What is the most important information I should know about entecavir?
You should not take entecavir if you have HIV (human immunodeficiency virus) that is not being treated.
Symptoms of hepatitis B can come back or get worse after you stop taking entecavir. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.
This medicine may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.
What is entecavir?
Entecavir is an antiviral medicine that prevents certain viruses from multiplying in your body.
Entecavir is used to treat chronic hepatitis B virus (HBV) in adults and children who are at least 2 years old and weigh at least 22 pounds (10 kilograms).
Entecavir is not a cure for hepatitis. It is not known whether this medicine will prevent cirrhosis or liver cancer.
Entecavir may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking entecavir?
You should not take entecavir if you are allergic to it, or if you also have HIV (human immunodeficiency virus) that is not being treated.
You may need to be tested for HIV before you start taking entecavir. Taking medicine to treat chronic hepatitis B can cause HIV infection to become resistant to certain HIV and AIDS medications.
To make sure entecavir is safe for you, tell your doctor if you have:
- HIV or AIDS (or if you have been exposed to HIV);
- kidney disease;
- liver disease;
- if you also take lamivudine (Epivir, Epzicom, Trizivir) or telbivudine (Tyzeka); or
- if you have had a liver transplant.
Tell your doctor about all medicines you have used to treat hepatitis B in the past.
Some people taking entecavir develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, a heart attack or stroke, a severe infection, if you are 65 or older, if you are dehydrated, or if you drink a lot of alcohol. Talk with your doctor about your risk.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of entecavir on the baby.
It is not known whether entecavir passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
How should I take entecavir?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You must remain under the care of a doctor while you are using entecavir.
Tell your doctor if you have any changes in weight. Entecavir doses are based on weight (especially in children), and any changes may affect the dose.
Take entecavir on an empty stomach, at least 2 hours before or 2 hours after eating.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Measure liquid medicine carefully, using the dosing spoon and instructions provided with your medicine. You must hold the spoon upright while pouring in the medicine and measuring the dose. Rinse the dosing spoon with water after each use. If you do not have an entecavir dose-measuring spoon, ask your pharmacist for one.
Call your doctor if your hepatitis symptoms do not improve, or if they get worse while using entecavir.
Symptoms of hepatitis B can come back or get worse after you stop taking entecavir. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.
Use entecavir regularly to get the most benefit and to keep your condition from getting worse. Get your prescription refilled before you run out of medicine completely.
Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.
Keep the bottle of oral liquid in its original carton. Throw away any unused entecavir 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking entecavir?
Taking this medicine will not prevent you from passing hepatitis B to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HBV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
What are the possible side effects of entecavir?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some people develop lactic acidosis while taking entecavir. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms 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
- fast or uneven heart rate.
Entecavir may also cause severe liver symptoms. Call your doctor at once if you have: nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
- nausea;
- dizziness, tired feeling; or
- headache.
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.
What other drugs will affect entecavir?
Other drugs may interact with entecavir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about entecavir.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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