Chronic hepatitis B with evidence of hepatitis B viral replication & active liver inflammation.
Lamivudine is a synthetic nucleoside analogue. Lamivudine 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. Lamivudine triphosphate also inhibits the RNA and DNA dependent DNA polymerase activities of HIV-1 reverse transcriptase (RT). Lamivudine triphosphate is a very weak inhibitor of mammalian alpha, beta, and gamma-DNA polymerases.
Oral HIV infection Adult: 150 mg bid or 300 mg once daily, in combination w/ other antiretrovirals. Child: As soln: >3 mth <14 kg: 4 mg/kg bid. As tab: 14-21 kg: 75 mg bid; 22-30 kg: 75 mg in the morning and 150 mg at night; >30 kg: 150 mg bid. Max: 300 mg daily. Doses are given in combination w/ other antiretrovirals. Oral Chronic hepatitis B Adult: 100 mg once daily. For patients w/ concomitant HIV infection: 150 mg bid or 300 mg once daily. Child: 2-17 yr 3 mg/kg once daily. Max: 100 mg daily. May be taken with or without food.
The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when the main route of elimination is active renal secretion. Administration of trimethoprim/sulfamethoxazole 160 mg/800 mg results in a 40% increase in Lamivudine exposure. Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of one another. Therefore, use of Lamivudine in combination with zalcitabine is not recommended.
Hypersensitivity. Lactation. Patient w/ hepatomegaly, hepatitis or other risk factors for hepatic disease; childn w/ history or risk factors for pancreatitis. Pregnancy.
Lactic acidosis & severe hepatomegaly with steatosis, post treatment exacerbations of hepatitis B, pancreatitis, & emergence of viral mutants malaise, fatigue, fever, ENT infections, sore throat, nausea, vomiting, abdominal discomfort, pain, diarrhea, myalgia, arthralgia, headache, skin rashes may occur.
Lamivudine should be used during pregnancy only if the potential benefits outweigh the risks. Mothers should be instructed not to breast feed if they are receiving Lamivudine.
Tablet: Store in a cool and dry place, protect from light and moisture.
Oral Solution: Store in a cool and dry place, protect from light.
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