Viral infections:

Indications for: EPIVIR

HIV-1 infection, in combination with other antiretroviral agents.

Adult Dosage:

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 Dosage:

<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.

Boxed Warning:

Exacerbations of hepatitis B. Important differences in formulations of Epivir.

EPIVIR 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 Classification:

Nucleoside analogue (reverse transcriptase inhibitor).

EPIVIR 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.

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.

Note:

Register pregnant patients exposed to lamivudine by calling (800) 258-4263.

Generic Drug Availability:

YES

How Supplied:

Tabs 150mg—60; 300mg—30; Soln—240mL