BARACLUDE ORAL SOLUTION Dosage & Rx Info

Baraclude Oral Solution Generic Name & Formulations

Legal Class

General Description

Entecavir 0.05mg/mL; orange flavor; contains parabens.

Pharmacological Class

Nucleoside analogue (HBV polymerase inhibitor).

How Supplied

Tabs 0.5mg—30, 90; 1mg—30; Soln—210mL (w. dosing spoon)

Manufacturer

Bristol Myers Squibb

Baraclude Oral Solution Indications

Indications

Chronic hepatitis B virus (HBV) infection in patients with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Baraclude Oral Solution Dosage and Administration

Adult

Take on empty stomach. ≥16yrs: compensated liver disease (nucleoside-naive): 0.5mg once daily; (lamivudine-refractory or known lamivudine or telbivudine resistance mutations): 1mg once daily. Decompensated liver disease: 1mg once daily. Renal impairment (nucleoside-naive): CrCl 30–49mL/min: 0.25mg once daily or 0.5mg every 48hrs; CrCl 10–29mL/min: 0.15mg once daily or 0.5mg every 72hrs; CrCl <10mL/min or on hemodialysis: 0.05mg once daily or 0.5mg every 7 days; (lamivudine-refractory or decompensated liver disease): CrCl 30–49mL/min: 0.5mg once daily or 1mg every 48hrs; CrCl 10–29mL/min: 0.3mg once daily or 1mg every 72hrs; CrCl <10mL/min or on hemodialysis: 0.1mg once daily or 1mg every 7 days. For doses <0.5mg: use oral soln. If on hemodialysis day, give after session.

Children

<2yrs: not established. Take on empty stomach. Give once daily. ≤30kg: use oral soln. ≥2yrs (nucleoside-naive): 10–11kg: 3mL; 12–14kg: 4mL; 15–17kg: 5mL; 18–20kg: 6mL; 21–23kg: 7mL; 24–26kg: 8mL; 27–30kg: 9mL; >30kg: 10mL or 0.5mg tab; (lamivudine-experienced): 10–11kg: 6mL; 12–14kg: 8mL; 15–17kg: 10mL; 18–20kg: 12mL; 21–23kg: 14mL; 24–26kg: 16mL; 27–30kg: 18mL; >30kg: 20mL or 1mg tab.

Baraclude Oral Solution Contraindications

Not Applicable

Baraclude Oral Solution Boxed Warnings

Boxed Warning

Severe acute exacerbations of hepatitis B. Patients co-infected with HIV and HBV. Lactic acidosis and hepatomegaly.

Baraclude Oral Solution Warnings/Precautions

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. HIV/HBV co-infected patients not receiving highly active antiretroviral therapy (HAART): not recommended. Do HIV antibody testing before initiation. Suspend therapy if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Renal impairment (see Adults). Liver disease or transplant. Pregnancy. Nursing mothers.

Baraclude Oral Solution Pharmacokinetics

See Literature

Baraclude Oral Solution Interactions

Interactions

May potentiate or be potentiated by drugs that reduce renal function or compete for active tubular secretion; monitor.

Baraclude Oral Solution Adverse Reactions

Adverse Reactions

Headache, fatigue, dizziness, nausea; lactic acidosis, severe hepatomegaly with steatosis.

Baraclude Oral Solution

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