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Gong z, evans hl: effect of chelation with meso-dimercaptosuccinic acid dmsa ; before and after the appearance of lead-induced neurotoxicity in the rat, toxicology & applied pharmacology, 1997 jan; 144 2 ; : 205-14. For pediatric use has not yet been fully implemented, three of the medicines approved in 1999 are specifically approved for children. These include drugs for respiratory distress syndrome in premature infants, hypoxic respiratory failure in neonates, and influenza A and B for children 12 years and older ; . The law requires FDA to publish annual reports of its progress in meeting its performance goals. For FY 1998. AMOPLACE Treatment of Intermediate-Grade and High-Grade Malignant Lymphoma: A Cancer and Leukemia Group B Study . BarbaraA. Parker, Maria Santarelli, Mark R. Green, James R. Anderson, M. Robert Cooper, Delvyn Case, Jr, Maurice Barcos, Bruce A. Peterson, and Arlan J. Gottlieb Second Malignancies After Treatment of Hodgkin's Disease: The Influence of Treatment, Follow-Up Time, and Age . Jenny Foss Abrahamsen, Aage Andersen, Einar Hannisdal, Ole Nome, Arne Foss Abrahamsen, Stein Kvaloy, and Herman Host Second Malignant Neoplasms in Children Treated for Rhabdomyosarcoma . Ruth Heyn, Veronica Haeberlen, William A. Newton, Abdelsalam H. Ragab, R. Beverly Raney, Melvin Tefft, Moody Wharam, Lisa G. Ensign, and HaroldM. Maurerfor the Intergroup Rhabdomyosarcoma Study Committee Treatment of CNS Relapse in Children With Acute Lymphoblastic Leukemia: A Pediatric Oncology Group Study . Naomi J. Winick, Stephen D. Smith, JonathanShuster, Stephen Lauer, Moody D. Wharam, Vita Land, George Buchanan, and Gaston Rivera Does Cranial Irradiation Reduce the Risk for Bone Marrow Relapse in Acute Myelogenous Leukemia? Unexpected Results of the Childhood Acute Myelogenous Leukemia Study BFM-87 U. Creutzig, J. Ritter, M. Zimmermann, and G. Schellong Escalating Teniposide Systemic Exposure to Increase Dose Intensity for Pediatric Cancer Patients John H. Rodman, Wayne L. Furman, Marc Sunderland, Gaston Rivera, and William E. Evans Dose-Escalation Trial of M195 Labeled With Iodine 131 for Cytoreduction and Marrow Ablation in Relapsed or Refractory Myeloid Leukemias . Michael A. Schwartz, David R. Lovett, Arlene Redner, Ronald D. Finn, Martin C. Graham, ChaitanyaR. Divgi, Lucy Dantis, Timothy S. Gee, Michael Andreeff, Lloyd J. Old, Steven M. Larson, and David A. Scheinberg Second Allogeneic Marrow Transplantation for Patients With Recurrent Leukemia After Initial Transplant With Total-Body Irradiation-Containing Regimens . JeraldP. Radich, Jean E. Sanders, C.D. Buckner, PaulJ. Martin, Finn Bo Petersen, William Bensinger, George B. McDonald, Motomi Mori, Gary Schoch, and John A. Hansen Autologous Bone Marrow Transplant in Acute Myeloid Leukemia in First Remission Peter A. Cassileth, JanetAndersen, HillardM. Lazarus, O. Michael Colvin, John M. Bennett, EdwardA. Stadtmauer, Herbert Kaizer, Roy S. Weiner, Marian Edelstein, and Martin M. Oken Harvesting Bone Marrow in an Outpatient Setting Using Newer Anesthetic Agents Alisa C. Thorne, MargaretStewart, and Subhash C. Gulati Surgical Salvage of Chemorefractory Germ Cell Tumors . Brian R. Murphy, Elyse S. Breeden, John P. Donohue, Jon Messemer, William Walsh, Bruce J. Roth, and Lawrence H. Einhorn Randomized Trial of Hepatic Arterial Floxuridine, Mitomycin, and Carmustine Versus Floxuridine Alone in Previously Treated Patients With Liver Metastases From Colorectal Cancer Nancy Kemeny, Alfred Cohen, Karen Seiter, John A. Conti, Elin R. Sigurdson, Yue Tao, Donna Niedzwiecki, Jose Botet, and Andrew Budd.

18. Ng, J. S. K., Lam, D. S. C., Li, C. K., Chik, K. W., Cheng, G. P. M., Yuen, P. M. P., and Tso, M. O. M. Ocular complications of pediatric bone marrow transplantation. Ophthalmology, 106: 160 164, Frisk, P., Hagberg, H., Mandahl, A., Soderberg, P., and Lonnerholm, G. Cataracts after autologous bone marrow transplantation in children. Acta Pediatr., 89: 814 819, Grimes, P., von Sallmann, L., and Frichette, A. Influence of Myleran on cell proliferation in the lens epithelium. Investig. Ophthalmol., 3: 566 576, Kaida, T., Ogawa, T., and Amemiya, T. Cataract induced by short-term administration of large doses of busulfan: a case report. Ophthalmologica, 231: 397399, 1999. Holford, N. H. G. A size standard for pharmacokinetics. Clin. Pharmacokinet., 30: 329 332, Herman, E. H., Zhang, J., Chadwic, D. P., and Ferrans, V. J. Comparison of the protective effects of amifostine and dexrazoxane against the toxicity of doxorubicin in spontaneously hypertensive rats. Cancer Chemother. Pharmacol., 45: 329 334, Korst, A. E. C., Boven, E., van der Sterre, M. L. T., Fichtinger-Schepman, A. M. J., and van der Vijgh, W. J. F. Influence of single and multiple doses of amifostine on the efficacy and the pharmacokinetics of carboplatin in mice. Br. J. Cancer, 75: 1439 1446, Himms-Hagen, J. Physiological roles of the leptin endocrine system: differences between mice and humans. Crit. Rev. Clin. Lab. Sci., 36: 575 655, Lipshultz, S. E., Colan, S. D., Gelber, R. D., Perez-Atayde, A. R., Sallan, S. E., and Sanders, S. P. Late cardiac effects of doxorubicin therapy for acute lymphoblastic leukemia in childhood. N. Engl. J. Med., 324: 808 815.

