Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LAMIVUDINE
UNIMED SDN BHD
LAMIVUDINE
240ml mL
Aurobindo Pharma Limited (Unit III),
_Lamivox 10mg/ml (Lamivudine Oral Solution 10mg/m_ LAMIVOX 10MG/ML (LAMIVUDINE ORAL SOLUTION 10MG/ML) DESCRIPTION: A clear, colorless to pale yellow, strawberry-banana flavored liquid. Each ml contains Lamivox 10mg. PHARMACODYNAMICS: Lamivudine is a potent, selective inhibitor of HIV-1 and HIV-2 replication in vitro. It is also active against zidovudine-resistant clinical isolates of HIV. Lamivudine is metabolized intracellularly to the 5’-triphosphate, the active moiety, which has an intra-cellular half-life of 16 to 19 h. lamivudine 5’-triphosphate is a weak inhibitor of the RNA and DNA dependent activities of HIV reverse transcriptase, its main mode of action is as a chain terminator of HIV reverse transcription. Lamivudine has been shown to act additively or synergistically with other anti-HIV agents, particularly zidovudine, inhibiting the replication of HIV in cell culture. Lamivudine does not interfere with cellular deoxynucleotide metabolism and has little effect on mammalian cell and mitochondrial DNA content. I n 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, in vitro, a high therapeutic index. HIV-1 resistance to lamivudine involves the development of a M184V amino acid change close to the active site of the rival reverse transcriptase (RT). This variant arises both in vitro and in HIV-1 infected p atients treated with lamivudine-containing antiretroviral therapy. M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro. In vitro studies indicate that zidovudine-resistant virus isolates can become zidovudine sensitive when they simultaneously acquire resistance to lamivudine. The clinical relevance of such findings remains, however, not well defined. Cross-resistance conferred by the M184V RT is limited within the nucleoside inhibitor class of antiretrovir Les hele dokumentet