Abacavir and Lamivudine Tablets

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  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take Abacavir and Lamivudine Tablets.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the­-counter medicines, vitamins, and herbal supplements.

Some medicines interact with Abacavir and Lamivudine Tablets. Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Abacavir and Lamivudine Tablets. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Abacavir and Lamivudine Tablets with other medicines.

Tell your healthcare provider if you take:

When used with other antiretroviral medicines to treat HIV-1 infection, Abacavir and Lamivudine Tablets may help:

1. reduce the amount of HIV-1 in your blood. This is called “viral load”.

2. increase the number of CD4+ (T) cells in your blood, that help fight off other infections.

Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

Abacavir and Lamivudine Tablets do not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

Who should not take Abacavir and Lamivudine Tablets?

Do not take Abacavir and Lamivudine Tablets if you:

  • have a certain type of gene variation called the HLA-B*5701 allele. Your healthcare provider will test you for this before prescribing treatment with Abacavir and Lamivudine Tablets.
  • are allergic to abacavir or any of the ingredients in Abacavir and Lamivudine Tablets. See the end of this Medication Guide for a complete list of ingredients in Abacavir and Lamivudine Tablets.
  • have liver problems.

What should I tell my healthcare provider before taking Abacavir and Lamivudine Tablets?

Before you take Abacavir and Lamivudine Tablets tell your healthcare provider if you:

  • have been tested and know whether or not you have a particular gene variation called HLA-B*5701.
  • have or have had liver problems, including hepatitis B or C virus infection.
  • have kidney problems.
  • have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.
  • drink alcohol or take medicines that contain alcohol.
  • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take Abacavir and Lamivudine Tablets.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the­-counter medicines, vitamins, and herbal supplements.

Some medicines interact with Abacavir and Lamivudine Tablets. Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Abacavir and Lamivudine Tablets. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Abacavir and Lamivudine Tablets with other medicines.

Tell your healthcare provider if you take:

  • any other medicine to treat HIV-1
  • medicines to treat hepatitis viruses such as interferon or ribavirin
  • methadone

How should I take Abacavir and Lamivudine Tablets?

  • Take Abacavir and Lamivudine Tablets exactly as your healthcare provider tells you.
  • Do not change your dose or stop taking Abacavir and Lamivudine Tablets without talking with your healthcare provider. If you miss a dose of Abacavir and Lamivudine Tablets, take it as soon as you remember. Do not take 2 doses at the same time. If you are not sure about your dosing, call your healthcare provider.
  • Stay under the care of a healthcare provider while taking Abacavir and Lamivudine Tablets.
  • Abacavir and Lamivudine Tablets may be taken with or without food.
  • Tell your healthcare provider if your child has trouble swallowing Abacavir and Lamivudine Tablets.
  • Do not run out of Abacavir and Lamivudine Tablets. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
  • If you take too much abacavir and lamivudine, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of Abacavir and Lamivudine Tablets?

  • Abacavir and Lamivudine Tablets can cause serious side effects including:
  • SeeWhat is the most important information I should know about Abacavir and Lamivudine Tablets?
  • Build-upof acid in your blood (lactic acidosis). Lactic  acidosis can happen in some people who take abacavir and lamivudine  tablets. Lactic acidosis is a serious medical emergency that can cause death. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:

    • feel very weak or tired
    • feel cold, especially in your arms and legs
    • unusual (not normal) muscle pain
    • feel dizzy or light-headed
    • trouble breathing
    • have a fast or irregular heartbeat
    • stomach pain with nausea and vomiting
  • Seriousliver problems can  happen in people who take abacavir and lamivudine  tablets. In some  cases, these serious liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

    • your skin or the white part of your eyes turns yellow (jaundice)
    • loss of appetite for several days or longer
    • dark or “tea-colored” urine
    • nausea
    • light-colored stools (bowel movements)
    • pain, aching, or tenderness on the right side of your stomach area
  • You may be more likely to get lactic acidosis or serious liver problems if you are female or very overweight (obese).

    • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking abacavir and lamivudine tablets.

    • Heart attack (myocardial infarction). Some HIV-1 medicines including abacavir and lamivudine tablets may increase your risk of heart attack.

    The most common side effects of Abacavir and Lamivudine Tablets include:

    • trouble sleeping
    • nausea
    • depression
    • diarrhea
    • headache
    • rash
    • tiredness
    • fever
    • dizziness

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    These are not all the possible side effects of abacavir and lamivudine tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Abacavir and Lamivudine Tablets are a prescription HIV-1 (Human Immunodeficiency Virus-type 1) medicine used with other antiretroviral medicines to treat HIV-1 infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Abacavir and Lamivudine Tablets contain 2 prescription medicines, abacavir (ZIAGEN) and lamivudine (EPIVIR).

    Abacavir and Lamivudine Tablets should not be used in children weighing less than 55 pounds (25 kg).

    When used with other antiretroviral medicines to treat HIV-1 infection, Abacavir and Lamivudine Tablets may help:

    1. reduce the amount of HIV-1 in your blood. This is called “viral load”.

    2. increase the number of CD4+ (T) cells in your blood, that help fight off other infections.

    Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

    Abacavir and Lamivudine Tablets do not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

    Who should not take Abacavir and Lamivudine Tablets?

    Do not take Abacavir and Lamivudine Tablets if you:

    • have a certain type of gene variation called the HLA-B*5701 allele. Your healthcare provider will test you for this before prescribing treatment with Abacavir and Lamivudine Tablets.
    • are allergic to abacavir or any of the ingredients in Abacavir and Lamivudine Tablets. See the end of this Medication Guide for a complete list of ingredients in Abacavir and Lamivudine Tablets.
    • have liver problems.

    What should I tell my healthcare provider before taking Abacavir and Lamivudine Tablets?

    Before you take Abacavir and Lamivudine Tablets tell your healthcare provider if you:

    • have been tested and know whether or not you have a particular gene variation called HLA-B*5701.
    • have or have had liver problems, including hepatitis B or C virus infection.
    • have kidney problems.
    • have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.
    • drink alcohol or take medicines that contain alcohol.
    • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

    Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

    • are breastfeeding or plan to breastfeed. Do not breastfeed if you take Abacavir and Lamivudine Tablets.
      • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the­-counter medicines, vitamins, and herbal supplements.

    Some medicines interact with Abacavir and Lamivudine Tablets. Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Abacavir and Lamivudine Tablets. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Abacavir and Lamivudine Tablets with other medicines.

    Tell your healthcare provider if you take:

    • any other medicine to treat HIV-1
    • medicines to treat hepatitis viruses such as interferon or ribavirin
    • methadone

    How should I take Abacavir and Lamivudine Tablets?

    • Take Abacavir and Lamivudine Tablets exactly as your healthcare provider tells you.
    • Do not change your dose or stop taking Abacavir and Lamivudine Tablets without talking with your healthcare provider. If you miss a dose of Abacavir and Lamivudine Tablets, take it as soon as you remember. Do not take 2 doses at the same time. If you are not sure about your dosing, call your healthcare provider.
    • Stay under the care of a healthcare provider while taking Abacavir and Lamivudine Tablets.
    • Abacavir and Lamivudine Tablets may be taken with or without food.
    • Tell your healthcare provider if your child has trouble swallowing Abacavir and Lamivudine Tablets.
    • Do not run out of Abacavir and Lamivudine Tablets. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
    • If you take too much abacavir and lamivudine, call your healthcare provider or go to the nearest hospital emergency room right away.

    What are the possible side effects of Abacavir and Lamivudine Tablets?

  • Abacavir and Lamivudine Tablets can cause serious side effects including:
  • SeeWhat is the most important information I should know about Abacavir and Lamivudine Tablets?
  • Build-upof acid in your blood (lactic acidosis). Lactic  acidosis can happen in some people who take abacavir and lamivudine  tablets. Lactic acidosis is a serious medical emergency that can cause death. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:

    • feel very weak or tired
    • feel cold, especially in your arms and legs
    • unusual (not normal) muscle pain
    • feel dizzy or light-headed
    • trouble breathing
    • have a fast or irregular heartbeat
    • stomach pain with nausea and vomiting
  • Seriousliver problems can  happen in people who take abacavir and lamivudine  tablets. In some  cases, these serious liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

    • your skin or the white part of your eyes turns yellow (jaundice)
    • loss of appetite for several days or longer
    • dark or “tea-colored” urine
    • nausea
    • light-colored stools (bowel movements)
    • pain, aching, or tenderness on the right side of your stomach area
  • You may be more likely to get lactic acidosis or serious liver problems if you are female or very overweight (obese).

    • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking abacavir and lamivudine tablets.

    • Heart attack (myocardial infarction). Some HIV-1 medicines including abacavir and lamivudine tablets may increase your risk of heart attack.

    The most common side effects of Abacavir and Lamivudine Tablets include:

    • trouble sleeping
    • nausea
    • depression
    • diarrhea
    • headache
    • rash
    • tiredness
    • fever
    • dizziness

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    These are not all the possible side effects of abacavir and lamivudine tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Abacavir and Lamivudine Tablets are a prescription HIV-1 (Human Immunodeficiency Virus-type 1) medicine used with other antiretroviral medicines to treat HIV-1 infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Abacavir and Lamivudine Tablets contain 2 prescription medicines, abacavir (ZIAGEN) and lamivudine (EPIVIR).

    Abacavir and Lamivudine Tablets should not be used in children weighing less than 55 pounds (25 kg).

    When used with other antiretroviral medicines to treat HIV-1 infection, Abacavir and Lamivudine Tablets may help:

    1. reduce the amount of HIV-1 in your blood. This is called “viral load”.

    2. increase the number of CD4+ (T) cells in your blood, that help fight off other infections.

    Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

    Abacavir and Lamivudine Tablets do not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

    Who should not take Abacavir and Lamivudine Tablets?

    Do not take Abacavir and Lamivudine Tablets if you:

    • have a certain type of gene variation called the HLA-B*5701 allele. Your healthcare provider will test you for this before prescribing treatment with Abacavir and Lamivudine Tablets.
    • are allergic to abacavir or any of the ingredients in Abacavir and Lamivudine Tablets. See the end of this Medication Guide for a complete list of ingredients in Abacavir and Lamivudine Tablets.
    • have liver problems.

    What should I tell my healthcare provider before taking Abacavir and Lamivudine Tablets?

    Before you take Abacavir and Lamivudine Tablets tell your healthcare provider if you:

    • have been tested and know whether or not you have a particular gene variation called HLA-B*5701.
    • have or have had liver problems, including hepatitis B or C virus infection.
    • have kidney problems.
    • have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.
    • drink alcohol or take medicines that contain alcohol.
    • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

    Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

    • are breastfeeding or plan to breastfeed. Do not breastfeed if you take Abacavir and Lamivudine Tablets.
      • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the­-counter medicines, vitamins, and herbal supplements.

    Some medicines interact with Abacavir and Lamivudine Tablets. Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Abacavir and Lamivudine Tablets. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Abacavir and Lamivudine Tablets with other medicines.

    Tell your healthcare provider if you take:

    • any other medicine to treat HIV-1
    • medicines to treat hepatitis viruses such as interferon or ribavirin
    • methadone

    How should I take Abacavir and Lamivudine Tablets?

    • Take Abacavir and Lamivudine Tablets exactly as your healthcare provider tells you.
    • Do not change your dose or stop taking Abacavir and Lamivudine Tablets without talking with your healthcare provider. If you miss a dose of Abacavir and Lamivudine Tablets, take it as soon as you remember. Do not take 2 doses at the same time. If you are not sure about your dosing, call your healthcare provider.
    • Stay under the care of a healthcare provider while taking Abacavir and Lamivudine Tablets.
    • Abacavir and Lamivudine Tablets may be taken with or without food.
    • Tell your healthcare provider if your child has trouble swallowing Abacavir and Lamivudine Tablets.
    • Do not run out of Abacavir and Lamivudine Tablets. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
    • If you take too much abacavir and lamivudine, call your healthcare provider or go to the nearest hospital emergency room right away.

    What are the possible side effects of Abacavir and Lamivudine Tablets?

  • Abacavir and Lamivudine Tablets can cause serious side effects including:
  • SeeWhat is the most important information I should know about Abacavir and Lamivudine Tablets?
  • Build-upof acid in your blood (lactic acidosis). Lactic  acidosis can happen in some people who take abacavir and lamivudine  tablets. Lactic acidosis is a serious medical emergency that can cause death. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:

    • feel very weak or tired
    • feel cold, especially in your arms and legs
    • unusual (not normal) muscle pain
    • feel dizzy or light-headed
    • trouble breathing
    • have a fast or irregular heartbeat
    • stomach pain with nausea and vomiting
  • Seriousliver problems can  happen in people who take abacavir and lamivudine  tablets. In some  cases, these serious liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

    • your skin or the white part of your eyes turns yellow (jaundice)
    • loss of appetite for several days or longer
    • dark or “tea-colored” urine
    • nausea
    • light-colored stools (bowel movements)
    • pain, aching, or tenderness on the right side of your stomach area
  • You may be more likely to get lactic acidosis or serious liver problems if you are female or very overweight (obese).

    • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking abacavir and lamivudine tablets.

    • Heart attack (myocardial infarction). Some HIV-1 medicines including abacavir and lamivudine tablets may increase your risk of heart attack.

    The most common side effects of Abacavir and Lamivudine Tablets include:

    • trouble sleeping
    • nausea
    • depression
    • diarrhea
    • headache
    • rash
    • tiredness
    • fever
    • dizziness

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    These are not all the possible side effects of abacavir and lamivudine tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Abacavir and Lamivudine Tablets are a prescription HIV-1 (Human Immunodeficiency Virus-type 1) medicine used with other antiretroviral medicines to treat HIV-1 infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Abacavir and Lamivudine Tablets contain 2 prescription medicines, abacavir (ZIAGEN) and lamivudine (EPIVIR).

    Abacavir and Lamivudine Tablets should not be used in children weighing less than 55 pounds (25 kg).

    When used with other antiretroviral medicines to treat HIV-1 infection, Abacavir and Lamivudine Tablets may help:

    1. reduce the amount of HIV-1 in your blood. This is called “viral load”.

    2. increase the number of CD4+ (T) cells in your blood, that help fight off other infections.

    Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

    Abacavir and Lamivudine Tablets do not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

    Who should not take Abacavir and Lamivudine Tablets?

    Do not take Abacavir and Lamivudine Tablets if you:

    • have a certain type of gene variation called the HLA-B*5701 allele. Your healthcare provider will test you for this before prescribing treatment with Abacavir and Lamivudine Tablets.
    • are allergic to abacavir or any of the ingredients in Abacavir and Lamivudine Tablets. See the end of this Medication Guide for a complete list of ingredients in Abacavir and Lamivudine Tablets.
    • have liver problems.

    What should I tell my healthcare provider before taking Abacavir and Lamivudine Tablets?

    Before you take Abacavir and Lamivudine Tablets tell your healthcare provider if you:

    • have been tested and know whether or not you have a particular gene variation called HLA-B*5701.
    • have or have had liver problems, including hepatitis B or C virus infection.
    • have kidney problems.
    • have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.
    • drink alcohol or take medicines that contain alcohol.
    • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

    Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

    • are breastfeeding or plan to breastfeed. Do not breastfeed if you take Abacavir and Lamivudine Tablets.
      • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the­-counter medicines, vitamins, and herbal supplements.

    Some medicines interact with Abacavir and Lamivudine Tablets. Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Abacavir and Lamivudine Tablets. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Abacavir and Lamivudine Tablets with other medicines.

    Tell your healthcare provider if you take:

    • any other medicine to treat HIV-1
    • medicines to treat hepatitis viruses such as interferon or ribavirin
    • methadone

    How should I take Abacavir and Lamivudine Tablets?

    • Take Abacavir and Lamivudine Tablets exactly as your healthcare provider tells you.
    • Do not change your dose or stop taking Abacavir and Lamivudine Tablets without talking with your healthcare provider. If you miss a dose of Abacavir and Lamivudine Tablets, take it as soon as you remember. Do not take 2 doses at the same time. If you are not sure about your dosing, call your healthcare provider.
    • Stay under the care of a healthcare provider while taking Abacavir and Lamivudine Tablets.
    • Abacavir and Lamivudine Tablets may be taken with or without food.
    • Tell your healthcare provider if your child has trouble swallowing Abacavir and Lamivudine Tablets.
    • Do not run out of Abacavir and Lamivudine Tablets. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
    • If you take too much abacavir and lamivudine, call your healthcare provider or go to the nearest hospital emergency room right away.

    What are the possible side effects of Abacavir and Lamivudine Tablets?

  • Abacavir and Lamivudine Tablets can cause serious side effects including:
  • SeeWhat is the most important information I should know about Abacavir and Lamivudine Tablets?
  • Build-upof acid in your blood (lactic acidosis). Lactic  acidosis can happen in some people who take abacavir and lamivudine  tablets. Lactic acidosis is a serious medical emergency that can cause death. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:

    • feel very weak or tired
    • feel cold, especially in your arms and legs
    • unusual (not normal) muscle pain
    • feel dizzy or light-headed
    • trouble breathing
    • have a fast or irregular heartbeat
    • stomach pain with nausea and vomiting
  • Seriousliver problems can  happen in people who take abacavir and lamivudine  tablets. In some  cases, these serious liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

    • your skin or the white part of your eyes turns yellow (jaundice)
    • loss of appetite for several days or longer
    • dark or “tea-colored” urine
    • nausea
    • light-colored stools (bowel movements)
    • pain, aching, or tenderness on the right side of your stomach area
  • You may be more likely to get lactic acidosis or serious liver problems if you are female or very overweight (obese).

    • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking abacavir and lamivudine tablets.

    • Heart attack (myocardial infarction). Some HIV-1 medicines including abacavir and lamivudine tablets may increase your risk of heart attack.

    The most common side effects of Abacavir and Lamivudine Tablets include:

    • trouble sleeping
    • nausea
    • depression
    • diarrhea
    • headache
    • rash
    • tiredness
    • fever
    • dizziness

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    These are not all the possible side effects of abacavir and lamivudine tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Abacavir and Lamivudine Tablets are a prescription HIV-1 (Human Immunodeficiency Virus-type 1) medicine used with other antiretroviral medicines to treat HIV-1 infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Abacavir and Lamivudine Tablets contain 2 prescription medicines, abacavir (ZIAGEN) and lamivudine (EPIVIR).

    Abacavir and Lamivudine Tablets should not be used in children weighing less than 55 pounds (25 kg).

    When used with other antiretroviral medicines to treat HIV-1 infection, Abacavir and Lamivudine Tablets may help:

    1. reduce the amount of HIV-1 in your blood. This is called “viral load”.

    2. increase the number of CD4+ (T) cells in your blood, that help fight off other infections.

    Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

    Abacavir and Lamivudine Tablets do not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

    Who should not take Abacavir and Lamivudine Tablets?

    Do not take Abacavir and Lamivudine Tablets if you:

    • have a certain type of gene variation called the HLA-B*5701 allele. Your healthcare provider will test you for this before prescribing treatment with Abacavir and Lamivudine Tablets.
    • are allergic to abacavir or any of the ingredients in Abacavir and Lamivudine Tablets. See the end of this Medication Guide for a complete list of ingredients in Abacavir and Lamivudine Tablets.
    • have liver problems.

    What should I tell my healthcare provider before taking Abacavir and Lamivudine Tablets?

    Before you take Abacavir and Lamivudine Tablets tell your healthcare provider if you:

    • have been tested and know whether or not you have a particular gene variation called HLA-B*5701.
    • have or have had liver problems, including hepatitis B or C virus infection.
    • have kidney problems.
    • have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.
    • drink alcohol or take medicines that contain alcohol.
    • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

    Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

    • are breastfeeding or plan to breastfeed. Do not breastfeed if you take Abacavir and Lamivudine Tablets.
      • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the­-counter medicines, vitamins, and herbal supplements.

    Some medicines interact with Abacavir and Lamivudine Tablets. Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Abacavir and Lamivudine Tablets. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Abacavir and Lamivudine Tablets with other medicines.

    Tell your healthcare provider if you take:

    • any other medicine to treat HIV-1
    • medicines to treat hepatitis viruses such as interferon or ribavirin
    • methadone

    How should I take Abacavir and Lamivudine Tablets?

    • Take Abacavir and Lamivudine Tablets exactly as your healthcare provider tells you.
    • Do not change your dose or stop taking Abacavir and Lamivudine Tablets without talking with your healthcare provider. If you miss a dose of Abacavir and Lamivudine Tablets, take it as soon as you remember. Do not take 2 doses at the same time. If you are not sure about your dosing, call your healthcare provider.
    • Stay under the care of a healthcare provider while taking Abacavir and Lamivudine Tablets.
    • Abacavir and Lamivudine Tablets may be taken with or without food.
    • Tell your healthcare provider if your child has trouble swallowing Abacavir and Lamivudine Tablets.
    • Do not run out of Abacavir and Lamivudine Tablets. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
    • If you take too much abacavir and lamivudine, call your healthcare provider or go to the nearest hospital emergency room right away.

    What are the possible side effects of Abacavir and Lamivudine Tablets?

  • Abacavir and Lamivudine Tablets can cause serious side effects including:
  • SeeWhat is the most important information I should know about Abacavir and Lamivudine Tablets?
  • Build-upof acid in your blood (lactic acidosis). Lactic  acidosis can happen in some people who take abacavir and lamivudine  tablets. Lactic acidosis is a serious medical emergency that can cause death. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:

    • feel very weak or tired
    • feel cold, especially in your arms and legs
    • unusual (not normal) muscle pain
    • feel dizzy or light-headed
    • trouble breathing
    • have a fast or irregular heartbeat
    • stomach pain with nausea and vomiting
  • Seriousliver problems can  happen in people who take abacavir and lamivudine  tablets. In some  cases, these serious liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

    • your skin or the white part of your eyes turns yellow (jaundice)
    • loss of appetite for several days or longer
    • dark or “tea-colored” urine
    • nausea
    • light-colored stools (bowel movements)
    • pain, aching, or tenderness on the right side of your stomach area
  • You may be more likely to get lactic acidosis or serious liver problems if you are female or very overweight (obese).

    • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking abacavir and lamivudine tablets.

    • Heart attack (myocardial infarction). Some HIV-1 medicines including abacavir and lamivudine tablets may increase your risk of heart attack.

    The most common side effects of Abacavir and Lamivudine Tablets include:

    • trouble sleeping
    • nausea
    • depression
    • diarrhea
    • headache
    • rash
    • tiredness
    • fever
    • dizziness

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    These are not all the possible side effects of abacavir and lamivudine tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Abacavir and Lamivudine Tablets are a prescription HIV-1 (Human Immunodeficiency Virus-type 1) medicine used with other antiretroviral medicines to treat HIV-1 infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Abacavir and Lamivudine Tablets contain 2 prescription medicines, abacavir (ZIAGEN) and lamivudine (EPIVIR).

    Abacavir and Lamivudine Tablets should not be used in children weighing less than 55 pounds (25 kg).

    When used with other antiretroviral medicines to treat HIV-1 infection, Abacavir and Lamivudine Tablets may help:

    1. reduce the amount of HIV-1 in your blood. This is called “viral load”.

    2. increase the number of CD4+ (T) cells in your blood, that help fight off other infections.

    Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

    Abacavir and Lamivudine Tablets do not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

    Who should not take Abacavir and Lamivudine Tablets?

    Do not take Abacavir and Lamivudine Tablets if you:

    • have a certain type of gene variation called the HLA-B*5701 allele. Your healthcare provider will test you for this before prescribing treatment with Abacavir and Lamivudine Tablets.
    • are allergic to abacavir or any of the ingredients in Abacavir and Lamivudine Tablets. See the end of this Medication Guide for a complete list of ingredients in Abacavir and Lamivudine Tablets.
    • have liver problems.

    What should I tell my healthcare provider before taking Abacavir and Lamivudine Tablets?

    Before you take Abacavir and Lamivudine Tablets tell your healthcare provider if you:

    • have been tested and know whether or not you have a particular gene variation called HLA-B*5701.
    • have or have had liver problems, including hepatitis B or C virus infection.
    • have kidney problems.
    • have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.
    • drink alcohol or take medicines that contain alcohol.
    • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

    Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

    • are breastfeeding or plan to breastfeed. Do not breastfeed if you take Abacavir and Lamivudine Tablets.
      • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the­-counter medicines, vitamins, and herbal supplements.

    Some medicines interact with Abacavir and Lamivudine Tablets. Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Abacavir and Lamivudine Tablets. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Abacavir and Lamivudine Tablets with other medicines.

    Tell your healthcare provider if you take:

    • any other medicine to treat HIV-1
    • medicines to treat hepatitis viruses such as interferon or ribavirin
    • methadone

    How should I take Abacavir and Lamivudine Tablets?

    • Take Abacavir and Lamivudine Tablets exactly as your healthcare provider tells you.
    • Do not change your dose or stop taking Abacavir and Lamivudine Tablets without talking with your healthcare provider. If you miss a dose of Abacavir and Lamivudine Tablets, take it as soon as you remember. Do not take 2 doses at the same time. If you are not sure about your dosing, call your healthcare provider.
    • Stay under the care of a healthcare provider while taking Abacavir and Lamivudine Tablets.
    • Abacavir and Lamivudine Tablets may be taken with or without food.
    • Tell your healthcare provider if your child has trouble swallowing Abacavir and Lamivudine Tablets.
    • Do not run out of Abacavir and Lamivudine Tablets. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
    • If you take too much abacavir and lamivudine, call your healthcare provider or go to the nearest hospital emergency room right away.

    What are the possible side effects of Abacavir and Lamivudine Tablets?

  • Abacavir and Lamivudine Tablets can cause serious side effects including:
  • SeeWhat is the most important information I should know about Abacavir and Lamivudine Tablets?
  • Build-upof acid in your blood (lactic acidosis). Lactic  acidosis can happen in some people who take abacavir and lamivudine  tablets. Lactic acidosis is a serious medical emergency that can cause death. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:

    • feel very weak or tired
    • feel cold, especially in your arms and legs
    • unusual (not normal) muscle pain
    • feel dizzy or light-headed
    • trouble breathing
    • have a fast or irregular heartbeat
    • stomach pain with nausea and vomiting
  • Seriousliver problems can  happen in people who take abacavir and lamivudine  tablets. In some  cases, these serious liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

    • your skin or the white part of your eyes turns yellow (jaundice)
    • loss of appetite for several days or longer
    • dark or “tea-colored” urine
    • nausea
    • light-colored stools (bowel movements)
    • pain, aching, or tenderness on the right side of your stomach area
  • You may be more likely to get lactic acidosis or serious liver problems if you are female or very overweight (obese).

    • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking abacavir and lamivudine tablets.

    • Heart attack (myocardial infarction). Some HIV-1 medicines including abacavir and lamivudine tablets may increase your risk of heart attack.

    The most common side effects of Abacavir and Lamivudine Tablets include:

    • trouble sleeping
    • nausea
    • depression
    • diarrhea
    • headache
    • rash
    • tiredness
    • fever
    • dizziness

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    These are not all the possible side effects of abacavir and lamivudine tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    How should I store abacavir and lamivudine tablets?

    • Store abacavir sulfate and lamivudine tablets at room temperature between 59° to 86°F (15° to 30°C).

    Keep abacavir and lamivudine tablets and all medicines out of the reach of children.

    General information for safe and effective use of abacavir and lamivudine tablets.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Abacavir and Lamivudine Tablets for a condition for which it was not prescribed. Do not give Abacavir and Lamivudine Tablets to other people, even if they have the same symptoms that you have. They may harm them.

    If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for the information about Abacavir and Lamivudine Tablets that is written for health professionals.

    For more information, call Aurobindo Pharma USA, Inc at 1-866-850-2876.

    What are the ingredients in abacavir and lamivudine tablets?

    Active ingredients: abacavir sulfate and lamivudine

      Inactive ingredients: magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

      Tablet film coating contains: Opadry Orange YS-1-13065-A that is made of FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide.

      This Medication Guide has been approved by the U.S. Food and Drug Administration.

      EPIVIR, TRIUMEQ, TRIZIVIR, and ZIAGEN are trademarks owned by or licensed to the ViiV Healthcare group of companies.

      The other brands listed are trademarks owned by or licensed to their respective owners and are not trademarks owned by or licensed to the Aurobindo Pharma Limited. The makers of these brands are not affiliated with and do not endorse the Aurobindo Pharma Limited or its products.

    Manufactured for:
    Burel Pharmaceuticals, Inc.
    Richland, MS 39218

    Manufactured by:
    Aurobindo Pharma Limited
    Hyderabad-500 090, India

    Issued: October 2019

    WARNING CARD

    Abacavir and Lamivudine Tablets USP


    Patients taking Abacavir and Lamivudine Tablets may have a serious allergic reaction (hypersensitivity reaction) that can cause death. If you get a symptom from 2 or more of the following groups while taking Abacavir and Lamivudine Tablets, call your healthcare provider right away to find out if you should stop taking this medicine.
     

      Symptom(s)
    Group 1 Fever
    Group 2 Rash
    Group 3 Nausea, vomiting, diarrhea, or abdominal (stomach area) pain
    Group 4 Generally ill feeling, extreme tiredness, or achiness
    Group 5 Shortness of breath, cough, or sore throat

    Always carry this Warning Card with you to help recognize symptoms of this allergic reaction.

    If you must stop treatment with Abacavir and Lamivudine Tablets because you have had an allergic reaction to abacavir, NEVER take Abacavir and Lamivudine Tablets or another abacavir-containing medicine (ZIAGEN®, TRIUMEQ®, or TRIZIVIR®) again. If you have an allergic reaction, dispose of any unused Abacavir and Lamivudine Tablets. Ask your pharmacist how to properly dispose of medicines. If you take Abacavir and Lamivudine Tablets or another abacavir-containing medicine again after you have had an allergic reaction, WITHIN HOURS you may get life-threatening symptoms that may include very low blood pressure or death.

     

    Please read the Medication Guide for additional information on Abacavir and Lamivudine Tablets.

    ZIAGEN, TRIUMEQ, and TRIZIVIR are registered trademarks of ViiV Healthcare group of companies.

    Manufactured for:
    Burel Pharmaceuticals, Inc.
    Richland, MS 39218

    Manufactured by:
    Aurobindo Pharma Limited
    Hyderabad-500 090, India

    Issued: October 2019

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 600 mg/300 mg (30 Tablets Container)

    NDC 35573-430-30
    burelpharma
    Abacavir and Lamivudine 
    Tablets USP
    600 mg / 300 mg

    Notice to Authorized Dispenser: Each time Abacavir and
    Lamivudine Tablets USP are dispensed, give the patient
    a Medication Guide and Warning Card from the carton.
    30 Tablets                 Rx only


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 600 mg/300 mg (30 Tablets Container Carton)

    NDC 35573-430-30
    burelpharma
    Abacavir and Lamivudine 
    Tablets USP
    600 mg / 300 mg

    Notice to Authorized Dispenser:
    Each time Abacavir and Lamivudine
    Tablets USP are dispensed, give the
    patient a Medication Guide and
    Warning Card from the carton.
    30 Tablets                 Rx only

    ABACAVIR AND LAMIVUDINE 
    abacavir and lamivudine tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:35573-430
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ABACAVIR SULFATE (ABACAVIR) ABACAVIR 600 mg
    LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 300 mg
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM STEARATE  
    MICROCRYSTALLINE CELLULOSE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    FD&C YELLOW NO. 6  
    HYPROMELLOSE 2910 (3 MPA.S)  
    HYPROMELLOSE 2910 (6 MPA.S)  
    POLYETHYLENE GLYCOL 400  
    POLYSORBATE 80  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color ORANGE Score no score
    Shape CAPSULE Size 21mm
    Flavor Imprint Code H;27
    Contains     
    Packaging
    # Item Code Package Description
    1 NDC:35573-430-30 1 BOTTLE in 1 CARTON
    1 30 TABLET, FILM COATED in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090159 11/15/2019
    Labeler – Burel Pharma (002152814)
    Registrant – APL HEALTHCARE LIMITED (650844777)
    Establishment
    Name Address ID/FEI Operations
    Aurobindo Pharma Limited 918917642 ANALYSIS(35573-430), MANUFACTURE(35573-430)

     
    Burel Pharma

    Availability of Medication Guide

    Instruct patients to read the Medication Guide before starting abacavir and lamivudine and to re-read it each time the prescription is renewed. Instruct patients to inform their physician or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens.

    MEDICATION GUIDE

    Abacavir and Lamivudine Tablets USP

    (a bak’ a vir and la miv’ ue deen)


    What is the most important information I should know about Abacavir and Lamivudine Tablets?

    Abacavir and Lamivudine Tabletscan cause serious side effects, including:

    • Serious allergic reactions (hypersensitivity reaction) that can cause death have happened with abacavir and lamivudine tablets and other abacavir-containing products. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701. Your healthcare provider can determine with a blood test if you have this gene variation.

    Ifyou get a symptom from 2 or more of the following groups while taking Abacavir and Lamivudine Tablets, call your healthcare provider right away to find out if you should stop taking Abacavir and Lamivudine Tablets.


                                                   Symptom(s)
    Group 1 Fever
    Group 2 Rash
    Group 3 Nausea, vomiting, diarrhea, abdominal (stomach area) pain
    Group 4 Generally ill feeling, extreme tiredness, or achiness
    Group 5 Shortness of breath, cough, sore throat

    A list of these symptoms is on the Warning Card your pharmacist gives you. Carry this Warning Card with you at all times.

    If you stop Abacavir and Lamivudine Tablets because of an allergic reaction, never take Abacavir and Lamivudine Tablets or any other abacavir-containing medicine (TRIUMEQ, TRIZIVIR,or ZIAGEN) again.

    • If you have an allergic reaction, dispose of any unused Abacavir and Lamivudine Tablets. Ask your pharmacist how to properly dispose of medicines.
    • If  you take Abacavir and Lamivudine Tablets or any other abacavir-containing medicine again after you have had an allergic reaction, within hours you may get life-threatening symptoms that may include very low blood pressure or death
    • If you stop Abacavir and Lamivudine Tablets for any other reason, even for a few days, and you are not allergic to Abacavir and Lamivudine Tablets, talk with your healthcare provider before taking them again. Taking abacavir and lamivudine tablets again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to them before.

    If your healthcare provider tells you that you can take Abacavir and Lamivudine Tablets again, start taking them when you are around medical help or people who can call a healthcare provider if you need one.

    • Worsening of hepatitis B virus in people who have HIV-1 infection. If you have HIV-1 and hepatitis B virus (HBV) infection, your HBV may get worse (flare-up) if you stop taking Abacavir and Lamivudine Tablets.  A ” flare-up” is when your HBV infection suddenly returns in a worse way than before. Worsening liver disease can be serious and may lead to death

    • Do not run out of Abacavir and Lamivudine Tablets. Refill your prescription or talk to your healthcare provider before your Abacavir and Lamivudine Tablets are all gone.
    • Do not stop abacavir and lamivudine tablets without first talking to your healthcare provider.
    • If you stop taking Abacavir and Lamivudine Tablets, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver.

    • Resistant Hepatitis B Virus (HBV). If you have HIV-1 and hepatitis B, the hepatitis B virus can change (mutate) during your treatment with Abacavir and Lamivudine Tablets and become harder to treat (resistant).

    What are Abacavir and Lamivudine Tablets?

    Abacavir and Lamivudine Tablets are a prescription HIV-1 (Human Immunodeficiency Virus-type 1) medicine used with other antiretroviral medicines to treat HIV-1 infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Abacavir and Lamivudine Tablets contain 2 prescription medicines, abacavir (ZIAGEN) and lamivudine (EPIVIR).

    Abacavir and Lamivudine Tablets should not be used in children weighing less than 55 pounds (25 kg).

    When used with other antiretroviral medicines to treat HIV-1 infection, Abacavir and Lamivudine Tablets may help:

    1. reduce the amount of HIV-1 in your blood. This is called “viral load”.

    2. increase the number of CD4+ (T) cells in your blood, that help fight off other infections.

    Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

    Abacavir and Lamivudine Tablets do not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

    Who should not take Abacavir and Lamivudine Tablets?

    Do not take Abacavir and Lamivudine Tablets if you:

    • have a certain type of gene variation called the HLA-B*5701 allele. Your healthcare provider will test you for this before prescribing treatment with Abacavir and Lamivudine Tablets.
    • are allergic to abacavir or any of the ingredients in Abacavir and Lamivudine Tablets. See the end of this Medication Guide for a complete list of ingredients in Abacavir and Lamivudine Tablets.
    • have liver problems.

    What should I tell my healthcare provider before taking Abacavir and Lamivudine Tablets?

    Before you take Abacavir and Lamivudine Tablets tell your healthcare provider if you:

    • have been tested and know whether or not you have a particular gene variation called HLA-B*5701.
    • have or have had liver problems, including hepatitis B or C virus infection.
    • have kidney problems.
    • have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.
    • drink alcohol or take medicines that contain alcohol.
    • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

    Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

    • are breastfeeding or plan to breastfeed. Do not breastfeed if you take Abacavir and Lamivudine Tablets.
      • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the­-counter medicines, vitamins, and herbal supplements.

    Some medicines interact with Abacavir and Lamivudine Tablets. Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Abacavir and Lamivudine Tablets. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Abacavir and Lamivudine Tablets with other medicines.

    Tell your healthcare provider if you take:

    • any other medicine to treat HIV-1
    • medicines to treat hepatitis viruses such as interferon or ribavirin
    • methadone

    How should I take Abacavir and Lamivudine Tablets?

    • Take Abacavir and Lamivudine Tablets exactly as your healthcare provider tells you.
    • Do not change your dose or stop taking Abacavir and Lamivudine Tablets without talking with your healthcare provider. If you miss a dose of Abacavir and Lamivudine Tablets, take it as soon as you remember. Do not take 2 doses at the same time. If you are not sure about your dosing, call your healthcare provider.
    • Stay under the care of a healthcare provider while taking Abacavir and Lamivudine Tablets.
    • Abacavir and Lamivudine Tablets may be taken with or without food.
    • Tell your healthcare provider if your child has trouble swallowing Abacavir and Lamivudine Tablets.
    • Do not run out of Abacavir and Lamivudine Tablets. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
    • If you take too much abacavir and lamivudine, call your healthcare provider or go to the nearest hospital emergency room right away.

    What are the possible side effects of Abacavir and Lamivudine Tablets?

    • Abacavir and Lamivudine Tablets can cause serious side effects including:
    • SeeWhat is the most important information I should know about Abacavir and Lamivudine Tablets?
    • Build-upof acid in your blood (lactic acidosis). Lactic  acidosis can happen in some people who take abacavir and lamivudine  tablets. Lactic acidosis is a serious medical emergency that can cause death. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:

      • feel very weak or tired
      • feel cold, especially in your arms and legs
      • unusual (not normal) muscle pain
      • feel dizzy or light-headed
      • trouble breathing
      • have a fast or irregular heartbeat
      • stomach pain with nausea and vomiting
    • Seriousliver problems can  happen in people who take abacavir and lamivudine  tablets. In some  cases, these serious liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

      • your skin or the white part of your eyes turns yellow (jaundice)
      • loss of appetite for several days or longer
      • dark or “tea-colored” urine
      • nausea
      • light-colored stools (bowel movements)
      • pain, aching, or tenderness on the right side of your stomach area

    You may be more likely to get lactic acidosis or serious liver problems if you are female or very overweight (obese).

    • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking abacavir and lamivudine tablets.

    • Heart attack (myocardial infarction). Some HIV-1 medicines including abacavir and lamivudine tablets may increase your risk of heart attack.

    The most common side effects of Abacavir and Lamivudine Tablets include:

    • trouble sleeping
    • nausea
    • depression
    • diarrhea
    • headache
    • rash
    • tiredness
    • fever
    • dizziness

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    These are not all the possible side effects of abacavir and lamivudine tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    How should I store abacavir and lamivudine tablets?

    • Store abacavir sulfate and lamivudine tablets at room temperature between 59° to 86°F (15° to 30°C).

    Keep abacavir and lamivudine tablets and all medicines out of the reach of children.

    General information for safe and effective use of abacavir and lamivudine tablets.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Abacavir and Lamivudine Tablets for a condition for which it was not prescribed. Do not give Abacavir and Lamivudine Tablets to other people, even if they have the same symptoms that you have. They may harm them.

    If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for the information about Abacavir and Lamivudine Tablets that is written for health professionals.

    For more information, call Aurobindo Pharma USA, Inc at 1-866-850-2876.

    What are the ingredients in abacavir and lamivudine tablets?

    Active ingredients: abacavir sulfate and lamivudine

    Inactive ingredients: magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

    Tablet film coating contains: Opadry Orange YS-1-13065-A that is made of FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    EPIVIR, TRIUMEQ, TRIZIVIR, and ZIAGEN are trademarks owned by or licensed to the ViiV Healthcare group of companies.

    The other brands listed are trademarks owned by or licensed to their respective owners and are not trademarks owned by or licensed to the Aurobindo Pharma Limited. The makers of these brands are not affiliated with and do not endorse the Aurobindo Pharma Limited or its products.

    Manufactured for:
    Burel Pharmaceuticals, Inc.
    Richland, MS 39218

    Manufactured by:
    Aurobindo Pharma Limited
    Hyderabad-500 090, India

    Issued: October 2019

    WARNING CARD

    Abacavir and Lamivudine Tablets USP


    Patients taking Abacavir and Lamivudine Tablets may have a serious allergic reaction (hypersensitivity reaction) that can cause death. If you get a symptom from 2 or more of the following groups while taking Abacavir and Lamivudine Tablets, call your healthcare provider right away to find out if you should stop taking this medicine.
     

      Symptom(s)
    Group 1 Fever
    Group 2 Rash
    Group 3 Nausea, vomiting, diarrhea, or abdominal (stomach area) pain
    Group 4 Generally ill feeling, extreme tiredness, or achiness
    Group 5 Shortness of breath, cough, or sore throat

    Always carry this Warning Card with you to help recognize symptoms of this allergic reaction.

    If you must stop treatment with Abacavir and Lamivudine Tablets because you have had an allergic reaction to abacavir, NEVER take Abacavir and Lamivudine Tablets or another abacavir-containing medicine (ZIAGEN®, TRIUMEQ®, or TRIZIVIR®) again. If you have an allergic reaction, dispose of any unused Abacavir and Lamivudine Tablets. Ask your pharmacist how to properly dispose of medicines. If you take Abacavir and Lamivudine Tablets or another abacavir-containing medicine again after you have had an allergic reaction, WITHIN HOURS you may get life-threatening symptoms that may include very low blood pressure or death.

     

    Please read the Medication Guide for additional information on Abacavir and Lamivudine Tablets.

    ZIAGEN, TRIUMEQ, and TRIZIVIR are registered trademarks of ViiV Healthcare group of companies.

    Manufactured for:
    Burel Pharmaceuticals, Inc.
    Richland, MS 39218

    Manufactured by:
    Aurobindo Pharma Limited
    Hyderabad-500 090, India

    Issued: October 2019

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 600 mg/300 mg (30 Tablets Container)

    NDC 35573-430-30
    burelpharma
    Abacavir and Lamivudine 
    Tablets USP
    600 mg / 300 mg

    Notice to Authorized Dispenser: Each time Abacavir and
    Lamivudine Tablets USP are dispensed, give the patient
    a Medication Guide and Warning Card from the carton.
    30 Tablets                 Rx only


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 600 mg/300 mg (30 Tablets Container Carton)

    NDC 35573-430-30
    burelpharma
    Abacavir and Lamivudine 
    Tablets USP
    600 mg / 300 mg

    Notice to Authorized Dispenser:
    Each time Abacavir and Lamivudine
    Tablets USP are dispensed, give the
    patient a Medication Guide and
    Warning Card from the carton.
    30 Tablets                 Rx only

    ABACAVIR AND LAMIVUDINE 
    abacavir and lamivudine tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:35573-430
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ABACAVIR SULFATE (ABACAVIR) ABACAVIR 600 mg
    LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 300 mg
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM STEARATE  
    MICROCRYSTALLINE CELLULOSE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    FD&C YELLOW NO. 6  
    HYPROMELLOSE 2910 (3 MPA.S)  
    HYPROMELLOSE 2910 (6 MPA.S)  
    POLYETHYLENE GLYCOL 400  
    POLYSORBATE 80  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color ORANGE Score no score
    Shape CAPSULE Size 21mm
    Flavor Imprint Code H;27
    Contains     
    Packaging
    # Item Code Package Description
    1 NDC:35573-430-30 1 BOTTLE in 1 CARTON
    1 30 TABLET, FILM COATED in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090159 11/15/2019
    Labeler – Burel Pharma (002152814)
    Registrant – APL HEALTHCARE LIMITED (650844777)
    Establishment
    Name Address ID/FEI Operations
    Aurobindo Pharma Limited 918917642 ANALYSIS(35573-430), MANUFACTURE(35573-430)

     
    Burel Pharma

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