OSPHOS® (clodronate injection)
Bisphosphonate For use in horses only.
An affordable option- Ask your veterinarian for details!
A stride forward for Navicular Syndrome
Introducing OSPHOS, the new FDA approved intramuscular bisphosphonate injection from Dechra Veterinary Products
Easily administered via intramuscular injection
Proven efficacy* at 6 months post treatment
Quick and convenient
Well tolerated* in clinical trials
OSPHOS contains clodronate disodium, a bisphosphonate indicated for the control of clinical signs associated with navicular syndrome in horses. OSPHOS is the only FDA-approved bisphosphonate for use in horses that is labeled for intramuscular injection. In a clinical trial evaluating OSPHOS in 86 horses, lameness improved in 74.7% of horses by at least one grade 56 days after treatment. Only 9% of horses displayed clinical signs of being uncomfortable, nervous, colicky and or pawing after receiving OSPHOS. Less than 1% of horses experienced colic requiring treatment.
WITH OSPHOS THE BENEFITS ARE CLEAR . . . Learn more online
www.dechra-us.com www.equinelameness.com www.osphos.com
Call our 24 hour Tech Support (866) 933-2472
As with all drugs, side effects may occur. In field studies, the most common side effects reported were signs of discomfort or nervousness, colic, and/or pawing. 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.dechra-us.com.
* Freedom of Information Summary, Original New Animal Drug Application, NADA 141-427, for OSPHOS. April 28, 2014. CAUTION: Federal law restricts this drug to use by or on the order of licensed veterinarian.
Distributed by: Dechra Veterinary Products 7015 College Boulevard, Suite 525 Overland Park, KS 66211 866-933-2472
© 2015 Dechra Ltd. OSPHOS is a registered trademark of Dechra Ltd. All rights reserved. NADA 141-427, Approved by FDA
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,
(dichloromethylene) diphosphonic acid disodium 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:
associated with gastrointestinal and renal toxicity. Sensitivity 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,
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
diseases affecting renal function is not recommended. Administration of bisphosphonates has been associated with abdominal pain (colic),
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, immedi- ately 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 horses 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 abnormalities 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.
discomfort, and agitation of bisphosphonates in patients with conditions or conditions causing renal As a class, bisphosphonates may be clodronate disodium is
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