Entavir 5mg Tablets

Product Description

5 mg Entavir Tablets contain Entecavir, an antiviral medication primarily used to treat chronic hepatitis B (HBV) infection. Entecavir works by inhibiting the replication of the hepatitis B virus, helping to reduce viral load and prevent liver damage caused by the infection.

Indications

Entavir (Entecavir) is used for the treatment of:

1. Chronic Hepatitis B Virus Infection:

   • In adults with chronic HBV infection, Entavir is prescribed to lower HBV DNA levels, reduce liver inflammation, and improve liver function. It can be used for HBV-positive patients with cirrhosis or those at risk of progressing to liver failure.

2. Hepatitis B-related Cirrhosis:

   • Entavir can help reduce liver damage and the progression of liver disease in patients with cirrhosis caused by HBV.

3. HBV Reactivation Prevention:

   • It is also used to prevent reactivation of hepatitis B in patients undergoing immunosuppressive therapy (e.g., chemotherapy or organ transplantation).

Mechanism of Action

Entecavir is a nucleoside reverse transcriptase inhibitor (NRTI). It works by inhibiting the enzyme reverse transcriptase, which the hepatitis B virus needs to replicate. By blocking this enzyme, Entecavir prevents viral DNA synthesis, halting the replication process and reducing the viral load in the body. This action reduces the risk of liver damage from chronic HBV infection.

Dosage and Administration

• Typical Dosage:

  • For Adults with Chronic Hepatitis B:
    • The typical dose is 0.5 mg once daily for patients who have no prior exposure to lamivudine or other NRTIs.
    • For lamivudine-resistant HBV infection, the dose is typically 1 mg once daily.
  • For Children (2 years and older):
    • The dose depends on the child's body weight. It can range from 0.05 mg to 0.5 mg daily.

• Renal Impairment: For patients with kidney problems, the dose of Entecavir may need to be reduced, as the drug is primarily excreted through the kidneys.

• Administration:

  • Entavir tablets should be taken once daily, with or without food. It™s recommended to take the tablet at the same time each day to help remember the dosage.

Side Effects

Common side effects of Entavir (Entecavir) may include:

• Headache
• Fatigue
• Dizziness
• Nausea
• Abdominal pain
• Loss of appetite

Serious side effects (though less common) may include:

• Lactic acidosis: A build-up of lactic acid in the blood, leading to symptoms like deep, rapid breathing, muscle pain, and weakness.
• Severe liver problems: Stopping Entecavir suddenly can cause hepatitis B reactivation, leading to a worsening of liver disease.
• Kidney problems: Rarely, Entecavir can cause kidney issues, so kidney function should be monitored, especially in patients with pre-existing kidney problems.

Precautions and Warnings

• Hepatitis B Reactivation: Discontinuation of Entecavir should only be done under medical supervision, as stopping the medication may lead to hepatitis B reactivation (flare-up of the virus), which can cause severe liver damage.

• Liver Function: Regular monitoring of liver function tests and HBV DNA levels is necessary to assess the effectiveness of the treatment and detect any worsening liver conditions.

• Renal Function: Entecavir is primarily excreted by the kidneys, so it is essential to check kidney function periodically, especially in patients with kidney disease.

• Pregnancy: Entecavir is classified as Category C for pregnancy, meaning it should only be used if the potential benefits outweigh the risks. It is essential to discuss with a healthcare provider if you are pregnant or planning to become pregnant.

• Breastfeeding: It is unknown whether Entecavir passes into breast milk, so it is advised to consult a doctor before using this medication while breastfeeding.

Important Considerations

• Adherence to Treatment: It is important to take Entavir (Entecavir) regularly as prescribed. Missing doses or stopping the medication can result in the reactivation of hepatitis B and may lead to resistance to the drug.

• Iron Deficiency: In some patients, iron supplementation may be needed to support the body as Entecavir helps in controlling the viral load and improving liver health.

• Resistance: While Entecavir is effective, in patients who are resistant to lamivudine (another antiviral for HBV), higher doses of Entecavir (such as 1 mg) may be required. Resistance testing may be performed if treatment fails to show improvement.

Conclusion

5 mg Entavir Tablets (Entecavir) are an effective treatment for managing chronic hepatitis B and hepatitis B-related cirrhosis. It works by inhibiting the replication of the hepatitis B virus, reducing viral load, and preventing liver damage. Regular monitoring of liver and kidney function is essential during treatment, as well as adherence to the prescribed regimen.