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 wmarrow 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-b-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 on deoxyribose.
It has the following molecular formula: C9H13N3O5
with a molecular weight of 243.22.
Cytarabine for Injection USP is available in vials containing 100 mg,
500mg, 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.