The Horse

JAN 2019

The Horse:Your Guide To Equine Health Care provides monthly equine health care information to horse owners, breeders, veterinarians, barn/farm managers, trainer/riding instructors, and others involved in the hands-on care of the horse.

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As with all drugs, side effects may occur. The most common adverse reactions reported in the field study were clinical signs of discomfort or nervousness, colic and/or pawing. Other signs reported were: lip licking, yawning, head shak- ing, injection site swelling, and hives/pruritus. Osphos should not be used in pregnant or lactating mares, or mares intended for breeding. Use of Osphos in patients with conditions affecting renal function or mineral or electrolyte homeostasis is not recommended. Refer to the prescribing information for complete details or visit www.osphos.com. * Freedom of Information Summary, Original New Animal Drug Application, NADA 141-427, for OSPHOS. April 28, 2014. Dechra Veterinary Products US and the Dechra D logo are registered trademarks of Dechra Pharmaceuticals PLC. © 2018 Dechra Ltd. CAUTION: Federal law restricts this drug to use by or on the order of licensed veterinarian. F O R E V E R Y E Q U I N E D I S C I P L I N E Learn more online www.dechra-us.com www.osphos.com OSPHOS ® (clodronate injection) Bisphosphonate. For use in horses only. Brief Summary (For Full Prescribing Information, see package insert) CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: Clodronate disodium is a non-amino, chloro-containing bisphosphonate. Chemically, clodronate disodium is (dichloromethylene) diphosphonic acid disodi - um salt and is manufactured from the tetrahydrate form. INDICATION: For the control of clinical signs associated with navicular syndrome in horses. CONTRAINDICATIONS: Horses with hypersensitivity to clodronate disodium should not receive OSPHOS. WARNINGS: Do not use in horses intended for human consumption. HUMAN WARNINGS: Not for human use. Keep this and all drugs out of the reach of children. Consult a physician in case of accidental human exposure. PRECAUTIONS: As a class, bisphosphonates may be associated with gastrointestinal and renal toxicity. Sen - sitivity to drug associated adverse reactions varies with the individual patient. Renal and gastrointestinal adverse reactions may be associated with plasma concentrations of the drug. Bisphosphonates are excreted by the kidney; therefore, conditions causing renal impairment may increase plasma bisphosphonate concentrations resulting in an increased risk for adverse reactions. Concurrent administration of other potentially nephrotoxic drugs should be approached with caution and renal function should be monitored. Use of bisphosphonates in patients with conditions or diseases affecting renal function is not recommended. Administration of bisphosphonates has been associated with abdominal pain (colic), discomfort, and agitation in horses. Clinical signs usually occur shortly after drug administration and may be associated with alterations in intestinal motility. In horses treated with OSPHOS these clinical signs usually began within 2 hours of treatment. Horses should be monitored for at least 2 hours following administration of OSPHOS. Bisphosphonates affect plasma concentrations of some minerals and electrolytes such as calcium, magnesium and potassium, immediately post-treatment, with effects lasting up to several hours. Caution should be used when administering bisphosphonates to horses with conditions affecting mineral or electrolyte homeostasis (e.g. hyper - kalemic periodic paralysis, hypocalcemia, etc.). The safe use of OSPHOS has not been evaluated in hors - es less than 4 years of age. The effect of bisphosphonates on the skeleton of growing horses has not been studied; however, bisphosphonates inhibit osteoclast activity which impacts bone turnover and may affect bone growth. Bisphosphonates should not be used in pregnant or lactating mares, or mares intended for breeding. The safe use of OSPHOS has not been evaluated in breeding horses or pregnant or lactating mares. Bisphosphonates are incorporated into the bone matrix, from where they are gradually released over periods of months to years. The extent of bisphosphonate incorporation into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the total dose and duration of bisphosphonate use. Bisphosphonates have been shown to cause fetal developmental abnormal - ities in laboratory animals. The uptake of bisphosphonates into fetal bone may be greater than into maternal bone creating a possible risk for skeletal or other abnormalities in the fetus. Many drugs, including bisphosphonates, may be excreted in milk and may be absorbed by nursing animals. Increased bone fragility has been observed in animals treated with bisphosphonates at high doses or for long periods of time. Bisphosphonates inhibit bone resorption and decrease bone turnover which may lead to an inability to repair micro damage within the bone. In humans, atypical femur fractures have been reported in patients on long term bisphosphonate therapy; however, a causal relationship has not been established. ADVERSE REACTIONS: The most common adverse reactions reported in the field study were clinical signs of discomfort or nervousness, colic and/or pawing. Other signs reported were lip licking, yawning, head shaking, injection site swelling, and hives/pruritus. Distributed by: Dechra Veterinary Products 7015 College Boulevard, Suite 525 Overland Park, KS 66211 866-933-2472 © 2018 Dechra Ltd. OSPHOS is a registered trademark of Dechra Ltd. All rights reserved. NADA 141-427, Approved by FDA The intramuscular bisphosphonate injection for control of clinical signs associated with Navicular Syndrome

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