is limited to uncontrolled clinical reports; therefore, this drug is not recommended for use in breeding animals. WARNINGS: Do not use in horses intended for human consumption. Not for human use. Keep out of reach of children. HUMAN SAFETY INFORMATION: Care should be taken to assure that detomidine hydrochloride is not inadvertently ingested as safety studies have indicated that the drug is well absorbed when administered orally. Standard ocular irritation tests in rabbits using the proposed market formulation have shown detomidine hydrochloride to be nonirritating to eyes. Primary dermal irritation tests in guinea pigs using up to 5 times the proposed market concentration of detomidine hydrochloride on intact and abraded skin have demonstrated that the drug is nonirritating to skin and is apparently poorly absorbed dermally. However, in accordance with prudent clinical procedures, exposure of eyes or skin should be avoided and affected areas should be washed immediately if exposure does occur. As with all injectable drugs causing profound physiological effects, routine precautions should be employed by practitioners when handling and using loaded syringes to prevent accidental self-injection. PRECAUTIONS: Before administration, careful consideration should be given to administering Dormosedan® to horses approaching or in endotoxic or traumatic shock, to horses with advanced liver or kidney disease, or to horses under stress from extreme heat, cold, fatigue, or high altitude. Protect treated horses from temperature extremes. Some horses, although apparently deeply sedated, may still respond to external stimuli. Routine safety measures should be employed to protect practitioners and handlers. Allowing the horse to stand quietly for 5 minutes before administration and for 10–15 minutes after injection may improve the response to Dormosedan®. Dormosedan® is a potent α 2 -agonist, and extreme caution should be exercised in its use with other sedative or analgesic drugs for they may produce additive effects. When using any analgesic to help alleviate abdominal pain, a complete physical examination and diagnostic work-up are necessary to determine the etiology of the pain. Food and water should be withheld until the sedative effect of Dormosedan® has worn off. ADVERSE REACTIONS: Occasional reports of anaphylactic-like reactions have been received, including 1 or more of the following: urticaria, skin plaques, dyspnea, edema of the upper airways, trembling, recumbency, and death. The use of epinephrine should be avoided since epinephrine may potentiate the effects of α 2 -agonists. Reports of mild adverse reactions have resolved uneventfully without treatment. Severe adverse reactions should be treated symptomatically. As with all α 2 -agonists, the potential for isolated cases of hypersensitivity exist, including paradoxical response (excitation). SIDE EFFECTS: Horses treated with Dormosedan® exhibit hypertension. Bradycardia routinely occurs 1 minute after injection. The relationship between hypertension and bradycardia is consistent with an adaptive baroreceptor response to the increased pressure and inconsistent with a primary drug-induced bradycardia. Piloerection, sweating, salivation, and slight muscle tremors are frequently seen after administration. Partial transient penis prolapse may be seen. Partial AV and SA blocks may occur with decreased heart and respiratory rates. Urination typically occurs during recovery at about 45–60 minutes posttreatment, depending on dosage. Incoordination or staggering is usually seen only during the first 3–5 minutes after injection, until animals have secured a firm footing. Because of continued lowering of the head during sedation, mucus discharges from the nose and, occasionally, edema of the head and face may be seen. Holding the head in a slightly elevated position generally prevents these effects. OVERDOSAGE: Detomidine hydrochloride is tolerated in horses at up to 200 mcg/kg of body weight (10 times the low dosage and 5 times the high dosage). In safety studies in horses, detomidine hydrochloride at 400 mcg/kg of body weight administered daily for 3 consecutive days produced microscopic foci of myocardial necrosis in 1 of 8 horses. HOW SUPPLIED: Dormosedan® is supplied in 5- and 20-mL multidose vials. NADA #140-862, Approved by FDA Manufactured by: ® Distributed by: Zoetis Inc. Kalamazoo, MI 49007 Revised: January 2013 107224US-10A&P Made in Finland Brief Summary of Prescribing Information.

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