Cytarabine USP 100 mg (100 mg / 1 ml)
COMPOSITION: Cytomia Injection: Each vial contains Cytarabine USP 100 mg (100 mg / 1 ml).
INDICATIONS: Cytarabine may be used alone or in
combination with other chemotherapeutic agents. It is indicated for induction
of remission of leukaemia, particularly for acute myeloid leukaemia, in adults
and children. Cytarabine has been used for remission induction in acute
lymphocytic leukaemia, chronic myeloid leukaemia and erythroleukaemia; and in
the treatment and maintenance therapy of meningeal leukaemia and other
meningeal neoplasms. Chidren with non-Hodgkin's lymphoma have benefitted from a
combination drug programme (LSA2L2) that includes cytarabine
DOSAGE AND
ADMINISIRATION
Being orally inactive, cytarabine is administered by a variety of parenteral
routes: subcutaneously, intravenously either as a bolus "push" or as
a continuous infusion, or intrathecally. Thrombophlebitis has occurred at the
site of drug injection or infusion in some patients. Pain and inflammation at
subcutaneous injection sites are rare. Subcutaneous injection sites should be
rotated around the areas of body fat: the abdomen, thighs and flank region. The
drug is generally well tolerated in most instances. Higher total doses can be
better tolerated when administered by rapid IV injection as compared to slow
infusion. Such a phenomenon can be explained by the rapid inactivation of the
drug and the brief exposure of susceptible normal neoplastic cells to
significant levels after rapid injection. Normal and neoplastic cells appear to
respond in almost parallel manner to these two modes of administration and no
distind advantage has been established for either. Clinical experience to date
indicates that success with cytarabine therapy depends more on adeptness in
modifying day-to-day dosage to obtain maximum leukaemic cell killed with
tolerable toxicity, then on the fundamental treatment protocol selected at the
start of therapy.Toxicity necessitating dosage modification almost always
occurs. Dosage of cytarabine must be based on the clinical and haematological
response and tolerance of the patient so as to obtain optimum therapeutic
results with minimum adverse effects. Even though higher total doses of
cytarabine can be given by IV injection compared to continuous IV infusion with
similar haematologic toxicity, the most effective dosage schedule and method of
administration are yet to be established. Moreover, cytarabine is often used in
combination with other cytotoxic drugs, thereby necessitating dose modification
of cytarabine and other chemotherapeutic agents, and the method as well as the
sequence of administration. Following is an outline of dosage schedules for
cytarabine therapy as reported in the literature.
Use in Pregnancy: Cytarabine is suspected to have
caused or may be expected to cause an increased incidence of human fetal
malformations or irreversible damages. It may also have adverse pharmacological
effects. Cytarabine has been shown to be teratogenic in some animal species and
should not be used during pregnancy, especially during the first trimester, not
in women likely to become pregnant.
Use in
Lactation: It is not known whether cytarabine is excreted in human milk.
Women should be advised not to breast feed while being treated with cytarabine,
because of the risks to the infant
Packaging: Cytomia Injection: Each commercial box contains 1 vial of Cytarabine 100 mg Injection