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DBL CYTARABINE INJECTION 1G/10ML

Product Information

Registration Status: Active

SIN05088P

DBL CYTARABINE INJECTION 1G/10ML is approved to be sold in Singapore with effective from 1990-09-17. It is marketed by HOSPIRA SINGAPORE PTE LTD, with the registration number of SIN05088P.

This product contains Cytarabine 100mg/ml in the form of INJECTION. It is approved for INTRAVENOUS, SUBCUTANEOUS use.

This product is manufactured by Hospira Australia Pty Ltd in AUSTRALIA, andZydus Hospira Oncology Private Limited in INDIA.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Product Reference
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Description

A pyrimidine nucleoside analog that is used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia. Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. Its actions are specific for the S phase of the cell cycle. It also has antiviral and immunosuppressant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p472)

Indication

For the treatment of acute non-lymphocytic leukemia, acute lymphocytic leukemia and blast phase of chronic myelocytic leukemia.

Mechanism of Action

Cytarabine acts through direct DNA damage and incorporation into DNA. 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 G1 phase to the S-phase. Although the mechanism of action is not completely understood, it appears that cytarabine acts through the inhibition of DNA polymerase. A limited, but significant, incorporation of cytarabine into both DNA and RNA has also been reported.

Pharmacokinetics

Absorption
Less than 20% of the orally administered dose is absorbed from the gastrointestinal tract.
Distribution
Metabolism
Hepatic.
Elimination

Toxicity

Cytarabine syndrome may develop - it is characterized by fever, myalgia, bone pain, occasionally chest pain, maculopapular rash, conjunctivitis, and malaise.

Active Ingredient/Synonyms

1-beta-D-Arabinofuranosylcytosine | 4-Amino-1-beta-D-arabinofuranosyl-2(1H)-pyrimidinone | Citarabina | Cytarabinum | Cytosine arabinoside | Cytosine-1-beta-D-arabinofuranoside | cytosine-β-D-arabinofuranoside | Cytarabine |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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