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 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 acci-
dental human exposure.
PRECAUTIONS: As a class, bisphosphonates may be associ-
ated 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, conditions causing renal im-
pairment 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 mon-
itored. 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 min-
erals and electrolytes such as calcium, magnesium and po-
tassium, 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. hyperkalemic 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 skel-
eton of growing horses has not been studied; however, bisphos-
phonates 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 lac-
tating 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 to-
tal 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; how-
ever, 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
© 2016 Dechra Ltd. OSPHOS is a registered
trademark of Dechra Ltd. All rights reserved.
NADA 141-427, Approved by FDA
OSPHOS
®
controls the
clinical signs
associated
with
Navicular
Syndrome
Learn more online
www.dechra-us.com
www.osphos.com
Easily Administered
via intramuscular injection
Well Tolerated*
in clinical trials
Proven Efficacy*
at 6 months post treatment
No Reconstitution
Required
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 or call 866.933.2472.
* 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. © 2016 Dechra Ltd.
CAUTION: Federal law restricts this drug to use by or on the order of licensed veterinarian.
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