Lamivudine

What it is and how it works

Mechanism of Action Lamivudine is an antiviral agent with activity against HBV .

Mechanism class: Nucleoside Reverse Transcriptase Inhibitors

Indications

Lamivudine tablets (HBV) are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation . The following points should be considered when initiating therapy with lamivudine tablets (HBV): • Due to high rates of resistance development in treated patients, initiation of treatment with lamivudine tablets (HBV) should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate. • Lamivudine tablets (HBV) have not been evaluated in patients co-infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis delta virus. • Lamivudine tablets (HBV) have not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease.

Dosage and administration (summary)

• Adults: 100 mg, once daily. • Pediatric Patients aged 2 to 17 years: 3 mg per kg once daily up to 100 mg once daily. Prescribe oral solution for pediatric patients requiring less than 100 mg daily. • Patients with Renal Impairment: Doses of lamivudine tablets (HBV) must be adjusted in accordance with renal function. • Lamivudine tablets (HBV) should not be used with other medications that contain lamivudine or emtricitabine.

Contraindications

Lamivudine tablets (HBV) are contraindicated in patients with a previous hypersensitivity reaction to lamivudine. Lamivudine tablets (HBV) is contraindicated in patients with previous hypersensitivity reaction to lamivudine.

Warnings and precautions

• Emergence of Resistance-Associated HBV Substitutions: Consider a switch to an alternative regimen if serum HBV DNA remains detectable after 24 weeks of treatment. ( 2.6 , 5.3 ) • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. Exacerbations of Hepatitis after Discontinuation of Treatment Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.

Storage and supply

Lamivudine tablets (HBV), 100 mg are pink colored, capsule shaped, biconvex, film coated tablets, debossed with ‘37’ on one side and ‘I’ on the other side. Bottle of 60 tablets NDC 31722-752-60 Bottle of 600 tablets NDC 31722-752-06 Blister card of 10 Unit-dose tablets NDC 31722-752-31 Blister pack of 100 (10x10) Unit-dose tablets NDC 31722-752-32 …

Source: Lamivudine (Lamivudine) — US FDA prescribing information, 2026-07-29, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.