Consumer Information

Baraclude

Generic name: Entecavir
Brand names: Baraclude

Why is Baraclude prescribed?

Baraclude is a prescription medicine used for chronic infection with hepatitis B virus (HBV) in adults who also have active liver damage. Baraclude will not cure HBV. This drug may lower the amount of HBV in the body and its ability to multiply and infect new liver cells. Baraclude may improve the condition of your liver.

Most important fact about Baraclude

Baraclude may cause lactic acidosis, a build up of acid in the blood. This condition is considered an emergency and must be treated in a hospital. Baraclude may also cause severe liver problems, such as toxicity (hepatotoxicity), liver enlargement (hepatomegaly), and fatty liver (steatosis). Also, Baraclude may make your hepatitis B infection worse.

How should you take Baraclude?

Take Baraclude once a day on an empty stomach to help it work better. Empty stomach means at least 2 hours after a meal and at least 2 hours before the next meal. To help you remember to take your Baraclude, try to take it at the same time each day.

If you miss a dose...
If you forget to take Baraclude, take it as soon as you remember and then take your next dose at its regular time. If it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

Storage instructions...
Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Baraclude.

Side effects may include:
Diarrhea, dizziness, headache, indigestion, nausea, sleepiness, tiredness, trouble sleeping, vomiting

Why should Baraclude not be prescribed?

Do not take Baraclude if you are allergic to any of its ingredients. Also, Baraclude is not recommended for children under 16.

Special warnings about Baraclude

Avoid running out of Baraclude, or stopping treatment without talking to your doctor.

Possible food and drug interactions when taking Baraclude

If Baraclude is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is important to check with your doctor before combining Baraclude with any other prescription, over-the-counter, or herbal medication.

Special information if you are pregnant or breastfeeding

The effects of Baraclude during pregnancy and breastfeeding are unknown. Talk with your doctor before taking Baraclude if you are pregnant, plan to become pregnant, or are breastfeeding.

Recommended dosage for Baraclude

ADULTS

Not Previously Treated with Anti-HIV Medication
The recommended dose of Baraclude for chronic hepatitis B virus infection in treatment-naive adults and adolescents (16 years and older) is 0.5 milligrams (mg) once daily.

Previously Treated with Lamivudine Therapy or Developed Tolerance to Treatment
The recommended dose of Baraclude in adults and adolescents (16 years and older) with a history of hepatitis B viremia while receiving lamivudine is 1 mg once daily.