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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.
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
10 tablets Pack
60 tablets Pack
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Quality
