Generic Name: abacavir/lamivudine (a-BAK-a-vir/la-MIV-ue-deen)
Brand Name: Epzicom
Abacavir/lamivudine has caused severe and sometimes fatal allergic reactions. Contact your doctor right away if you develop fever; rash; nausea, vomiting, diarrhea, or stomach pain; cough, sore throat, or trouble breathing; unusual tiredness or achiness; or general feeling of being unwell. Do NOT take abacavir/lamivudine again or take any other medicine that contains abacavir if you have had an allergic reaction to abacavir/lamivudine. You may be at risk for an even more severe allergic reaction. If you stop taking abacavir/lamivudine for any other reason, even for a few days, and you are not allergic to it, check with your doctor before restarting it.
Patients who have a certain gene type called HLA-B*5701 have an increased risk of having an allergic reaction to abacavir. A lab test may be performed before you start abacavir/lamivudine to see if you have this gene type. Discuss any questions or concerns with your doctor.
High levels of lactic acid in the blood (lactic acidosis) and severe liver problems, including fatal cases, have been reported in patients taking certain HIV medicines, such as abacavir/lamivudine. The risk may be greater in women, in patients who are very overweight, or in patients who have a history of liver problems. It may also be increased in patients who have taken certain HIV medicines for a prolonged period of time. Tell your doctor immediately if you have dark urine; fast or irregular heartbeat; pale stools; rapid or difficult breathing; severe or unusual drowsiness, dizziness, or light-headedness; sluggishness; stomach pain (with or without nausea or vomiting); unusual muscle pain or tenderness; unusual tiredness or weakness; or yellowing of the eyes and skin. Contact your doctor right away if you start to feel unusually cold, especially in your arms and legs, or if you have a general feeling of being unwell.
Severe worsening of hepatitis B virus (HBV) has been reported in patients who have both HIV and HBV infection and have stopped taking lamivudine. Patients who have both HIV and HBV infection need close medical follow-up to check for worsening liver problems for at least several months after stopping lamivudine. Be sure to keep all doctor and lab appointments.
Abacavir/ lamivudine is used for:
Treating HIV infection. Abacavir/lamivudine is used in combination with other medicines.
Abacavir/lamivudine is a nucleoside analog reverse transcriptase inhibitor (NRTI) combination. It works by blocking HIV from reproducing.
Do NOT use abacavir/ lamivudine if:
- you are allergic to any ingredient in abacavir/lamivudine
- you have liver problems (eg, an enlarged liver), abnormal liver function tests, severe kidney problems, or high levels of lactic acid in the blood (lactic acidosis)
- you are taking another medicine that contains abacavir, emtricitabine, or lamivudine
- you are taking zalcitabine
Contact your doctor or health care provider right away if any of these apply to you.
Before using abacavir/ lamivudine:
Some medical conditions may interact with abacavir/lamivudine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney problems, heart problems (eg, a heart attack), high blood pressure, high cholesterol, diabetes, pancreatitis, hepatitis B infection, or nerve problems
- if you have a history of high levels of lactic acid in the blood or are at risk of liver problems
- if you smoke, drink alcohol, or are very overweight
- if you are taking any other medicine for HIV infection
- if you have been tested and know whether or not you have a gene type called HLA-B*5701
Some MEDICINES MAY INTERACT with abacavir/lamivudine. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Interferon alfa or trimethoprim/sulfamethoxazole (TMP-SMZ) because they may increase the risk of abacavir/lamivudine's side effects
- Ribavirin or zalcitabine because their effectiveness may be decreased
- Methadone because its effectiveness may be decreased by abacavir/lamivudine
- Other medicines that contain abacavir, emtricitabine, or lamivudine because the risk of side effects may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if abacavir/lamivudine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use abacavir/ lamivudine:
Use abacavir/lamivudine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Abacavir/lamivudine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get abacavir/lamivudine refilled.
- Abacavir/lamivudine comes with a warning card that provides information about recognition of allergic reactions. Carry the warning card of allergy symptoms with you. Tell your health care provider immediately about any side effects you experience while taking abacavir/lamivudine.
- Take abacavir/lamivudine by mouth with or without food.
- Taking abacavir/lamivudine at the same time each day will help you remember to take it.
- Take abacavir/lamivudine on a regular schedule to get the most benefit from it.
- Continue to take abacavir/lamivudine even if you feel well. Do not miss any doses.
- If you miss a dose of abacavir/lamivudine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use abacavir/lamivudine.
Important safety information:
- Abacavir/lamivudine may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use abacavir/lamivudine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Tell your doctor or dentist that you take abacavir/lamivudine before you receive any medical or dental care, emergency care, or surgery.
- Drinking alcohol while taking abacavir/lamivudine may cause an increased risk of side effects. Talk to your doctor before drinking alcohol while you are taking abacavir/lamivudine.
- Abacavir/lamivudine is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
- When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking abacavir/lamivudine, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
- If you stop taking abacavir/lamivudine even for a few days (eg, if you run out of your medicine and do not get it refilled right away), contact your doctor before you start taking it again. You may experience a serious allergic reaction if you stop taking abacavir/lamivudine and then start again.
- Abacavir/lamivudine does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
- Abacavir/lamivudine may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start abacavir/lamivudine.
- Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking abacavir/lamivudine. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
- Diabetes patients - Abacavir/lamivudine may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Patients who have a certain gene type called HLA-B*5701 have an increased risk of a severe or even fatal allergic reaction to abacavir/lamivudine. A lab test may be performed before you start abacavir/lamivudine to see if you have this gene type. Discuss any questions or concerns with your doctor.
- Lab tests, including CD4 counts, complete blood cell counts, and liver function, may be performed while you use abacavir/lamivudine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Abacavir/lamivudine should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking abacavir/lamivudine while you are pregnant. Abacavir/lamivudine is found in breast milk. Do not breast-feed while taking abacavir/lamivudine. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or abacavir/lamivudine to the baby.
Possible side effects of abacavir/ lamivudine:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Dizziness; headache; trouble sleeping.
Severe allergic reactions (fever; rash; tiredness; achiness; nausea; diarrhea; vomiting; stomach pain; sore throat; hives; itching; difficulty breathing; cough; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest, jaw, or arm pain or discomfort; decreased urination; fainting; fever, chills, or persistent sore throat; mental or mood problems (eg, depression); mouth ulcers; muscle pain, cramping, or weakness; numbness, tingling, or pain in the hands and feet; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness; shortness of breath; sudden, unusual sweating; swelling; symptoms of lactic acidosis (eg, fast or irregular heartbeat; feeling cold, especially in your arms and legs; rapid or difficult breathing; severe or unusual drowsiness, dizziness, or light-headedness; sluggishness; stomach pain with nausea and vomiting; unusual tiredness or weakness); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the eyes or skin).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of abacavir/lamivudine:
Store abacavir/lamivudine at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep abacavir/lamivudine out of the reach of children and away from pets.
- If you have any questions about abacavir/lamivudine, please talk with your doctor, pharmacist, or other health care provider.
- Abacavir/lamivudine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take abacavir/lamivudine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about abacavir/lamivudine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to abacavir/lamivudine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using abacavir/lamivudine.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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- Drug class: antiviral combinations
Other brands: Epzicom