Lamivox 10mgml (Lamivudine Oral Solution 10mgml)

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

LAMIVUDINE

Dostupné z:

UNIMED SDN BHD

INN (Medzinárodný Name):

LAMIVUDINE

Počet v balení:

240ml mL

Výrobca:

Aurobindo Pharma Limited (Unit III),

Súhrn charakteristických

_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