What is Baraclude?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.
What is the most important information I should know about Baraclude?Your hepatitis B virus infection may get worse or become very serious if you stop taking Baraclude. Take Baraclude exactly as prescribed and do not run out of or stop without consulting your doctor.
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, this drug may make your hepatitis B infection worse. If you have HIV and use Baraclude at the same time, some of the HIV medications might not work as well.
Who should not take Baraclude?Do not take Baraclude if you are allergic to any of its ingredients. Also, this drug is not recommended for children less than 16 years of age.
What should I tell my doctor before I take the first dose of Baraclude?Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Baraclude. Also, talk to your doctor about your complete medical history, especially if you have kidney problems, are pregnant or planning to become pregnant, are breastfeeding, or if you have HIV.
What is the usual dosage?The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.
Adults and adolescents ≥16 years: The recommended dose of Baraclude for chronic hepatitis B virus infection in treatment-naive adults and adolescents is 0.5 milligrams (mg) once daily. The oral solution provides 0.5 mg in 10 milliliters (mL) according to the dosing spoon,
With Lamivudine Therapy or Tolerance
Adults and adolescents ≥16 years: The recommended dose of Baraclude in adults and adolescents with a history of hepatitis B virus in the bloodstream is 1 mg once daily while receiving lamivudine. The oral solution provides 1 mg in 20 mL.
Your dose may be reduced or taken less frequently if you have kidney problems.
How should I take Baraclude?Take Baraclude once a day on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal) to help it work better. To help you remember to take your Baraclude, try to take it at the same time each day.
When using the oral solution, hold the dosing spoon in a vertical position and fill it gradually to the mark indicating the dose prescribed. Rinse the dosing spoon with water after each daily dose.
What should I avoid while taking Baraclude?Avoid running out of Baraclude. Do not stop treatment without talking to your doctor. Baraclude does not stop you from spreading HBV to others; avoid unsafe sexual practices, sharing needles, and sharing personal items contaminated with blood or body fluids (toothbrushes/razor blades).
What are possible food and drug interactions associated with Baraclude?If Baraclude is used with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Baraclude with drugs that may affect how your kidneys function.
What are the possible side effects of Baraclude?Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.
Side effects may include: diarrhea, dizziness, headache, indigestion, nausea, sleepiness, tiredness, trouble sleeping, vomiting
Symptoms of lactic acidosis include: cold arms and legs, dizziness, fast or irregular heartbeat, lightheadedness, muscle pain, stomach pain with nausea/vomiting, tiredness, trouble breathing, weakness
Symptoms of liver problems include: dark urine, light-colored stool, loss of appetite, lower stomach pain, nausea, yellow skin/eyes
Can I receive Baraclude if I am pregnant or breastfeeding?Talk to your doctor if you are pregnant, planning to become pregnant, or are nursing, before you begin treatment with Baraclude. The effects of this drug on pregnancy are unknown, and it may pass into breast milk.
What should I do if I miss a dose of Baraclude?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.
How should I store Baraclude?Store Baraclude tablets in a tightly closed container, at room temperature and away from humidity.
Store Baraclude oral solution in the outer carton at room temperature; protect from light. After opening the oral solution, use it until the expiration date on the bottle and then dispose of unused medicine after the expiration date has passed.