País: Sudáfrica
Idioma: inglés
Fuente: South African Health Products Regulatory Authority (SAHPRA)
Bm_squib
CeeNU 10 mg CAPSULES CeeNU 40 mg CAPSULES SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): CeeNU 10 mg CAPSULES CeeNU 40 mg CAPSULES COMPOSITION: Capsules containing 10 mg and 40 mg lomustine respectively. PHARMACOLOGICAL CLASSIFICATION: A 26 Cytostatic agents. PHARMACOLOGICAL ACTION: CeeNU [1-(2-chlorethyl)-3-cyclohexyl-1-nitrosourea] is one of a group of nitrosoureas. It is a yellow powder with the empirical formula of C9H16ClN3O2 and a molecular mass of 233,71. It is soluble in water, saline and alcohol and highly lipid soluble. It is relatively unionized at a physiological pH. The structural formula is: {Structure here} It is generally agreed that CeeNU acts as an alkylating agent but, as with other nitrosoureas, it may also inhibit several key enzymatic processes. CeeNU is given orally. Following oral administration of radioactive CeeNU at doses ranging from 30 mg/m2 to 100 mg/m2, about half of the radioactivity given was excreted within 24 hours. The serum half-life of the drug and/or metabolites ranges from 16 hours to 2 days. Tissue levels are comparable to plasma levels at 15 minutes after intravenous administration. Because of the high lipid solubility and the relative lack of ionization at a physiological pH, CeeNU crosses the blood brain barrier quite effectively. Levels of radioactivity in the CSF are 50% or greater than those measured concurrently in plasma. INDICATIONS: CeeNU (lomustine) is indicated as adjuvant therapy to surgery and radiotherapy or in combination therapy with other chemotherapeutic agents in the following clinical situations: Brain tumours - both primary and metastatic in patients who have already received appropriate surgical and/or radio therapeutic procedures. Hodgkin’s Disease - as a secondary therapy. [Alone or in combinat Leer el documento completo