Brand Trizivir

This product contains 3 drugs: abacavir, lamivudine, and zidovudine. It is used alone or with other medications to help control your HIV infection, thereby improving your quality of life. It helps to decrease the amount of HIV in your body so your immune system can work better. This product also lowers your risk of getting HIV disease complications (such as new infections, cancer). 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 and it does not prevent the spread of HIV to others through sexual contact or blood contamination (such as sharing used needles).

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. This product 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 times each day. Tell your doctor if your condition does not improve or if it worsens.

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. 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). To decrease your risk of spreading HIV disease to others, always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details. 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/zidovudine 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 and zidovudine pass into breast milk. Because breast milk can transmit HIV, do not breast-feed.

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.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Some products that may interact with this drug include: interferon alfa, methadone, probenecid, ribavirin, stavudine, zalcitabine, 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 fluconazole, 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. This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

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. 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 immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as depression, anxiety), signs of pancreatitis (such as nausea, vomiting, stomach/abdominal/back pain, fever), easy bruising/bleeding, skin/nail color changes. 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.

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.