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Baraclude Generic Name & Formulations
Legal Class
Rx
General Description
Entecavir 0.5mg, 1mg; tabs.
Pharmacological Class
Nucleoside analogue (HBV polymerase inhibitor).
See Also
How Supplied
Tabs 0.5mg—30, 90; 1mg—30; Soln—210mL (w. dosing spoon)
Manufacturer
Baraclude 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 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 Contraindications
Not Applicable
Baraclude Boxed Warnings
Boxed Warning
Severe acute exacerbations of hepatitis B. Patients co-infected with HIV and HBV. Lactic acidosis and hepatomegaly.
Baraclude 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 Pharmacokinetics
See Literature
Baraclude Interactions
Interactions
May potentiate or be potentiated by drugs that reduce renal function or compete for active tubular secretion; monitor.
Baraclude Adverse Reactions
Adverse Reactions
Headache, fatigue, dizziness, nausea; lactic acidosis, severe hepatomegaly with steatosis.
Baraclude Clinical Trials
See Literature
Baraclude Note
Notes
Register pregnant patients exposed to entecavir by calling (800) 258-4263.
Baraclude Patient Counseling
See Literature
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