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EPIVIR-HBV
Viral infections
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Drug Name:

EPIVIR-HBV Rx

Generic Name and Formulations:
Lamivudine 100mg; tabs.

Company:
GlaxoSmithKline

Therapeutic Use:

Indications for EPIVIR-HBV:

Chronic hepatitis B virus (HBV) infection associated with viral replication and active liver inflammation.

Adult:

100mg once daily. Renal impairment: CrCl 30–49mL/min: 100mg for 1st dose then 50mg once daily; CrCl 15–29mL/min: 100mg for 1st dose then 25mg once daily; CrCl 5–14mL/min: 35mg for 1st dose then 15mg once daily; CrCl <5mL/min: 35mg for 1st dose then 10mg once daily.

Children:

<2yrs: not established. 2–17yrs: 3mg/kg (max 100mg) once daily.

Boxed Warning:

Lactic acidosis and severe hepatomegaly with steatosis. Exacerbations of hepatitis B. Risk of HIV-1 resistance if used in patients with unrecognized or untreated HIV-1.

Warnings/Precautions:

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. Post-treatment severe acute exacerbation of hepatitis B; monitor closely during and for several months after treatment. Not for treatment of HIV/HBV co-infection (use doses appropriate for HIV). Unrecognized or untreated HIV-1 infection (do HIV testing and counseling before and periodically during treatment); risk of HIV-1 resistance. Emergence of resistance-associated HBV substitutions: monitor ALT and HBV DNA levels during treatment. Diabetes (oral soln). Liver transplant recipient, chronic HBV with decompensated liver disease: not established. Reevaluate annually. Pregnancy. Nursing mothers.

See Also:

EPIVIR-HBV ORAL SOLUTION

Pharmacological Class:

Nucleoside analogue (reverse transcriptase inhibitor).

Interactions:

Avoid concomitant sorbitol-containing products. Caution with drugs eliminated by active organic cationic secretion (eg, trimethoprim).

Adverse Reactions:

Ear, nose, and throat infections, sore throat, diarrhea; lactic acidosis, severe hepatomegaly with steatosis, emergence of viral mutations, ALT elevations.

Note:

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

Generic Availability:

Tabs (YES); Soln (NO)

How Supplied:

Tabs—60; Soln—240mL


Data provided by MPR.

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