CYTARABINE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional LLC

INN (International Name):

CYTARABINE

Composition:

CYTARABINE 100 mg in 5 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparation only) is indicated in the prophylaxis and treatment of meningeal leukemia. Cytarabine Injection is contraindicated in those patients who are hypersensitive to the drug.

Product summary:

Cytarabine Injection is available as follows: 100 mg/5 mL in a single-dose flip top vial (brown) packaged in a carton of 10. NDC No.: 67457-455-52 STORAGE CONDITIONS Protect from light. Retain in carton until time of use. Store between 20° and 25°C (68° and 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYTARABINE- CYTARABINE INJECTION
MYLAN INSTITUTIONAL LLC
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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.
Cytarabine Injection 100 mg/5 mL is a sterile solution of cytarabine
for intravenous, intrathecal or
subcutaneous administration. Each mL contains 20 mg Cytarabine, USP,
and the following inactive
ingredients: sodium chloride 6.8 mg and Water for Injection q.s. When
necessary the pH is adjusted with
hydrochloric acid and/or sodium hydroxide to a pH of 7.4. Each mL
contains approximately 0.12 mEq
sodium.
Cytarabine is chemically 1-ß-D-Arabinofuranosylcytosine. The
structural formula is:
Cytarabine is an odorless, white to off-white, crystalline powder
which is freely soluble in water,
practically insoluble in ethanol (96%) and in methylene chloride.
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 progre