GENERIC NAME: ABACAVIR/LAMIVUDINE - ORAL (a-BAK-a-vir/la-MIV-ue-deen)
BRAND NAME(S): Epzicom
WARNING: In some patients, the abacavir in this product has caused a serious (sometimes fatal) allergic reaction. Your doctor may order a blood test to measure your risk before you start this medication or take it again. If the blood test shows you are at greater risk, your doctor should discuss the risks and benefits of abacavir and other treatment choices with you. Symptoms of an allergic reaction may include any of the following: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, fever, extreme tiredness, nausea, vomiting, diarrhea, stomach pain, muscle aches, sore throat, mouth sores, or cough. Get medical help right away if you experience any of these symptoms. If you have stopped taking abacavir because of an allergic reaction, you must never take any form of abacavir again. Notify all of your doctors and pharmacists if you have stopped taking abacavir due to an allergic reaction. Read the warning card provided with this medication for more details.
Rarely, abacavir/lamivudine has caused severe (sometimes fatal) liver problems and a certain metabolic problem (lactic acidosis). Get medical help right away if you develop any of the following symptoms: nausea, vomiting, stomach/abdominal pain, unusual tiredness, dark urine, yellowing eyes/skin, deep/rapid breathing, or drowsiness. These serious side effects may occur more often in women and obese patients.
If you have hepatitis B infection and HIV, you may have a serious worsening of hepatitis symptoms if you stop taking lamivudine. Talk with your doctor before stopping this medication. Your doctor will monitor liver tests for several months after you stop lamivudine. Get medical help right away if you develop symptoms of worsening liver problems.
USES: This product contains 2 drugs: abacavir and lamivudine. It is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Abacavir and lamivudine both belong to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs).Abacavir/lamivudine is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This product may also be used in combination with other HIV medications to reduce the risk of getting HIV infection after contact with the virus. Consult your doctor for more details.
HOW TO USE: Read the Medication Guide and Warning Card provided by your pharmacist before you start taking abacavir/lamivudine and each time you get a refill. Carry the Warning Card with you at all times. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food, usually once daily or as directed by your doctor.Because this combination product has fixed doses of abacavir and lamivudine, it should only be used if your doctor has determined that the doses of both medications in this product are right for you. The Canadian manufacturer of this product states that it is not to be used in patients weighing less than 40 kilograms (88 pounds).If you stop taking any medication containing abacavir even for a short time and then restart the drug, you have an increased chance of developing a very serious (possibly fatal) allergic reaction. Refill your medication before you run out. Do not stop treatment unless directed by your doctor. Before restarting any medication containing abacavir, consult your doctor or pharmacist, and be sure you have easy access to medical care.It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Do not increase your dose, take this drug more often than prescribed, or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.
SIDE EFFECTS: See also Warning and How to Use sections.Headache, nausea, diarrhea, dizziness, tiredness, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), easy bruising/bleeding, signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat).Get medical help right away if you have any very serious side effects, including: signs of pancreatitis (such as nausea, vomiting, stomach/abdominal/back pain, fever).Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking abacavir/lamivudine, tell your doctor or pharmacist if you are allergic to either of these drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems (such as hepatitis B or C, cirrhosis), disease of the pancreas (pancreatitis), alcohol use.Abacavir may increase your risk of a heart attack. Discuss the risks and benefits of treatment with your doctor and ways to lower your risk of heart disease. Tell your doctor if you have heart problems, if you smoke, or if you have other conditions that increase your risk of heart disease, such as high blood pressure, diabetes, or high cholesterol levels.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages, because they can increase dizziness and increase the risk of liver problems and pancreatitis.Children may be more sensitive to the side effects of this drug, especially pancreatitis.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. Abacavir/lamivudine may be part of that treatment. Discuss the risks and benefits with your doctor.It is not known if abacavir passes into breast milk, however, lamivudine passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: interferon alfa, methadone, ribavirin, zalcitabine.Do not take other products that contain abacavir or lamivudine with this medication.Emtricitabine is similar to lamivudine and should not be taken with this medication.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as blood tests, liver tests, kidney tests, viral load, T-cell counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Keep all medical and laboratory appointments.
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MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised January 2014. Copyright(c) 2014 First Databank, Inc.
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HIV (human immunodeficiency virus) infection left untreated causes AIDS (acquired immunodeficiency syndrome). The human immunodeficiency virus (HIV) is a type of virus called a retrovirus, which can infect humans when it comes in contact with tissues that line the vagina, anal area, mouth, or eyes, or through a break in the skin. HIV infection is generally a slowly progressive disease in which the virus is present throughout the body at all stages of the disease. Three stages of HIV infection have been described. The initial stage of infection (primary infection), which occurs within weeks of acquiring the virus, often is characterized by the flu- or mono-like illness that generally resolves within weeks. The stage of chronic asymptomatic infection (meaning a long duration of infection without symptoms) lasts an average of eight to 10 years without treatment. The stage of symptomatic infection, in which the body's immune (or defense) system has been suppressed and complications have developed, is called the acquired immunodeficiency syndrome (AIDS). The symptoms are caused by the complications of AIDS, which include one or more unusual infections or cancers, severe loss of weight, and intellectual deterioration (called dementia). When HIV grows (that is, by reproducing itself), it acquires the ability to change (mutate) its own structure. These mutations enable the virus to become resistant to previously effective drug therapy. The goals of drug therapy are to prevent damage to the immune system by the HIV virus and to halt or delay the progress of the infection to symptomatic disease. Therapy for HIV includes combinations of drugs that decrease the growth of the virus to such an extent that the treatment prevents or markedly delays the development of viral resistance to the drugs. The best combination of drugs for HIV are those that effectively suppress viral replication in the blood and also are well tolerated and simple to take so that people can take the medications consistently without missing doses.
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