Epivir-HBV is a nucleoside reverse transcriptase inhibitor, used to treat a chronic viral infection of the liver (hepatitis B). It works by slowing the growth of the virus. It is not a cure for hepatitis B and does not prevent the passing of hepatitis B to others.
How to use
Take this medication by mouth, usually once daily; or take as directed by your doctor. May take with or without food. Take this medication exactly as prescribed. Do not increase or decrease your dose or stop taking this medication unless directed to do so by your doctor or pharmacist. The safety and effectiveness of this medication after one year of use has not been established. The optimal duration of use of this medication is unknown. Consult your doctor or pharmacist for more information. Epivir-HBV is not appropriate for the treatment of patients, infected with both hepatitis B and HIV. An HIV test is recommended both before and during treatment to ensure you receive appropriate treatment. Consult your doctor or pharmacist for more information. Worsening of your condition, decreased response to therapy, or the occurrence of resistant strains of the virus may occur during or after treatment. Promptly report any new symptoms that occur during or after treatment to your doctor.
Drug Class and Mechanism
Lamivudine (generic name for Epivir HBV) is an analogue of cytidine. It can inhibit both types (1 and 2) of HIV reverse transcriptase and also the reverse transcriptase of hepatitis B. It needs to be phosphorylated to its triphosphate form before it is active. 3TC-triphosphate also inhibits cellular DNA polymerase.
Lamivudine is administered orally, and it is rapidly absorbed with a bio-availability of over 80%. Some research suggests that lamivudine can cross the blood-brain barrier. Lamivudine is often given in combination with zidovudine, with which it is highly synergistic. Lamivudine treatment has been shown to restore zidovudine sensitivity of previously resistant HIV. Several mutagenicity tests show that lamivudine should not show a mutagenic activity in therapeutical doses.
Missed Dose
If you miss a dose of Epivir-HBV, 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.
Storage
Store the tablets at room temperature 77 degrees F (25 degrees C) away from light and moisture. Brief storage from 59 to 86 degrees F (15 to 30 degrees C) is permitted. Store the oral solution at room temperature 68 to 77 degrees F (20 to 25 degrees C). Canadian product: Store the tablets between 36 and 86 degrees F (2 and 30 degrees C). Store the oral solution between 59 to 77 degrees F (15 to 25 degrees C). Keep all medicines away from children and pets.
Warnings/Precautions
Lactic acid build-up in the blood (lactic acidosis) and severe liver disease, including death, have been reported with the use of lamivudine, either alone or in combination with other drugs, used to treat human immunodeficiency virus (HIV) infection (e.g., zidovudine, ritonavir). HIV counseling and testing should be offered both before and during treatment to all patients, using Epivir-HBV. Lamivudine-HBV contains a lower dose of lamivudine drug, used to treat HIV infection. Use of Epivir-HBV in patients with unknown or untreated HIV infection could result in resistant strains of HIV. Consult your doctor or pharmacist for more information.
Tell your doctor your medical history especially of: infection with HIV, kidney problems, liver problems, blood disorders, pancreas problems, alcohol use, allergies (especially drug allergies). This drug may make you dizzy; use caution, engaging in activities, requiring alertness such as driving or using machinery. Avoid alcoholic beverages. Liquid preparations of lamivudine may contain sugar (sucrose); caution is advised in patients with diabetes. If you are diabetic, close monitoring of your blood sugar is recommended as you begin using this drug. Ask your doctor or pharmacist for more details. Caution is advised when using this drug in children (especially in children with pancreatitis) because they may be more sensitive to the effects of this drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This medication has not been shown to affect the transmission of hepatitis B from mother to infant. Consult your doctor for more information. Epivir HBV passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
Possible Side Effects
Nausea, vomiting, diarrhea, dizziness, or headache may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly. Tell your doctor immediately if any of these side effects occur: fatigue, sore throat, fever. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, persistent or severe stomach pain, yellowing eyes or skin, dark urine. Tell your doctor immediately if any of these highly unlikely but serious side effects occur: rapid breathing, tingling or numbness of the hands or feet. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects, not listed above, contact your doctor or pharmacist.
More Information
Do not share this medication with others. Laboratory and/or medical tests may be performed to monitor your progress. Keep all laboratory and medical appointments during and for several months after treatment.
