Lamivudine (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET, FOR SUSPENSION.
Routes of administration: ORAL.
Brand Names
- LAMIVUDINE/NEVIRAPINE/ZIDOVUDINE TABLETS
Boxed Warning
Exacerbations of Hepatitis B Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1)]. Important Differences among Lamivudine-Containing Products Lamivudine tablets (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than EPIVIR-HBV tablets and oral solution (used to treat chronic HBV infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1 [see Warnings and Precautions (5.1)].
Indications and Usage
Lamivudine is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV.
Contraindications
Lamivudine Tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine.
Adverse Reactions
The following adverse reactions are discussed in other sections of the labeling: Exacerbations of hepatitis B [see Boxed Warning, Warnings and Precautions (5.1)]. Lactic acidosis and severe hepatomegaly with steatosis[see Warnings and Precautions (5.2)]. Pancreatitis[see Warnings and Precautions (5.3)]. Immune reconstitution syndrome [see Warnings and Precautions (5.4)].
Mechanism of Action
Lamivudine is an antiretroviral agent [see Microbiology (12.4)].
Overdosage
There is no known specific treatment for overdose with lamivudine. If overdose occurs, the patient should be monitored, and standard supportive treatment applied as required. Because a negligible amount of lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event.