Epivir-HBV Solution

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Epivir-HBV Solution


Generic Name: Lamivudine 5 mg/mL Oral Solution (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 currently taking zalcitabine or other products 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 side effects and actions may be increased by Epivir-HBV Solution
  • Zalcitabine because the action of Epivir-HBV Solution and lamivudine will be decreased

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.

  • Epivir-HBV Solution may be taken with or without food.
  • Use a measuring device marked for medicine dosing. Ask your pharmacist if you are unsure of how to measure your dose.
  • Continue to take Epivir-HBV Solution even if you feel well.
  • If it important not to miss any doses of Epivir-HBV Solution. Taking Epivir-HBV Solution at the same times each day will help you to remember.
  • Epivir-HBV Solution comes with an additional patient leaflet. Read it carefully and reread it each time you get Epivir-HBV Solution refilled.
  • 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. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Epivir-HBV Solution. Using Epivir-HBV Solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
  • 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.
  • Diabetes patients - Epivir-HBV Solution contains sucrose and may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
  • LAB TESTS, including liver and kidney function tests, may be required to monitor your progress. 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 is not recommended for use in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Epivir-HBV Solution during pregnancy. Epivir-HBV Solution is excreted 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:

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.

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

Severe allergic reactions (rash; hives; 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 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-HBV Solution:

Store in a tightly closed bottle at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). 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.

General information:

  • 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.

This information is a summary only. It does not contain all information about Epivir-HBV 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.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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