Entehep 0.5mg Tablets

Product Description

Entehep 0.5 mg Tablets contain Entecavir, which is an antiviral medication used primarily in the treatment of chronic hepatitis B (a viral infection of the liver). Entecavir works by inhibiting the replication of the hepatitis B virus (HBV) in the body, reducing the viral load and helping to prevent liver damage.

Indications

Entehep (Entecavir) is primarily used for:

1. Chronic Hepatitis B Virus Infection: It is used to treat chronic HBV infection in both adults and children (usually aged 2 years and older). Entecavir is used in patients who have:

   • Elevated liver enzymes (evidence of liver inflammation).
   • High levels of HBV DNA (indicating active viral replication).
   • Evidence of significant liver damage (such as cirrhosis or fibrosis).

2. HBV-related Cirrhosis: Entecavir may be prescribed to reduce the progression of liver damage in people with chronic HBV infection and cirrhosis.

3. Prevention of HBV Reactivation: It is sometimes used in patients who are about to undergo immunosuppressive therapy (such as chemotherapy) to prevent the reactivation of hepatitis B.

Mechanism of Action

Entecavir works by inhibiting the reverse transcriptase enzyme, which is essential for the replication of the hepatitis B virus. By binding to the reverse transcriptase, Entecavir prevents the viral RNA from being converted into DNA, which is a critical step in the replication of the virus. This reduces the viral load in the body, decreases liver inflammation, and can prevent further liver damage.

Dosage and Administration

• Typical Dosage:

  • Adults: The usual dose for adults is 0.5 mg once a day, but for patients with lamivudine-resistant HBV, the dose may increase to 1 mg once daily.
  • Children: For children aged 2 years and older, the dose is typically based on weight and ranges from 0.05 mg to 0.5 mg once a day, depending on the child's weight.
  • Renal Impairment: Dose adjustments may be necessary for patients with severe kidney impairment (creatinine clearance < 50 mL/min), as Entecavir is primarily eliminated by the kidneys.

• Administration: Entecavir should be taken once a day with or without food. It's important to take the tablet at the same time every day to maintain consistent drug levels in the bloodstream.

Side Effects

Common side effects of Entehep (Entecavir) include:

• Headache
• Dizziness
• Fatigue
• Nausea
• Abdominal pain
• Liver enzyme changes: These can show up in blood tests and may indicate liver inflammation or damage.

Serious side effects (less common):

• Lactic acidosis: A rare but serious side effect where lactic acid builds up in the blood, leading to symptoms like deep, rapid breathing, muscle pain, and weakness.
• Severe liver problems: In rare cases, discontinuing Entecavir can lead to worsening of hepatitis B or liver failure.
• Hepatitis B reactivation: Although Entecavir helps control HBV, stopping the medication can cause reactivation of the virus.
• Kidney problems: Rarely, Entecavir can lead to kidney problems, especially in people with existing kidney issues.

Precautions and Warnings

• Liver function monitoring: Regular blood tests to monitor liver function and HBV DNA levels are recommended while taking Entecavir, particularly in patients with pre-existing liver disease.
• Renal function: Since Entecavir is eliminated through the kidneys, it is important to monitor kidney function, especially in people with renal impairment. Dose adjustments may be required.
• Hepatitis B reactivation: Discontinuation of Entecavir should be done under a healthcare provider™s guidance, as stopping the medication can lead to the reactivation of hepatitis B, with possible worsening of liver disease.
• Pregnancy: Entecavir is categorized as Category C in pregnancy, meaning that there are no well-controlled studies in pregnant women. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. It is recommended to use effective contraception during treatment.
• Breastfeeding: It is unknown whether Entecavir passes into breast milk, so it should be used cautiously in breastfeeding mothers.

Important Considerations

• Adherence to Treatment: It's important to take Entecavir exactly as prescribed and not skip doses. Missing doses can cause the virus to replicate again, leading to resistance or worsening of liver damage.
• Resistance: In cases where there is lamivudine-resistant HBV, the dosage may need to be adjusted, or alternative treatments may be considered. Resistance to Entecavir itself is relatively rare.
• Kidney function: Entecavir is eliminated through the kidneys, so patients with renal impairment should be closely monitored.
• Hepatitis B monitoring: It is essential for healthcare providers to regularly check HBV DNA levels and liver enzyme levels to monitor how well Entecavir is working and to adjust the treatment plan accordingly.

Conclusion

Entehep (Entecavir) 0.5 mg Tablets are an effective treatment option for chronic hepatitis B infection, especially in cases with significant liver damage or cirrhosis. It works by inhibiting the replication of the hepatitis B virus, helping to reduce the viral load and prevent further liver damage. Regular monitoring of liver and kidney function is essential during treatment, and adherence to the prescribed dosage is important to avoid complications like viral resistance or hepatitis B reactivation.