Product Description.:
BMS, 1611
tablet , film-coated , white , triangular 3 sided
DebossedWhite to off-white
Baraclude (entecavir) is a nucleoside analog with selective activity against hepatitis B virus (HBV). Nucleoside analogs inhibit DNA synthesis in HBV infected cells, reducing viral load and disease burden in infected patients. In animal studies, long term administration of the drug was shown to reduce viral load to undetectable levels for 3-5 years.
Baraclude is specifically indicated for the treatment of chronic HBV 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.
Baraclude is supplied as both an oral tablet and an oral solution. The recommended dose for treatment-na?ve adults and adolescents age 16 or older is 0.5 mg once daily on an empty stomach. The recommended dose is increased to 1.0 mg once daily for patients with a history of hepatitis B viremia receiving lamivudine or with known lamivudine resistance mutations. For patients with renal impairment (creatine clearance <50 mL/min), dosage adjustment may be necessary.
Side Effects
Adverse events associated with the use of Baraclude may include, but are not limited to, the following:
* Headache
* Fatigue
* Dizziness
* Nausea
* Liver enzyme elevation
In addition, nucleoside analogs have been associated with lactic acidosis and severe hepatomegaly with steatosis, including fatal cases. Abrupt cessation of nucleoside therapy, including Baraclude, has been associated with severe acute exacerbations of HBV disease state. Patients are recommended to consult closely with their doctors regarding liver function both while taking Baraclude and before stopping treatment.