"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"...
for Injection USP
For Intravenous, Intrathecal, or Subcutaneous Use Only
Only physicians experienced in cancer chemotherapy should use Cytarabine for Injection USP.
For induction therapy, patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The main toxic effect of cytarabine is bone marrow suppression with leukopenia, thrombocytopenia, and anemia. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration, and hepatic dysfunction.
The physician must judge possible benefit to the patient against known toxic effects of this drug in considering the advisability of therapy with cytarabine. Before making this judgement or beginning treatment, the physician should be familiar with the following text.
Cytarabine for Injection USP, commonly known as ara-C, an antineoplastic for intravenous, intrathecal, or subcutaneous administration, contains sterile lyophilized cytarabine (1-β-D-Arabinofuranosylcytosine). Cytarabine is an odorless, white to off-white, crystalline powder which is freely soluble in water and slightly soluble in alcohol and in chloroform. Cytarabine is a synthetic nucleoside which differs from the normal nucleosides cytidine and deoxycytidine in that the sugar moiety is arabinose rather than ribose or deoxyribose. Its structural formula is:
Cytarabine for Injection USP is available in vials containing 100 mg, 500 mg, 1 g, and 2 g cytarabine. When necessary, the pH of Cytarabine for Injection USP was adjusted with hydrochloric acid and/or sodium hydroxide. Reconstitute with Bacteriostatic Water for Injection USP with benzyl alchohol for intravenous and subcutaneous use only. Do not use this diluent intrathecally. See "WARNINGS" Section.
What are the possible side effects of cytarabine (Cytosar-U, Tarabine PFS)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have a serious side effect such as:
- fever with nausea, vomiting, and headache;
- problems with your vision or hearing;
- loss of movement in any part of your body;
- loss of bowel or bladder control;
- fever, chills, body aches, flu symptoms, sores in your mouth and throat;
- pale skin, feeling light-headed or short of breath, rapid...
Last reviewed on RxList: 11/3/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Cytarabine Information
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