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What is the most important information I should know about lamivudine?

Lamivudine should not be taken together with Combivir, a medication that contains a combination of lamivudine and zidovudine.

Lamivudine may cause lactic acidosis (the build up of lactic acid in the body). Symptoms can start slowly and gradually get worse: unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Call your doctor at once if you have any of these symptoms, even if they are only mild.

Lamivudine can also cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms while taking lamivudine: severe pain in your upper stomach spreading to your back, fast heart rate, nausea and vomiting, diarrhea, loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Before taking lamivudine, tell your doctor if you have kidney disease, liver disease, a history of pancreatitis, or if you have used a medicine similar to lamivudine in the past, such as abacavir (Ziagen), didanosine (Videx), stavudine (Zerit), tenofovir (Viread), zalcitabine (Hivid), or zidovudine (Retrovir).

If you have hepatitis B you may develop liver symptoms after you stop taking lamivudine, 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.

Epivir tablets and liquid contain a higher dose of lamivudine than Epivir-HBV. Epivir is for treating HIV and Epivir-HBV is for treating hepatitis B. Each time you get a refill of this medication, be sure you have received the correct brand to treat your condition.

Warning

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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What is lamivudine?

Lamivudine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

The Epivir brand of lamivudine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Lamivudine is not a cure for HIV or AIDS. The Epivir-HBV brand of lamivudine is used to treat chronic hepatitis B. Epivir-HBV should not be used in people who are infected with both hepatitis B and HIV.

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

Precautions

You should not take lamivudine if you are also taking Combivir (lamivudine/zidovudine), or if you have ever had an allergic reaction to a medicine containing lamivudine, including Combivir, Epzicom, or Trizivir.

Before taking lamivudine, tell your doctor if you are allergic to any drugs, or if you have:

  • kidney disease;
  • liver disease (including hepatitis B);
  • a history of pancreatitis; or
  • if you have used a medicine similar to lamivudine in the past, such as abacavir (Ziagen), didanosine (Videx), stavudine (Zerit), tenofovir (Viread), zalcitabine (Hivid), or zidovudine (Retrovir).

If you have any of the conditions listed above, you may need a dose adjustment or special tests to safely take this medication.

Lamivudine may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis symptoms can start slowly and gradually get worse. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Call your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal.

Lamivudine can also cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms while taking lamivudine: severe pain in your upper stomach spreading to your back, fast heart rate, nausea and vomiting, diarrhea, loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Lamivudine may also be more likely to cause pancreatitis in a pregnant woman. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an antiviral pregnancy registry when you start using lamivudine. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether lamivudine had any effect on the baby.

You should not breast-feed while you are using lamivudine. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

If you have diabetes, you should know that the liquid forms of lamivudine contain 3 to 4 grams of sucrose (sugar) per dose.

Avoid drinking alcohol while taking lamivudine. Alcohol may increase the risk of damage to the pancreas and/or liver.

Taking lamivudine will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV 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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Instructions

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a lamivudine 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 the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Side Effects

Stop using lamivudine and 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.

Call your doctor at once if you have any of these other serious side effects:

  • liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, and fast or uneven heart rate;
  • pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • peripheral neuropathy - numbness, tingling, or pain in your hands or feet;
  • easy bruising or bleeding, unusual weakness, pale skin;
  • white patches or sores inside your mouth or on your lips;
  • fever, chills, body aches, flu symptoms; or
  • any other signs of new infection.

Less serious side effects may include:

  • cough;
  • sleep problems (insomnia), strange dreams;
  • nausea, vomiting, diarrhea;
  • joint or muscle pain;
  • dizziness, headache, tired feeling; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

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.

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Interactions

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

  • interferon-alfa (Roferon, Intron, Rebetron);
  • trimethoprim (Bactrim, Proloprim, Septra, Trimpex); or
  • ribavirin (Rebetol, Ribasphere, Copegus Virazole).

This list is not complete and there may be other drugs that can interact with lamivudine. 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.

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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 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04