"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
In an early uncontrolled study without dexamethasone prophylaxis, single doses up to 125 mg were administered. One patient at the 125 mg dose level died of encephalopathy 36 hours after receiving an intraventricular dose of DepoCyt (see WARNINGS). This patient, however, was also receiving concomitant whole brain irradiation and had previously received intraventricular methotrexate.
There is no antidote for overdose of intrathecal DepoCyt or unencapsulated cytarabine released from DepoCyt. Exchange of CSF with isotonic saline has been carried out in a case of intrathecal overdose of free cytarabine, and such a procedure may be considered in the case of DepoCyt overdose. Management of overdose should be directed at maintaining vital functions.
DepoCyt® (cytarabine liposome injection) is contraindicated in patients who are hypersensitive to cytarabine or any component of the formulation, and in patients with active meningeal infection.
Last reviewed on RxList: 8/19/2011
This monograph has been modified to include the generic and brand name in many instances.
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