Abacavir-Lamivudine Treatment Report

Precautions

Instructions

Side Effects

Interactions

You should not take abacavir and lamivudine 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 Trizivir or Ziagen. Once you have had an allergic reaction to abacavir and lamivudine, you must never use it again.

You may need a blood test before you start taking abacavir and lamivudine 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;
• heart disease or high blood pressure; or
• a risk factor for heart disease such as smoking, diabetes, or high cholesterol.

FDA pregnancy category C. It is not known whether abacavir and lamivudine 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 abacavir. 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 given to children under 18 years old.

Avoid taking other medications that contain abacavir or lamivudine, such as Combivir, Epivir, 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.

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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 abacavir again. If you stop taking abacavir and lamivudine for any reason, talk to your doctor before you start taking the medication again.

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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 abacavir and lamivudine for any reason, talk to your doctor before you start taking the medication again.

Other serious side effects that may not be signs of an allergic reaction include:

• 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; or
• white patches or sores inside your mouth or on your lips.

Less serious side effects 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.

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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);
• zalcitabine (ddC, Hivid); or
• other medications that contain abacavir or lamivudine (Combivir, Epivir, Trizivir, Ziagen).

This list is not complete and there may be other drugs that can interact with abacavir and lamivudine. 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.

Epzicom, abacavir-lamivudine, and lamivudine-abacavir

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