lamivudine 100 mg tablet

Generic name:
Lamivudine-hbv - oral

Pronunciation
(la-MIV-ue-deen)

Brand name(s)
Epivir HBV

HIV counseling and testing should be offered to all patients both before and during treatment with lamivudine-HBV. Lamivudine-HBV contains a lower dose of the drug lamivudine, which is used to treat HIV infection as well as hepatitis B. Use of lamivudine-HBV in patients with unknown or untreated HIV infection could result in new types of HIV virus that are more difficult to treat (drug-resistant).

Severe worsening of hepatitis has occurred when this medication is stopped. Liver and blood testing should continue for several months after lamivudine-HBV is stopped. Consult your doctor or pharmacist for more information.

Lamivudine-HBV is used to treat hepatitis B infection. It is not a cure for hepatitis B and does not prevent the passing of hepatitis B to others. This medication is a nucleoside reverse transcriptase inhibitor (NRTI) that works by slowing the growth of the virus, thereby decreasing liver damage caused by the virus.

Read the Patient Information Leaflet if available from your pharmacist before you start using lamivudine-HBV and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take lamivudine-HBV by mouth with or without food as directed by your doctor, usually once a day. The dosage is based on your medical condition and response to treatment.

Use this medicine regularly in order to get the most benefit from it. This medication works best when the amount of drug in your body is kept at a constant level. Remember to use it at the same time each day. Do not skip any doses.

Do not stop taking this medication without consulting your doctor. Worsening of your condition, decreased response to medication, or development of drug-resistant types of the virus may occur during or after treatment. Promptly report any new symptoms that occur during or after treatment to your doctor.

Nausea, vomiting, diarrhea, dizziness, headache, tiredness, or infections of the ear/nose/throat may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

Rarely, lamivudine-HBV has caused severe (sometimes fatal) liver problems and a buildup of lactic acid in the blood (lactic acidosis). These serious side effects may occur more often in women and obese patients. Get medical help right away if you have any very serious side effects, including:

• symptoms of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)
• symptoms of lactic acidosis (such as deep/rapid breathing, drowsiness, nausea/vomiting)

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes
• muscle/joint pain
• tingling/numbness in hands or feet

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking lamivudine-HBV, 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 lamivudine-HBV, tell your doctor or pharmacist your medical history, especially of:

• pancreatitis
• HIV infection
• kidney disease
• blood disorders
• liver disease

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Liquid preparations of lamivudine-HBV contain sugar (sucrose). If you are a diabetic using the liquid form of this drug, closer monitoring of your blood sugar is recommended as you begin using this drug. Talk with your doctor or pharmacist for more details.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially the increased risk of pancreatitis.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This medication has not been shown to prevent the passing of hepatitis B from the mother to the newborn. Consult your doctor for more information.

This medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• sorbitol

Do not take this medication with other products (including those that treat HIV infection) that contain lamivudine.

Emtricitabine is similar to lamivudine and should not be taken with this medication.

This medication may interfere with certain lab tests (such as liver function tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

To avoid spreading hepatitis B to others, always use an effective barrier method (such as latex condoms/dental dams) during sexual activity. Consult your doctor or pharmacist for more details.

Do not share this medication with others.

Lab and/or medical tests (such as liver function, blood chemistries, complete blood counts, hepatitis B virus DNA levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Different brands of this drug have different amounts of active drug. Do not switch brands of this medication without first checking with your doctor. If you have an HIV infection, you should be taking the higher-strength dosage. Consult your doctor or pharmacist for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.