Epzicom

DRUG DESCRIPTION

EPZICOM

EPZICOM Tablets contain the following 2 synthetic nucleoside analogues: abacavir sulfate (ZIAGEN, also a component of TRIZIVIR) and lamivudine (also known as EPIVIR or 3TC) with inhibitory activity against HIV-1.

EPZICOM Tablets are for oral administration. Each orange, film-coated tablet contains the active ingredients 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine, and the inactive ingredients magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film (OPADRY® orange YS-1-13065-A) that is made of FD&C Yellow No. 6, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide.

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. All dosages for 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.

What are the possible side effects of abacavir and lamivudine (Epzicom)?

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 abacavir and lamivudine for any reason, talk to your doctor...

Read All Potential Side Effects and See Pictures of Epzicom »

What are the precautions when taking abacavir sulfate and lamivudine tablets (Epzicom)?

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...

Read All Potential Precautions of Epzicom »


Epzicom Consumer (continued)

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.

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, easy bruising/bleeding, signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat), 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).

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 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.


Epzicom Patient Information Including Side Effects

Brand Names: Epzicom

Generic Name: abacavir and lamivudine (Pronunciation: a BAK a veer and la MIV yoo deen)

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

What is abacavir and lamivudine (Epzicom)?

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

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

Abacavir and lamivudine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of abacavir and lamivudine (Epzicom)?

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 abacavir and lamivudine for any reason, talk to your doctor before you start taking the medication again.

Other serious side effects that may not be signs of an allergic reaction include:

  • 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; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects 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 and lamivudine (Epzicom)?

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 abacavir and lamivudine, you must never use it again.

Before taking abacavir and lamivudine, tell your doctor if you have kidney disease, heart disease, high blood pressure, or a risk factor for heart disease such as smoking, diabetes, or high cholesterol.

You may need a blood test before you start taking abacavir and lamivudine for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction.

Read the Warning Card that comes with this medication, and carry it with you at all times so you will know the symptoms of allergic reaction to watch for.

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.

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 abacavir and lamivudine for any reason, talk to your doctor before you start taking the medication again.

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