Entavir 0.5 Mg Tablet (10 Tab)

ENTAVIR 0.5 MG TABLET

Entavir 0.5 mg Tablet, manufactured by Cipla Ltd., is an antiviral medication used to treat chronic Hepatitis B virus (HBV) infection. It helps to reduce the amount of hepatitis B virus in the body, improve liver function, and prevent further liver damage.

Name

• Brand Name: Entavir 0.5 mg Tablet
• Common Name: Entecavir (active ingredient)

Composition Each tablet contains Entecavir 0.5 mg.

Uses Entavir is prescribed for the treatment of chronic Hepatitis B virus (HBV) infection in:

• Adults and pediatric patients 2 years of age and older with evidence of active viral replication and persistent elevations in serum aminotransferases or histologically active disease.
• Patients with compensated and decompensated liver disease.
• Patients who are nucleoside-inhibitor-treatment-naïve or lamivudine-refractory.

Dosage and Administration Entavir 0.5 mg Tablet is typically taken orally once daily on an empty stomach, at least 2 hours before or 2 hours after a meal.

• Adults (nucleoside-naive): The usual recommended dose is 0.5 mg once daily.
• Adults (lamivudine-refractory or with decompensated liver disease): A dose of 1 mg once daily may be recommended.
• Pediatric Patients (2 to less than 18 years): The dose is determined by the child's weight, and an oral solution may be used for those weighing less than 32.6 kg. It is crucial to take the medicine regularly at the same time each day and not to stop treatment without consulting a doctor.

Side Effects Common side effects may include:

• Headache
• Fatigue/Tiredness
• Dizziness
• Nausea
• Diarrhea
• Stomach pain
• Insomnia (difficulty sleeping)
• Dyspepsia (indigestion)

Serious side effects, though rare, can include:

• Skin reactions or liver damage.
• Lactic acidosis (increased acid in the blood), which can be severe and requires immediate medical attention.
• Severe acute exacerbation of HBV infection if the medication is stopped abruptly.

Precautions

• Kidney Impairment: Patients with kidney problems may require a dosage adjustment and regular monitoring of renal function.
• HIV Co-infection: Entavir is not recommended for HBV patients co-infected with HIV who are not on highly active antiretroviral therapy (HAART) for HIV, due to the risk of developing resistance to HIV NRTIs.
• Pregnancy and Breastfeeding: Use during pregnancy should only occur if the potential benefits outweigh the risks. Women of childbearing age should use effective contraception. Breastfeeding is generally not advised as it's unknown if entecavir passes into breast milk. Always consult a doctor.
• Alcohol Consumption: Avoid alcohol as it may increase the risk of liver damage.
• Liver Function Monitoring: Routine liver function tests are recommended during treatment and for several months after stopping the medication to monitor for flare-ups of hepatitis.
• Driving and Operating Machinery: Entavir may cause dizziness or sleepiness; caution is advised when driving or operating machinery until its effects are known.
• Do not stop suddenly: Abruptly discontinuing the medicine can lead to a severe worsening of hepatitis B.

Storage Store Entavir 0.5 mg Tablets at room temperature (15°C to 30°C or below 30°C) in a dry place, away from heat and moisture. Keep it out of reach and sight of children and pets.

Frequently Asked Questions about ENTAVIR 0.5 MG TABLET

What is ENTAVIR 0.5 MG TABLET used for?

ENTAVIR 0.5 MG TABLET, containing Entecavir, is an antiviral medicine primarily used for the treatment of chronic hepatitis B virus (HBV) infection in adults and children aged 2 years and older. It helps to reduce the amount of virus in the body, improve liver health, and lower the risk of severe complications like liver damage, cirrhosis, or liver cancer.

How does ENTAVIR 0.5 MG TABLET work?

Entecavir is a guanosine nucleoside analogue. It works by inhibiting the activity of the HBV polymerase enzyme in liver cells, which is crucial for the virus to multiply. By blocking this enzyme, it prevents the virus from replicating and significantly reduces the amount of hepatitis B virus in the body.

What is the usual dosage for ENTAVIR 0.5 MG TABLET?

For most adults and adolescents (16 years and older) who are new to nucleoside treatment, the recommended dose is 0.5 mg once daily. It should generally be taken on an empty stomach, at least two hours before or two hours after a meal. For patients who have previously been treated with lamivudine and have shown resistance, or for adults with decompensated liver disease, a dose of 1 mg once daily is typically recommended, also on an empty stomach.

What are the possible side effects of ENTAVIR 0.5 MG TABLET?

Common side effects include headache, fatigue, dizziness, nausea, vomiting, diarrhea, indigestion, and insomnia. More serious, though rare, side effects can include lactic acidosis (an increase in acid in the blood) and severe liver problems (like an enlarged liver with fat build-up). It's important to contact your doctor if you experience symptoms such as persistent nausea, vomiting, stomach pain, unusual tiredness, dark urine, or yellowing of the skin or eyes.

Is ENTAVIR 0.5 MG TABLET safe during pregnancy or breastfeeding?

ENTAVIR 0.5 MG TABLET is generally not recommended during pregnancy unless specifically prescribed by your doctor, and only if the potential benefits outweigh the potential risks to the fetus. Women of childbearing age are advised to use effective contraception methods to avoid pregnancy during treatment. It is not known whether entecavir is excreted in human milk, so breastfeeding is generally not advised while taking this medicine.

Can ENTAVIR 0.5 MG TABLET be taken with other medications?

It's important to inform your doctor about all other medicines, supplements, or herbal products you are taking. Caution should be exercised with certain medications, including other antivirals, some antibiotics, and drugs that affect kidney function. Concurrent use with HIV antiretroviral agents may impact efficacy or lead to resistance if the patient is not on a fully suppressive anti-HIV regimen. However, in studies, entecavir did not show significant drug interactions with lamivudine, adefovir dipivoxil, and tenofovir disoproxil fumarate.

What precautions should be taken while on ENTAVIR 0.5 MG TABLET?

Do not stop taking the medicine suddenly, as this can lead to a severe worsening of hepatitis B. Regular blood tests and liver function tests are necessary during and for several months after treatment to monitor your condition. If you have kidney problems, your doctor may need to adjust your dosage. If you are co-infected with HIV, inform your doctor, as entecavir alone will not control HIV. This medication does not prevent the spread of HBV to others, so appropriate precautions should still be taken.

What happens if a dose of ENTAVIR 0.5 MG TABLET is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose (typically more than 12 hours since the missed dose), skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should ENTAVIR 0.5 MG TABLET be stored?

Store ENTAVIR 0.5 MG TABLET at room temperature, typically between 15°C to 30°C (59°F to 86°F), in a dry place, away from heat and moisture. Keep it out of reach of children.