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|Combivir

LAMIVUDINE AND ZIDOVUDINE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Combivir

† Not commercially available in Canada.

Category

• Antiviral (systemic)

Description

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).

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. 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.

The zidovudine component of this combination medicine may cause some serious side effects, including bone marrow problems. Symptoms of bone marrow problems include fever, chills, sore throat, pale skin, and unusual tiredness or weakness. These problems may require blood transfusion or temporarily stopping treatment with lamivudine and zidovudine combination. Check with your doctor if any new health problems or symptoms occur while you are taking lamivudine and zidovudine combination.

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

• Oral
• Tablets (U.S.)

Before Using This Medicine

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 lamivudine and zidovudine combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to lamivudine or zidovudine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Lamivudine and zidovudine combination has not been studied in pregnant women. However, studies in animals have shown that zidovudine causes birth defects when given in very high doses. Before taking this lamivudine and zidovudine combination, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Zidovudine passes into breast milk. It is not known whether lamivudine passes into 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—Either lamivudine or zidovudine used alone may cause serious side effects, and children should receive less of these medicines than adults. However, lamivudine and zidovudine combination contains a fixed amount of each medicine that cannot be decreased. Therefore, lamivudine and zidovudine combination is not recommended for children less than 12 years of age, or children who weigh less than 50 kilograms (110 pounds) because the amounts of 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. Many older people have problems with their liver, heart and kidneys. Your doctor may change the amount of medicine you take because of other health problems.

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 lamivudine and zidovudine combination, it is especially important that your health care professional know if you are taking any of the following:

• Abacavir/lamivudine/zidovudine combination (e.g., Trizivir) or
• Lamivudine (e.g., Epivir) or
• Zidovudine (e.g., Retrovir)—Using products containing additional lamivudine or zidovudine with the combination product may increase the chance of side effects of lamivudine or zidovudine

• 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)
• Uracil mustard—Taking lamivudine and zidovudine combination while you are using or receiving these medicines may make anemia or other blood problems worse

• Doxorubicin (e.g., Adriamycin) or
• Ribavirin (e.g., Copegus, Rebetol) or
• Stavudine (e.g., Zerit)—Should not be used with lamivudine and zidovudine combination; may prevent medicine from working properly

Other medical problems—The presence of other medical problems may affect the use of lamivudine and zidovudine combination. Make sure you tell your doctor if you have any other medical problems, especially:

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

• Infection of human immunodeficiency virus (HIV) and hepatitis B virus (HBV) at the same time—This medicine could make your hepatitis worse or prevent the medicine from working properly.

• Kidney disease—Patients with kidney disease may experience an increase in side effects

• Liver disease or
• Risk factors for liver disease or
• Obesity (being overweight) or
• Use of other HIV medicines over a long period of time—This medicine may make liver disease worse in patients with liver disease, obesity or other HIV medicine use.

Proper Use of This Medicine

Lamivudine and zidovudine combination may be taken with food or on an empty stomach.

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 lamivudine and zidovudine combination without checking with your doctor first.

Keep taking lamivudine and zidovudine combination for the full time of treatment , even if you begin to feel better.

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—Lamivudine and zidovudine combination contains a fixed amount of each medicine.

• For oral dosage form (tablets):
  • For human immunodeficiency virus (HIV) infection:
    • Adults and teenagers who weigh more than 50 kilograms (kg) (110 pounds)—150 milligrams (mg) of lamivudine and 300 mg of zidovudine (equivalent to one tablet) two times a day.
    • Adults and teenagers who weigh 50 kg (110 pounds) or less—Use is not recommended.
    • Children—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.

Precautions While Using This Medicine

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

Do not take any other medicines without checking with your doctor first . To do so may increase the chance of side effects from lamivudine and zidovudine combination.

If you have both HIV and hepatitis B virus (HBV) infections, deterioration of liver disease has occurred when lamivudine and zidovudine treatment is stopped. Discuss any changes in your treatment and medicines with your doctor.

HIV may be acquired from or spread to other people through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”) . Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex . The use of a spermicide (such as nonoxynol-9) may also help prevent transmission of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly , are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs , get help to stop. Do not share needles or equipment with anyone . In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your health care professional.

Side Effects of This Medicine

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.

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:

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

Developed: 02/23/1998
Revised: 10/27/2004

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