Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets)

Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets)
© The Swiss Pharmacy

Lamivir-HBV (Generic Lamivudine-HBV
Tablets) is a nucleoside analogue reverse
transcriptase inhibitor indicated for the treatment
of chronic hepatitis B virus infection associated
with evidence of hepatitis B viral replication and
active liver inflammation.

Lamivir-HBV Tablets are manufactured by Cipla Limited, India
in the strength of 100 mg.

Chemical Structure

The active ingredient contained in Lamivir-
HBV tablets is Lamivudine.
Each Lamivir-HBV tablet contains 100 mg of
Lamivudine.

Uses of Lamivir- HBV 100 mg Tablets:
Lamivir-HBV tablets (Generic Lamivudine-HBV tablets) are used for the
treatment of adults and children aged 2 years and older with chronic hepatitis B
and evidence of hepatitis B virus (HBV) replication.
Lamivudine-HBV tablets are used to treat hepatitis B infection. It is not a cure
for hepatitis B and does not prevent the passing of hepatitis B to others.
This medication is a nucleoside reverse transcriptase inhibitor (NRTI) that works
by slowing the growth of the virus, thereby decreasing liver damage caused by
the virus.
The formulation and dosage of lamivudine in Lamivir-HBV Tablets are not
appropriate for patients dually infected with hepatitis B virus (HBV) and HIV. If
Lamivudine is administered to such patients, the higher dosage indicated for
HIV therapy should be used as part of an appropriate combination regimen,
and the appropriate prescribing information should be consulted.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html

Recommended Adult Dosage
The recommended oral dose of Lamivir-HBV Tablets
(Generic Lamivudine-HBV Tablets) for the treatment of chronic
hepatitis B in adults is 100 mg once daily.
The formulation and dosage of Lamivudine in Lamivir-HBV
tablets are not appropriate for patients dually infected with
hepatitis B virus (HBV) and HIV.
If Lamivudine is administered to such patients, the higher dosage
indicated for HIV therapy should be used as part of an
appropriate combination regimen, and the appropriate
prescribing information should be consulted.

Recommended Adult Dosage
Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) has
not been evaluated in pediatric patients.
It is recommended that doses of Lamivudine be adjusted in
accordance with renal function.

Contraindications
➔
Lamivir-HBV tablets is contraindicated in patients with
a known hypersensitivity to Lamivudine or any
component of the tablet.

Storage Instructions
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
Exacerbations of Hepatitis after Discontinuation of Treatment: Clinical
and laboratory evidence of exacerbations of hepatitis have occurred
after discontinuation of Lamivudine (Lamivir-HBV Tablets). These
exacerbations have been detected primarily by serum ALT elevations
in addition to re-emergence of HBV DNA commonly observed after
stopping treatment.
Risk of HIV-1 Resistance if Lamivir-HBV Tablets is Used in Patients with
Unrecognized or Untreated HIV-1 Infection: Lamivir-HBV tablets and
oral solution contain a lower Lamivudine dose than the Lamivudine
dose used to treat HIV-1 infection with Lamivir tablets or with
Lamivudine-containing antiretroviral fixed-dose combination products.

Warnings
Emergence of Resistance-Associated HBV Substitutions: Consider a
switch to an alternative regimen if serum HBV DNA remains detectable
after 24 weeks of treatment.
Lactic Acidosis and Severe Hepatomegaly with Steatosis: Lactic
acidosis and severe hepatomegaly with steatosis, including fatal cases,
have been reported with the use of nucleoside analogues, including
Lamivudine-HBV Tablets (Lamivir-HBV). A majority of these cases have
been in women. Female sex and obesity may be risk factors for the
development of lactic acidosis and severe hepatomegaly with
steatosis in patients treated with antiretroviral nucleoside analogues.

Possible Side Effects
Most common Lamivudine-HBV (Lamivir-HBV Tablets) side effects
with an incidence rate of greater than or equal to 2% 10% and
reported at a rate greater than placebo were ear, nose, and throat
infections; sore throat; and diarrhea.

Possible Side Effects
The following side effects have been identified during post-approval use of
Lamivudine 100 mg tablets (Lamivir-HBV Tablets) .
Blood and Lymphatic: Anemia (including pure red cell aplasia and severe anemias
progressing on therapy), lymphadenopathy, splenomegaly, thrombocytopenia.
Digestive: Stomatitis.
Ear and Labyrinth Disorders:Hearing loss
Endocrine and Metabolic: Hyperglycemia. General Weakness.
Hepatic and Pancreatic: Lactic acidosis and steatosis , posttreatment exacerbations
of hepatitis , pancreatitis.
Hypersensitivity: Anaphylaxis, urticaria.
Musculoskeletal: Cramps, rhabdomyolysis.
Nervous: Paresthesia, peripheral neuropathy.
Respiratory: Abnormal breath sounds/wheezing.
Skin: Alopecia, pruritus, rash.

Lamivir-HBV Tablets Overdosage
There is no known antidote for an overdose of Lamivudine (Lamivir-
HBV Tablets). In case overdose occurs, the patient should be
monitored and standard supportive treatment applied, as required. In
studies, a negligible amount of Lamivudine was removed via (4-hour)
hemodialysis, continuous ambulatory peritoneal dialysis and
automated peritoneal dialysis; hence, it is not known if continuous
hemodialysis would provide clinical benefit in a Lamivudine overdose
event.

Lamivir-HBV Tablets During Pregnancy
Lamivudine Tablets (Lamivir-HBV) has been classified by the US FDA
as Pregnancy Category C.
Animal reproduction studies have shown an adverse effect on the fetus
and there are no adequate and well-controlled studies of Lamivudine
Tablets in pregnant women.
This medicine should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
Studies in pregnant rats and rabbits showed that Lamivudine is
transferred to the fetus through the placenta.

Lamivir-HBV Tablets (Generic Lamivudine-HBV
Tablets) are manufactured by Cipla Limited, India.

Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets)

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