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Each tablet
contains :
Composition:
Stavudine
..................................30 mg
Lamivudine..............................150
mg
Indications:
Lamovir-S
is indicated for the treatment of HIV
infection as part of combination
therapy.
Description:
Stavudine is an
analog
of
thymidine.
It is phosphorylated by cellular
kinases
into active triphosphate. Stavudine
triphosphate inhibits the HIV
reverse transcriptase
by competing with natural substrate,
thymidine triphosphate. It also causes
termination of
DNA synthesis
by incorporating into it.Simultaneous
use of
AZT
is not recommended, as it can inhibit
the intracellular
phosphorylation
of stavudine. Other anti-HIV drugs do
not possess this property.
Adverse events
The main severe adverse effect is
peripheral
neuropathy,
which can be corrected by reducing
dosage. Stavudine has been shown in
laboratory test to be
genotoxic,
but with clinical doses its
carcinogenic
effects are non-existent. It is also one
of the most likely antiviral drugs to
cause
lipodystrophy,
and for this reason it is no longer
recommended as a component of first line
therapy.
CONTRA-INDICATIONS:
STAVUDINE is contra-indicated in
patients with hypersensitivity to
stavudine or to any of the components in
the formulation.
Pregnancy and Lactation
Safety in pregnancy has not been
established. Studies in animals suggest
that stavudine is excreted in milk.
Because of both the potential for HIV
transmission and the potential for
side-effects in breast-feeding infants,
Stavudine is not recommended for use by
breast-feeding mothers.
WARNINGS:
Less frequent cases of lactic
acidosis and severe hepatomegaly with
steatosis, including fatal cases, have
been reported with the use of nucleoside
analogues alone or in combination,
including Stavudine and other
antiretrovirals. Obesity and prolonged
nucleoside exposure may be risk factors.
The majority of cases reported have been
in women and fatal lactic acidosis has
been reported in pregnant women who
received
the combination of Stavudine and
didanosine with other antiretrovirals.
Caution should be exercised when
prescribing Stavudine to patients with
known risk factors for liver disease.
Patients with risk factors and those
being given a combination of Aspen
Stavudine, didanosine and hydroxyurea
should be closely monitored for liver
toxicity.
Peripheral neuropathy is a dose-related
clinical toxicity that is characterized
by numbness, tingling or pain in the
hands and feet. Therapy should be
withdrawn immediately. Symptoms may
temporarily worsen following
discontinuation of Aspen Stavudine.
Should symptoms resolve satisfactorily,
then a lower dose therapy may be
considered (see “DOSAGE AND DIRECTIONS
FOR USE”).
Patients with either a history of
neuropathy, or in the advanced stages of
HIV infection or those using combination
therapy of Stavudine with didanosine,
are at greater risk for peripheral
neuropathy and should be monitored
closely.
Pancreatitis, either fatal or non-fatal,
has been reported in patients on
combination therapy with didanosine
(with or without hydroxyurea).
Combination therapy should be suspended
should pancreatitis be suspected and
reinstitution of stavudine therapy
alone, once diagnosis is confirmed,
should be undertaken with particular
caution and close patient monitoring.
Dosage:
1 tablet twice daily for patients
weighing < 60 kg
Presentations:
MRP Retailer
Stockist
10 tablets
108.00 86.40
77.76
60 tablets
611.00 488.80 439.92
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