Dear Health Care Professional:

In consultation with FDA, Pfizer has recently amended the prescribing information for TROVAN I.V. (alatrofloxacin mesylate injection) to include information on the potential incompatibility of alatrofloxacin mesylate injection with two commonly used diluents, 0.9% sodium chloride injection, USP (usually referred to as normal saline solution) and Lactated Ringer's, USP.

Specifically, the DOSAGE and ADMINISTRATION section of the TROVAN I.V. labeling has been revised to include the following information:

"TROVAN I.V. should not be diluted with 0.9% Sodium Chloride Injection, USP (normal saline), alone or in combination with other diluents. A precipitate may form under these conditions. In addition, TROVAN I.V. should not be diluted with Lactated Ringer's, USP.

Normal saline, 0.9% Sodium Chloride Injection, USP can be used for flushing I.V. lines prior to or after administration of Trovan I.V."

Health Care Professionals should carefully follow the instructions included in the attached REVISED LABELING when preparing alatrofloxacin mesylate injection for administration. It should be noted that TROVAN I.V. is compatible in the following intravenous solutions:

Compatible Intravenous Solutions:
5% Dextrose Injection, USP
0.45% Sodium Chloride Injection, USP
5% Dextrose and 0.45% Sodium Chloride Injection, USP
5% Dextrose and 0.2% Sodium Chloride Injection, USP
Lactated Ringer's and 5% Dextrose Injection, USP

Joseph M. Feczko, M.D.
Senior Vice President – Medical & Regulatory Operations
Pfizer Pharmaceuticals

Attachment - REVISED LABELING FOR TROVAN I.V.

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