DBL Cytarabine

DBL Cytarabine





Zuellig Pharma
Concise Prescribing Info
Alone or in combination w/ other antineoplastic agents for remission induction & maintenance of AML in adulsts & childn. Acute lymphocytic leukaemia (ALL), blast phase chronic myeloid leukaemia (CML). Intrathecal administration in meningeal leukaemia.
Dosage/Direction for Use
Induction of remission in AML 200 mg/m2 daily by continuous IV infusion over 24 hr for 5 days repeated approx every 2 wk. Intrathecal use in meningeal leukaemia 5-75 mg/m2 once daily for 4 days to once every 4 days.
Special Precautions
Anaphylactic reactions. Preexisting drug-induced bone marrow suppression. Increased risk of spinal cord toxicity if administered both intrathecal & IV w/in few days. Neurological reactions eg, headache to paralysis, coma & stroke-like episodes; induced hyperuricaemia secondary to rapid lysis of neoplastic cells; acute pancreatitis; nausea & vomiting. Abdominal tenderness (peritonitis) & guaiac +ve colitis w/ concurrent neutropenia & thrombocytopenia in conventional-dose schedules. Severe, fatal CNS, GI & pulmonary toxicity in experimental-dose schedules. Severe fatal pulmonary toxicity, adult resp distress syndrome & pulmonary oedema in high-dose schedules. Cardiomyopathy w/ subsequent death following experimental high-dose therapy; complete alopecia in experimental high-dose therapy. Perform periodic monitoring of bone marrow, liver & kidney functions; daily leukocyte & platelet counts. Monitor blood uric acid levels. High-dose use. Avoid use w/ live or live-attenuated vaccines. Preexisting hepatic dysfunction, renal or hepatic impairment. Women of childbearing potential should use effective contraception. Not recommended during pregnancy. Not to be used during lactation.
Adverse Reactions
Sepsis, pneumonia, infection; bone marrow failure, thrombocytopenia, anaemia, megaloblastic anaemia, leukopenia, decreased reticulocyte count; stomatitis, mouth ulceration, anal ulcer & inflammation, diarrhoea, vomiting, nausea, abdominal pain; abnormal hepatic function; alopecia, rash; cytarabine syndrome; cerebral & cerebellar disorder, somnolence; haemorrhagic conjunctivitis, corneal disorder; acute resp distress syndrome, pulmonary oedema. Anorexia; bleeding, thrombophlebitis; skin ulceration; necrotising colitis; skin rash leading to desquamation.
Drug Interactions
Severe neurological reactions w/ intrathecal MTX. Reduced effectiveness of MTX. Decreased steady-state plasma digoxin conc. Antagonism for K pneumoniae strains susceptibility w/ gentamicin. Inhibition of fluorocytosine efficacy therapy. Incompatibility w/ heparin, insulin, fluorouracil, penicillins (eg, oxacillin, penicillin G Na), methylprednisolone Na succinate.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC01 - cytarabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
DBL Cytarabine inj 100 mg/mL
10 mL x 1's
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