In the U.S.—

• Antiviral (systemic)

Abacavir (a-BAK-a-veer) , lamivudine ( la-MI-vyoo-deen) , and zidovudine (zye-DOE-vyoo-deen ) combination is used in the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Abacavir, lamivudine, and zidovudine combination will not cure or prevent HIV infection or the symptoms of AIDS; however, it helps keep HIV from reproducing, and appears to slow down the destruction of the immune system. This may help delay the development of serious health problems usually related to AIDS or HIV infection. Abacavir, lamivudine, and zidovudine combination will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV infection.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For abacavir, lamivudine, and zidovudine combination the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to abacavir, lamivudine, or zidovudine. This medicine should not be taken if you have ever had an allergic reaction to it or to abacavir, because it could cause another severe reaction that may result in death.Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Abacavir, lamivudine, and zidovudine combination has not been studied in pregnant women. However, abacavir has been found to cause birth defects and other problems in animals at doses many times the human dose, and zidovudine has been studied in animals and causes birth defects when given in very high doses. Before taking this abacavir, lamivudine, and zidovudine combination, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Zidovudine passes into human breast milk. It is not known whether abacavir or lamivudine passes into human breast milk. However, if your baby does not already have the AIDS virus, there is a chance that you could pass it to your baby by breast-feeding. Talk to your doctor first if you are thinking about breast-feeding your baby.

Children—Abacavir, lamivudine, and zidovudine combination contains a fixed amount of each medicine that cannot be decreased. Therefore, this medicine is not recommended for patients who weigh less than 40 kilograms (88 pounds) because the amounts of abacavir, lamivudine, and zidovudine in this product cannot be adjusted for smaller body sizes.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of abacavir, lamivudine, and zidovudine combination in the elderly with use in other age groups.

Other medicines— Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking abacavir, lamivudine, and zidovudine combination, it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antineoplastics (cancer medicine) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Clozapine (e.g., Clozaril) or
• Colchicine or
• Didanosine (e.g., Videx) or
• Eflornithine (e.g., Ornidyl) or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A)—Using any of these medicines with the combination medicine may cause blood problems to become worse

• Abacavir (e.g., Ziagen) or
• Lamivudine (e.g., Epivir) or
• Zidovudine (e.g., Retrovir)—Using additional abacavir, lamivudine, or zidovudine with the combination medicine may increase the chance of side effects of abacavir, lamivudine, or zidovudine

• Doxorubicin (e.g., Adriamycin) or
• Ribavirin (e.g., Virazole) or
• Stavudine (e.g., Zerit)—Use of these medicines with abacavir, lamivudine, and zidovudine combination may result in these medicines or the combination not working as well as they should

• Blood problems, including anemia and decreased bone marrow production—Abacavir, lamivudine, and zidovudine combination may make these conditions worse

• Kidney disease or
• Liver disease—Patients with kidney or liver disease may have more side effects

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking abacavir, lamivudine, and zidovudine combination without checking with your doctor first.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help in planning the best times to take your medicine, check with your health care professional.

Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with others.

Dosing—

Abacavir, lamivudine, and zidovudine combination contains a fixed amount of each medicine.

• For oral dosage form (tablets):

• For human immunodeficiency virus (HIV) infection:

• Adults, teenagers, and children who weigh more than 40 kilograms (kg) (88 pounds)—300 milligrams (mg) of abacavir, 150 mg of lamivudine, and 300 mg of zidovudine (equal to one tablet) two times a day.
• Adults, teenagers, and children who weigh 40 kg (88 pounds) or less—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits. Abacavir, lamivudine, and zidovudine combination may cause blood problems, and your doctor will want to test your blood regularly.

This medicine may cause a severe allergic reaction in some patients. This reaction usually occurs within 6 weeks after the medicine is started but may occur at any time. If untreated, it can lead to severe low blood pressure and even death. Stop taking this medicine and check with your doctor immediately if you notice abdominal or stomach pain; cough; diarrhea; fever; headache; nausea; numbness or tingling of face, feet, or hands; pain in joints; pain in muscles; shortness of breath; skin rash; sore throat; swelling of feet or lower legs; unusual feeling of discomfort or illness; unusual tiredness or weakness; or vomiting.

When you begin taking this medicine, you will be given a warning card which describes symptoms of severe allergic reactions that may be caused by abacavir, lamivudine, and zidovudine combination. The warning card also provides information about how to treat these allergic reactions. For your safety, you should carry the warning card with you at all times.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if the following side effect occurs:

• Less common
  • Hypersensitivity reaction, including abdominal or stomach pain; cough; diarrhea; fever; headache; nausea; numbness or tingling of face, feet, or hands; pain in joints; pain in muscles; shortness of breath; skin rash; sore throat; swelling of feet or lower legs; unusual feeling of discomfort or illness; unusual tiredness or weakness; or vomiting 
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Chills 
  
  

• Less common
  • Muscle weakness;  pale skin;  yellow eyes or skin 
  
  

• Rare
  • Black tarry stools;  blood in urine or stools;  pinpoint red spots on skin;  unusual bleeding or bruising 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Bone pain;  loss of appetite;  sleeplessness;  trouble sleeping 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.