Lamivir-S (Stavudine and Lamivudine Tablets)

Lamivir-S (Lamivudine and Stavudine Tablets)
© The Swiss Pharmacy

Lamivir-S (Stavudine and Lamivudine Tablets) is a
combination of two medicines commonly used in the
management of Human Immunodeficiency Virus (HIV)
infection. Both Stavudine and Lamivudine belong to the
nucleoside analogue class of antiretroviral drugs. Both
medications act by inhibiting the reverse transcriptase of
HIV
, and by terminating the growth of the DNA chain.
Stavudine in combination with Lamivudine has been
shown to have synergistic antiretroviral activity.

Lamivir-S Tablets are manufactured by
Cipla Limited, India in the strengths of
Lamivir-S 30 (Stavudine 30 mg and
Lamivudine 150 mg) and Lamivir-S 40
(Stavudine 40 mg and Lamivudine 150 mg).

Chemical Structure - Stavudine

Chemical Structure - Lamivudine

The active ingredients contained in
Lamivir-S tablets are Stavudine and
Lamivudine.
Each Lamivir-S tablet contains
Stavudine 30 mg and Lamivudine 150 mg
(Lamivir-S 30) or Stavudine 40 mg and
Lamivudine 150 mg (Lamivir-S 40).

Uses of Lamivir-S 30 and Lamivir-S 40 Tablets:
Stavudine and Lamivudine Tablets in combination with other
antiretroviral agents are used for the treatment of HIV-1
infection in patients that are 12 years of age or older.
Lamivir-S tablets contain two active ingredients that are used to treat
HIV infection: Lamivudine and Stavudine. Lamivudine and
Stavudine belongs to a group of anti-retroviral medicines called
nucleoside analogue reverse transcriptase inhibitors (NRTIs). Both
medications act by terminating the growth of the DNA chain and
inhibiting the reverse transcriptase of HIV-1.

Recommended Adult Dosage
The recommended oral dosage of
Lamivir-S (Stavudine and Lamivudine Tablets) for adults
weighing 60kg or more is one Stavudine 40mg and
Lamivudine 150mg combination tablet twice daily under
fasted conditions. The interval between doses of Lamivir-S should
be 12 hours.
For patients weighing less than 60 kg the recommended oral
dosage is Lamivir-S 30 (Stavudine 30 mg/ Lamivudine 150 mg)
every 12 hours.

Recommended Dosage
Pediatrics Dosage: One Stavudine and Lamivudine Tablet
( Stavudine 40 mg/ Lamivudine 150 mg) tablet twice daily under
fasted conditions for patients weighing more than 60 kg and more
than 12 years of age.
Dose Adjustment: Stavudine and Lamivudine Tablets should not be
prescribed for patients requiring dosage adjustment, such as those
with reduced renal function (creatinine clearance 50 ml/min or less)
and those experiencing dose-limiting adverse events. In addition,
Stavudine and Lamivudine Tablets should not be prescribed for
patients who require mg/kg dosing regiments.

Contraindications
➔
Lamivir-S is contraindicated in patients with a known
hypersensitivity (eg, anaphylaxis, Stevens-Johnson Syndrome) to
Lamivudine, Stavudine or any other component of this medication.
➔
Co-administration with Didanosine due to the potential for serious
and/or life-threatening events notably lactic acidosis, liver function
abnormalities, pancreatitis and peripheral neuropathy
➔
Lamivir-S is contraindicated in patients with moderate or severe
(Child-Pugh Class B or C, respectively) hepatic impairment.
➔
Use of this medicine as part of occupational and non-
occupational post-exposure prophylaxis (PEP) regimens, an
unapproved use

Storage Instructions
Lamivir-S (Stavudine and Lamivudine Tablets)
have to be stored at controlled room temperature
i.e. from 20°C to 25°C (68°F to 77°F) with
excursions permitted between 15° to 30°C (59°
to 86°F).
Keep this as well as all other medicines away
from children and pets.

Warnings
Lamivir-S Tablets (Lamivudine and Stavudine Tablets) should not be
administered concomitantly with formulations containing any of
the two medications. The complete prescribing information for all
agents being considered for use with Lamivudine and Stavudine
Tablets should be consulted before therapy with Lamivir-S Tablets is
started.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal
cases, has been reported with the use of nucleoside analogues alone or in
combination, including Stavudine, Lamivudine and other antiretrovirals.
A majority of these cases have been in women. Obesity and prolonged
nucleoside exposure may be risk factors.

Warnings
Severe acute exacerbations of hepatitis B have been reported in patients
who are co-infected with hepatitis B virus (HBV) and human
immunodeficiency virus (HIV-1) and have discontinued Lamivudine, a
component of Lamivir-S.
Monitor hepatic function closely in these patients and, if appropriate,
initiate anti-hepatitis B treatment.
Lamivir-S Tablets should not be administered with other Lamivudine or
Stavudine containing products or Emtricitabine containing products.
Hepatic decompensation, some fatal, has occurred in HIV-1/HCV co-
infected patients receiving combination antiretroviral therapy and
interferon alfa with/without Ribavirin.

