Baraclude

Pronunciation

Generic Name: entecavir (en TE ka veer)
Brand Names: Baraclude

What is Baraclude?

Baraclude (entecavir) is an antiviral medication. It prevents certain virus cells from multiplying in your body and reduces the amount of hepatitis B virus in the blood.

Baraclude is used to treat chronic hepatitis B. It also helps prevent the hepatitis B virus from multiplying and infecting new liver cells.

Baraclude may also be used for other purposes not listed in this medication guide.

Important information

You should not take Baraclude if you are allergic to entecavir, or if you also have HIV (human immunodeficiency virus) that is not being treated.

Some people have developed a life-threatening condition called lactic acidosis while taking Baraclude. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

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Baraclude may also cause severe liver symptoms such as nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms.

Some people with hepatitis B develop liver symptoms after they stop taking Baraclude, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits.

What should I discuss with my healthcare provider before taking Baraclude?

You should not take Baraclude if you are allergic to entecavir, or if you also have HIV (human immunodeficiency virus) that is not being treated. If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before you take Baraclude, tell your doctor if you are allergic to any drugs, or if you have:

  • HIV or AIDS;

  • kidney disease;

  • liver disease; or

  • if you have had a liver transplant.

Some people have developed a life-threatening condition called lactic acidosis while taking Baraclude. You may be more likely to develop lactic acidosis if you have liver or kidney disease, congestive heart failure, or if you drink large amounts of alcohol. Talk with your doctor about your individual risk.

FDA pregnancy category C. It is not known whether Baraclude is harmful to an unborn baby. Before you take Baraclude, tell your doctor if you are pregnant or plan to become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

Your name may need to be listed on an antiviral pregnancy registry when you start using this medication.

It is not known whether entecavir passes into breast milk or if it could harm a nursing baby. Do not use Baraclude without telling your doctor if you are breast-feeding a baby.

How should I take Baraclude?

Take Baraclude exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

You may be required to be tested for HIV before you start taking Baraclude. Follow your doctor's instructions.

Take Baraclude with a full glass of water. Take this medicine on an empty stomach, at least 2 hours before or 2 hours after eating.

Measure the liquid form (oral solution) of Baraclude with the dosing spoon provided with this medication. Hold the dosing spoon in an upright position and fill it slowly until the liquid reaches the mark of your correct dose. Rinse the dosing spoon with water after each use. If you do not receive a dosing spoon with your medication, ask your pharmacist for one.

Some people with hepatitis B develop liver symptoms after they stop taking Baraclude, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits.

Store Baraclude at room temperature away from moisture and heat.

Keep the tablets in a tightly-closed container.

Keep the bottle of oral liquid in its original carton to help protect the medicine from light. Throw away any unused Baraclude oral liquid after the expiration date on the label has passed.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an Baraclude overdose are not known.

What should I avoid?

Taking Baraclude will not prevent you from passing hepatitis B to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing hepatitis transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

Baraclude side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Baraclude may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

  • muscle pain or weakness;

  • numb or cold feeling in your arms and legs;

  • trouble breathing;

  • feeling dizzy, light-headed, tired, or very weak;

  • stomach pain, nausea with vomiting; or

  • slow or uneven heart rate.

Baraclude may also cause severe liver symptoms. Call your doctor at once if you have any of these liver symptoms:

  • low fever;

  • nausea, stomach pain, loss of appetite;

  • dark urine, clay-colored stools; or

  • jaundice (yellowing of the skin or eyes).

Less serious Baraclude side effects may include:

  • mild nausea, vomiting, diarrhea, upset stomach;

  • temporary hair loss;

  • headache;

  • skin rash; or

  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Baraclude?

Before taking Baraclude, tell your doctor if you are using any of the following drugs:

  • drugs that weaken your immune system (such as cancer medicine or steroids);

  • amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);

  • cyclosporine (Neoral, Sandimmune, Gengraf);

  • pentamidine (Nebupent, Pentam);

  • sirolimus (Rapamune), tacrolimus (Prograf);

  • antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled); or

  • any other antiviral medicines.

This list is not complete and there may be other drugs that can interact with Baraclude. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Baraclude.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Baraclude only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 4.02. Revision Date: 05/13/2009 1:24:04 PM.

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