FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
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. Acute renal failure has been reported in horses concurrently administered NSAIDs and TILDREN within a 48 hour period. Additionally, horses concurrently administered TILDREN and NSAIDs in field studies demonstrated a statistically significant increase in serum blood urea nitrogen (BUN) and creatinine concentrations. These elevations were not always associated with clinical signs of renal dysfunction. Therefore, 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
TILDREN is indicated for the control of clinical signs associated with navicular syndrome in horses.
History
There is currently no drug history available for this drug.
Other Information
TILDREN® contains the sodium salt of tiludronic acid, which is a bisphosphonate characterized by a (4-chlorophenylthio) group on the carbon atom of the basic P-C-P structure common to all bisphosphonates. Its United States Adopted Name (USAN) is tiludronate disodium. Tiludronate disodium is the hydrated hemihydrate form of the disodium salt of tiludronic acid. Its chemical name is [[(4-Chlorophenyl) thio]methylene] bis[phosphonic acid], disodium salt, and its structural formula is as follows:
TILDREN is a sterile powder. Each vial of TILDREN contains 500 mg of tiludronic acid (as tiludronate disodium) and 250 mg mannitol USP (excipient).
Sources
Tildren Manufacturers
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Ceva Sante Animale
Tildren | Ceva Sante Animale
A single dose of TILDREN should be administered as an intravenous infusion at a dose of 1 mg/kg (0.45 mg/lb). The infusion should be administered slowly and evenly over 90 minutes to minimize the risk of adverse reactions.
Maximum effect may not occur until 2 months post-treatment.
Do not reconstitute or mix TILDREN with calcium containing solutions or other solutions containing divalent cations such as Lactated Ringers as it may form complexes with these ions.
STEP 1: Preparation of the reconstituted solution (20 mg/mL). TILDREN should be reconstituted using strict aseptic technique. Remove 25 mL of solution from a 1 liter bag of sterile 0.9% Sodium Chloride Injection, USP and add it to one vial of TILDREN. Shake gently until the powder is completely dissolved. This reconstituted solution contains 20 mg of tiludronate disodium per mL. After reconstitution further dilution is required before administration.
STEP 2: Preparation of the solution for infusion. Using strict aseptic technique, withdraw the appropriate volume of the reconstituted solution based on the horse’s body weight (see Table 1 below). Inject that volume back into the 1 liter bag of sterile 0.9% Sodium Chloride Injection, USP. Horses greater than 1,210 lbs. will require a second vial of reconstituted TILDREN solution. Invert the infusion bag to mix the solution before infusion. Label the infusion bag to ensure proper use.
After preparation, the infusion should be administered either within 2 hours of preparation, or it can be stored for up to 24 hours under refrigeration at 36-46° F (2-8° C) and protected from light.
STEP 3: Administer for infusion through a suitable intravenous catheter inserted into a jugular vein and connected to the infusion bag using sterile disposable infusion tubing.
Table 1: Dosing Table
Weight Range (lbs)
Volume of Reconstituted
TILDREN Solution (20 mg/mL) to be added to the infusion bag
550-770
15 mL
771-990
20 mL
991-1210
25 mL*
1211-1430
30 mL (25 mL* + 5 mL from additional vial)
1431-1650
35 mL (25 mL* + 10 mL from additional vial)
1651-1875
40 mL (25 mL* + 15 mL from additional vial)
*1 vial = 25 mL
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