Drug Interaction:
Drug interaction -summary
Digoxin + cytabarine
combination therapy ( including cytabarine ) decrease digoxin absorption even several days after stopping chemotherapy
Indication:
Acute myelocytic leukemia (AML )
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Cytabrine Injection 100mg 10-02-2010
Addl.Pack size 20ml
In combination with other approved anticancer drugs is indicated for
remission induction in acute Non-Lymphocytic Leukemia of adults and
children. It is also been found useful in the treatment of acute Lymphocytic
Leukemia and the Blast phase of Chronic Myelocytic Leukemia .
Intrathecal administration of Cytarbine is indicated in the prophylaxis
and treatment of Meningal Leukemia
Adverse Reaction:
Dementia,convulsions and cerebellar dysfunction,
Respiratory distress syndrome,
G.I.perforation, G.I.disturbances, G.I.haemorrhage,
Marrow suppression. Bone marrow depression, ,
Hepatic dysfunction, renal dysfunction,
Neurotoxicity, Rashes, oral and anal ulceration,
Oseophagitis, Conjuntivitis,
Flu-like syndrome,
Anaphylactoid reactions.
Contra-Indications:
Hypersensitivity, pregnancy.
Special precautions:
Hepatic dysfunction, regular blood counts, infections, lactation.
Dosages/ Overdosage Etc:
Indication-
Acute myelocytic leukemia (AML )
Dosage-
Given SC or intrathecally or by IV infusion or injection
Patient Information:
1. Allergies- Tell your doctor if you have ever had any unusual or allergic reactions to cytarbine or other related medicines. Also tell your doctor if youn are allergic to any other substances such as foods, preservatives or dyes.
2. Pregnancy- this may cvause birth defects which occured ifeither male or female is taking it at the time of conception or itis taken during pregnancy. Although sterility has been reported it is usually only temporary.
3. Breast feeding- not recommended
4. Children- not reported to cause different side effects or problems in children than adults
5. Elderly- not expected to cause different side effects in older people tan it does in younger adults
6. Other medicines- tell your doctor if you are taking any other medicines- Amphotericin B by injection or Antithyroid agents or Azathioprine or Chloramphenicol or Colchicine or Flucytosine or Ganciclovir or Interferon or Plicamycin or Zidovudine - if you have treated with radiation or cancer medicines - cytarabine may increase the effects of these medicines or radiation therapy on the blood
7. Other medical problems- tell your doctor if you have any other medical problems- Chickenpox or Herpes zoster -risk of severe disease afecting other parts of the body Gout or Kidney stones - cytarabine may increase levels of uric acid in the body which can cause gout or kidney stones
8. Missed dose- If you miss a dose of this medicine take it as soon as possible. However if it is almost time for your next dose go back to your regular dosing schedule. Do not double doses.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Cytarabine exhibits cell phase specificity, primarily killing cells undergoing desoxyribonuleic acid(DNA) synthesis (S-phase) and under certain conditions blocking the progression of cells from the G1 phase to S-phase.
Pharmacokinetics:
When given orally, cytarabine is rapidly metabolised by the G I mucosa and liver, resulting in more than 20% systemic availability. After SC or IM use, peak plasma levels are acheived in 20 to 60 minutes, and are considerably lower than after IV use.
Pregnancy and lactation:
Pregnancy:
Cytarabine can cause fetal harm when administered to pregnant women. Advise women of childbearingpotential to avoid becoming pregnant during treatment. Administer to pregnant only if the benefits outweigh the potential risks.
Lactation:
Not known whether the drug is excreted in breast milk. Decide whether to discontinue nursing or discontinue the drug depending on the importance to the mother.
