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Complete Prescribing Information for COMBIVIR Tablets
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COMBIVIR May Help Perserve Future Treatment Options
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Why Prescribe COMBIVIR
Why Keep Patients on COMBIVIR
Safety and Tolerability
Efficacy
Dosing Convenience
Patient Education
Important Safey Information
Questions Frequently Asked by Patients
Prescribing Info
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Questions Frequently Asked by Patients



What is COMBIVIR?

How does COMBIVIR work?

Will COMBIVIR work the same as EPIVIR and RETROVIR taken together?

How should I take COMBIVIR?

What should I do if I miss a dose of COMBIVIR?

Does COMBIVIR cure HIV infection or AIDS?

Does COMBIVIR reduce the risk of passing HIV to others?

Who should not take COMBIVIR?

What medical problems or conditions should I discuss with my healthcare provider?

Can COMBIVIR be taken with other medications?

What are the possible side effects of COMBIVIR?

How should I store COMBIVIR Tablets?

What is COMBIVIR?

COMBIVIR is the brand name of a tablet that combines EPIVIR® Tablets (lamivudine tablets) [3TC®] and RETROVIR® (zidovudine) Tablets [ZDV], two drugs which are used to treat HIV (human immunodeficiency virus). HIV is the virus that causes AIDS (acquired immune deficiency syndrome).

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How does COMBIVIR work?

COMBIVIR is a combination of lamivudine (la-MIV-u-deen) and zidovudine (zi-DOHV-udeen), two medicines (nucleoside analogues) that slow down the replication of the HIV virus. This can reduce the virus’ ability to infect new cells. It may help lower the amount of HIV in your body (called “viral load”) and raise your CD4 (T) cell count. Lamivudine plus zidovudine when used together can have stronger (synergistic) effects against the virus. COMBIVIR is a convenient way of taking lamivudine and zidovudine. COMBIVIR should usually be taken with other anti-HIV therapy.

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Will COMBIVIR work the same as EPIVIR and RETROVIR taken together?

Taking one COMBIVIR Tablet twice a day is the same as taking one EPIVIR 150 mg Tablet twice a day and either two RETROVIR 100 mg Capsules three times a day or one RETROVIR 300 mg Tablet twice a day.

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How should I take COMBIVIR?

Take COMBIVIR as your doctor prescribes it. The recommended dose is one COMBIVIR Tablet orally two times a day, with or without food. To help make sure you will benefit from COMBIVIR, you must not skip doses or take “drug holidays.”

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What should I do if I miss a dose of COMBIVIR?

If you miss a dose by more than 4 hours, wait and then take the next dose at the regularly scheduled time. However, if you miss a dose by less than 4 hours, take your missed dose immediately. Then take your next dose at the regularly scheduled time. Do not take more or less than your prescribed dose of COMBIVIR at any one time.

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Does COMBIVIR cure HIV infection or AIDS?

No, there is not a cure for HIV infection or AIDS. People taking COMBIVIR may still develop infections or other illnesses associated with HIV. Because of this, it is very important to remain under the care of a healthcare provider. Use of lamivudine plus zidovudine has been shown to help patients with HIV infection stay healthy and live longer.

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Does COMBIVIR reduce the risk of passing HIV to others?

No, COMBIVIR, as well as other HIV medications, has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination.

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Who should NOT take COMBIVIR?

You should not take COMBIVIR if you have had a serious allergic reaction to either lamivudine (also known as EPIVIR or 3TC) or zidovudine (also known as RETROVIR or ZDV).

Do not take COMBIVIR at the same time as EPIVIR or RETROVIR, or TRIZIVIR® (abacavir sulfate/lamivudine/zidovudine), because they also contain lamivudine and zidovudine. Individual dosing with EPIVIR plus RETROVIR, rather than COMBIVIR, should be considered for:

  • A child under 12 years of age.
  • Anyone who requires dosage adjustments due to drug side effects or poor kidney function.

If you are 65 years of age or over, consult your healthcare professional about the functioning of your liver, kidneys, and heart; about other illnesses you may suffer from, and about any other medications you may be taking. It is possible that the dosage may need to be modified.

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What medical problems or conditions should I discuss with my healthcare provider?

Talk to your healthcare provider if:

  • You are pregnant or if you become pregnant while taking COMBIVIR. Ask your doctor about enrolling you in the Antiretroviral Pregnancy Registry: 1-800-258-4263.
  • You are breast-feeding. Mothers infected with HIV should not breast-feed their infants because HIV is present in breast milk.

Also talk to your nurse or doctor about:

  • Problems with your blood counts
  • Problems with your muscles
  • Problems with your kidneys
  • Problems with your liver, especially if you have mild or moderate liver disease, such as hepatitis.

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Can COMBIVIR be taken with other medications?

Yes. COMBIVIR can be taken with most other medications, including most anti-HIV drugs. Be sure to tell your doctor about all medications, over-the-counter or prescription, that you are taking.

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What are the possible side effects of COMBIVIR?

Do not rely on this summary alone for information about side effects. Your healthcare provider can discuss with you a more complete list of side effects that may be relevant to you.

The safety of COMBIVIR is not expected to be different from the safety of EPIVIR and RETROVIR given separately.

In clinical studies of lamivudine plus zidovudine, side effects occurring in 5% or more of patients included: muscle and joint pain, headache, nausea, weakness and fatigue, nasal symptoms, cough, diarrhea, nausea and vomiting, neuropathy, trouble sleeping, fever or chills, loss of appetite, dizziness, abdominal pain or cramps, depression, skin rashes, and indigestion.

It’s important to know that serious side effects can occur with COMBIVIR, such as a decrease in red and white blood cells and muscle damage. A buildup of lactic acid and an enlarged liver, including fatal cases, have been reported rarely with some HIV drugs, including nucleoside analogues.

For HIV-infected individuals, periodic blood tests are recommended. If certain changes occur in your laboratory results while you are taking COMBIVIR, particularly if you become anemic or if your white blood cell count falls too low, your medication may need to be adjusted; your doctor may prescribe EPIVIR plus RETROVIR separately in place of COMBIVIR.

Some patients infected with both hepatitis B virus (HBV) and HIV have worsening of hepatitis after stopping lamivudine (a component of COMBIVIR). Discuss any change in treatment with your doctor. If you have both HBV and HIV and stop treatment with COMBIVIR, you should be closely monitored by your doctor for at least several months.

Tell your doctor promptly about any side effects or other unusual symptoms you may experience. Although it may make you healthier, COMBIVIR does not cure HIV.

Other Information

This medication is prescribed for a particular condition. Do not use it for any other condition or give it to anybody else. Keep COMBIVIR® (lamivudine and zidovudine) Tablets and all medicines out of the reach of children.

Like most prescription drugs, lamivudine and zidovudine were required to be tested on animals before they were allowed for human use. In animal studies with doses much higher than those used in humans, zidovudine was associated with vaginal tumors. Your healthcare provider can tell you more about how drugs are tested on animals and what the results of these tests may mean about safety for you.

How should I store COMBIVIR Tablets?

COMBIVIR Tablets may be stored at room temperature and do not require refrigeration.

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Complete Prescribing Information for COMBIVIR® (lamivudine/zidovudine) Tablets


I Have Been Diagnosed With HIV | I Am Taking COMBIVIR
I Am A Healthcare Professional | Why Prescribe COMBIVIR
Why Keep Patients on COMBIVIR | Safety and Tolerability | Efficacy
Dosing Convenience | Patient Education

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