Epivir Generic Name & Formulations
Legal Class
Rx
General Description
Lamivudine 150mg (+), 300mg; tabs; (+) scored.
Pharmacological Class
Nucleoside analogue (reverse transcriptase inhibitor).
See Also
How Supplied
Tabs 150mg—60; 300mg—30; Soln—240mL
Manufacturer
Generic Availability
YES
Epivir Indications
Indications
HIV-1 infection, in combination with other antiretroviral agents.
Epivir Dosage and Administration
Adult
CrCl ≥50mL/min: 300mg once daily or 150mg twice daily; CrCl 30–49mL/min: 150mg once daily; CrCl 15–29mL/min: 150mg for 1st dose then 100mg once daily; CrCl 5–14mL/min: 150mg for 1st dose then 50mg once daily; CrCl <5mL/min: 50mg for 1st dose then 25mg once daily.
Children
<3mos: not established. ≥3mos (oral soln): 5mg/kg twice daily or 10mg/kg once daily; max 300mg/day. Use all-tablet regimen when possible, unless unable to swallow tabs (14–<20kg): 150mg once daily or 75mg twice daily; (≥20–<25kg): 225mg once daily or 75mg in the AM and 150mg in the PM; (≥25kg): 300mg once daily or 150mg twice daily. Renal impairment: consider dose reduction and/or increase dosing interval.
Epivir Contraindications
Not Applicable
Epivir Boxed Warnings
Boxed Warning
Exacerbations of hepatitis B. Important differences in formulations of Epivir.
Epivir Warnings/Precautions
Warnings/Precautions
Not interchangeable with Epivir-HBV. Not for treating chronic HBV infection; closely monitor patients co-infected with HBV and HIV for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection); if appropriate, initiate anti-hepatitis B therapy may be warranted. Suspend if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Children with prior antiretroviral nucleoside exposure, history of pancreatitis or risk factors for pancreatitis. Oral soln: lower virologic suppression rates and increased risk of viral resistance; consider monitoring HIV-1 viral load more frequently. Renal impairment. Women. Obesity. Elderly. Pregnancy. Nursing mothers: not recommended.
Epivir Pharmacokinetics
See Literature
Epivir Interactions
Interactions
Avoid concomitant sorbitol-containing products. Caution with drugs eliminated by active organic cationic secretion (eg, trimethoprim). Monitor for treatment-associated toxicities (esp. hepatic decompensation) with interferon-alpha with or without ribavirin.
Epivir Adverse Reactions
Adverse Reactions
Headache, nausea, malaise, fatigue, nasal signs/symptoms, diarrhea, cough; lactic acidosis, severe hepatomegaly with steatosis, immune reconstitution syndrome. Children: fever, cough, rash; pancreatitis (discontinue if occurs), paresthesias, peripheral neuropathy.
Epivir Clinical Trials
See Literature
Epivir Note
Notes
Register pregnant patients exposed to lamivudine by calling (800) 258-4263.
Epivir Patient Counseling
See Literature