EPIVIR-HBV ORAL SOLUTION Rx

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EPIVIR-HBV ORAL SOLUTION

Viral infections
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Generic Name and Formulations:

Lamivudine 5mg/mL; strawberry-banana flavor; contains sucrose.

Company:

GlaxoSmithKline

Select therapeutic use:

Indications for EPIVIR-HBV ORAL SOLUTION:

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:

Post-treatment severe acute exacerbation of hepatitis B. Risk of HIV-1 resistance if used in patients with unrecognized or untreated HIV-1.

Warnings/Precautions:

Discontinuation of anti-HBV therapy may be associated with severe acute exacerbations of hepatitis B. Closely monitor for several months after stopping treatment; if appropriate, anti-HBV therapy may be warranted. Not for treatment of HIV/HBV co-infection (use doses appropriate for HIV). Risk of HIV-1 resistance in patients with unrecognized or untreated HIV-1 infection; do HIV testing and counseling before and periodically during treatment. Emergence of resistance-associated HBV substitutions: monitor ALT and HBV DNA levels during treatment; consider alternative regimen if serum HBV DNA remains detectable after 24wks of treatment. Suspend if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Diabetes (oral soln). Liver transplant recipient, chronic HBV with decompensated liver disease, HCV or hepatitis delta virus co-infection: not established. Women. Obesity. Pregnancy. Nursing mothers.

See Also:

EPIVIR-HBV

Pharmacological Class:

Nucleoside analogue (reverse transcriptase inhibitor).

Interactions:

Concomitant lamivudine- or emtricitabine-containing medications: not recommended. 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, 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