Monograph Details
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Infections & Infestations
> Viral infections
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BARACLUDE ORAL SOLUTION |
| Manufacturer |
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Bristol-Myers Squibb |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Nucleoside analogue (HBV polymerase inhibitor). |
| Generic Name |
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Entecavir 0.05mg/mL; orange flavor; contains parabens. |
| Also |
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• BARACLUDE
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| Indications |
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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. |
| Children |
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<16yrs: not recommended. |
| Adults |
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≥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. |
| Precautions |
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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 |
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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 |
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Headache, fatigue, GI upset; rare: lactic acidosis, severe hepatomegaly with steatosis (may be fatal), post-treatment severe, acute exacerbation of hepatitis. |
| Extra Text |
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Note: Register pregnant patients exposed to entecavir by calling (800) 258-4263. |
| How Supplied |
Tabs 0.5mg—30, 90
1mg—30
Soln—210mL (w. dosing spoon) |
| Additional Resources |
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• Related Prescribing Note |
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