Abacavir-Lamivudine-Zidovudine.

(Abacavir-lamivudine-zidovudine) This product contains 3 drugs: abacavir, lamivudine, and zidovudine. It is used alone or 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, lamivudine, and zidovudine all belong to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). Abacavir/lamivudine/zidovudine 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.

Read the Medication Guide and Warning Card provided by your pharmacist before you start taking abacavir/lamivudine/zidovudine 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 twice daily or as directed by your doctor. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Because this combination product has fixed doses of abacavir, lamivudine, and zidovudine, it should only be used if your doctor has determined that the doses of all 3 medications in this product are right for you. 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. For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same times every day.

Before taking abacavir/lamivudine/zidovudine, tell your doctor or pharmacist if you are allergic to any 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, low red/white blood cell counts. 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. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Alcohol may also increase the risk of liver problems and pancreatitis. Talk to your doctor if you are using marijuana (cannabis). 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). Tell your doctor if you are pregnant before using this medication. Treatment can lower the risk of passing HIV infection to your baby. Discuss the risks and benefits with your doctor. This medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

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: orlistat, probenecid, ribavirin, sorbitol, stavudine, drugs that may decrease bone marrow function or lower blood cell counts (such as ganciclovir, trimethoprim, cancer chemotherapy including doxorubicin), drugs that may affect the kidneys (including NSAIDs such as ibuprofen or naproxen). Other medications can affect the removal of zidovudine from your body, which may affect how abacavir/lamivudine/zidovudine works. Examples include rifampin, valproic acid, among others. If you are also taking clarithromycin, take this medication at least 2 hours apart from your clarithromycin dose. Do not take other products that contain abacavir, lamivudine, or zidovudine with this medication. Emtricitabine is similar to lamivudine and should not be taken with this medication.

In some patients, the abacavir in this product has caused a serious (sometimes fatal) allergic reaction. Your doctor should 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, you should not take this medication and your doctor should discuss 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, or death could result. Tell all of your doctors and pharmacists if you have stopped taking abacavir due to an allergic reaction. Also, properly throw away any unused medications containing abacavir. Read the warning card provided with this medication for more details. The zidovudine in this product can decrease bone marrow function, which may lead to low numbers of red and white blood cells. A low number of red blood cells can lead to anemia. A low number of white blood cells can decrease your body's ability to fight serious, life-threatening infections. These serious side effects occur more frequently in people with advanced HIV disease (AIDS). Get medical help right away if you develop any signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat) or signs of infection (such as fever, chills, cough, persistent sore throat). Your doctor will check your blood cell counts while you are taking this medication to decrease the risk of these side effects. Zidovudine may also cause muscle problems. Get medical help right away if you develop signs of muscle problems (such as wasting or decrease in muscle size, weight loss, muscle weakness/pain/tenderness). Rarely, abacavir/lamivudine/zidovudine 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.

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. Take your next dose at the regular time. Do not double the dose to catch up.

See also Warning and How to Use sections. Headache, tiredness, weakness, nausea, vomiting, loss of appetite, diarrhea, dizziness, 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. As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, 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 trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking). Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), easy bruising/bleeding, skin/nail color changes. 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). Loss of body fat (such as in the face, arms, legs, and buttocks) may occur while you are taking this medication. This effect may be permanent. Tell your doctor right away if you notice any changes in body fat. 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.