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ABACAVIR SULFATE tablet, film coated


  1. Abacavir Tablets Can Cause Serious Side Effects, Including:
  2. What Is Abacavir?
  3. When Used With Other Antiretroviral Medicines To Treat Hiv-1 Infection, Abacavir Tablets May Help:
  4. Do Not Take Abacavir Tablets If You:
  5. Abacavir Tablets Can Cause Serious Side Effects Including:
  6. Manufactured For:
  7. Manufactured By:
  8. Patient Information
  9. How To Identify A Hypersensitivity Reaction[abacavir Can Cause Serious Side Effects, Including:
  10. Call Your Healthcare Provider Right Away If You Get Any Of The Following Symptoms That Could Be Signs Of Lactic Acidosis:
  11. Call Your Healthcare Provider Right Away If You Have Any Of The Following Signs Of Liver Problems:
  12. What Are Abacavir Tablets?
  13. When Used With Other Antiretroviral Medicines To Treat Hiv-1 Infection, Abacavir May Help:
  14. Before You Take Abacavir Tablets, Tell Your Healthcare Provider If You:
  15. You Should Not Take Abacavir Tablets If You Also Take:
  16. Tell Your Healthcare Provider If You Take:
  17. How Should I Take Abacavir Tablets?
  18. What Are The Possible Side Effects Of Abacavir Tablets?
  19. What Are The Ingredients In Abacavir Tablets?
  20. Distributed By:
  21. Hypersensitivity Reactions:
  22. Lactic Acidosis/hepatomegaly With Steatosis:
  23. Immune Reconstitution Syndrome:
  24. Pregnancy Registry:
  25. Lactation:
  26. Missed Dose:
  27. Availability Of Medication Guide:

Abacavir Tablets Can Cause Serious Side Effects, Including: 

  • Serious allergic reactions (hypersensitivity reaction)that can cause death have happened with abacavir 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.

    If you get a symptom from 2 or more of the following groups while taking abacavir tablets, call your healthcare provider right away to find out if you should stop taking abacavir 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 tablets because of an allergic reaction, never take abacavir tablets or any other abacavir-containing medicine (EPZICOM, TRIUMEQ, or TRIZIVIR) again.
  1. If you have an allergic reaction, dispose of any unused abacavir tablets. Ask your pharmacist how to properly dispose of medicines.
  2. If you take abacavir tablets or any other abacavir-containing medicine again after you have had an allergic reaction,within hoursyou may getlife-threatening symptomsthat may includevery low blood pressure or death.
  3. If you stop abacavir tablets for any other reason, even for a few days, and you are not allergic to abacavir, talk with your healthcare provider before taking them again. Taking abacavir 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 tablets again, start taking them when you are around medical help or people who can call a healthcare provider if you need one.

What Is Abacavir? 

Abacavir is 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).

The safety and effectiveness of abacavir has not been established in children under 3 months of age.

When Used With Other Antiretroviral Medicines To Treat Hiv-1 Infection, Abacavir Tablets May Help: 

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

Do Not Take Abacavir 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 tablets.
  • are allergic to abacavir or any of the ingredients in abacavir tablets.

Abacavir Tablets Can Cause Serious Side Effects Including: 

    • Store abacavir tablets at room temperature, between 20 to 25 C (68 to 77 F).

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

    General information for safe and effective use of abacavir tablets

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use abacavir tablets for a condition for which they were not prescribed. Do not give abacavir 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 tablets that is written for health professionals.

    For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

  • Manufactured For: 

    Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

    Manufactured By: 

    Mylan Laboratories Limited, Hyderabad 500 096, India

    The brands listed are trademarks of their respective owners.

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

    Manufactured for:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Manufactured by:
    Mylan Laboratories Limited
    Hyderabad 500 096, India

    Distributed by:
    Mylan Institutional Inc.
    Rockford, IL 61103 U.S.A.

    S-11275 R5
    3/19

    Patient Information 

    Advise the patient to read the FDA-approved patient labeling (Medication Guide).

    Hypersensitivity Reactions
    Inform patients

    that a Medication Guide and Warning Card summarizing the symptoms of the abacavir hypersensitivity reaction and other product information will be dispensed by the pharmacist with each new prescription and refill of abacavir tablets, and instruct the patient to read the Medication Guide and Warning Card every time to obtain any new information that may be present about abacavir tablets. The complete text of the Medication Guide is reprinted at the end of this document.
    to carry the Warning Card with them.

    How To Identify A Hypersensitivity Reaction[abacavir Can Cause Serious Side Effects, Including: 

    1.
    Serious allergic reactions (hypersensitivity reaction)that can cause death have happened with abacavir 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.

    If you get a symptom from two or more of the following groups while taking abacavir tablets, call your healthcare provider right away to find out if you should stop taking abacavir 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 tablets because of an allergic reaction, never take abacavir tablets or any other abacavir-containing medicine (EPZICOM, TRIUMEQ, or TRIZIVIR) again.

    1.
    If you take abacavir tablets or any other abacavir-containing medicine again after you have had an allergic reaction, within hoursyou may getlife-threatening symptomsthat may includevery low blood pressure or death.
    2.
    If you stop abacavir tablets for any other reason, even for a few days, and you are not allergic to abacavir, talk with your healthcare provider before taking it again. Taking abacavir tablets again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before.

    If your healthcare provider tells you that you can take abacavir again, start taking it when you are around medical help or people who can call a healthcare provider if you need one.

    1.
    Build-up of acid in your blood (lactic acidosis).Lactic acidosis can happen in some people who take abacavir. 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: 

    1.
    feel very weak or tired
    2.
    unusual (not normal) muscle pain
    3.
    trouble breathing
    4.
    stomach pain with nausea and vomiting
    5.
    feel cold, especially in your arms and legs
    6.
    feel dizzy or light-headed
    7.
    have a fast or irregular heartbeat

    Serious liver problemscan happen in people who take abacavir 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) when you take abacavir.

    Call Your Healthcare Provider Right Away If You Have Any Of The Following Signs Of Liver Problems: 

    1.
    your skin or the white part of your eyes turns yellow (jaundice)
    2.
    dark or "tea-colored" urine
    3.
    light-colored stools (bowel movements)
    4.
    loss of appetite for several days or longer
    5.
    nausea
    6.
    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, very overweight (obese), or have been taking nucleoside analogue medicines for a long time.

    What Are Abacavir Tablets? 

    Abacavir 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).

    The safety and effectiveness of abacavir has not been established in children under 3 months of age.

    When Used With Other Antiretroviral Medicines To Treat Hiv-1 Infection, Abacavir 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 tablets does not cure HIV-1 infection or AIDS.You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

    Avoid doing things that can spread HIV-1 infection to others.

    1.
    Do not share or re-use needles or other injection equipment.
    2.
    Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
    3.
    Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.

    Ask your healthcare provider if you have any questions about how to prevent passing HIV to other people.

    Before You Take Abacavir Tablets, Tell Your Healthcare Provider If You: 

    1.
    have been tested and know whether or not you have a particular gene variation called HLA-B*5701.
    2.
    have or have had liver problems, including hepatitis B or C virus infection.
    3.
    have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.
    4.
    drink alcohol or take medicines that contain alcohol.
    5.
    are pregnant or plan to become pregnant. Taking abacavir during pregnancy has not been associated with an increased risk of birth defects. 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.
    6.
    are breastfeeding or plan to breastfeed.Do not breastfeed if you take abacavir.
    1.
    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 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 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 tablets with other medicines.

    You Should Not Take Abacavir Tablets If You Also Take: 

    1.
    abacavir (EPZICOM, TRIUMEQ, or TRIZIVIR)

    Tell Your Healthcare Provider If You Take: 


    1.
    any other medicine to treat HIV-1
    2.
    methadone

    How Should I Take Abacavir Tablets? 

    1.
    Take abacavir tablets exactly as your healthcare provider tells you.
    2.
    Do not change your dose or stop taking abacavir tablets without talking with your healthcare provider. If you miss a dose of abacavir, 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.
    3.
    Stay under the care of a healthcare provider while taking abacavir tablets.
    4.
    Abacavir tablets may be taken with or without food.
    5.
    For children aged 3 months and older, your healthcare provider will prescribe a dose of abacavir tablets based on your child s body weight.
    6.
    Tell your healthcare provider if you or your child has trouble swallowing tablets.
    7.
    Do not run out of abacavir tablets. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run out, get more from your healthcare provider or pharmacy.
    8.
    If you take too much abacavir tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

    What Are The Possible Side Effects Of Abacavir Tablets? 

