CYTARABINE injection

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

CYTARABINE (UNII: 04079A1RDZ) (CYTARABINE - UNII:04079A1RDZ)

MAH:

Pfizer Laboratories Div Pfizer Inc.

INN:

CYTARABINE

composition:

CYTARABINE 20 mg in 1 mL

prescription_type:

PRESCRIPTION DRUG

authorization_status:

Abbreviated New Drug Application

SPC

CYTARABINE- CYTARABINE INJECTION
PFIZER LABORATORIES DIV PFIZER INC.
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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