Avilam is a synthetic nucleoside analogue. Avilam is phosphorylated intracellularly to lamivudine triphosphate. Incorporation of the monophosphate form into viral DNA occurs by hepatitis B virus (HBV) polymerase. As a result DNA chain is terminated. Avilam triphosphate also inhibits the RNA and DNA-dependent DNA polymerase activities of HIV-1 reverse transcriptase (RT). Avilam triphosphate is a very weak inhibitor of mammalian alpha, beta, and gamma-DNA polymerases.
Avilam is used for the treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation.
Avilam is also used to associated treatment for these conditions: Hepatitis B Chronic Infection, Human Immunodeficiency Virus (HIV) Infections
|Other Names||Lamivudin, Lamivudina, Lamivudine, Lamivudinum|
<36% bound to plasma protein.
|Therapeutic Class||Hepatic viral infections (Hepatitis B)|
|Manufacturer||Beximco Pharmaceuticals Ltd|
|Last Updated:||June 23, 2021 at 11:22 am|
Table Of contents
The recommended oral dose of Avilam for the treatment of chronic hepatitis B in adults is 100 mg once daily.
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.
Patients should be assessed before beginning treatment and during treatment with lamivudine by a physician experienced in the management of chronic hepatitis B.
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.
- Take with or without food. Food delays drug absorption, but not to a clinically significant extent.
Volume of Distribution
Apparent volume of distribution, IV administration = 1.3 ± 0.4 L/kg. Volume of distribution was independent of dose and did not correlate with body weight.
5 to 7 hours (healthy or HBV-infected patients)
- Renal clearance = 199.7 ± 56.9 mL/min [300 mg oral dose, healthy subjects]
- Renal clearance = 280.4 ± 75.2 mL/min [single IV dose, HIV-1-infected patients]
- Total clearance = 398.5 ± 69.1 mL/min [HIV-1-infected patients]
Pregnancy & Breastfeeding use
There is no adequate and well-controlled study in pregnant women. Avilam should be used during pregnancy only if the potential benefits outweigh the risks. Although it is not known if lamivudine is excreted in human milk, there is the potential for adverse effects from lamivudine in nursing infants. Mothers should be instructed not to breast feed if they are receiving lamivudine.
Avilam is contraindicated in patients hypersensitive to any of the components of the product.
It is recommended that doses of Avilam should be adjusted in accordance with renal function. Dosage adjustment of Avilam in accordance with creatinine clearance is as follows:
- CrCl 50 ml/min: 100 mg once daily
- CrCl 30-49 ml/min: 100 mg first dose, then 50 mg once daily
- CrCl 15-29 ml/min: 100 mg first dose, then 25 mg once daily
- CrCl 5-14 ml/min: 35 mg first dose, then 15 mg once daily
- CrCl <5 ml/min: 35 mg first dose, then 10 mg once daily
Use in children: Safety and efficacy of lamivudine for the treatment of chronic hepatitis B in children have not been established.
Store below 30˚C. Protect from light. Keep out of the reach of children.