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EnteHep is also known as Indian Generic BARACLUD, is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
DOSAGE AND ADMINISTRATION
Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily.
• Nucleoside-inhibitor-treatment-naïve and lamivudine-experienced pediatric patients at least 2 years of age and weighing at least 10 kg: dosing is based on weight
WARNINGS AND PRECAUTIONS
• Severe acute exacerbations of hepatitis B virus infection after discontinuation: Monitor hepatic function closely for at least several months.
• Co-infection with HIV: EnteHep is not recommended unless the patient is also receiving HAART.
• Lactic acidosis and severe hepatomegaly with steatosis: If suspected, treatment should be suspended
Most common adverse reactions (≥3%, all severity grades) are headache, fatigue, dizziness, and nausea.
EnteHep’s brand name in usa is BARACLUDE by Bristol-Myers Squibb. EnteHep is a generic prescription medicine from Zydus, which is one of the biggest pharmaceutical company in India.