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CYTARINE INJECTION 100MG/ML

Product Information

Registration Status: Active

SIN13245P

CYTARINE INJECTION 100MG/ML is approved to be sold in Singapore with effective from 2007-10-04. It is marketed by FRESENIUS KABI (SINGAPORE) PTE LTD, with the registration number of SIN13245P.

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

This product is manufactured by FRESENIUS KABI ONCOLOGY LTD 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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