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Bisphosphonate drug for intravenous infusion. For use in horses only.
Brief Summary: See package insert for full prescribing information.
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Description
TILDREN is a sterile powder. Each vial of TILDREN contains 500 mg of tiludronic acid (as tiludronate disodium) and 250 mg mannitol USP (excipient).
Indication
TILDREN is indicated for the control of clinical signs associated with navicular syndrome in horses.
Contraindications
Do not use in horses with known hypersensitivity to tiludronate disodium or to mannitol. Do not use in horses with impaired renal function or with a history of renal disease. Bisphosphonates are excreted by the kidney; therefore, conditions causing renal impairment may increase plasma bisphosphonate concentrations resulting in an increased risk for adverse reactions.
Warnings
Do not use in horses intended for human consumption. NSAIDs should not be used concurrently with TILDREN. Concurrent use of NSAIDs with TILDREN may increase the risk of renal toxicity and acute renal failure. Appropriate wash-out periods should be observed between NSAID and TILDREN administration, and BUN and creatinine should be monitored. If treatment for discomfort is required after TILDREN administration, a non-NSAID treatment should be used.
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
Approximately 30-45% of horses administered TILDREN will demonstrate transient signs consistent with abdominal pain (colic). Hand-walking the horse may improve or resolve the colic signs in many cases. If a horse requires medical therapy, non-NSAID treatments should be administered due to the risk for renal toxicity. Avoid NSAID use.
TILDREN should be administered slowly and evenly over 90 minutes to minimize the risk of adverse reactions.
Horses should be well hydrated prior to administration of TILDREN due to the potential nephrotoxic effects of TILDREN.
Concurrent administration of other potentially nephrotoxic drugs should be approached with caution, and if administered, renal function should be monitored.
Caution should be used when administering TILDREN to horses with conditions affecting mineral or electrolyte homeostasis (e.g. hyperkalemic periodic paralysis (HYPP), hypocalcemia, etc.) and conditions which may be exacerbated by hypocalcemia (e.g. cardiac disease). TILDREN should be used with caution in horses receiving concurrent administration of other drugs that may reduce serum calcium (such as tetracyclines) or whose toxicity may exacerbate a reduction in serum calcium (such as aminoglycosides).
Horses with HYPP (heterozygous or homozygous) may be at an increased risk for adverse reactions, including colic signs, hyperkalemic episodes, and death.
The safe use of TILDREN 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 TILDREN has not been evaluated in pregnant or lactating mares, or in breeding horses.
Increased bone fragility has been observed in laboratory 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 microdamage 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 efficacy and safety studies were clinical signs consistent with abdominal discomfort or colic. Other reported signs were frequent urination, muscle fasciculations, polyuria with or without polydipsia, and inappetance/anorexia.
For technical assistance or to report suspected adverse reactions, call 1-800-999-0297.
France
Marketed by: Ceva Animal Health, LLC Lenexa, KS 66215 Tildren®
is a registered trademark of Ceva Santé Animale, NADA 141-420, approved by the FDA
© 2015 EVJ Ltd
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