Brand Name: Hepavir
Manufacturer:Ā Square Pharmaceuticals Ltd.
INDICATION
HepavirĀ® (Lamivudine) is indicated for the treatment of chronic hepatitis B
associated with evidence of hepatitis B viral replication and active liver
inflammation.
DOSAGE AND ADMINISTRATION
The recommended oral dose of HepavirĀ® for the treatment of chronic
hepatitis B in adults is 100 mg once daily.
It is recommended that doses of HepavirĀ® should be adjusted in accordance
with renal function. Dosage adjustment of HepavirĀ® in accordance with
creatinine clearance is as follows:
Creatinine clearance (ml/min) Recommended dosage of HepavirĀ®
50 100 mg once daily
30-49 100 mg first dose, then 50 mg once daily
15-29 100 mg first dose, then 25 mg once daily
5-14 35 mg first dose, then 15 mg once daily
<5 35 mg first dose, then 10 mg once daily
CONTRAINDICATION AND PRECAUTION
HepavirĀ® (Lamivudine) is contraindicated in patients hypersensitive to any of
the components of the product.
Patients should be assessed before beginning treatment and during
treatment with lamivudine by a physician experienced in the management
of chronic hepatitis B.
Safety and efficacy of lamivudine for the treatment of chronic hepatitis B in
children have not been established.
SIDE EFFECT
Several serious adverse events reported with lamivudine (lactic acidosis and
severe hepatomegaly with steatosis, post treatment exacerbations of
hepatitis B, pancreatitis, and emergence of viral mutants associated with
reduced drug susceptibility and diminished treatment response).
Malaise, fatigue, fever, ENT infections, sore throat, nausea, vomiting,
abdominal discomfort, pain, diarrhea, myalgia, arthralgia, headache, skin
rashes may occur. Lactic acidosis and severe hepatomegaly with steatosis,
have been reported.
DRUG INTERACTION
Trimethoprim 160 mg/Sulfamethoxazole 800 mg once daily has been shown
to increase lamivudine exposure (AUC). The effect of higher doses of
trimethoprim /sulfamethoxazole on lamivudine pharmacokinetics has not
been investigated.
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