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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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