EPIVIR ORAL SOLUTION Dosage & Rx Info

Epivir Oral Solution Generic Name & Formulations

Legal Class

General Description

Lamivudine 10mg/mL; strawberry-banana flavor; contains sucrose 3g/15mL.

Pharmacological Class

Nucleoside analogue (reverse transcriptase inhibitor).

How Supplied

Tabs 150mg—60; 300mg—30; Soln—240mL

Manufacturer

ViiV Healthcare

Generic Availability

YES

Epivir Oral Solution Indications

Indications

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

Epivir Oral Solution 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 1^st dose then 100mg once daily; CrCl 5–14mL/min: 150mg for 1^st dose then 50mg once daily; CrCl <5mL/min: 50mg for 1^st 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 Oral Solution Contraindications

Not Applicable

Epivir Oral Solution Boxed Warnings

Boxed Warning

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

Epivir Oral Solution 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 Oral Solution Pharmacokinetics

See Literature

Epivir Oral Solution 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 Oral Solution 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 Oral Solution

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