abacavir, lamivudine, and zidovudine

Stop using this medication and call your doctor at once if you have any of these signs of an allergic reaction: fever; rash; nausea, vomiting, diarrhea, stomach pain; general tiredness, body aches; shortness of breath, cough, sore throat.

Once you have had an allergic reaction to this medication, you must never use it again.

Do not allow this medicine to run out completely before you get your prescription refilled. If you miss several doses, you could have a dangerous or even fatal allergic reaction when you start taking the medicine again. If you stop taking this medication for any reason, talk to your doctor before you start taking the medication again.

Some people have developed a life-threatening condition called lactic acidosis while taking this medicine. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Abacavir-lamivudine-zidovudine is an antiviral medication. It is in a group of human immunodeficiency virus (HIV) medicines called reverse transcriptase inhibitors. This medication helps keep the HIV virus from reproducing in the body.

This medication is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). This medication is not a cure for HIV or AIDS.

This medication may also be used for other purposes not listed in this medication guide. This medication should not be given to people who weigh less than 90 pounds.

You should not take this medication if you have liver disease. Do not take this medicine if you have ever had an allergic reaction to abacavir. Tell your doctor if you have had an allergic reaction to any medicine that contains abacavir, such as Epzicom or Ziagen. Once you have had an allergic reaction to abacavir, you must never use it again.

You may need a blood test before you start taking this medication for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction.

Some people have developed a life-threatening condition called lactic acidosis while taking this medicine. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, or if you have taken certain HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• kidney disease;
• hepatitis B;
• high blood pressure or heart disease, or a risk factor for heart disease such as smoking, diabetes, or high cholesterol.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection while you are pregnant.

You should not breast-feed while you are using this medication. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

This medication should not be used to treat HIV in adolescents weighing less than 90 pounds.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the instructions on your prescription label.

You may take this medication with or without food.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

This medicine comes with a Medication Guide and a Warning Card that lists the symptoms of an allergic reaction. Read this information carefully and carry the Warning Card with you at all times so you will know what symptoms to watch for.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop taking abacavir, lamivudine, and zidovudine. Do not miss any scheduled appointments.

Store this medication at room temperature away from moisture and heat. You may keep the oral solution (liquid) in the refrigerator but do not let it freeze.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Do not allow this medicine to run out completely before you get your prescription refilled. It is important that you not stop taking the medicine once you have started. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking the medicine again. If you stop taking Trizivir for any reason, talk to your doctor before you start taking the medication again.

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, headache, dizziness, drowsiness, lethargy, and confusion.

Avoid taking other medications that contain abacavir, lamivudine, or zidovudine, such as Combivir, Epivir, Epzicom, Trizivir, or Ziagen.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Stop using this medication and call your doctor at once if you have any of these signs of an allergic reaction to abacavir:

• Group 1 - fever;
• Group 2 - rash;
• Group 3 - nausea, vomiting, diarrhea, stomach pain;
• Group 4 - general tiredness, body aches;
• Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to abacavir, you must never use it again. If you stop taking Trizivir for any reason, talk to your doctor before you start taking the medication again.

You may have other serious side effects that may not be signs of an allergic reaction. Continue using this medicine and call your doctor if you have any of these side effects:

• liver problems -- stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired;
• fever, chills, body aches, flu symptoms, pale skin; or
• white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk);
• sleep problems or strange dreams;
• headache, depression, anxiety; or
• mild diarrhea.

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.

Before taking this medication, tell your doctor if you are using any of the following drugs:

• methadone (Methadose, Dolophine);
• ribavirin (Copegus, Rebetron, Virazole);
• interferon (Rebetron, Roferon, Intron, Alferon, Infergen, Avonex, Rebif, Betaseron, Actimune);
• sulfa drugs such as Bactrim or Septra;
• doxorubicin (Adriamycin);
• ganciclovir (Cytovene); or
• these other HIV medicines - emtricitabine (Emtriva, Truvada), zalcitabine (Hivid), stavudine (Zerit), or zidovudine (Retrovir).

This list is not complete and there may be other drugs that can interact with Trizivir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Your pharmacist can provide more information about abacavir-lamivudine-zidovudine (Trizivir).

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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