DrugindexOnline^{2nd edition}

Generic Name: Lamivudine 10 mg/mL Oral Solution (la-MI-vyoo-deen)
Brand Name: Epivir

High levels of lactic acid in the blood and severe, life-threatening liver problems have been reported with the use of Epivir Solution alone or with other medicines. Epivir Solution contains a higher dose of the same active ingredient (lamivudine) in Epivir-HBV. These formulations are not interchangeable. Worsening of hepatitis B virus infection has been reported in patients who also have HIV and stop taking Epivir Solution. Patients with both HIV and hepatitis B virus infection should have their liver function monitored closely for at least several months after stopping use of Epivir Solution.

Epivir Solution is used for:

Treating HIV infection in combination with other medicines.

Epivir Solution is a nucleoside analogue. It works by blocking the growth of HIV.

Do NOT use Epivir Solution if:

• you are allergic to any ingredient in Epivir Solution
• you have an enlarged liver, abnormal liver function tests, or high levels of lactic acid in the blood (lactic acidosis)
• you are taking zalcitabine or other medicines containing lamivudine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Epivir Solution:

Some medical conditions may interact with Epivir Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of muscle problems, pancreas problems, abnormal blood cell counts, liver disease (eg, hepatitis) or other liver problems (eg, abnormal liver function tests), lactic acidosis, kidney problems, diabetes, or a nerve disorder
• if you are very overweight

Some MEDICINES MAY INTERACT with Epivir Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Trimethoprim/sulfamethoxazole because it may increase the risk of Epivir Solution's side effects
• Zalcitabine because it may decrease Epivir Solution's effectiveness
• Interferon alfa or ribavirin because severe liver problems may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Epivir Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Epivir Solution:

Use Epivir Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Epivir Solution by mouth with or without food.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Continue to take Epivir Solution even if you feel well. Do not miss any doses.
• Taking Epivir Solution at the same time each day will help you remember to take it.
• If you miss a dose of Epivir Solution, take it as soon as possible. If it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Epivir Solution.

Important safety information:

• Epivir Solution may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Epivir Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Epivir Solution, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
• Epivir Solution is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
• Epivir Solution does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
• Cases of worsening liver disease have been reported when Epivir Solution is stopped in patients with both HIV and hepatitis B virus infection. Discuss any medicine changes with your doctor.
• If you have hepatitis B virus infection, your doctor will perform lab tests for several months after you stop taking Epivir Solution. Some patients have had worsening hepatitis B virus after stopping use of Epivir Solution. Tell your doctor about any new or unusual symptoms that you notice after stopping treatment.
• Diabetes patients - Epivir Solution contains sucrose and may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Epivir Solution. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
• Lab tests, including liver and kidney function tests, may be performed while you use Epivir Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Epivir Solution with caution in CHILDREN younger than 3 months old, children who have taken other HIV medicines, or children who have a history of pancreas problems; they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Epivir Solution while you are pregnant. Epivir Solution is found in breast milk. Do not breast-feed while taking Epivir Solution. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Epivir Solution to the baby.

Possible side effects of Epivir Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Changes in body fat; chills; cough; diarrhea; dizziness; general body discomfort; headache; indigestion; loss of appetite; muscle or joint pain; nausea; runny/stuffy nose; sleeplessness; stomach cramps.

Children: Abnormal breathing sounds/wheezing; cough; diarrhea; ear problems; fever; mouth inflammation; nasal discharge; nausea; stuffy nose; swollen lymph nodes; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; depression (mental or mood changes); enlarged stomach; increased heart rate; numbness, tingling, or weakening of the arms or legs; persistent sore throat, chills, or fever; severe muscle or joint pain; severe or persistent nausea; stomach tenderness or pain; unusual bleeding or bruising; unusual weakness or exhaustion; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Epivir Solution:

Store Epivir Solution at 77 degrees F (25 degrees C). Store in a tightly closed bottle away from heat, moisture, and light. Do not store in the bathroom. Keep Epivir Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Epivir Solution, please talk with your doctor, pharmacist, or other health care provider.
• Epivir Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Epivir Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.