Epiruba-50

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.

Prescribing Description

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