Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ASPEN EPIRUBICIN 10 mg ASPEN EPIRUBICIN 50 mg SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ASPEN EPIRUBICIN 10 mg (powder for solution for injection) ASPEN EPIRUBICIN 50 mg (powder for solution for injection) COMPOSITION: ASPEN EPIRUBICIN 10 mg: Epirubicin HCl 10 mg ASPEN EPIRUBICIN 50 mg: Epirubicin HCl 50 mg Methyl parahydroxybenzoate 3,2% m/m. PHARMACOLOGICAL CLASSIFICATION: A 26 Cytostatic agents PHARMACOLOGICAL ACTION: Epirubicin is an anthracycline antibiotic with antineoplastic activity. The exact mechanism of action is unclear, but it appears to be due to intercalation of anthracycline with DNA, eventually inducing DNA cleavage by topoisomerase II. Other cytotoxic mechanisms may be due to inhibition of DNA helicase, thus impairing DNA synthesis and free radical generation. These mechanisms inhibit cellular nucleic acid synthesis and mitosis, resulting in cell death. Pharmacokinetics: Epirubicin, after intravenous administration is extensively distributed into tissues, resulting in a triphasic elimination pattern with half-lives of 3 minutes, 2,5 hours and 33 hours (mean half-life of 40 hours). Epirubicin undergoes hepatic biotransformation to less active metabolites or to metabolites with no inherent activity. It is highly bound to plasma albumin (77%) and is excreted via the biliary (35%) and renal (20%) systems. It does not cross the blood-brain barrier. INDICATIONS: ASPEN EPIRUBICIN is indicated as mono chemotherapy for the treatment of a wide spectrum of neoplasms including breast and gastric carcinomas, malignant lymphomas and soft tissue sarcomas. It may have some benefit in advanced colorectal carcinoma and in malignant melanoma. When given in combination with other chemotherapeutic agents, ASPEN EPIRUBICIN has been used in the treatment of lung and ovarian Read the complete document