Generic Name: lamivudine (la-MIH-vyoo-deen)
Brand Name: Epivir-HBV
High levels of lactic acid in the blood and severe, life-threatening liver problems have been reported with the use of Epivir-HBV solution alone or with other medicines. HIV counseling and testing should be offered to all patients before treatment for hepatitis B virus is started with Epivir-HBV solution and periodically during treatment. Epivir-HBV solution has a lower dose of the same active ingredient (lamivudine) than in Epivir, a medicine used to treat HIV infection. These formulations are not interchangeable. If Epivir-HBV solution is prescribed for a patient with hepatitis B virus and undiagnosed or untreated HIV infection, the HIV infection will be less treatable with Epivir-HBV solution and other medicines. Worsening of hepatitis B virus infection has been reported in patients who stop taking Epivir-HBV solution. Patients should have their liver function monitored closely for at least several months after stopping use of Epivir-HBV solution.
Epivir-HBV solution is used for:
Treating certain types of chronic hepatitis B virus infection.
Epivir-HBV solution is a nucleoside analogue. It works by reducing the amount of hepatitis B virus in the body by blocking the ability of the virus to multiply and infect new liver cells.
Do NOT use Epivir-HBV solution if:
- you are allergic to any ingredient in Epivir-HBV solution
- you have HIV infection, abnormal liver function tests, severe liver problems, or lactic acidosis
- you are taking zalcitabine or another product containing lamivudine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Epivir-HBV solution:
Some medical conditions may interact with Epivir-HBV 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 muscle problems, swelling of the pancreas, abnormal blood counts, liver or kidney problems, diabetes, or a nerve disorder
Some MEDICINES MAY INTERACT with Epivir-HBV 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-HBV solution's side effects
- Zalcitabine because it may decrease Epivir-HBV solution's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Epivir-HBV 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-HBV solution:
Use Epivir-HBV solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Epivir-HBV solution. Talk to your pharmacist if you have questions about this information.
- Take Epivir-HBV 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-HBV solution even if you feel well. Do not miss any doses.
- It is important not to miss any doses of Epivir-HBV solution. Taking Epivir-HBV solution at the same time each day will help you remember to take it.
- If you miss a dose of Epivir-HBV 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-HBV solution.
Important safety information:
- Epivir-HBV solution may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Epivir-HBV solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Your doctor will offer you counseling and testing for HIV infection (the virus that causes AIDS) before treatment with Epivir-HBV solution and periodically during treatment. You should not take Epivir-HBV solution if you have HIV infection. If you have both hepatitis B virus and HIV, make sure that your doctor knows you have both infections. If you are prescribed lamivudine, you should only use the medicine that is for HIV treatment ( Epivir). The lower dose of lamivudine in Epivir-HBV solution could make the HIV infection harder to treat.
- Epivir-HBV solution is not a cure for hepatitis B virus infection. It is unknown if Epivir-HBV solution reduces the risk of liver cancer or cirrhosis that may be caused by hepatitis B virus. Some patients developed hepatitis B virus that is resistant to Epivir-HBV solution. These patients had less benefit from Epivir-HBV solution and some experienced worsening of hepatitis after the resistant virus appeared.
- Your doctor will perform lab tests for several months after you stop taking Epivir-HBV solution. Some patients have had worsening hepatitis B virus after stopping use of Epivir-HBV solution. Tell your doctor about any new or unusual symptoms that you notice after stopping treatment.
- Epivir-HBV solution has not been shown to reduce the risk of passing hepatitis B to other people through sexual contact or blood contamination. Use barrier forms of contraception (eg, condoms) if you are infected with hepatitis B virus. Do not share needles, injection supplies, or items like toothbrushes or razors.
- Diabetes patients - Epivir-HBV 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.
- Lab tests, including liver and kidney function tests, may be performed while you use Epivir-HBV solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Caution is advised when using Epivir-HBV solution in CHILDREN with a history of swelling of the pancreas. Epivir-HBV solution should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Epivir-HBV solution while you are pregnant. Epivir-HBV solution is found in breast milk. Do not breast-feed while taking Epivir-HBV solution.
Possible side effects of Epivir-HBV 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Changes in body fat; chills; coughing; decreased appetite; diarrhea; difficulty sleeping; dizziness; ear, nose, and throat infection; general body discomfort; headache; indigestion; joint pain; muscle pain; nausea; sinus drainage; sore throat; stomach discomfort; tiredness.
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 or tingling in the arms or legs; persistent sore throat, chills, or fever; severe muscle or joint pain; 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 about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Epivir-HBV solution:
Store at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in a tightly closed bottle. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Epivir-HBV solution out of the reach of children and away from pets.
- If you have any questions about Epivir-HBV solution, please talk with your doctor, pharmacist, or other health care provider.
- Epivir-HBV 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Epivir-HBV solution or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Epivir-HBV solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Epivir-HBV solution. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Epivir-HBV solution.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.