CYTARABINE- cytarabine injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Fresenius Kabi USA, LLC

INN (International Name):

CYTARABINE

Sammensætning:

CYTARABINE 100 mg in 1 mL

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute non-lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia. Cytarabine Injection is contraindicated in those patients who are hypersensitive to the drug.

Produkt oversigt:

The container closure is not made with natural rubber latex.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CYTARABINE - CYTARABINE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
CYTARABINE INJECTION
Rx only
FOR INTRAVENOUS, INTRATHECAL AND 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
injection 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
Injection. Before making this judgment or beginning treatment, the
physician
should be familiar with the following text.
DESCRIPTION:
Cytarabine Injection, an antineoplastic, is a sterile solution of
cytarabine for intravenous,
intrathecal or subcutaneous administration. Each mL contains 100 mg
cytarabine USP,
in 2 g/20 mL (100 mg/mL) single dose vial and the following inactive
ingredients: water
for injection q.s. When necessary the pH is adjusted with hydrochloric
acid and/or
sodium hydroxide to a pH of 7.7.
Cytarabine is chemically 1-β-D-Arabinofuranosylcytosine. The
structural formula is:
C
H
N
O M.W. 243.22
9
13
3
5
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
understood, it appears
that cytarabine