FLUPHENAZINE DECANOATE INJECTION, USP 25 mg mL Rx Only DESCRIPTION Fluphenazine decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. Fluphenazine Decanoate is 2-4-[3- ; -propyl]-piperazin-1-yl]ethyl decanoate. It is a highly potent behavior modifier with a markedly extended duration of effect. Fluphenazine Decanoate Injection is a sterile solution available for intramuscular or subcutaneous administration, providing 25 mg fluphenazine decanoate per mL in a sesame oil vehicle with 1.2% w v ; benzyl alcohol as a preservative. Fluphenazine decanoate has the following structural formula: the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of neuroleptic treatment, which patients are likely to develop the syndrome. Whether neuroleptic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of neuroleptic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if neuroleptic treatment is withdrawn. Neuroleptic treatment, itself, however, may suppress or partially suppress ; the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. Given these considerations, neuroleptics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic neuroleptic treatment should generally be reserved for patients who suffer from a chronic illness that, 1 ; is known to respond to neuroleptic drugs, and, 2 ; for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically. If signs and symptoms of tardive dyskinesia appear in a patient on neuroleptics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome. For further information about the description of tardive dyskinesia and its clinical detection, please refer to the sections on PRECAUTIONS, Information for Patients and ADVERSE REACTIONS, Tardive Dyskinesia. ; Neuroleptic Malignant Syndrome NMS ; : A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome NMS ; has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias ; . The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness e.g., pneumonia, systemic infection, etc. ; and untreated or inadequately treated extrapyramidal signs and symptoms EPS ; . Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system CNS ; pathology. The management of NMS should include 1 ; immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2 ; intensive symptomatic treatment and medical monitoring, and 3 ; treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported. The use of this drug may impair the mental and physical abilities required for driving a car or operating heavy machinery. Physicians should be alert to the possibility that severe adverse reactions may occur which require immediate medical attention. Potentiation of the effects of alcohol may occur with the use of this drug. Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established. Usage in Pregnancy: The safety for the use of this drug during pregnancy has not been established; therefore, the possible hazards should be weighed against the potential benefits when administering this drug to pregnant patients. PRECAUTIONS General: Because of the possibility of cross-sensitivity, fluphenazine decanoate should be used cautiously in patients who have developed cholestatic jaundice, dermatoses, or other allergic reactions to phenothiazine derivatives. Psychotic patients on large doses of a phenothiazine drug who are undergoing surgery should be watched carefully for possible hypotensive phenomena. Moreover, it should be remembered that reduced amounts of anesthetics or central nervous system depressants may be necessary. The effects of atropine may be potentiated in some patients receiving fluphenazine because of added anticholinergic effects. Fluphenazine decanoate should be used cautiously in patients exposed to extreme heat or phosphorus insecticides. The preparation should be used with caution in patients with a history of convulsive disorders, since grand mal convulsions have been known to occur. Use with caution in patients with special medical disorders such as mitral insufficiency or other cardiovascular diseases and pheochromocytoma. The possibility of liver damage, pigmentary retinopathy, lenticular and corneal deposits, and development of irreversible dyskinesia should be remembered when patients are on prolonged therapy. Outside state hospitals or other psychiatric institutions, fluphenazine decanoate should be administered under the direction of a physician experienced in the clinical use of psychotropic drugs, particularly phenothiazine derivatives. Furthermore, facilities should be available for periodic checking of hepatic function, renal function, and the blood picture. Renal function of patients on long-term therapy should be monitored; if BUN blood urea nitrogen ; becomes abnormal, treatment should be discontinued. As with any phenothiazine, the physician should be alert to the possible development of "silent pneumonias" in patients under treatment with fluphenazine decanoate. Neuroleptic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of neuroleptic drugs. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is considered too limited to be conclusive at this time. Information for Patients: Given the likelihood that some patients exposed chronically to neuroleptics will develop tardive dyskinesia, it is advised that all patients in whom chronic use is contemplated be given, if possible, full information about this risk. The decision to inform patients and or their guardians must obviously take into account the clinical circumstances and the competency of the patient to understand the information provided. ADVERSE REACTIONS Central Nervous System: The side effects most frequently reported with phenothiazine compounds are extrapyramidal symptoms including pseudoparkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, and hyperreflexia. Muscle rigidity sometimes accompanied by hyperthermia has been reported following use of fluphenazine decanoate. Most often these extrapyramidal symptoms are reversible; however, they may be persistent see below ; . The frequency of such reactions is related in part to chemical structure.

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