Trizivir

DRUG DESCRIPTION

TRIZIVIR: TRIZIVIR Tablets contain the following 3 synthetic nucleoside analogues: abacavir sulfate (ZIAGEN), lamivudine (also known as EPIVIR or 3TC), and zidovudine (also known as RETROVIR, azidothymidine, or ZDV) with inhibitory activity against HIV-1. TRIZIVIR Tablets are for oral administration. Each film-coated tablet contains the active ingredients 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine, and the inactive ingredients magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film (OPADRY® green 03B11434) that is made of FD&C Blue No. 2, hypromellose, polyethylene glycol, titanium dioxide, and yellow iron oxide.

Abacavir Sulfate: The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2•H2SO4 and a molecular weight of 670.76 daltons. It has the following structural formula:

Abacavir Sulfate Structural Formula Illustration

Abacavir sulfate is a white to off-white solid with a solubility of approximately 77 mg/mL in distilled water at 25°C.

In vivo, abacavir sulfate dissociates to its free base, abacavir. In this insert, all dosages for ZIAGEN (abacavir sulfate) are expressed in terms of abacavir.

Lamivudine: The chemical name of lamivudine is (2R,cis)-4-amino-1-(2hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-) enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2',3'-dideoxy, 3'thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 daltons. It has the following structural formula:

Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20°C.

Zidovudine: The chemical name of zidovudine is 3'-azido-3'-deoxythymidine. It has a molecular formula of C10H13N5O4 and a molecular weight of 267.24 daltons. It has the following structural formula:

Zidovudine is a white to beige, crystalline solid with a solubility of 20.1 mg/mL in water at 25°C.

What are the possible side effects of abacavir, lamivudine, and zidovudine (Trizivir) (Trizivir)?

Stop using this medication and call your doctor at once if you have any of these signs of an allergic reaction to abacavir:

  • Group 1 - fever;
  • Group 2 - rash;
  • Group 3 - nausea, vomiting, diarrhea, stomach pain;
  • Group 4 - general tiredness, body aches;
  • Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to abacavir, you must never use it again. If you stop taking Trizivir for any reason, talk to your...

Read All Potential Side Effects and See Pictures of Trizivir »

What are the precautions when taking abacavir sulfate, lamivudine, and zidovudine (Trizivir)?

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...

Read All Potential Precautions of Trizivir »


Trizivir Consumer (continued)

SIDE EFFECTS: 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as depression, anxiety), numbness/tingling of hands/feet, 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.

PRECAUTIONS: 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.


Trizivir Patient Information Including Side Effects

Brand Names: Trizivir

Generic Name: abacavir, lamivudine, and zidovudine (Pronunciation: a BACK a veer, la MIV yoo deen, zye DOE vyoo deen)

  • What is abacavir, lamivudine, and zidovudine (Trizivir) (Trizivir)?
  • What are the possible side effects of abacavir, lamivudine, and zidovudine (Trizivir) (Trizivir)?
  • What is the most important information I should know about abacavir, lamivudine, and zidovudine (Trizivir) (Trizivir)?
  • What should I discuss with my healthcare provider before taking abacavir, lamivudine, and zidovudine (Trizivir) (Trizivir)?
  • How should I take abacavir, lamivudine, and zidovudine (Trizivir) (Trizivir)?
  • What happens if I miss a dose (Trizivir)?
  • What happens if I overdose (Trizivir)?
  • What should I avoid while taking abacavir, lamivudine, and zidovudine (Trizivir) (Trizivir)?
  • What other drugs will affect abacavir, lamivudine, and zidovudine (Trizivir) (Trizivir)?
  • Where can I get more information?

What is abacavir, lamivudine, and zidovudine (Trizivir) (Trizivir)?

Abacavir, lamivudine, and zidovudine (Trizivir) is an antiviral medication. It is in a group of human immunodeficiency virus (HIV) medicines called reverse transcriptase inhibitors. This medication helps keep the HIV virus from reproducing in the body.

This medication is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). This medication is not a cure for HIV or AIDS.

This medication may also be used for other purposes not listed in this medication guide. This medication should not be given to people who weigh less than 90 pounds.

What are the possible side effects of abacavir, lamivudine, and zidovudine (Trizivir) (Trizivir)?

Stop using this medication and call your doctor at once if you have any of these signs of an allergic reaction to abacavir:

  • Group 1 - fever;
  • Group 2 - rash;
  • Group 3 - nausea, vomiting, diarrhea, stomach pain;
  • Group 4 - general tiredness, body aches;
  • Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to abacavir, you must never use it again. If you stop taking Trizivir for any reason, talk to your doctor before you start taking the medication again.

You may have other serious side effects that may not be signs of an allergic reaction. Continue using this medicine and call your doctor if you have any of these side effects:

  • liver problems -- stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired;
  • fever, chills, body aches, flu symptoms, pale skin; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk);
  • sleep problems or strange dreams;
  • headache, depression, anxiety; or
  • mild diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about abacavir, lamivudine, and zidovudine (Trizivir) (Trizivir)?

Stop using this medication and call your doctor at once if you have any of these signs of an allergic reaction: fever; rash; nausea, vomiting, diarrhea, stomach pain; general tiredness, body aches; shortness of breath, cough, sore throat.

Once you have had an allergic reaction to this medication, you must never use it again.

Do not allow this medicine to run out completely before you get your prescription refilled. If you miss several doses, you could have a dangerous or even fatal allergic reaction when you start taking the medicine again. If you stop taking this medication for any reason, talk to your doctor before you start taking the medication again.

Some people have developed a life-threatening condition called lactic acidosis while taking this medicine. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

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