Epivir

DRUG DESCRIPTION

EPIVIR (also known as 3TC) is a brand name for lamivudine, a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4- amino-l-(2-hydroxymethyl-l,3-oxathiolan-5-yl)-(lH)-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. It has the following structural formula:

EPIVIR (lamivudine) structural formula illustration

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

EPIVIR (lamivudine) Tablets are for oral administration. Each scoredl50-mg film-coated tablet contains 150 mg of lamivudine and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.

Each 300-mg film-coated tablet contains 300 mg of lamivudine and the inactive ingredients black iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.

EPIVIR (lamivudine) Oral Solution is for oral administration. One, milliliter (1 mL) of EPIVIR Oral Solution contains 10 mg of lamivudine (10 mg/mL) in an aqueous solution and the inactive ingredients artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg).

What are the possible side effects of lamivudine (Epivir, Epivir HBV)?

Stop using lamivudine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these other serious side effects:

  • liver damage - nausea, stomach pain, low fever, loss of 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,...

Read All Potential Side Effects and See Pictures of Epivir

What are the precautions when taking lamivudine (Epivir)?

Before taking lamivudine, tell your doctor or pharmacist if you are allergic to it; 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: pancreatitis, kidney problems, liver problems (such as hepatitis B or C, cirrhosis), alcohol use.

Avoid alcoholic beverages because they may increase your risk for liver problems and/or pancreatitis.

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. Avoid alcoholic beverages.

Before having...

Read All Potential Precautions of Epivir


Epivir Consumer (continued)

SIDE EFFECTS: See also Warning section.

Headache, dizziness, nausea, diarrhea, or trouble sleeping may occur. If any of these effects persist or worsen, notify 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), tingling/numbness of hands or feet, muscle weakness, stomach/back pain with nausea (pancreatitis).

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, signs of anemia (unusual tiredness, rapid heartbeat, pale/bluish skin).

Changes in body fat (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs) may occur while you are taking HIV medication. The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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 the 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 lamivudine, tell your doctor or pharmacist if you are allergic to it; 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: pancreatitis, kidney problems, liver problems (such as hepatitis B or C, cirrhosis), alcohol use.

Avoid alcoholic beverages because they may increase your risk for liver problems and/or pancreatitis.

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. Avoid alcoholic beverages.

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.

Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially the increased risk of pancreatitis.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, caution is advised when using this drug in older adults because they may be more sensitive to the effects of the drug.

During pregnancy, this medication should be used only when clearly needed. However, it is now normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. Lamivudine may be part of that treatment. Discuss the risks and benefits with your doctor.

Lamivudine passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.


Epivir Patient Information Including Side Effects

Brand Names: Epivir, Epivir HBV

Generic Name: lamivudine (Pronunciation: la MIV yoo deen)

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

What is lamivudine (Epivir)?

Lamivudine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

The Epivir brand of lamivudine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Lamivudine is not a cure for HIV or AIDS. The Epivir-HBV brand of lamivudine is used to treat chronic hepatitis B. Epivir-HBV should not be used in people who are infected with both hepatitis B and HIV.

Lamivudine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of lamivudine (Epivir)?

Stop using lamivudine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these other serious side effects:

  • liver damage - nausea, stomach pain, low fever, loss of 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, nausea with vomiting, and fast or uneven heart rate;
  • pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • peripheral neuropathy - numbness, tingling, or pain in your hands or feet;
  • easy bruising or bleeding, unusual weakness, pale skin;
  • white patches or sores inside your mouth or on your lips;
  • fever, chills, body aches, flu symptoms; or
  • any other signs of new infection.

Less serious side effects may include:

  • cough;
  • sleep problems (insomnia), strange dreams;
  • nausea, vomiting, diarrhea;
  • joint or muscle pain;
  • dizziness, headache, tired feeling; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about lamivudine (Epivir)?

Lamivudine should not be taken together with Combivir, a medication that contains a combination of lamivudine and zidovudine.

Lamivudine may cause lactic acidosis (the build up of lactic acid in the body). Symptoms can start slowly and gradually get worse: unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Call your doctor at once if you have any of these symptoms, even if they are only mild.

Lamivudine can also cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms while taking lamivudine: severe pain in your upper stomach spreading to your back, fast heart rate, nausea and vomiting, diarrhea, loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Before taking lamivudine, tell your doctor if you have kidney disease, liver disease, a history of pancreatitis, or if you have used a medicine similar to lamivudine in the past, such as abacavir (Ziagen), didanosine (Videx), stavudine (Zerit), tenofovir (Viread), zalcitabine (Hivid), or zidovudine (Retrovir).

If you have hepatitis B you may develop liver symptoms after you stop taking lamivudine, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits.

Epivir tablets and liquid contain a higher dose of lamivudine than Epivir-HBV. Epivir is for treating HIV and Epivir-HBV is for treating hepatitis B. Each time you get a refill of this medication, be sure you have received the correct brand to treat your condition.

Related Drug Centers
  • Epivir


Related Drugs Index: