Combivir contains a combination of lamivudine and zidovudine. Lamivudine and zidovudine are antiviral medications that prevent human immunodeficiency virus (HIV) from multiplying in your body.

Combivir is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS).

Combivir is not a cure for HIV or AIDS.

Do not take Combivir if you have ever had an allergic reaction to any medicine that contains lamivudine or zidovudine.

Zidovudine can weaken your immune system and cause signs of infection (fever, mouth sores, skin sores, flu symptoms, pale skin). Your blood will need to be tested often. Long-term use of zidovudine can cause muscle weakness, or loss of muscle tissue similar to "wasting syndrome" caused by HIV.

Combivir may cause a serious condition called lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

If you've ever had hepatitis B, it may become active or get worse after you stop using this medicine. You may need frequent liver function tests for several months after you stop using Combivir.

Take Combivir exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take this medicine with or without food.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store Combivir at room temperature away from moisture and heat.

If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using Combivir. You may need frequent liver function tests while using this medicine and for several months after your last dose.

Usual Adult Dose of Combivir for HIV Infection:

1 tablet orally twice a day

Use: In combination with other antiretrovirals, for the treatment of HIV-1 infection

Usual Adult Dose of Combivir for Nonoccupational Exposure:

US CDC recommendations: 1 tablet orally every twice a day
Duration of therapy: 28 days

Comments:
-Recommended as part of a preferred NNRTI-based or protease inhibitor-based regimen for nonoccupational postexposure prophylaxis of HIV infection; also recommended as part of alternative regimens (NNRTI-based, protease inhibitor-based, or triple NRTI)
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Occupational Exposure:

US Public Health Service working group recommendations: 1 tablet orally twice a day
Duration of therapy: 28 days, if tolerated

Comments:
-Recommended as part of alternative regimens for HIV postexposure prophylaxis
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on the institution protocol.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection:

At least 30 kg: 1 tablet orally twice a day

Comments:
-Use of the individual components is not recommended for patients less than 30 kg; the manufacturer product information for lamivudine and zidovudine should be consulted.

Use: In combination with other antiretrovirals, for the treatment of HIV-1 infection

You should not take Combivir if you are allergic to lamivudine. Do not take Combivir with any other medicine that contains lamivudine, zidovudine, or emtricitabine. This includes Atripla, Biktarvy, Cimduo, Complera, Descovy, Emtriva, Epzicom, Genvoya, Odefsey, Retrovir, Stribild, Symfi, Triumeq, Trizivir, and Truvada.

Combivir can also cause severe or fatal liver problems. Tell your doctor if you have liver disease, especially hepatitis B.

Combivir should not be used to treat HIV in adolescents weighing less than 66 pounds.

Tell your doctor if you have ever had:

• kidney disease;

• pancreas disorder (especially in a child taking this medicine); or

• if you take ribavirin to treat hepatitis C.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. Ask your doctor about your risk.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid taking other medications that contain an ingredient called sorbitol, often used as a sweetener in liquid medicines. Ask your pharmacist if you are not sure a medicine contains this ingredient.

Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction to Combivir: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have:

• liver problems - swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;

• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or

• pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting.

Lamivudine and zidovudine affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Combivir side effects may include:

• headache;

• nausea, diarrhea;

• tiredness, general ill feeling;

• cold symptoms such as stuffy nose, sneezing, sinus pain, cough; or

• loss of body fat (especially in your arms, legs, face, and buttocks).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• ganciclovir;

• interferon alfa; or

• ribavirin.

This list is not complete. Other drugs may interact with lamivudine and zidovudine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.