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X-VIR (0.5mg) 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: X-VIR 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.
Entecavir side effects.
1.Lactic acidosis (buildup of acid in the blood). Some people who have taken ENTECAVIR or medicines like ENTECAVIR (a nucleoside analogue) have developed a serious condition called lactic acidosis. Lactic acidosis is a serious medical emergency that can cause death. Lactic acidosis must be treated in the hospital. Reports of lactic acidosis with 37 Reference ID: 3474744 ENTECAVIR generally involved patients who were seriously ill due to their liver disease or other medical condition.
Call your healthcare provider right away if you get any of the following signs or symptoms of lactic acidosis:
• You feel very weak or tired.
• You have unusual (not normal) muscle pain.
• You have trouble breathing.
• You have stomach pain with nausea and vomiting.
• You feel cold, especially in your arms and legs.
• You feel dizzy or light-headed.
• You have a fast or irregular heartbeat.
2. Serious liver problems. Some people who have taken medicines like ENTECAVIR have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Hepatomegaly with steatosis is a serious medical emergency that can cause death.
Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:
• Your skin or the white part of your eyes turns yellow (jaundice).
• Your urine turns dark. • Your bowel movements (stools) turn light in color.
• You don’t feel like eating food for several days or longer.
• You feel sick to your stomach (nausea).
You have lower stomach pain. You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight, or have been taking nucleoside analogue medicines, like ENTECAVIR, for a long time.
The most common side effects of ENTECAVIR include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Entecavir Cost & Price:
Generic Entecavir’s price is only 1-5% of the brand one BARACLUDE ®.
X-VIR’s(0.5mg) brand name in USA is BARACLUDE by Bristol-Myers Squibb. X-VIR is a generic prescription medicine from Natoco, which is one of the biggest pharmaceutical company in India.