• Lamivudine and Zidovudine

    (la mi' vyoo deen) (zye doe' vyoo deen)

    IMPORTANT WARNING:

    [Posted 03/01/2011] ISSUE: FDA updated the public about an ongoing safety review of abacavir and a possible increased risk of heart attack. There has been conflicting information on the potential increased risk of heart attack with abacavir (Ziagen) treatment. An increased risk of heart attack (myocardial infarction or MI) has been seen in several observational studies and one randomized controlled trial (RCT) with abacavir. However, an increased risk of heart attack has not been seen in other RCTs and the safety database maintained by the drug manufacturer.
    FDA conducted a meta-analysis of 26 randomized clinical trials that evaluated abacavir. This meta-analysis did not show an increased risk of MI associated with the use of abacavir. FDA will continue to communicate any new safety information to the public as it becomes available.
    BACKGROUND: Abacavir is an antiviral medication used in combination with other antiretroviral drugs [abacavir and lamivudine (Epzicom); abacavir, lamivudine, and zidovudine (Trizivir)] for the treatment of HIV-1 infection.
    RECOMMENDATION: Healthcare professionals should continue to prescribe abacavir according to the professional label. Patients should not stop taking their abacavir without first talking to their healthcare professional. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety .

    IMPORTANT WARNING:

    Lamivudine and zidovudine may stop your body from making enough blood cells. Tell your doctor if you have or have ever had any blood disorders such as anemia or bone marrow problems. If you experience any of the following symptoms, call your doctor immediately: unusual bleeding or bruising; shortness of breath; pale skin; fever, sore throat, chills, and other signs of infection; or unusual tiredness or weakness.
    Lamivudine and zidovudine may cause muscle disorders. Tell your doctor if you have or have ever had any disease or swelling of the muscles. If you experience muscle pain or weakness, call your doctor immediately.
    When used alone or in combination with other antiretroviral medication, lamivudine and zidovudine may also cause serious damage to the liver and a condition called lactic acidosis. Tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had liver disease. Tell your doctor and pharmacist if you are taking acetaminophen (Tylenol) and if you have been taking medication to treat HIV infection for a long time. If you experience any of the following symptoms, call your doctor immediately: fatty and foul-smelling stools, upset stomach, extreme tiredness, unusual bleeding or bruising, lack of energy, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, or flu-like symptoms.
    Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to lamivudine and zidovudine.

    WHY is this medicine prescribed?

    The combination of lamivudine and zidovudine is used to treat human immunodeficiency virus (HIV) in patients with or without acquired immunodeficiency syndrome (AIDS). Lamivudine and zidovudine are in a class of antiviral medications called synthetic nucleoside analogues. They work by slowing the spread of HIV infection in the body. Lamivudine and zidovudine is not a cure and may not decrease the number of HIV-related illnesses. Lamivudine and zidovudine does not prevent the spread of HIV to other people.

    HOW should this medicine be used?

    The combination of lamivudine and zidovudine comes as a tablet to take by mouth. It is usually taken twice a day with or without food. To help you remember to take this medication, take it around the same time every day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand. Take this medication exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
    Lamivudine and zidovudine controls HIV infection but does not cure it. Continue to take lamivudine and zidovudine even if you feel well. Do not stop taking lamivudine and zidovudine without talking to your doctor.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking lamivudine and zidovudine,
    • tell your doctor or pharmacist if you are allergic to lamivudine (Epivir, Epivir HBV); zidovudine (Retrovir); lamivudine, zidovudine, and abacavir (Trizivir); or any other medications.
    • you should know that lamivudine and zidovudine are also available individually with the brand names Epivir, Epivir HBV, and Retrovir, and in another combination as Trizivir. Tell your doctor if you are taking any of these medications, to be sure you do not receive the same medication twice.
    • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking. Be sure to mention any of the following: acetaminophen (Tylenol), acyclovir (Zovirax), atovaquone (Mepron), cancer chemotherapy drugs, cidofovir (Vistide), dapsone (Avlosulfon), didanosine (ddI, Videx), doxorubicin (Adriamycin, Rubex), fluconazole (Diflucan), foscarnet (Foscavir), ganciclovir (Cytovene, Vitrasert), interferon alpha (Alferon N, Infergen, Intron A, Roferon A), interferon beta-1b (Betaseron), methadone, nelfinavir (Viracept), probenecid (Benemid, Probalan), ribavarin (Rebetol, Virazole), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane), ritonavir (Norvir), stavudine (Zerit), trimethoprim (Trimpex, Proloprim ), trimethoprim and sulfamethoxazole (Bactrim, Septra), valproic acid (Depakene, Depakote), and zalcitabine (ddC, Hivid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • in addition to the conditions listed in the IMPORTANT WARNING section, tell your doctor if you have or have ever had kidney disease.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking lamivudine and zidovudine, call your doctor. You should not breast-feed while taking lamivudine and zidovudine.
    • you should be aware that your body fat may increase or move to different areas of your body, such as your breasts and your upper back.

    What SPECIAL DIETARY instructions should I follow?

    Unless your doctor tells you otherwise, continue your normal diet.

    What should I do IF I FORGET to take a dose?

    Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Lamivudine and zidovudine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • headache
    • upset stomach
    • diarrhea
    • constipation
    • loss of appetite
    • dizziness
    • difficulty falling asleep or staying asleep
    • excessive tiredness
    • depression
    • stuffy nose
    • cough
    • hair loss
    Some side effects can be serious. The following side effects are uncommon, but if you experience any of them, or any of those listed in the IMPORTANT WARNING section, call your doctor immediately:
    • hives
    • skin rash
    • itching
    • difficulty breathing or swallowing
    • seizures
    • numbness, tingling, or burning in your fingers or toes
    • fever
    • wheezing
    Lamivudine and zidovudine may cause other side effects. Call your doctor if you have any unusual problems while taking lamivudine and zidovudine.
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor and the laboratory.
    Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking lamivudine and zidovudine.
    Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Combivir® (as a combination product containing Lamivudine, Zidovudine)

    Other Names

    • 3TC and ZDV
    • 3TC and AZT
    • 3TC and azidothymidine
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