Krajina: Južná Afrika
Jazyk: angličtina
Zdroj: South African Health Products Regulatory Authority (SAHPRA)
Bm_squib
VUMON SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): VUMON For I.V. infusion. COMPOSITION: Each ampoule contains 50 mg teniposide , benzyl alcohol 150 mg as preservative and dehydrated ethanol 42,7% (v/v) per 5 mL. PHARMACOLOGICAL CLASSIFICATION: A26 Cytostatic agents. PHARMACOLOGICAL ACTION: VUMON (also known as VM-26) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4'-0-demethyl-1-0 (4,6-0-2 thenylidene-beta-D-glucopyranosyl) epipodophyllotoxin. VUMON is a phase-specific cytotoxic drug, acting in the late S 2 or G 2 phase of the cell cycle by preventing cells from entering mitosis. VUMON also produces single-strand breaks in DNA. The mechanism of action appears to be due to inhibition of type II topoisomerases. Cells resistant to etoposide were fully cross resistant to teniposide and vice versa in both in vivo and in vitro studies, although there have been occasional clinical reports suggesting a lack of complete cross-resistance. Pharmacokinetics The pharmacokinetics of teniposide appear to be linear over a range of doses. Accumulation does not occur after daily administration for 3 days. No major differences in the disposition of the agent in adults and children have been identified. Following intravenous infusion, initial clearance from the central compartment is rapid with a distribution half-life of approximately 1 hour. Teniposide is highly protein bound, >99%, which may limit its distribution within the body. Levels of teniposide in CSF are low relative to simultaneously measured plasma levels. Mean terminal half-life has ranged from approximately 6 to 20 hours with renal clearance accounting for only about 10% of total clearance. While metabolic pathways for teniposide have not been characterised, a Prečítajte si celý dokument