Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
CYTARABINE (UNII: 04079A1RDZ) (CYTARABINE - UNII:04079A1RDZ)
Pfizer Laboratories Div Pfizer Inc.
CYTARABINE
CYTARABINE 20 mg in 1 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
CYTARABINE- CYTARABINE INJECTION PFIZER LABORATORIES DIV PFIZER INC. ---------- CYTARABINE INJECTION 20MG/ML -25ML RX ONLY NOT FOR INTRATHECAL USE - CONTAINS BENZYL ALCOHOL FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY WARNING Only physicians experienced in cancer chemotherapy should use Cytarabine Injection. 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 judgment or beginning treatment, the physician should be familiar with the following text. DESCRIPTION Cytarabine Injection, an antineoplastic agent, is a sterile preserved solution for intravenous or subcutaneous administration, and is available in a 500 mg (20 mg/mL) multidose vial. Each mL contains: 20 mg Cytarabine, USP and the following inactive ingredients: benzyl alcohol 0.9% and Water for Injection q.s. The pH is adjusted with hydrochloric acid and/or sodium hydroxide to a target pH of 7.6. Cytarabine is chemically 4-amino-1-β-D-arabinofuranosyl-2(1H)-pyrimidinone. The structural formula is: Cytarabine is an odorless, white to off-white, crystalline powder which is freely soluble in water and slightly soluble in alcohol and in chloroform. CLINICAL PHARMACOLOGY CELL CULTURE STUDIES Cytarabine is cytotoxic to a wide variety of proliferating mammalian cells in culture. It exhibits cell phase specificity, primarily killing cells undergoing DNA synthesis (S-phase) and under certain conditions blocking the progression of cells from the G phase to the S-phase. Although the mechanism of action is not completely u Lugege kogu dokumenti