TILDREN- tiludronate disodium powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TILUDRONATE DISODIUM (UNII: BH6M93CIA0) (TILUDRONIC ACID - UNII:6PNS59HP4Y)

Available from:

Bimeda, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

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.

Product summary:

TILDREN is supplied in a 30 mL glass vial as a white, sterile lyophilized powder containing 500 mg tiludronic acid (as tiludronate disodium) packaged in a folding carton. For technical assistance or to report suspected adverse reactions, call 1-800-999-0297.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

TILDREN- TILUDRONATE DISODIUM POWDER, FOR SOLUTION
BIMEDA, INC.
----------
TILDREN®
(tiludronate disodium)
Bisphosphonate drug for intravenous infusion. For use in horses only.
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A LICENSED VETERINARIAN.
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A LICENSED VETERINARIAN.
DESCRIPTION
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).
INDICATION
TILDREN is indicated for the control of clinical signs associated with
navicular syndrome in horses.
DOSAGE AND ADMINISTRATION
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.
DIRECTIONS FOR ADMINISTRATION
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. Aft