What is entecavir?
Entecavir is an antiviral medication. Entecavir prevents certain virus cells from multiplying in your body
Entecavir is used to treat chronic hepatitis B.
Entecavir may also be used for other purposes not listed in this medication guide.
You should not take this medication 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 entecavir, 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 entecavir. 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 entecavir is harmful to an unborn baby. Before you take entecavir, tell your doctor if you are pregnant or plan to become pregnant during treatment.
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 this medication without telling your doctor if you are breast-feeding a baby.
Taking entecavir 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.
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Seek emergency medical attention if you think you have used too much of this medicine.
Symptoms of an entecavir overdose are not known.
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.
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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.
This medication 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.
Entecavir 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 side effects may include:
- mild nausea, vomiting, diarrhea, upset stomach;
- temporary hair loss;
- skin rash; or
- sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Before taking entecavir, 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 entecavir. 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.
Baraclude and entecavir
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