Epirubicin hydrochloride 50mg/vial (freeze dried powder for reconstitution): i.v injection. Epirubicin is an antimitotic and cytotoxic anthracycline antibiotic drug.

Ind: Cancers of breast, stomach, liver, pancreas, sigmoid colon, rectum, lungs, ovaries head & neck; leukemia; malignant lymphomas & soft tissue sarcomas.

C/I: Hypersensitivity to epirubicin or any other component of the product, hydroxybenzoates or other anthracenediones/anthracyclines such as doxorubicin; patients already treated with maximum cumulative doses of epirubicin &/or other anthracyclines; persistent myelosuppression; severe hepatic impairment; current or prior history of cardiac impairment including severe myocardial insufficiency; recent myocardial infarction & severe arrhythmias.

A/R: Important drug-related adverse events that occurred during clinical trials included leukope¬nia, neutropenia, anemia, thrombocytopenia,

asymptomatic drops in lelt ventricular ejection fraction, congestive heart failure, acute leukemia, nausea/vomiting, mucositis/stomatitis, diarrhea, anorexia, malaise/asthenia, infection fever, amenorrhea, hot flashes, alopecia, local toxicity, rash/itch, congestive heart failure, acute leukemia, nausea/vomiting, mucositis/stomatitis, diarrhea, anorexia, malaise/asthenia, infection, fever, amenorrhea, hot flashes, alopecia, local toxicity, rash/ itch, hepatic dysfunction, conjunctivitis/keratitis.

Precautions & warnings: Leukopenia being the most common acute toxicity, hematologic profiles should be assessed before & during each cycle of therapy. Life-threatening congestive heart failure (CHF) can occur, particularly if cumulative dose of 900 to 1000mg/m2 is exceeded. Cardiac function should be assessed before starting treatment & monitored throughout therapy; prompt discontinuation of epirubicin at the first sign of impaired function is recommended. As it is excreted by liver, liver function should be evaluated before & during treatment. Epirubicin may induce hyperuricemia due to tumor-lysis syndrome. The i.v injection may produce local pain; if there is extravasation during administration, severe local tissue necrosis & cellulitis will occur. In such an event, drug infusion should be immediately stopped. Epirubi¬cin is mutagenic & carcinogenic in animals. Pregnancy & lactation: Epirubicin use during pregnancy & lactation is potentially hazardous. Patients should be advised against conception & breast feeding during epirubicin chemotherapy. Dosage & admin: Intravenous administration: As a single agent, dose per cycle in adults is 60-135mg/m2. Each treatment cycle could be repeated every 3 to 4 weeks. When used in combination with other cytotoxic drugs, the dose per cycle should be reduced. Dose of 120mg/m2 per cycle should not be exceeded in such cases.

Reconstitution of vial: Trained personnel shou¬ld reconstitute injection vial. The vial contents should be reconstituted with either water for injection or sodium chloride injection. Dissolution will take place with gentle shaking & without inversion within 30 seconds. Intravesical administration: Epirubicin rapid dissolution is used by intravesical administration for treatment of papillary transitional cell carcinoma of the bladder & carcinoma in situ. For dosage please see full prescribing information.

Pediatric patients: Safety & efficacy in pediatric patients is not established.

Overdose: Treat by support & careful monitoring. Delayed cardiac failure can occur for up to 6 months after the event.

Note: Please consult the full prescribing information (manufacturer's literature) before using epirubicin injection.

50mg vial x l's pack: 3704.60 MRP