This combination product contains 3 medications: abacavir, lamivudine, and zidovudine. Abacavir, lamivudine, and zidovudine belong to a class of medications known as nucleoside reverse transcriptase inhibitors. Reverse transcriptase is a part of HIV required to infect cells and make more virus. Abacavir, lamivudine, and zidovudine prevent reverse transcriptase from working properly.

The combination of these medications into a single product creates a simpler alternative to taking these medications individually.

Abacavir - lamivudine - zidovudine is used in combination to help prevent the human immunodeficiency virus (HIV) from reproducing. The HIV virus is the virus responsible for acquired immune deficiency syndrome (AIDS). HIV infection destroys CD4 (T) cells, which are important to the immune system. The immune system helps fight infections.

This medication does not cure AIDS and does not prevent it from being spread to others. It is used in combination with other anti-HIV medications to slow further growth or reproduction of HIV and seems to slow down the destruction of the immune system. This may help to delay the development of problems such as infections related to AIDS or HIV disease.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The usual recommended dose of abacavir - lamivudine - zidovudine for adults is one tablet (300 mg of abacavir, 150 mg of lamivudine, and 300 mg of zidovudine) twice daily, taken with or without food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each blue-green, capsule-shaped, film-coated tablet, imprinted with "GX LL1" on one side contains abacavir 300 mg as abacavir sulfate, lamivudine 150 mg, and zidovudine 300 mg. Nonmedicinal ingredients: hydroxypropyl methylcellulose, indigotine aluminium lake, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.

Do not take this medication if you:

• are allergic to abacavir, lamivudine, zidovudine, or any ingredients of this medication
• have a very low white blood cell count (neutropenia) or very low red blood cell count (anemia)
• have end-stage kidney disease
• have had a hypersensitivity reaction to abacavir or any medication containing abacavir
• have reduced liver function

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• diarrhea (without other symptoms)
• difficulty sleeping
• fatigue
• fever (without other symptoms)
• hair loss
• headache (without other symptoms)
• lack of energy
• loss of appetite
• muscle pain and inflammation (without other symptoms)
• nausea (without other symptoms)
• skin rash (without other symptoms)
• upper abdominal pain (without other symptoms)
• vomiting (without other symptoms)

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• increased fat on the upper back, neck, breasts, and around the trunk; and loss of fat from the legs, arms, and face
• muscle weakness and pain
• signs of infection (e.g., fever or chills, sore throat, cough)
• signs of liver problems, e.g.:
  • dark urine
  • diarrhea
  • loss of appetite
  • nausea
  • pale stools
  • vomiting
  • weight loss
  • yellowing of the skin or whites of the eyes
• symptoms of anemia (e.g., pale skin, shortness of breath, fatigue)
• symptoms of inflammation of the pancreas (e.g., nausea, vomiting, and abdominal pain)

Seek immediate medical attention if any of the following occur:

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Fat redistribution: Over time, this medication may change how fat is distributed in your body and may change your body shape. You may notice increased fat in the upper back and neck, breast, around the back, chest, and stomach area; or loss of fat from the legs, arms, and face. The long-term effects of this are not known.

Heart attack: This medication may increase your risk of heart attack. If you have heart problems, smoke, have high blood pressure or diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Hepatitis B: If you have hepatitis B, your condition may worsen or recur if you stop taking this medication. Do not stop taking this medication unless recommended by your doctor. If your doctor recommends that you stop taking this medication, your doctor will monitor you for several months after stopping treatment.

Hypersensitivity reactions: This medication can cause serious hypersensitivity reactions. If you experience any of the following sets of symptoms, stop taking this medication and contact your doctor immediately:

• fever
• headache
• nausea, vomiting, diarrhea, or abdominal pain
• rash
• severe tiredness, achiness, or generally feeling ill
• sore throat, shortness of breath, or cough

These reactions usually occur within 6 weeks of starting this medication, but may occur at any time. If you have previously had an allergic reaction to abacavir or a medication that contains abacavir, you should not take this medication.

Immune reconstitution syndrome: This medication may cause immune reconstitution syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medication and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms (such as pneumonia, herpes, or tuberculosis). Report any new symptoms to your doctor as soon as possible.

Kidney function: This medication should not be used by people with end-stage kidney disease. If you have reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Lactic acidosis and enlarged fatty liver: Lamivudine can cause a rare but serious condition called lactic acidosis (build-up of lactic acid in the blood) together with an enlarged liver. This tends to occur more often in women, especially if they are overweight. If you experience any of the following symptoms, call your doctor immediately:

• abdominal pain, swelling, or bloating
• diarrhea
• fatigue
• feeling unwell
• nausea
• shortness of breath
• vomiting
• weakness
• weight loss

Your doctor will monitor your liver function periodically by ordering laboratory tests.

Liver function: This medication should not be used by people who have reduced liver function.

Muscle weakness: This medication may cause muscle weakness. If you experience muscle weakness while taking this medication, contact your doctor immediately.

Pancreatitis: Abacavir - lamivudine - zidovudine may cause or worsen pancreatitis (inflammation of the pancreas). If you have a history of or are at risk for developing pancreatitis, you should be closely monitored by your doctor while taking this medication. If you develop signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen), contact your doctor.

Red blood cells: Pure red cell aplasia is a rare bone marrow disorder characterized by a reduction in red blood cells produced by the bone marrow. Symptoms include pallor, weakness, shortness of breath, heart palpitations, and decreased blood pressure. If you experience any of these symptoms contact your doctor immediately.

Zidovudine may also cause low levels of red blood cells without causing red cell aplasia. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Reduced white blood cells: The zidovudine in this medication can cause low levels of white blood cells. This usually happens after this medication has been taken for more than 4 to 6 weeks. Your doctor should order regular blood tests to monitor for changes in the numbers of blood cells during treatment. If you experience symptoms of an infection (e.g., fever, sore throat), contact your doctor immediately.

If you have low levels of white blood cells, your doctor may consider a different combination of medications to treat your condition.

Stopping the medication: If you stop taking this medication, your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Lamivudine and zidovudine pass into breast milk. It is not known if abacavir passes into breast milk. Women who have HIV infection are cautioned against breast-feeding because of the risk of passing HIV to a baby who does not have the infection.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: Seniors are at an increased risk of experiencing side effects of this medication. The safety and effectiveness of using this medication have not been established for people over 65 years of age.

There may be an interaction between abacavir - lamivudine - zidovudine and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.