Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
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ALKERAN* 2 mg Tablets SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form) ALKERAN* 2 mg Tablets COMPOSITION Each ALKERAN tablet contains 2 mg melphalan . PHARMACOLOGICAL CLASSIFICATION: A26 Cytostatic agents PHARMACOLOGICAL ACTION: Melphalan is a bifunctional alkylating agent. Formation of carbonium intermediates from each of the two bis-chloroethyl groups enables alkylation through covalent binding with the 7-nitrogen of guanine on DNA, cross-linking two DNA strands and thereby preventing cell replication. INDICATIONS: ALKERAN Tablets are indicated in the treatment of: Multiple myeloma and advanced ovarian adenocarcinoma. ALKERAN Tablets may be used in the treatment of: Breast carcinoma: either alone or in combination with other medicines. ALKERAN has been used as an adjuvant to surgery in the management of breast carcinoma. CONTRA-INDICATIONS: ALKERAN should not be given to patients who have suffered a previous allergic reaction to melphalan. Lactation: Mothers receiving ALKERAN should not breast feed. Pregnancy: The use of melphalan is contra-indicated during pregnancy as mutagenicity has been demonstrated in animals. WARNINGS: ALKERAN IS AN ACTIVE CYTOTOXIC AGENT FOR USE ONLY UNDER THE DIRECTION OF PHYSICIANS EXPERIENCED IN THE ADMINISTRATION OF SUCH AGENTS. Safe handling of ALKERAN formulations should follow guidelines for the handling of cytotoxic drugs according to prevailing local recommendations and/or regulations. Provided the outer coating of the tablet is intact, there is no risk in handling ALKERAN tablets. ALKERAN Tablets should not be divided. It is essential that careful attention should be paid to the monitoring of blood counts. (Refer to SIDE-EFFECTS AND SPECIAL PRECAUTIONS) Patients with renal impairment should be closely observed as they may have uraemic marrow su Read the complete document