Warnings
Discontinue Lamivir-S as medically appropriate and consider dose
reduction or discontinuation of interferon Alfa, Ribavirin, or both.
In pediatric patients with a history of prior antiretroviral nucleoside
exposure, a history of pancreatitis, or other significant risk factors
for the development of pancreatitis, Lamivudine should be used with
caution. Treatment with Lamivudine should be stopped immediately
if clinical signs, symptoms, or laboratory abnormalities suggestive
of pancreatitis occur.
Pancreatitis: Use with caution in patients with a history of pancreatitis or
other significant risk factors for pancreatitis. Discontinue treatment as
clinically appropriate.

Warnings
Immune reconstitution syndrome and redistribution/accumulation of
body fat have been reported in patients treated with combination
antiretroviral therapy.
Opportunistic infections: Patients receiving Lamivudine or any other
antiretroviral therapy can continue to develop opportunistic infections
and other complications of HIV infection. Therefore patients must remain
under close clinical observation by physicians experienced in the
treatment of HIV infection.
Motor weakness has been reported rarely in patients receiving
combination antiretroviral therapy including Stavudine. Most of these
cases occurred in the setting of lactic acidosis.

Warnings
The evolution of motor weakness may mimic the clinical
presentation of Guillain-Barré syndrome (including respiratory
failure). Symptoms may continue or worsen following
discontinuation of therapy.
Reduction of the dosage of both Stavudine and Lamivudine is
required in patients with reduced creatinine clearance. Hence,
Lamivudine/Stavudine a fixed dose combination cannot be used in
this patient population.

Possible Side Effects
Side effects reported with a frequency of 5% or more in four controlled
clinical trials for Lamivudine include Headache, Malaise and fatigue, Fever
or chills, Nausea, Diarrhea, Nausea and vomiting, Anorexia and/or
decreased appetite, Abdominal pain, Abdominal cramps, Dyspepsia,
Neuropathy, Insomnia and other sleep disorders, Dizziness, Depressive
disorders, Nasal signs and symptoms, Cough, Skin rashes, Musculoskeletal
pain, Myalgia and Arthralgia.
Selected side effects that occurred in adult patients receiving Stavudine in
a controlled monotherapy study include Headache, Diarrhea, Peripheral
neurologic symptoms/Neuropathy, Rash, Nausea and vomiting

Overdosage
There is limited experience of overdosage with Lamivudine and Stavudine
tablets (Lamivir-S 30 and Lamivir-S 40 ).
Lamivudine: Because a negligible amount of Lamivudine was removed via (4-
hour) hemodialysis, continuous ambulatory peritoneal dialysis, and
automated peritoneal dialysis, it is not known if continuous hemodialysis
would provide clinical benefit in a Lamivudine overdose event.
Stavudine: Experience with adults treated with 12 to 24 times the
recommended daily dosage revealed no acute toxicity. Complications of
chronic overdosage include peripheral neuropathy and hepatic toxicity.
Stavudine can be removed by hemodialysis; the mean ± SD hemodialysis
clearance of stavudine is 120 ± 18 ml/min. Whether Stavudine is eliminated
by peritoneal dialysis has not been studied.

Lamivir-S Tablets During Pregnancy
Stavudine and Lamivudine Tablets (Lamivir-S) have been classified by
the US FDA as Pregnancy Category C. Stavudine and Lamivudine are
both classified under category C. There are no adequate and well-
controlled studies in pregnant women. Stavudine and Lamivudine
tablets (Lamivir-S tablets) should be used during pregnancy only if the
potential benefits outweigh the potential risk.
Stavudine: Reproduction studies have been performed in rats and
rabbits with exposures (based on Cmax) up to 399 and 183 times,
respectively, of that seen at a clinical dosage of 1 mg/kg/day and
have revealed no evidence of teratogenicity.

Lamivir-S Tablets During Pregnancy
Lamivudine: Reproduction studies have been performed in rats and
rabbits at orally administered doses up to 4,000 mg/kg/day and
1,000 mg/kg/day, respectively, producing plasma levels up to
approximately 35 times that for the adult HIV dose. No evidence of
teratogenicity due to Lamivudine was observed.
Evidence of early embryo lethality was seen in the rabbit at
exposure levels similar to those observed in humans, but there was no
indication of this effect in the rat at exposure levels up to 35 times that in
humans. Studies in pregnant rats and rabbits showed that Lamivudine is
transferred to the fetus through the placenta.

Lamivir-S Tablets are manufactured by Cipla
Limited, India.
For More details Click Here

Lamivir-S (Stavudine and Lamivudine Tablets)

Recommended

Recommended

More Related Content

Similar to Lamivir-S (Stavudine and Lamivudine Tablets)

Similar to Lamivir-S (Stavudine and Lamivudine Tablets) (20)

More from The Swiss Pharmacy

More from The Swiss Pharmacy (20)

Recently uploaded

Recently uploaded (20)

Lamivir-S (Stavudine and Lamivudine Tablets)