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Epivir-HBV

Generic Name: lamivudine (la-MIV-ue-deen)
Brand Name: Epivir-HBV

Serious and sometimes fatal lactic acidosis (high blood lactic acid levels) and liver problems have occurred with the use of Epivir-HBV. The risk may be greater if you are a woman, are very overweight, or have taken similar medicines for a long period of time. Tell your doctor right away if you experience symptoms of lactic acidosis (eg, dizziness or light-headedness; fast or irregular heartbeat; feeling of being unusually cold [especially in the arms or legs]; stomach pain with nausea and vomiting; trouble breathing; unusual tiredness or weakness; unusual muscle pain). Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent loss of appetite, nausea, or stomach pain).

Worsening of hepatitis B infection, which may be fatal, has occurred in patients who have stopped treatment with Epivir-HBV. Do not stop taking Epivir-HBV without checking with your doctor. If you need to stop taking it, your liver function will be monitored for at least several months after you stop treatment.

Epivir-HBV is not approved to treat HIV infection. It contains a lower dose than other medicines that contain lamivudine and are used to treat HIV. If you have or get HIV that is not being treated with medicines while you are taking Epivir-HBV, the HIV virus may develop resistance to certain HIV medicines and become harder to treat. Your doctor will offer counseling and testing for HIV before you start Epivir-HBV and while you are taking it.


Epivir-HBV is used for:

Treating certain types of chronic hepatitis B virus (HBV) infection.

Epivir-HBV is a nucleoside analogue. It works by blocking the growth of HBV.

Do NOT use Epivir-HBV if:

  • you are allergic to any ingredient in Epivir-HBV
  • you are taking other medicines that contain emtricitabine or lamivudine

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Epivir-HBV:

Some medical conditions may interact with Epivir-HBV. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of lactic acidosis, abnormal liver function tests, or liver problems other than hepatitis B
  • if you have another type of hepatitis, HIV, or kidney problems, or if you are receiving dialysis
  • if you have received a liver transplant
  • if you are very overweight

Some MEDICINES MAY INTERACT with Epivir-HBV. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Trimethoprim because it may increase the risk of Epivir-HBV's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Epivir-HBV may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Epivir-HBV:

Use Epivir-HBV as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Epivir-HBV. Talk to your pharmacist if you have questions about this information.
  • Take Epivir-HBV by mouth with or without food.
  • If you have trouble swallowing Epivir-HBV, talk with your doctor.
  • Continue to take Epivir-HBV even if you feel well. Do not miss any doses.
  • It is important not to miss any doses of Epivir-HBV. Taking Epivir-HBV at the same time each day will help you remember to take it.
  • If you miss a dose of Epivir-HBV, take it as soon as possible. If it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Epivir-HBV.

Important safety information:

  • Epivir-HBV is not a cure for HBV infection. It is unknown if Epivir-HBV reduces the risk of liver cancer or cirrhosis that may be caused by HBV. Some patients developed HBV that is resistant to Epivir-HBV. These patients had less benefit from Epivir-HBV, and some experienced worsening of hepatitis after the resistant virus appeared.
  • HBV can change while you are taking Epivir-HBV and become harder to treat (resistant). This may cause the hepatitis to become worse and may lead to death. Tell your doctor right away if you have any new symptoms.
  • Do NOT take more than the recommended dose, change your dose, or stop taking Epivir-HBV without checking with your doctor.
  • Epivir-HBV does not stop the spread of HBV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HBV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HBV to others.
  • Tell your doctor or dentist that you take Epivir-HBV before you receive any medical or dental care, emergency care, or surgery.
  • LAB TESTS, including liver and kidney function tests, may be performed while you use Epivir-HBV. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Epivir-HBV should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Epivir-HBV while you are pregnant. Epivir-HBV is found in breast milk. Do not breast-feed while taking Epivir-HBV.

Possible side effects of Epivir-HBV:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; ear, nose, and throat infection; sore throat.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); cold feeling in the arms and legs; dark urine; dizziness; fast or irregular heartbeat; light-headedness; pale stools; persistent loss of appetite; severe or unusual muscle pain; stomach pain with nausea and vomiting; trouble breathing; unusual weakness or tiredness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Epivir-HBV:

Store Epivir-HBV between 68 to 77 degrees F (20 to 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Epivir-HBV out of the reach of children and away from pets.

General information:

  • If you have any questions about Epivir-HBV, please talk with your doctor, pharmacist, or other health care provider.
  • Epivir-HBV is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Epivir-HBV or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Epivir-HBV. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Epivir-HBV. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Epivir-HBV.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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