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EPIVIR ORAL SOLUTION
Viral infections
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Drug Name:

EPIVIR ORAL SOLUTION Rx

Generic Name and Formulations:
Lamivudine 10mg/mL; strawberry-banana flavor; contains sucrose 3g/15mL.

Company:
ViiV Healthcare

Therapeutic Use:

Indications for EPIVIR ORAL SOLUTION:

HIV-1 infection, in combination with other antiretrovirals.

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:

<3 months: not established. ≥3 months (oral soln): 4mg/kg twice daily or 8mg/kg once daily; max 300mg/day. 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.

Warnings/Precautions:

Not interchangeable with Epivir-HBV. Women, obesity, or prolonged nucleoside exposure: increased risk of lactic acidosis, hepatomegaly with steatosis. Other liver disease risk factors. Suspend therapy if lactic acidosis or pronounced hepatotoxicity (including hepatomegaly, steatosis) occurs. Hepatitis B virus co-infection: monitor for post-treatment exacerbation, emergence of lamivudine-resistant HBV variants. Children with prior antiretroviral nucleoside exposure, history of pancreatitis or risk factors for pancreatitis. Discontinue if signs/symptoms of pancreatitis occurs. Oral soln: lower virologic suppression rates and increased risk of viral resistance. Pregnancy. Nursing mothers: not recommended.

Interactions:

Concomitant zalcitabine: not recommended. Avoid concomitant drugs that contain lamivudine or emtricitabine. Caution with drugs eliminated by active organic cationic secretion (eg, trimethoprim). Triple therapy (once daily regimen) with abacavir + tenofovir or with didanosine + tenofovir: high rate of early viral non-response (see full labeling). Monitor for treatment-associated toxicities (esp. hepatic decompensation) with interferon-alpha with or without ribavirin.

See Also:

EPIVIR

Pharmacological Class:

Nucleoside analogue (reverse transcriptase inhibitor).

Adverse Reactions:

Adults: headache, malaise, fatigue, fever, nausea, diarrhea, nasal signs/symptoms, cough, neuropathy, dizziness, sleep or depressive disorders, rash, musculoskeletal pain; lactic acidosis, severe hepatomegaly with steatosis, fat redistribution, immune reconstitution syndrome, neutropenia, abnormal liver enzymes. Children: fever, cough, rash; pancreatitis, paresthesias, peripheral neuropathy, neutropenia, abnormal liver enzymes.

Note:

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

Generic Availability:

YES

How Supplied:

Tabs 150mg—60; 300mg—30; Soln—240mL

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