Страна: Нова Зеландия
Език: английски
Източник: Medsafe (Medicines Safety Authority)
Lamivudine 150mg; ; Zidovudine 300mg
GlaxoSmithKline NZ Limited
Lamivudine 150 mg
150 mg/300 mg
Film coated tablet
Active: Lamivudine 150mg Zidovudine 300mg Excipient: Colloidal silicon dioxide Magnesium stearate Microcrystalline cellulose Opadry white YS-1-7706-G Purified water Sodium starch glycolate
Blister pack, PVC & aluminium, 60 tablets
Prescription
Prescription
Mylan Laboratories Limited
Indicated for the treatment of HIV infected adults and adolescents over the age of 12 years, with progressive immunodeficiency (CD4 = Count = < 500 cells/mm3).
Package - Contents - Shelf Life: Blister pack, PVC/Al - 60 tablets - 24 months from date of manufacture stored at or below 30°C
1997-11-18
1 NEW ZEALAND DATA SHEET COMBIVIR ® TABLETS _LAMIVUDINE 150MG & ZIDOVUDINE 300MG TABLETS _ PRESENTATION COMBIVIR film-coated tablets contain 150mg lamivudine and 300mg zidovudine. COMBIVIR film-coated tablets are white to off-white capsule-shaped engraved with GXFC3 on one side. Do not halve tablet. USES _ACTIONS _ Pharmacotherapeutic group - nucleoside analogue. Lamivudine and zidovudine are potent, selective inhibitors of HIV-1 and HIV- 2. Lamivudine has been shown to be highly synergistic with zidovudine, inhibiting the replication of HIV in cell culture. Both active substances are metabolised sequentially by intracellular kinases to the 5’-triphosphate (TP). Lamivudine-TP and zidovudine-TP are substrates for and competitive inhibitors of HIV reverse transcriptase. However, their main antiviral activity is through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination. Lamivudine and zidovudine triphosphates show significantly less affinity for host cell DNA polymerases. _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. 2 Cros Прочетете целия документ