Country: Afrika t’Isfel
Lingwa: Ingliż
Sors: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ASPEN LAMIVUDINE 150 mg Tablets ASPEN LAMIVUDINE 10 mg/ML Solution SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ASPEN LAMIVUDINE 150 mg Tablets ASPEN LAMIVUDINE 10 mg/ML Solution COMPOSITION: Each Tablet contains: 150 mg lamivudine Each mL contains. 10 mg lamivudine Preservatives: 1,50 mg methyl hydroxybenzoate (0.15% w/v) 0,18 mg propyl hydroxybenzoate (0.018%w/v) PHARMACOLOGICAL CLASSIFICATION: A 20.2.8 - Antiviral agents PHARMACOLOGICAL ACTION: Lamivudine is a selective inhibitor of HIV-1 and HIV-2 replication in vitro, including zidovudine-resistant clinical isolates of the human immunodeficiency virus (HIV). Lamivudine is metabolised intracellularly to the active 5'- triphosphate which inhibits the RNA-and DNA-dependant activities of HIV reverse transcriptase by termination of the viral DNA chain. Lamivudine does not interfere with cellular deoxynucleotide metabolism and has little effect on mammalian cell and mitochondrial DNA content. In vitro, lamivudine demonstrates low cytotoxicity to peripheral blood lymphocytes, to established lymphocyte and monocyte-macrophage cell lines, and to a variety of bone marrow progenitor cells. In vitro, lamivudine therefore has a high therapeutic index. Reduced in-vitro sensitivity to lamivudine has been reported for HIV isolated from patients who have received lamivudine therapy before. Lamivudine has been shown to act additively or synergistically with other anti-HIV agents, particularly zidovudine, inhibiting the replication of HIV in cell culture. In vitro studies indicate that zidovudine-resistant virus isolates can become zidovudine-sensitive when they acquire resistance to lamivudine. Pharmacokinetics: Pharmacokinetics in adults: Following oral administration, lamivudine is well absorbed with bioavailability of approximately 80%. The mean time Aqra d-dokument sħiħ