Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LAMIVUDINE
PHARMANIAGA MANUFACTURING BERHAD
LAMIVUDINE
60tablet Tablets; 60tablet Tablets
PHARMANIAGA MANUFACTURING BERHAD
_Consumer Medication Information Leaflet (RiMUP) _ LAMYROX TABLET 150MG Lamivudine (150mg) _ _ 1 WHAT IS IN THIS LEAFLET 1. What Lamyrox Tablet 150mg is used for 2. How Lamyrox Tablet 150mg works 3. Before you use Lamyrox Tablet 150mg 4. How to use Lamyrox Tablet 150mg 5. While you are using Lamyrox Tablet 150mg 6. Side effects 7. Storage and disposal of Lamyrox Tablet 150mg 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT LAMYROX TABLET 150MG IS USED FOR Lamyrox Tablet 150mg is used with other antiretroviral medicines, to slow down the progression of Human Immunodeficiency Virus (HIV) infection in adults and children. HIV can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses. HOW LAMYROX TABLET 150MG WORKS Treatment with Lamyrox Tablet 150mg can hinder the growth of human immunodeficiency virus. In this way it stops ongoing damage to the body’s immune system (which fights infection) by stopping production of new viruses. BEFORE YOU USE LAMYROX TABLET 150MG _-When you must not use it _ Do not take Lamyrox Tablet 150mg if you have an allergy to any medicine containing lamivudine or any of the other ingredient (listed at the end of the leaflet). Do not take this medicine if you are pregnant or trying to become pregnant, without first talking to your doctor. Your doctor should discuss with you the risks and benefits of taking these tablets if you are pregnant. Breastfeeding is not recommended while you are taking Lamyrox Tablet 150mg because: lamivudine may enter the breast milk and there is a possibility your baby may be affected there is a risk of passing the HIV infection to your baby. Do not take this medicine after the expiry date printed on the pack or if the packaging is damaged or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal. If you have certain health conditions, your doctor may advise that you take lower dose of Lamyrox Tablet 150mg. If you are not sure whether you Baca dokumen lengkap
LAMYROX TABLET 150MG DESCRIPTION White to off white, biconvex, oval shaped, film coated tablet with Pharmaniaga icon on one side and plain on the other. COMPOSITION Each film-coated tablet contains Lamivudine 150 mg 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 metabolised intracellularly to the 5'-triphosphate, the active moiety, which has an intra-cellular half-life of 16-19 hours. Lamivudine 5'- triphosphate is a weak inhibitor of the RNA and DNA dependant activities of HIV reverse transcriptase, its main mode of action is as a chain terminator of HIV reverse transcription. 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, _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 viral reverse transcriptase (RT). This variant arises both _in vitro_ and in HIV-1 infected patients 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 antiretroviral agents. Zidovudine and stavudine maintain their antiretroviral activities against lamivudine-resistant HIV-1. Abacavir maintains its antiretrovira Baca dokumen lengkap