"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"...
(streptozocin) Sterile Powder
ZANOSAR (streptozocin) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
A patient need not be hospitalized but should have access to a facility with laboratory and supportive resources sufficient to monitor drug tolerance and to protect and maintain a patient compromised by drug toxicity. Renal toxicity is dose-related and cumulative and may be severe or fatal. Other major toxicities are nausea and vomiting which may be severe and at times treatment-limiting. In addition, liver dysfunction, diarrhea, and hematological changes have been observed in some patients. Streptozocin is mutagenic. When administered parenterally, it has been found to be tumorigenic or carcinogenic in some rodents.
The physician must judge the possible benefit to the patient against the known toxic effects of this drug in considering the advisability of therapy with ZANOSAR (streptozocin) . The physician should be familiar with the following text before making a judgment and beginning treatment.
Each vial of ZANOSAR contains 1 g of the active ingredient streptozocin 2 -deoxy - 2 -[[(methylnitrosoamino)carbonyl]amino] - α(and β) - D - glucopyranose and 220 mg citric acid anhydrous. ZANOSAR (streptozocin) is available as a sterile, pale yellow, freeze-dried preparation for intravenous administration. The pH was adjusted with sodium hydroxide. When reconstituted as directed, the pH of the solution will be between 3.5 and 4.5. Streptozocin is a synthetic antineoplastic agent that is chemically related to other nitrosoureas used in cancer chemotherapy. Streptozocin is an ivory-colored crystalline powder with a molecular weight of 265.2. It is very soluble in water or physiological saline and is soluble in alcohol. The structural formula is represented below:
What are the possible side effects of streptozocin (Zanosar)?
If you experience any of the following serious side effects from streptozocin, contact your doctor immediately or seek emergency medical attention:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- kidney damage (little or no urine production, blood in the urine);
- liver problems (changes in blood test results, abdominal pain, yellowing of the skin or eyes, decreased appetite, nausea);
- decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black,...
Last reviewed on RxList: 2/26/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Zanosar Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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