Epirubicin Hydrochloride USP
Composition:
Epiruba-10: Each vial contains Epirubicin
Hydrochloride USP 10mg solution for injection.
Epiruba-50: Each vial contains Epirubicin
Hydrochloride USP 50mg solution for injection.
Indications:
Epirubicin Injection is indicated as a component of adjuvant therapy in
patients with evidence of axillary node tumor involvement following resection
of primary breast cancer.
Dosage
and Administration: Recommended Dose: The recommended dose
of Epirubicin is 100 to 120mg/m². The following regimens are recommended:
|
CEF-120: |
Cyclophosphamide |
75 mg/m² PO D 1-14 |
|
Epirubicin |
60mg/m² IV D 1,8 |
|
|
5-Fluorouracil |
500mg/m² IV D 1,8 |
|
|
Repeated every
28 days for 6 cycles |
||
|
FEC-100: |
5-Fluorouracil |
500mg/m² |
|
Epirubicin |
100mg/m² |
|
|
Cyclophosphamide |
500mg/m² |
|
All drugs administered intravenously on day 1 and
repeated every 21 days for 6 cycles. Patients administered the 120mg/m² regimen
of Epirubicin should receive prophylactic antibiotic therapy. Or, as directed
by the registered physician.
Use
in Pregnancy and lactation: Pregnancy Category D. There are no
adequate and well controlled studies in pregnant women. It should be used in
pregnancy only if the potential benefit justifies the potential risk to the
fetus. It is not known whether this drug is excreted in human milk. Because of
the potential for serious adverse reactions from Epirubicin in nursing infants,
a decision should be made whether to discontinue nursing or to discontinue the
drug, taking into account the importance of the drug to the mother.
Packaing:
Epiruba-10: Each box contains one vial of 10mg
Epirubicin Hydrochloride USP solution for injection.
Epiruba-50: Each box contains one
vial of 50mg Epirubicin Hydrochloride USP solution for injection.
