BARACLUDE

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Generic Name for BARACLUDE

Entecavir 0.5mg, 1mg; tabs.

Legal Classification:

Rx

Pharmacological Class for BARACLUDE

Nucleoside analogue (HBV polymerase inhibitor).

Manufacturer of BARACLUDE

Bristol-Myers Squibb

Indications for BARACLUDE

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

Adult dose for BARACLUDE

≥16yrs: Take on empty stomach. Nucleoside-naive: 0.5mg once daily. Lamivudine-refractory: 1mg once daily. Renal impairment (nucleoside-naive): CrCl 30–49mL/min: 0.25mg once daily or 0.5mg every 48 hours; CrCl 10–29mL/min: 0.15mg once daily or 0.5mg every 72 hours; CrCl <10mL/min: 0.05mg once daily or 0.5mg every 7 days; lamivudine-refractory: see literature. Give after hemodialysis.

Children's dosing for BARACLUDE

<16yrs: not recommended.

Also:

Warnings/Precautions for BARACLUDE

Renal impairment (see Dose). HIV/HBV co-infected patients not receiving highly active antiretroviral therapy (HAART): not recommended. HIV antibody testing recommended before starting therapy. Monitor hepatic function during and for several months after ending therapy (risk of hepatitis B reactivation). Liver transplant. Reevaulate periodically. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions for BARACLUDE

May potentiate or be potentiated by drugs that reduce renal function or compete for active tubular secretion. May increase resistance to HIV drugs in HIV patients not on HAART.

Adverse Reactions for BARACLUDE

Headache, fatigue, GI upset; rare: lactic acidosis, severe hepatomegaly with steatosis (may be fatal), post-treatment severe, acute exacerbation of hepatitis.

Notes for BARACLUDE

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

How is BARACLUDE supplied?

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

Related Disease:

Hepatitis~antivirals

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