    1.

    What Are The Ingredients In Abacavir Tablets? 

    Active ingredient: abacavir sulfate, USP
    Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and croscarmellose sodium. The film-coating is made of hypromellose, polyethylene glycol, yellow iron oxide, and titanium dioxide.

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

    All registered trademarks in this document are the property of their respective owners.

    APOTEX INC.
    ABACAVIR TABLETS, USP 300 mg

    Manufactured by

    Manufactured for

    Apotex Research Pvt. Ltd.

    Apotex Corp.

    Bangalore-560 099

    Weston, Florida

    India.

    33326

    Distributed By: 

    MAJOR PHARMACEUTICALS

    31778 Enterprise Drive

    Livonia, MI 48150

    IH50030216

    Revised: February 2016

    Rev 8

    (Front of card)

    WARNING CARD
    Abacavir Tablets, USP

    Patients taking abacavir tablets may have a serious allergic reaction (hypersensitivity reaction) that can cause death. If you get a symptom from two or more of the following groups while taking abacavir 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.

    (Back of Card)

    WARNING CARD
    Abacavir Tablets, USP

    If you must stop treatment with abacavir because you have had an allergic reaction to abacavir,NEVERtake abacavir tablets or another abacavir-containing medicine (EPZICOM, TRIUMEQ, or TRIZIVIR) again. If you take abacavir tablets or another abacavir-containing medicine again after you have had an allergic reaction,WITHIN HOURSyou may getlife-threatening symptomsthat may includevery low blood pressureordeath.

    Please read the Medication Guide for additional information on abacavir tablets.

    February 2016

    Hypersensitivity Reactions: 

    Inform patients:

    • that a Medication Guide and Warning Card summarizing the symptoms of the abacavir hypersensitivity reaction and other product information will be dispensed by the pharmacist with each new prescription and refill of abacavir tablets, and instruct the patient to read the Medication Guide and Warning Card every time to obtain any new information that may be present about abacavir tablets. The complete text of the Medication Guide is reprinted at the end of this document.
    • to carry the Warning Card with them.
    • how to identify a hypersensitivity reaction[seeWarnings and Precautions (5.1),Medication Guide].
    • that if they develop symptoms consistent with a hypersensitivity reaction they should call their healthcare provider right away to determine if they should stop taking abacavir tablets.
    • that a hypersensitivity reaction can worsen and lead to hospitalization or death if abacavir tablets are not immediately discontinued.
    • to not restart abacavir tablets or any other abacavir-containing product following a hypersensitivity reaction because more severe symptoms can occur within hours and may include life-threatening hypotension and death.
    • that if they have a hypersensitivity reaction, they should dispose of any unused abacavir tablets to avoid restarting abacavir.
    • that a hypersensitivity reaction is usually reversible if it is detected promptly and abacavir tablets are stopped right away.
    • that if they have interrupted abacavir tablets for reasons other than symptoms of hypersensitivity (for example, those who have an interruption in drug supply), a serious or fatal hypersensitivity reaction may occur with reintroduction of abacavir.
    • to not restart abacavir tablets or any other abacavir-containing product without medical consultation and only if medical care can be readily accessed by the patient or others.

    Lactic Acidosis/hepatomegaly With Steatosis: 

    Advise patients that lactic acidosis and severe hepatomegaly with steatosis have been reported with use of nucleoside analogues and other antiretrovirals. Advise patients to stop taking abacavir tablets if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity[seeWarnings and Precautions (5.2)].

    Immune Reconstitution Syndrome: 

    Advise patients to inform their healthcare provider immediately of any signs and symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when abacavir tablets are started[seeWarnings and Precautions (5.3)].

    Pregnancy Registry: 

    Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir during pregnancy[seeUse in Specific Populations (8.1)].

    Lactation: 

    Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk[seeUse in Specific Populations (8.2)].

    Missed Dose: 

    Instruct patients that if they miss a dose of abacavir tablets, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose[seeDosage and Administration (2)].

    Availability Of Medication Guide: 

    Instruct patients to read the Medication Guide before starting abacavir tablets 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.



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