"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Patients receiving FLOLAN (epoprostenol sodium) should receive the following information. FLOLAN (epoprostenol sodium) must be reconstituted only with STERILE DILUENT for FLOLAN (epoprostenol sodium) . FLOLAN (epoprostenol sodium) is infused continuously through a permanent indwelling central venous catheter via a small, portable infusion pump. Thus, therapy with FLOLAN (epoprostenol sodium) requires commitment by the patient to drug reconstitution, drug administration, and care of the permanent central venous catheter. Patients must adhere to sterile technique in preparing the drug and in the care of the catheter, and even brief interruptions in the delivery of FLOLAN (epoprostenol sodium) may result in rapid symptomatic deterioration. A patient's decision to receive FLOLAN (epoprostenol sodium) should be based upon the understanding that there is a high likelihood that therapy with FLOLAN (epoprostenol sodium) will be needed for prolonged periods, possibly years. The patient's ability to accept and care for a permanent intravenous catheter and infusion pump should also be carefully considered.
Last reviewed on RxList: 5/24/2011
This monograph has been modified to include the generic and brand name in many instances.
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